AUG. 29. 2011 5:18PM NO 8742 P. 1 rm j no é DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service “mel Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20983 SAMSUNG Medison Co., Lid. SoM. Matk Job Responsible Third Party Oficial Regulatory Technology Services LLC 1394 25" Street NW 29 2M BUFFALO MN 55313 hue 2S Re: K112339 ‘Trade/Device Name: ACCUVIX A30 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class! 11 Product Code: IYN, IYO, and ITX Dated: August 12, 2011 Received: August 15, 2011 Dear Mr. Job: ‘We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. This determination of substantial equivalence applies to the following transducers intended for use with the ACCUVIX A30 Diagnostic Ultrasound System, as described in your premarket notification: ‘Transducer Model NumberAUG 29. 2011 5:19PM WO8742 PD If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895, In addition, FDA my publish farther announcements concerning your device in the Federal Register. Please bo advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies, You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic. product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as deseribed in your premarket, notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device resulis in a classification for your device and thus permits your device to proceed to market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 0 to http://www fda pov/AboutFD A/CentersO flices/CDRH/CDRHOffices/uem115809,him for the Center for Devices and Radiological Health's (CDRH?s) Office of Compliance, Also, please note the regulation entitled, "Misbranding by reference to premarket notification” (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to [Haran fda. cov/MedicalDevices/Safety/ReportaProblem/default htm for the CDRH's Office of Surveillance and Biometries/Division of Postmarket Surveillance. Ifyou have any questions regarding the content of this letter, please contact Lauren Hefner at (301) 796-6881. Sincerely Yours, , Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure(s)AUG 29. 2011 5:19PM WO8742 PF 510(k) Premarker NociGcation ACCUVIX A30 Diegnostic Ultrasound System a eS & y. SECTION 1.3 *. Sa INDICATIONS FOR USE 3 510(k) Number (if known): Device Name: ACCUVIX A30 Diagnostic Ultrasound System Indications for Use: ‘The ACCUVIX A30 Diagnostic Uliresound System and transducers are intended for diagnostic ultrasound imaging and uid analysis of the human body. The clinical applications include: Fetal, Abdominal, Pediatric, Smell Organ, Neonatal Cepbalic, Adult Cephalic, ‘Trans-tectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel } Prescription Uso __Y ANIOR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CER 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) y 4 LOO) S9FOF Diisionel Racor Deis ff ota vie Oscreste Dace Evakason and Safety Indications for Use Section 1.3, page ! won AUZS3P____AUG 29. 2011 5:19PM WO8742 P44 510(e) Premarket Notification ACCUVIX 430 Diagnostic Ultrasound System DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(&) No, Device Name: ACCUVIX 430 Diagnostic Ultrasound System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ciinieal Anplcatio Made of Operon (cies snmhaneps ode) Casal Soeeihe BPM PFA] CWD | Coker | Combine” Ober Cracktontyy Gasig emp Doppler | (Spec) Sp) ‘Opisieimie —]) Opemalnc Foal eesoesy TIN © Ras Overy Abionaal NTNT NTN Ww Noss oie, 7.0 Titeopentive Dee Roe Taiopeauve (Nea) Fetal imaging | Taparescoie | & Ot [Rota wy LS w Baar Roa A TED ‘Saal gan (ee Nove ws Ww Now| Noe? 567.8910 errata! Cephalic pew Ww Now Note27 a Cepnaio SNS IW w Rael Wasa? Tansecal w[N] © w Note Wae2, 7,1 Torrepal NINDS © Nat Wore2, 7.8, 1 Tansaretiel Trees woph, (oon Cetin) iasaloakal (Convent) NIN ® w Weel ERR Meselestal, Suporte) NTN] © Reet Note? 5.6.7.8 ae al inet) CuaarAan TINT STW ny Raw! Tee Canine | Caria Pedic N[NpN |X © Soe Noe d7 “Tae sopageal (Care) ibe pee Feaphea!