CONMED Title: Ethylene Oxide Sterilization Adoption

Doc Number: PDD1205118 Revision Number: A Effective Date: Mar 08, 2019

PROCEDURE APPROVALS
Note: Date of last approval will serve as the Approval Date for this document.
Name Function Signature Date
Duong Le Quality Assurance dle 03/08/2019
Yolanda Aviles Laboratory Services yaviles 03/08/2019
Ian McRury Product Engineering IMcRury 03/08/2019

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CONMED Title: Ethylene Oxide Sterilization Adoption
Doc Number: PDD1205118 Revision Number: A Effective Date: Mar 08, 2019

11311 Concept Boulevard Largo, Florida 33773-4908

Ethylene Oxide Sterilization Report

PDD1205118

Ethylene Oxide Sterilization Adoption by Equivalency

Evaluation for the Edge Probes Tyvek Lidding
Change under the ECN03187

INITIATOR

Title Signature Date

Microbiologist, Corporate Sterilization Sciences Electronic Signature
Bekcy Torres

APPROVERS

Title Signature Date

Manager, Corporate Sterilization Sciences Electronic Signature
Yolanda Aviles

Manager, R&D Electronic Signature

Ian McRury

Engineer, Quality Electronic Signature

Duong Le

1.0 Purpose

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CONMED Title: Ethylene Oxide Sterilization Adoption
Doc Number: PDD1205118 Revision Number: A Effective Date: Mar 08, 2019

1.1 The purpose of this Technical Report is to provide information to support the adoption of
the change on the tyvek lidding for the Edge Probe standard length products under the
change number ECN03187.
1.2 The tyvek lidding P28-023-000 supplied by BEMIS is currently used in the Edge Probe
standard length products and will be replaced by the tyvek lidding P28-029-000 supplied
by Amcor.
1.3 Currently the tyvek P28-029-000 is being used in the Edge Probes AES-HK00 and AES-
HK20 previously evaluated by equivalency under PDD1172540.
1.4 Memorandum from Maria Betancourt dated 02/26/2019 is included in Tab 1 of this report
for complete details and reference of the change.

2.0 Scope

2.1 This report applies to the Edge Probes listed in the following table and that are part of the
LightWave® Ablator family product grouped on Utica EO family 14 via Cycle # 647.

Catalog Number Description

AES-30 AES 30 Degree Probe
AES-50S AES 50 Degree Probe with Suction
AES-90S AES 90 Degree Probe with Suction
AES-90SC AES 90 Degree Probe, Suction, YTZP
AES-90SN AES-90SN Probe Assy, Suction Sin

3.0 Engineering Comparison of Predicate and Candidate

3.1 The AES-90S suction ablator is the predicate for the edge probes listed in section 2.1. Both
the predicate and candidates are represented by the LightWave® Suction Ablator EL-
2000S which is the master device for ConMed arthroscopic probes. These products are
grouped on Utica EO family 14.

3.2 The edge probes listed in section 2.1 are existing CONMED products which are part of the
arthroscopic probes group.
3.3 The tyvek lidding change will not have impact in the sterilization process since it has being
used in some edge probe products. The change in tyvek lidding is to standardized the
packaging components and supplier.
3.4 There are no changes to the design or configuration of the products.
3.5 There are no changes in materials, components, manufacturing process, environment or
location.

PDD1205118 Ethylene Oxide Sterilization Adoption by Equivalency Evaluation for the Edge Probes Tyvek Lidding Change under the
ECN03187

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CONMED Title: Ethylene Oxide Sterilization Adoption
Doc Number: PDD1205118 Revision Number: A Effective Date: Mar 08, 2019

4.0 Product Bioburden and Characterization Evaluation:

4.1 Bioburden test was not performed since the tyvek lidding material is the same and is
currently being used in some edge probes products. There are no changes in packaging
materials, packaging process, manufacturing materials, manufacturing processes or
manufacturing location. The only change is the part number on tyvek lidding since it is
provided from an existing supplier. Raw material remains the same.

5.0 Biocompatibility Evaluation:

5.1 Biocompability evaluation was not required since no changes were made to the design,
materials, components, manufacturing process or sterilization. These edge probes are
existing products.

6.0 EO Residual Evaluation:

6.1 These changes were evaluated and determine that will not have any impact in EO penetration
or dissipation.

7.0 Product Sterility Evaluation with Microbial Stasis:

7.1 Microbial stasis test was not performed since the routine product release uses biological
indicator (ePCD) rather than product sterility.

8.0 Conclusion
8.1 The change of supplier for the tyvek lidding will not impact the sterilization process since
the materials on the tyvek are not changing and its supplier is currently being used for
other edge probe products.
8.2 Arthroscopic Energy probes support the sterilization adoption to the Ablator family for
ethylene oxide sterilization via Cycle 647 at Sterigenics, Queensbury, NY, having the
LightWave® Ablator as the predicate master device.
9.0 Tabs
9.1 Tab 1 Memorandum from Maria Betancourt dated 02/26/2019

PDD1205118 Ethylene Oxide Sterilization Adoption by Equivalency Evaluation for the Edge Probes Tyvek Lidding Change under the
ECN03187

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