The Edwards Peripheral Dilation Catheter is an over-the-wire catheter with a flexible distal portion for maneuvering through regions of the peripheral vasculature. A balloon is mounted on the distal for mather and provides the mechanism for dilating the vessel. Two (2) lumens extended end of the cather and prohless the The first lumen is designed to accommodate a maximum this only of 0.035 inches. The second lumen is used for inflation and deflation of the galloon. The proximal end of the catheter contains a luer adapter with two ports; one port is used bulloon. The guidewire lumen while the second port facilitates inflation and deflation of the beloon. A strain relief between the proximal shaft and the luer adapter provides rigidity and transition between the two parts. The delivery catheter is offered in both 80cm and 120cm working lengths.

AI/ML Overview

The Edwards Peripheral Dilation Catheter's performance data is primarily based on bench testing, designed to demonstrate substantial equivalence to predicate devices, rather than a clinical study establishing specific acceptance criteria for a new clinical outcome.

Here's an analysis based on the provided text, addressing your questions:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance	Study Type
Dimensional Requirements	Performed in a manner substantially equivalent to predicate devices.	Bench Testing
Balloon Minimum Burst Strength	Performed in a manner substantially equivalent to predicate devices.	Bench Testing
Balloon Compliance	Performed in a manner substantially equivalent to predicate devices.	Bench Testing
Balloon Inflation/Deflation	Performed in a manner substantially equivalent to predicate devices.	Bench Testing
Balloon Fatigue	Performed in a manner substantially equivalent to predicate devices.	Bench Testing
Tensile Strength	Performed in a manner substantially equivalent to predicate devices.	Bench Testing
Biocompatibility	Identical or substantially equivalent to predicate devices.	Comparison to predicate (likely based on material testing, not specific new study)
Method of Sterilization	Identical or substantially equivalent to predicate devices.	Comparison to predicate
Packaging	Identical or substantially equivalent to predicate devices.	Comparison to predicate

2. Sample size used for the test set and the data provenance
Not applicable. The study was bench testing of the device itself, not a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for bench testing is typically based on engineering specifications and direct measurement, not expert consensus on clinical data.

4. Adjudication method for the test set
Not applicable. This device underwent bench testing, not a clinical study requiring adjudication of expert opinions on medical images or patient outcomes.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/imaging device and no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (catheter), not an algorithm.

7. The type of ground truth used
The ground truth for the bench testing was based on engineering specifications and direct measurements of the device against predefined performance parameters (e.g., burst pressure, compliance, tensile strength). The performance was then compared to that of legally marketed predicate devices to establish substantial equivalence.

8. The sample size for the training set
Not applicable. This is a medical device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established
Not applicable. This is a medical device, not an AI algorithm that requires ground truth for a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Edwards Lifesciences. The logo consists of the company name, "Edwards Lifesciences," in a serif font. To the left of the name is a small, abstract graphic, possibly representing a stylized heart or circulatory system.

CONFIDENTIA May not be reproduced without written permission fre Edwards Lifesciences

510(k) Summary

SEP 0 2 2005

1. Submitter's Name and Address:

Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614

2. Contact:

Kevin Drisko Sr. Regulatory Manager Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614 Phone: 949-250-2416 FAX: 949-250-3630 E-Mail: kevin_drisko@edwards.com

3. Date Prepared:

August 5, 2005

4. Device Trade Name:

Edwards Peripheral Dilation Catheter

5. Device Common Name:

Peripheral Dilation Catheter

6. Device Classification Name:

Catheter, percutaneous (DQY), Class II

7. Predicate Devices:

Edwards Peripheral Dilation Catheter (K032587) and LifeStent Turbo Biliary Stent System (K050627)

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FIDENTIAL

Image /page/1/Picture/1 description: The image shows the logo for Edwards Lifesciences. The logo consists of a stylized graphic on the left, followed by the company name "Edwards Lifesciences" in a clear, sans-serif font. The text is horizontally aligned and the overall design is clean and professional.