— | Pedpherl ves! wINp se © Newt Nene TED, vesst [Orie 'N= now indication P- previously elosrod by FDA; E= e0ded ander Appandin E ‘Additional Comments: ‘Color Dopoker includes Fower ampli) Doppler [Noi 1: BFM, BHPW, BIC, B-PD, B+CW, BYC#PW, B+PD*PW, B-C+M, DuclB, Dual BYC, Dual BYP Note? roles imaging fr guidance of toms} Nove: cides invry montorig of oie development Notes: Color Mode Nove 5: For example: tyro, patho, bras, scrotum and penis net, pin and neal pens ‘Nate6: Abdominal organs and pepe vse ‘ate’: Tssue Hannon imaging (TH) ‘Note: 30 imaging ‘ote 9: Panoramic imagiog Novel0: Blstcan Concurrence of CDRH, Office of In Vitro Dingnosie Devices (IVD) Prescription Use (Per 21 CFR 801.109) mr DreeerolRadiogen Doves ‘fee etn vara Dagnoste Dace ualon ana tty Aue TI acest II Indications for UseAUG. 29. 2011 5:20°M WO8742 PG 510(R) Premarket Notification ACCUVIX A30 Diagnostic Urasound System DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT : C1.A for use with ACCUVIX A30 Intended Use: Diagnostic ultrasound i or fluid flow analysis of the human body as follows: Clinial Appication Moco of Operon (aehdes Senaleneoss Bede) Gamal Spesiie ET MTPID] CHD | Cour | Combines ‘Oar inst only) Cac & tt) Depots | Spee) ox) "Opals J Opie Teal scene) www n Neer Neen “Abcam WENT ® N Nate Rois 2.7.8 Tnrasaprtie er Now | Tope Waray) Feal knasing [Caparo & Ove [Fede RT® AN i Roel Wish RE Sul Onan See ate Nese Cophalc ‘Ada Coale Tans "Tans gia asad Fanconi ao Cade) Vissaloskel (Convent) Maelo aat Supea) Tama oo) Cries Aa Corie | Cantae Pointe ies cpingsl (Cals) One pe) Tarte | Perper vest Vest [Oar pe) TE new indicaon; P= previously cleared by FD) Additional Comments; Coles Doppler teuses Power (ampliote) Doppler ‘Noi 1: BP0t, BPW, B*C, BPD, BrCW, BrCTPW, BoPDFW, BYCeM, Dal B, Dial BeC, Dual BPD ‘Nove 2 cludes naping fr gisanoe of biopsy Now 3: tues inetlty nontorng of lice dxelopmst ote §: Color Made [Note §: For example thyroid, parathyroid, beast, ermum and pens in ad, pata and onal patients ‘Note 6: Abdominal organs end peripheral vessel ‘Note 7 Tsu Haron imegng (TH) ded under Appendix E ‘Note &: 30 imaging ‘Note 9: Panoractic imaging Ssh omees emcee of CORI, Ofer fe Vno Drone Doves (VD) Farhi de ee WANA Ail All ‘Division Sign-On} Pa yet asthe ns Secon 15,9063 ‘fee of nies Cagnostc Des Even and Stely 0k.AUG. 29. 2011 5:20°M WO8742 PG 310(k) Premerket Notification ACCUVIX A30 Diagnostic Ultrasound Sysrern DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No Device Name: C2-6IC for use with ACCUVIX A30 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the hmman body as follows: Clncalappiaton Mode of Opeation (ede Tinalanaas Bi] Cee Specie BY] M PAW] cw) comr ) Combinesm Oa rac Lot (reeks 1 W) (Spee) (Spee) Coitsinis _] Omani Fea Seehee) “abril Tn-apentve (2 Nae Tnin-apeative Neuro) Tapaoiconie Fete Sail Grp See Nowe 3) Teooatl Coma Rn CaPale Tanseeal Tensei Taararaial Tens soph (oor CaeT Mss dal (Ceavent) rae Supe) bal ier ee Chaos A Cas Polis Tearsopnagel (Cae) Oe pe Perper | Peapheral vel a oc ‘Ne new indication; P= previously cleared by FDA K105597; E= added under Appendix E Additional Comments: Color Dogar sides Power (Armpit) Dopplr ‘Noe 1: Br, BYPW, B+C, B-PD, B+CW, BHC*PW, B+PDEPW, BHCHM, Dal B, Dua! BEC. Dual BPD Note: lckes imaging fe guise of iney Nee 3 eco tity oorng of le develope Noted: Color Made Nate For exirape tyrti, prathroi,bea, ona an penn dt oti a necnaa pts ‘Note: Abdominal organs and pipers eee] [Note 7 Taso Harmonie imaging (TH) Note §:3D imaging ‘Note: Panorama imaging ‘Notes ElastoSoan Concurrence af CDRH, Office of in Vitro Diegnostis Devices (OIVD) reseeiption Use (Per 21 CFR. £01,109) L if Z wed TU Onion of Radiata Devine Indications for Use (fice on vio Bagreate Dace Evaluation a Satty Section 13, page 4AUG. 29. 2011 5:20°M WO8742 PF 510(e) Premarket Notification ACCUVIX A30 Diagnostic Ultrasound System DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(6) No. Device Name: C5-8 for use with ACCUVIX A30 Intended Use: Diagnostic ultrasound or fluid flow analysis of the human body a3 follows! Ciel Appresoon (Ccldes squtanenus BeBe) pat Color | Combined aie (Tasks (8 1) Dopo | 5p Foal Gee Noe 3) Now, 8 ‘Rbdosnal Notes 2,768 Tse apersve (= ae) Tauzropeative (News) Foal ging | Tapaoscopie & Otber [Pennie Sasi] Org See NOS) evasil Capac Hak Cabale Tarra Taser Traut Tans sph (aor Coir] Tiessle sal (Come) Maxsioaeel Supetie) ‘Additional Comment Note 2: Inhuman for guidance of bigs [Note lnhides infertility mooring of fail development Note 4: Color M-mode [Not 5 Far scample: hoi, payed brea, erctum and pes in adh, pears and neopets ‘Note 6: Abdominal organs snd pesghee vessel [Note 7 Tinue Harorss Imaging (THI) ote &: 3D imaging [Nave9: Panerai aging ‘NotetO:ElastaSean Concurrence of CDRH, Office of In Vitro Disgnostic Devices (O1VD) Prescription Use (Per21 CFR 01.109) Er Indications for Use * fea tin pM alge Devene Section 1.3, page 5AUG. 29. 