Assignment #2

Learning Objective Learn how to write a description for a 510(k)

Deliverables and credit:

1. Device Description Section of the 510(k) 10 points

_________________________________________________________
The situation
You are working at Rabbit Medical, your manager has assigned you a new project, the
Target Guidewire.

The information to complete the indication for use and the device description is provided here:
The Target Guidewires are in development for with the Rabbit Medical platform of products.
The guidewires will be offered in 2 configurations (TG-180 and TG-300) will be single use and
packaged in the standard hoop configuration.
The guidewire is sterilized using ethylene oxide. There are no accessories packaged with the
device.
The Target Guidewire has the same indication for use/intended use and principles of operation as
the legally marketed predicate. In addition, the functional characteristics of the Target Guidewire
are substantially equivalent to the predicate, with similar materials, dimensions, and method of
construction. The design modifications to the new device include differences in material used on
the coating for the core, the proximal joint and the partial coil design on the distal end.
Performance and safety testing have shown that specifications have been met, including:
 FDA guidance Coronary, Peripheral and Neurovascular Guidewires Performance Tests and
Recommended Labeling (October 10, 2019) was utilized.
o Thermal Conditional and Packaging Distribution - Tested in accordance with ASTM
D4169 (Distribution simulation) and ISTA 2A (environmental conditioning).
o Package Integrity evaluation, including: • Visual Inspection – Tested in accordance
with EN ISO 11070 & FDA Guidance.
o Pouch Peel Tear - Tested in accordance with ASTM F88-15.
o Seal Integrity – Tested in accordance with ASTM F1929-15.
o Bubble Leak Testing – Tested in accordance with ASTM F2096-11(2019).
o Dimensional Inspection, including:
o Length, Outer Diameter – Tested in accordance with EN ISO 11070 & FDA
Guidance.
o Curve – Tested in accordance with internal procedures.
o Lubricity - Tested in accordance with FDA Guidance.
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o Guidewire Distal Joint Pull Test - Tested in accordance with EN ISO 11070 & FDA
Guidance.
o 3 Point Bend - Tested in accordance with internal procedures.
o Coating Adhesion – Tested in accordance with FDA Guidance.
o Radiopacity - Tested in accordance with EN ISO 11070 & FDA Guidance.
o ISO Corrosion Test - Tested in accordance with EN ISO 11070 & FDA Guidance.
o Particulate Residue Test - Tested in accordance with FDA Guidance.
o ISO Fracture Test - Tested in accordance with EN ISO 11070.
o ISO Flex Test - Tested in accordance with EN ISO 11070.
o Torque Fatigue - Tested in accordance with FDA Guidance.
o Kink Resistance – Tested in accordance with FDA guidance.
o Biocompatibility – Tested in accordance with ISO 10993-1 and all applicable parts of
this standard series. The battery of tests included cytotoxicity, sensitization, irritation,
systemic toxicity, material mediated pyrogenicity, hemocompatibility, and
thrombogenicity.

Table 1: Specifications
Specification & Information
The Target Guidewires are a hydrophilic coated device intended to
facilitate placement of balloon dilatation catheters or other
intravascular devices during percutaneous transluminal coronary
Indication for Use
angioplasty (PCTA) and percutaneous transluminal angioplasty
(PTA). The Target Guidewires are not to be used in cerebral blood
vessels.
180 cm ± 1cm
Guidewire Length
300 cm ± 1cm
Guidewire Diameter 0.014” ± .001”
Tip Length 2.00” ± .1
Tip Configurations Straight
Core Material and Tip
Stainless Steel 304
material
Flexible Tip Material Platinum & Tungsten
Coating Coating (distal)
Hoop Hoop: HDPE; Hoop clips: MDPE
Pouch Tyvek/Poly for EO to support up to five years
White Pressboard box that will be placed in a shipper box for
Primary box
shipment, configuration to be established.
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Table 1: Specifications
Specification & Information
With the guidewire through a guiding catheter positioned in a
simulated aortic arch and engaged in a simulated tortuous vessel in
Torqueability body temperature water, the distal tip will not lag the proximal end
of the guidewire by more than 175° when the guidewire is rotated in
45° increments up to 360°.
The guide must be able to rotate greater than 3 full rotations in a
Torque Strength
simulated, tortuous anatomy with the distal end fixed.
The guidewire will not kink, fracture, or flake coating after wrapping
Fracture Resistance the distal end 12 times around a cylinder equal to 4x the maximum
wire diameter
Coating Adherence/ When used in normal operating conditions, the coating should
Integrity remain adhered to the guidewire body and tip.
Corrosion Resistance No significant corrosion
Full Unit Tensile
min 1.0 lbf
Strength
Peel Strength min 1.0 lbf