May not be reprodu

510(k) Summary (continued)

8. Device Description:

9. Intended Use:

The Edwards Peripheral Dilation Catheter is intended to:

dilate stenoses in peripheral arteries, .
treat obstructive lesions of native or synthetic A-V fistulae and/or .
re-expand endoluminal stent graft elements in the aorta and iliac arteries �

10. Technological Characteristics:

Comparisons of the subject and predicate devices show that the technical characteristics such as materials, performance properties, biocompatibility, method of sterilization, and packaging are identical or substantially equivalent.

11. Performance Data:

Edwards Lifesciences completed bench testing, such as dimensional testing, balloon minimum burst strength, balloon compliance, balloon inflation/deflation, balloon fatigue and tensile strength testing on the Edwards Peripheral Dilation Catheter. The results indicate that the Edwards Perinheral Dilation Catheter performed in a manner substantially equivalent to the predicate devices cited in item 7 above.

12. Conclusion:

Since the Edwards Peripheral Dilation Catheter has the same intended use, similar performance properties, packaging and sterilization methods, it may be considered substantially equivalent to the predicate devices cited in item 7 above.

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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 0 2 2005

Edwards Lifesciences LLC c/o Mr. Kevin Drisko Senior Manager, Regulatory Affairs One Edwards Way Irvine, CA 92614

Re: K052149

Edwards Peripheral Dilation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 5, 2005 Received: August 11, 2005

Dear Mr. Drisko:

We have reviewed your Section 510(k) premarket notification of intent to market the device to We have reviewed your Section 310(K) premailsche equivalent (for the indications for the indications for referenced above and have determiled the devices marked in interstate commerce
use stated in the enclosure) to legally markets marketed in intervices that use stated in the enclosure) to legally materials Device Amendments, or to devices that prior to May 28, 1976, the enacment une visuale of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Peneral Proom of Cosme have been reclassified in accordance will the provisions of wal application (PMA). You may,
Act (Act) that do not require approval of a premarket approval application of th Act (Act) that do not require approval of a premated arcols provisions of the Act. The general
therefore, market the device, subject to the general controls provisions of th therefore, market the device, subject to the generation, listing of devices, good
controls provisions of the Act include requirements for annual registration, controls provisions of the Act include requirements for alsome of adulteration.
manufacturing practice, 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 If your device is classified (see above) into Eline Class II (president affecting your device can be
may be subject to such additional controls. Existing mayor regulations may be subject to such additional controls. Existing major regaracter and organization, FDA may publish
found in the Code of Federal Regulations, Title 21, Parts 800 to Regu found in the Code of Federal Regalations, and in the Federal Register.

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Page 2 – Mr. Kevin Drisko

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that ITDA s Issualled of a sabetained of the requirements of the Act or that FDA nas made a decentination mar your centry Federal agencies. You must comply with CDP Part 907V any Pederal Statutes and regulations administered of to: registration and listing (21 CFR Part 807); all the Act s requirements, mending, but noving were morements as set forth in the quality labeling (21 CFR Part 801), good manataling production of the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic produc Systems (QS) regulation (21-542 of the Act); 21 CFR 1000-1050. control provisions (Sections 551-512 or the 107), device as described in your Section 510(k) I his letter will anow you to begin manusing of substantial equivalence of your device to a legally premarket notification. The I DA midning of basistant for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your active of our accesse note the regulation entitled, Contact the Office of Compliance at (210) 21 0 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 11 MISolanding by reference to promaibilities under the Act from the Division of Small general intornation on your responsibilities and its toll-free number (800) 638-2041 or Manufacturers, International and Consultation://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Donna P. Vichner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for Edwards Lifesciences. The logo consists of a stylized letter "E" on the left, followed by the text "Edwards Lifesciences" in a serif font. A horizontal line is present under the text.

510(k) Number (if known): _ Kos 2149_

Device Name: Edwards Peripheral Dilation Catheter

Indications for Use:

The Edwards Peripheral Dilation Catheter is intended to:

dilate stenoses in peripheral arteries, .
diffate stenoses in perfordial ations of native or synthetic A-V fistulae and/or
treat obstructive lesions of native or synthetic A-V fistulae and/or .
treat obstructive lesions of hative of officient in the aorta and iliac arteries .

Prescription Use: X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Buna R. Vahner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K 652149

Page 1 of ___

Edwards Lifesciences LLC Edwards Lifesciences EEO
Special 510(k) for the Edwards Peripheral Dilation Catheter

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).