2011 5:20°M WO8742 PB 510(k) Premarker Notification ACCUVIX A30 Disgnosie Ultrsound System DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT. 510(k) No.: Device Name: EC4-9IS for use with ACCUVIX A30 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ciel Appenton TMde of Opetuon asi SeMuNaDoOUS BOG) ‘Gment “Speci BTM TRI] CwD ] Cour | Combine ier Gaskin) cracks 1g up art | (Spee, 5 ‘Ophetaimie J Opie Teal See Now 3) ‘Absioneal Tepe ee Nate) Tnrapertve (Nes) Taparseopie Pate Shall Ong Bee Nowa ‘Resa Cepaalie "Adult Cephalic Tassel Tanssaginal "Fr liad ‘Tras sph aoe Caraic) Missal sel (Convent) asi ake (Soper) Te oie One (ED) Cade Afar Coes Pedals Tran esophageal (Cai) ie pn) ‘Penptend | Penpheral vest Veset __[Otner(aperd ‘Ns ew indioation; P= previously clea by FDA KOSDIS9, E> added under Appendix E Additional Comments: ‘Color Dopole ialudes Power (Amine) Dopaler Note I: B*M, BePW. BYC. B+PD, BCW, BYC+PW, B+FD¥PW, BYCoM, Dual B, Dual B¢C, Dual B¥?D_ Note 2: Includes insging for guidance of biopsy Note}: lcluds iafelty atoning of elicle development Noted: Color Memes Note 5: Far exazple tyro, parathyroid, eas, rom and pes nat, pci and meatal pens [Note 6: Abdominal organs and peripheral vessel Note. Teas Harmonie inaing (TH) Note 20 imaging Note 8: Penoramie maging Notl0: ElastoSoar CConcunence of CDRH, Office of in Vitro Diagnostic Devies(O1VD) Proserpin Use (Per 21 CPR 301109) € Gude Dh Dion cfRasctogcal Ov ‘fea ot Vso Doghowte Dees Ethaton ar Saley sm QLIQGBF Indieations for Use Section 13. page 6AUG. 29. 2011 5:21PM WO8742 PO 50k) Premarket Notification ACCUVIX A30 Diagnostic Ulrasound System DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510K) No.: Device Name: L4-7 for use with ACCUVIX A30 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of thc human body as follows: Mode of Operation ("ncinessulaneous Bamods) Combined” Raen5.6 7) Woe? 56,79 asus skal (Convene) : ER Wiaselokel (Supee) Noe2. 5.67.9 Tea al Nae S678 Ne view indication, P= previously eeared by PDA; E= auded under Appendix E Additional Comments: Color Dopolerinciuis Power (Amptinae) Doreler ‘Note 1: BPM, BPW, BFC, R+PD, B+CW, BACHPW, BEPDAPW, ReCoM, Dual A, Dual BNC, Dual BSPD Note2: cludes imaging for auiance nf bogey [Note 3: Inluesinfetlty monitoring of olicledevelopeent ‘Note 4 Color meds [Note 5 For example: hyo, paryrid, reas, evtum and pea i dul pais an! neonatal yin [Nowe Abdomin! organs ond periph veel (Note? Tigo Harmonie bnaging (THD [Nove @: 3D inagiag” (Note 9, Pancras inging [Note Ebstesean ‘Concurrence of CDRH, Office of in Vitro Diagnostic Devices (OIVD) Prescription Use (Per 2 CFR 801.109) ist an Disson of acetyl bavees Indications for Use ea oto vrs Cognste Detee Eilon ac Safety Section 13. pageAUG. 29. 2011 5:21PM WO8742 P10 510(k) Premarket Notification ACCUVIX A30 Diagnostic Utasbund System DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(K) No.: Device Name: L5-131S for use with ACCUVIX A30 Intended Use: Diagnostic ultrasound imaging or fluid fow analysis of the human body a3 follows. ‘De ope Se Woe Tapers (Neuro) Taparoeopi| Posie Nowe 679 ‘Seal Organ Gea Rave) Roe2, 5.6, 7.9,10 ‘eval Cepbale Teas soph oe CHR) asst (Cameat) ase ater Supete) Pepe Neer S75 ibe Gree) 'N="new indication; P= previously cleateu by FDA K103307; E~ added under Append E Additional Comment (Coe Doppler nchides Power (Arplinde) Doppler ‘Note: BPM, BEPW, BsC, B+PD, BACH, B+C*PW. BEPD#PW, BYC#M, Dual B, De B+C, Dual BPO ‘Note 2:lclues imaging for guides of bionsy Note 3: Includes inferity monitoring of falcle development Nowe 4: Color M-mode Note 5: For example thro, carahyroi, rest scram and pes i ada, pani and neonatal pains Note 6: Abdominal organs ard peripheral ves! Noe 7: Tissue Harmonie fnaging (TH ‘Coneurrence of CDRH, Office of In Vitro Diagnostic Devices (OTVD) Prescription Ue (Per 21 CFR 01,108) dh LO Bean sano Drison Indcation for Use ee ott Days Bee ee Section 13, pae 8 IS tay ow A239AUG. 29. 2011 5:21PM WO8742 P11 510(k) Premarket Notifcstion ACCUVIX A3O Diagnostic Ulrasound System DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510K) No. Device Name: L7-16IS for use with ACCUVIX A30 Jnended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Cina) Appleton Meds of opeaton isidey cemuanenus Bove) Genet ‘Specie WARD] CWO [Color] Combinsar Oiier ceil] linet pee) el ill gs | ELF 7 TowT Newz ATO P[?[? P Nort Woe? 56.7.9 Nessa optic ‘Adult Cenc PrP? P Nasr Reet TD FF Le ? Noel Reed 56.7.9 Cade Ped “Tare sophagea (Caz) Gitar ree Penpoeal | Perper vase? Fle]? = Neel Tez oS Yess —_[Otheriapee ‘N= new indicanon, P= previously cleared by FDA KOG2IS9, E> edved under Appendix E ‘Additfonel Comment (Color Depoler ices Power(Azplitade) Depler ‘Nowe: BYM, BYPW, BYC, BePD, BeCW, B*C=PW, BEPD*PW, BEC#M, Dual B, Dual B=C, Dual B+PD Note 2: includes ining for uidance of tipsy Note 3: lclues infil motoring af folicle development Naw 4: Color Mende Nav 5: Fr example: thyroid, prathyri, bras ert and pens in al. pai ad neonatal tients [Noe 6: Abcomial organs and prinerl vessel [Note 7: Tae Harmon maging (T=) Nove &: 1 imaging Noe 9: Panoramic imaging Novel0: ElasoSean ‘Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Presrtin Use Per 21 CFR B00 Lita beg Lp 0 fhm biaon at Raulegeal Dees ‘tee etn vo Bugreaic Devoe Evauton an Salo Indications for Use a Section 13, page 9 sox ALD 229AUG. 29. 2011 5:22PM NO8742 P12 ‘510(R) Premaricet Netification ACCUVIX A30 Diagnostic Ultrasound System DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(K) No.: Device Name: P2-4BA for use with ACCUVIX A30 Intended Use: Dingnostic ultrasound imaging or fluid flow analysis ofthe human body as follows: TisralApstonien "oe of Operon ("aclog smuareous Bano) Car See a Cask Toa) asks tee | Ses) Opkiaaue —] OnE Peal See Noe “Redon rete pe F co WachT Tare pate ee NOT Troxapetive Neu) Feat imaging [Capieeeie & Ober [Pedic Sua Gah Be ae) Nevada Costa Ea Coa Alpe F Weer Roem Tara Teaser TTacsuebal Tea oph. RoE Cae) ‘Massa aah (Cavan) Niseviosee Supa] Tae baal Die eT Tas Ate rletet = wast or cortez [ater Peone Pre [ee z Noe Roca? Tre soph (Cle) ee) Feapteal | Papbeel vest Veet [Oiberiee) TWe'tew iaicaton: P= previously clearelby FDA KIGSS97 ‘Additional Comments: Color Dapper tines Power (Ample) Doppler Nore I: eM BPW, BC, B+PD, B+CW, B+C-PW, B+PDVPW, BXCHM, Oval 8 Dal 84C, Deal 42D Noe Ie nosing fe guidance of pry Noe 5: nls ty mong ale devloeent, ‘ore Color M-mode ‘Note 5: For sump oy, paoi a, anand px in lh pedi ond noel ate Note 6 Abdominal orgs end pepe! vel Nowe 7: Tans Hie asig (THD ‘ote 8:3D imaging Note 9: Panoramic ging ‘Nowe: BassoScan, ‘added under Append E Concurrence of CDRH, Office of In Vino Diagnostic Deviees (OIVD) Preseripsion Use (Per 21 CER 401.108) ‘ 7 LA MU, Sot il Dhcion facie Ceres y Indications for Use ‘tote Yo Daren hes Eason a Sal Secon 13, page 10 0K. \Q2AUG. 29. 2011 5:22PM 510{&) Premarket Notification NO.8742 P13 ACCUVIX A30 Diagnoste Ulrasound System DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT. 510(k) No: Device Name: V2.6 for use with ACCUVIX A30 Saal Organ ve Nowe) Teor Capac ‘sak Copbalio Taal Traasasoph (oon Care) ‘Masala ata (Convent) aera el (SpE) Tae ast Tinka Aa Casts Psa Tens Sphageal (Carne) [oie epee) Ne new indiaton; P= previously cleared by FDA ROOIISS, E= added under Aapendix E ‘Additional Comment Color Dopp inches Power (Amite) Dopales Nowe I: BoM B+P, BAC B+PD, B+CWy, B-C#PW. BPD PW, BHC+M, Du B, Daal BAC, Dual BFPD Note? laches imagine fr sidance of biopsy Nove lala inferty mmitoring of fle development Nowe4: Calor Meade ‘Noe Foe exasperated pe "Now 6: Abdomi! omans and paper vassel ‘Noe 7: Tisue Hamais imaging (TD) Nove: 39 imaging Noe: Panoramio imaging Noted: Basan ult, pez and neonatal patients Feapbeal — | Fedpberl ore Vest [Ottertapee) Concurrence of CDRH, Office of In Vitro Dissmostic Devices (OIVD) Proscrpcion Use (Per 21 CFR sO. 109) t Ahihl Q Diba ‘Dhison Sno) hain of Paetegcal Caveat (ce on Vivo Daproste Devoe Evahaton ara Sty ox LtD3 34 Indications for Use Section 1.3. page tlAUG. 29. 2011 5:23PM NO.8742 P14 51008) Premarker Nosifiation ACCUVIX A30 Diagnostie Urstound System DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT S10Q)No: Device Neme: V: a for use with ACCUVIX A30 Mads of Opeion aluderscmaansovs Dano) WT PWD] CUD | Color Biol ‘Cie 2 (Speed ‘pee Feat ee Noe) abdominal Teas epentine Sas Koa ‘Small Organ Ste Ne 3) ‘Neonatal Cepbalic ‘Alt Ceskalic Tanta are aga Tenet "Fens Soph (non Gaia) Miasealoel (Conveat) Miiseooake (Supeey Tres lamina oc) Crash Cerda Peiatie Tra ssopbepel (Cie) ‘ier pe) ‘N=new ingestion; P= previously clesred by FDA R103397; 6 added under Appendix E ‘Additional Comments: (Color Dopo inches Power (Ample) Dopoler Note: BeM, B+PW, B+C. B+PD, BXCW, B+C*PW, G+PD*PW, BxC=M, Dual B, Dal BYC, Dual BYPD Note2: Includes imaging fx guidance of biopsy Note: Kclaesinferilityrpoitoringo aliele development Note € Color M-mode Note § Forexample: hrs, perthyrid, bree erm aed penis adit peda and neon pense Not 6: Ademiaal onans ad peipbrl veel Now 9: Tissue Harmonic ieging (TH) Note 2D imaging Not 9: Panoearsaiaging Notl0: ElanoSean Concurrence of CDRH, Office of ln Vitro Diagnostic Devices (OIVD) Preseription Use (Per 21 CFR 801.108) ‘ Dra Dhivion ot dologiew Deioes (fice fo uo agrees Dstes Beano and Gay oo ARGAUG. 29. 2011 5:23PM NO.8742 P15 510(k) Premarket Notification ACCUVIX A30 Diagnostic Ulnasound System DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT S10(k) No Device Name: CW2.0 for use with ACCUVIX A30 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: ‘Cina Appice Tig of Operation cher semulancous Bods) Gaal Specie ETM [PWD] CWO | Cor | Combed ‘Oe Tack toay) Taek | lee | se 1S ‘Optimise | Onialmic Fal Gee Nate 3) abso Topensive Gee Rae) Ts-opentive Neuro Tapsrteapie Peiatss ‘Sisal Ore se Neve 5) Teoma Cepalis ‘Adal Cophalc Tara "Tease "Tannen Teas os] iarals ala (Convent) ates (Super) Trained Oiher pee) Cardia Atal Cardias Peis ans cophageal (Ca) Biker pe) Peapheral vexed ihe apes) (Colo Doppler neues Power (Aminue) Doser IM, BePW, BoC, B+PD. B+CW, B-CHPW, G+ PDYPW, B+C*M, Dual B, Deal BYC, Dual BHPD. utes imaging fr gudanee of biopsy [Note 3: Inelsesinfetity monitoring of olicle development Nowe: Color M-mode Note 5: For example thyroid, parathyroid, breast, seronum and pens in au, parc ad neon patent [Not : Abdominal organs an peripheral viel [Note 7: Tissue Harmonie tmging (THD) eee ‘hp Sima Conca Othe Daas eve OND caperenseasremeasst Ly ot Seas Pe onan BSE cst sen peAUG. 29. 2011 5:23PM NO.8742 P16 510(k) Premarker Notification ACCUVIX A30 Diagnostic Uirasound System DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510K) No.: Device Name: CW4.0 for use with ACCUVIX A30 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clad Apprieston Medea pcos Semtanenus Bode) Teastl ‘Specie Ey PPR] cw cick oat) sks U2 Es Peal Gee Noe) eominad Tris-operave See Note Thaw opeative Newo) Foal imaging | Tapeessop & Ote [Patz P Seal Organ ve Nove 5) ‘Rebaaal Cephalic ‘Rial Cephalic e "Tanto Teac Tassel Tans eek (oon Caras) Tussle (Conve) Mise ake (SiperE) Torun [Oar pen) Gaios Adak P Coriiee [Cartas Pais ? "Tame esopaagel (CHa) ‘ike pee) Penponal | Penpbera veser > Vessel [Otter pee) ‘N= new muication; P= previously cleared by FDA K103397, B= added under Append Additional Comments: Clot Doppler nels Power (Amplitude) Donlet Note I: BM, BePW, BSC. BPD, BeCW, B+C+PW, BePDHPW. BeC#M, Dual B, Dual BAC, Dual BPD Note 2: lnvlues inating fr guidance of biosy Note 3: Inches infer moniterieg a faliledewlopment Nove: Color Meee Note 5: For example tyro, perathyris reas. seronum and pers in atu, pec and neat! paints Note 6: Absominal organs ad peripheral vessel Note 7: Tssoe Harmonie toging (THD) ole: 3D imaging [Noe 9: Panos asiag Noel0: Elaroseaa Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 2 CFR 801.109} Dison ot Rage Devos Otic ote vie Dagrese Davee Burson ad Safty Ae Indications for Use Section 13, page 14 sx_OLAUG. 29. 2011 5:23PM WO.8742 P17 5100 Premarket Notification ACCUVIX A30 Diagnostic Ultrasound System DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No. Device Name: CW6.0 for use with ACCUVIX A30 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: ‘GiaialAppinon "Wind of Operon "ovine: seauraneous Ue) Teen Speniie ETM] PWD] CWO] Coor ~ | Combines™ Oe (ick Louy) (ack 1 ty S (Spee) ‘Gpitbamie J Opetric Fal ee Now Rbiarinal Tara operate NOES Tranconsntive New) Foal ugg [Tapani & Other [Pedic N Taal Ora ee Noes) eat Copalie ul Cake w Tras wear Taas-erial Tenearedial Tanssoph (noo Carian) Mascaloka (Comveat) Nisaloael(Sapee) Teena omer oe) Eats Ae x cutie Catar Fea ® Tes esophageal (Coa) ier ee) Ferplenl | Feiphel vescl N Vesel_ POrierGnee) Tow Indication, P= previously cleared by FDA, E= added under ApDeVGiRE ‘Additional Comments: ‘Color Dopier insides Power (Amplitaie) Dopoler Kove |: BeM, BHPW, B+, B+PD, B+CW. BAC +PW, BEPDYPW, BHC*M, Dos 6, Dual 8+C, Dal BPD [Note2: Ices maging for euidace of biopsy [Nate ede intraty monitoring af lice development Note4: Color Mermde ‘Note: For exarine yd patho, breast, srotun ad penis im a, pdians and neonatal pients [Note 6; Abomival orgs ad periph! wee [Note 7 Tse Maroc aging TE) ‘Nowe: 3D imaging Nate 8: Panorama imaging [Noteld: ElneSsae Concurrence of CDRH, Office of In Vitro Diagnestic Devices (O1VD) Prescription Use (Per 21 CFR 801.109) Lathe, bp usenatraacogea Owes Coffee atin iro Bograate Docs Crelunson and Baty Section 13, plg2 15 y ae MM Indications for UseAUG. 29. 2011 5:247M NO. 87! DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Sev Food and Drug Administration 10903 New Harpshite Avenue Document Contrat Reon —WO66-G609 Siler Spring, MD 20993-0002 OrthoFix, Inc. * clo Mr, Mark Job Responsible Third Party Official Regulatory Technology Services LLC Mug 26 20 1394 25" Street, NW Buffélo, MN 55313 Re: K091063 Trade Name: ProView Neuromonitoring Accessory Set Regulatory Class: Il Product Code: ETN Dated: May 16, 2011 Received: May 17, 2011 Dear Mr. Job: We have reviewed your Section 510(k) premarket notification of intent to market the devioe aferented above, We have determined the dovice is not substantially equivalent to devioss marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devise Amendments, o to any device which has been reclassified into cass T (General Controls) or class II (Special Controls), orto another device found to be substantially equivalent through the 51004) process. This decison s based on the fat that we requested validation of cleaning and ae ation instructions for the end user to demonstrate that your device i as safe for single use n'a patient as the pradicate devices on uly 12 and December 17, 2010 ane you have failed to adequately respond to our requests. You may resubmit e new 5100) if you have data you believe can show your device to be substantially equivalent. ‘Therefore, this device is classified by statute into class YIT (Premarket Approval), under Scction 513(P of the Federal Food, Drug, and Cosmetic Act (Act). Section 515(a)2) ofthe Act requires a class TM device to have an approved premarket approval application (PMA) before it can be legally markercd unless the device is reclassified, “Any commercial distribution ofthis device prot to approval of PMA, or the effective date of any order by the Food and Drug Adminstration re-cnssifying this device 129 class I or HI, would te wolation ofthe Act. Clinical investigations of ths device must be conducted in accordance ‘with the investigational device exemptions (IDE) regulations,AUG. 29. 2011 5:247M Page 2— Mr. Mark Job Ifyou wish to pursue the marketing of this device and need information OF assistance for preparing investigational or premarket submissions, please contck the Division of Small Pe farurers, International and Consumer Assistance at its tol free mummber (600) 638-2041 or (301) 796-7100, or at its Internet address Jitps Yoo fia gov Mes calDevioes/DevisR egulationand uidance/dsfaul. Bune Ifyou decide to submit a new 510(K) you should submit « complete submission which includes the information identified i Title 21, Code of Federal Regulations (73 CER), section 807,87 and follows the formatting specified in 21 CFR, Section 807.90, and also aeeete our document, titled Guidance for Industry and FDA Staff - Format for ‘Traditional find Abbrevigted 510(k)s which is available from the Internet at: www fda.gow/MedicalDevi ices/DeviceRegu ationandGuidance/GuidanceDocument tsfucm084365.hum. Fae ease ensure that any new 510(K) includes information that was previously requested and addresses the following issues: Labeling Instructions for End Users 1. You do not provide sufficient detail and clarity in your cleaning instruction Examples of specific deficiencies in your cleaning instructions inclade but are not Timited to the following: a. Please include visual inspection for cleanness and damage of devices following the cleaning process. b, Please dslete recommendations for end users to validate a manuel cleaning Pro°ess which includes a neutral detergent. . Please provide specific instructions to address the cleaning and flushing of less accessible eee humens, For exariic, please identify necessary equipment such as Sings and detailed rinse procedures, 4. Your reference to the use of “purified water” in your automated cleaning Profs is non specific and may be inconsistently interpreted by end users as the United States Fharmacopela (USP) definition allows for several different water quality yPet under this designation, Please revise this text na manner that is consistent wth yo! validation Geslen and that more accurately conveys the water quality recommendation t the end user, «Your revised lbeling instructions are not consistent with the procedures followed in the validation of your sterilization parameters. Please revise your sterlization {instructions to Specify use of the ProView instrument tray and to specify double wrapping with FDA- cleared CSR (central supply room) wrap. Your device accessories appear to be packaged separately i nonrsterile pouches. Please revise your labeling to instruct the user to remove the accessories from pouches andAUG. 29. 2011 5:247M Page 3 - Mr. Mark Job specity how instruments are to be placed inthe ProView mstruipent tray after cleaning and before wrapping for sterilization, ‘Validation of Cleaning Instructions for Ei 2 “Te revised labeling and performance data you provide in response 19 out December 17, 12010 additional information request are inadequate. You have not demonstrated that your Cleaning instructions and validation method are adequate to insure that the devices are clean, thet manufacturing and detergent residuals are removed, and that the devices are not damaged. Furthermore, che revised labeling instructions do not clearly state exactly what ton users are expected to do to clean and sterilize the device before is single use. Please provide detailed instructions forthe end user which addresses these concerns, Prior to conducting additional studies, we recommend that you subuat revised labeling root eicns for end users and a revised cleaning validation protocol ina pre-submission Pioase note that FDA docs not review performance data in a pre-submission, ‘You have not demonstrated that your test methods are valid to measure the effectiveness of your cleaning process, which inciude but are-potIimited #9 the following: a You have not characterized or demonstrated the removal of manuftturing residues on our paekeaged device 2 previously equested. Please provide this information. by. ‘TF there are manofacturing residues, please provide justification tht the test soil used in the cleaning validation is eprosentative ofthese residues m adition to the oil from handling, Please note that the sebum oil that you used in your prior tests only sinuulates device handling. e. You do not include any relevant, predetermined acceptance crteis for quantitative reessment of sol remove in the evaluation of your cleaning instructions ‘You also do ae nelude any criteria for visual inspection of cleaned devices. Your acoepiane® criteria Torevaluating the effectiveness of your manual and automated cleaning process XO sased solcly on bioburden reduction. However, assessment of bioburden reduction does rot demonstrate a clear comrlation between reduction ofthat surTogsté and a direct neayurement of soil reduction. Please revise your cleaning validation acoeptance criteria to address these concerns. 44. You have not demonstrated that your gravimetric assay and total organic carbon test methods are valid to micasure the effectiveness of your cleaning process, ‘Significant vpevanons iv yous gravimetric assay include damage to the device costing from hexane extraction in your analysis. You then used the damaged devices in You! Total Organic Carbon (TOC) assay, Please revise your validation studies 10 address these concems.AUG. 29. 2011 5:25°M Page 4— Mr. Mark Job e. You do not provide a valid correlation between your test results and the measured reduction in test soil components. Your baseline for comparison to determine the "Sfoniveness of the cleaning process is manufactured devices that have ne ‘been cleaned ‘Therefore your comparison to evaluate cleaning effectiveness is (0 rmannfactured devices which are not “clean,” Le., devi handling residuals. It is also unclear why you consider your approximately 15 petoent Meduction in hexane soluble components and approximately 30 percens reduction from vrtgmated cleaning 2s acoeptable, You ako do not correlate TOC residuals with device surface area (e.g., ug/cm), Please revise your test ‘methods to provide a valid correlation anween your quantitative test resolts and the measured reduction in test soil components. sebum of contains primarily fat sohible components. Please justify why TOC for water sable components is a relevant assay for evaluating reductions in seDum oil, “The information requested above represents the issues that we believe need to be resolved before cee review of 2 new 510(K) submission can be successfully completed. te developing the Getiiences, we carefully considered the statutory criteria as defines jn Section $136) of the Federal Food, Drug, and Cosmetic Act for determining substantial equivalence. fyou have any questions conceming the additional jnformation that should be svismitted in a new '510(6) submission, please contact Quynh Hoang at 301-796-6610 or by email to ‘quynh hoang @fda.bs.g0 Sincerely yours, wt “Malvina B. Eydet MD. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Contes for Devices and Radiological HealthAUG. 29. 2011 5:25°M NO. 8748 P. oe f C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Adminstration 10903 New Hampshire Avene Document Control Roo =WOS6-G609 Silver Spring, MD 20993-0002 Bard Medical Division CR. Bard, Inc. Se Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC an 1394 25" Street NW ays 2B” BUFFALO MN 55313 Re: K112137 Trade/Device Name: ComfortGlide™ Intermittent Catheter Regulation Number; 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: August 15, 2011 Received: August 16, 2011 Dear Mr. Job: ‘We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of ‘the Medical Deviee Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act, However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device ‘Amendments. Please note: If you purchase your device components in bulk (ie., unfinished) and further process (e.g. sterilize) you must submit a new 510(k) before including these ‘components in your kit, ‘The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898, In addition, FDA may publish further announcements conceming your device in the Federal Register.AUG. 29. 2011 5:26PM NO. 8748 P. Page 2 — Mr. Mark Job Please be advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CER Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic ‘product radiation contxol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www fia. gov/ Ahout FDA /CentersOffices/CDRH/CDRHOffices/uom|15809.htm for the Center for Devices and Radiological Health's (CDRH’s) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification” (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CER Part 803), please go to htipy/ www fda, cov/MedicalD evices/Safery/ReportaProblern/default.htm for the CDRH’s Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http/wwvor fila, cov/MedicalDevices/ResourcesforY¥ owlndustry/default htm. ert P. Herner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological HealthAUG. 29. 2011 5:26PM ‘Section 4; Indications for Use Stalament 5 0(e) Premarket Notficaton: ComfortGide™ Intermittent Cateter, Page 1 of 4 NO. 8748 P. 510(k) Number: Device Name: Indications for Use: Prescription Use: D3 K M2137 ComfortGlide™ Intermittent Catheter ‘The ComfortGlide™ Intermittent Catheter is intended for use by adult and pediatric, male and female patients for draining urine from the bladder. or Ovor the Counter Use [) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devi 510(k) Number Page 1 of _1. GR. Bard, Inc. res KN 137 Page 19 of 300