The Edwards Peripheral Dilatation 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 end of the catheter and provides the mechanism for dilating the vessel. The shaft of the delivery system is coaxial over the entire length of the catheter. The inner lumen of the coaxial catheter is designed to accommodate a maximum guidewire diameter of 0.035 inches. The outer lumen of the coaxial catheter is used for inflation and deflation of the balloon. The proximal end of the catheter contains a luer adapter with two ports; one port is used for accessing the guidewire lumen while the second port facilitates inflation and deflation of the balloon. The delivery catheter is offered in an 80 cm length. The Edwards Peripheral Dilatation Catheter products are supplied sterile and are "single-use only" devices.

AI/ML Overview

The provided text describes the Edwards Peripheral Dilatation Catheter and its 510(k) submission, focusing on establishing substantial equivalence to predicate devices rather than a standalone study with specific acceptance criteria and detailed performance metrics. As a result, many of the requested details are not present in the document.

Here's an analysis of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Bench Testing Parameters:
Balloon burst strength	Performed in a manner substantially equivalent to predicate devices.
Balloon compliance	Performed in a manner substantially equivalent to predicate devices.
Balloon inflation	Performed in a manner substantially equivalent to predicate devices.
Balloon fatigue	Performed in a manner substantially equivalent to predicate devices.
Tensile strength on applicable joints of the delivery system	Performed in a manner substantially equivalent to predicate devices.
Overall Performance:
Substantial equivalence to predicate devices (Cordis MAXI LD Esophageal Dilator (K023907), Guidant AGILTRAC™ 035 Peripheral Dilatation Catheter (K023320)) in:	Claimed due to similar intended use, design, materials, performance, safety, effectiveness, and labeling.
- Intended Use	Assessed for similarity.
- Design	Assessed for similarity.
- Materials	Assessed for similarity.
- Performance properties	Assessed for similarity.
- Biocompatibility	Assessed for similarity.
- Packaging	Assessed for similarity.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. The document mentions "bench testing," which implies laboratory tests, but no specific number of units tested is provided for any of the performance parameters.
Data Provenance: The studies were internal bench testing conducted by Edwards Lifesciences. The country of origin is not explicitly stated for the testing, but Edwards Lifesciences LLC is located in Irvine, CA, USA. The data is retrospective in the sense that it was generated for the 510(k) submission, but it's not clinical patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This information is for clinical studies where expert review is crucial for ground truth. The provided document only describes bench testing comparing the device to predicates, not a clinical trial requiring human expert assessments for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. As above, this pertains to clinical studies often involving human interpretation of data (e.g., imaging). The tests described are bench tests of physical performance.

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 type of study is relevant for AI/radiological interpretation devices. The Edwards Peripheral Dilatation Catheter is a physical medical device (catheter), not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. Again, this refers to AI algorithms. The device is a physical catheter.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Bench Testing Standards/Specifications: The "ground truth" for the bench tests would be the established engineering specifications for what constitutes acceptable performance (e.g., minimum burst pressure, maximum fatigue cycles, tensile strength limits) and consistency with the performance of the predicate devices. These standards are derived from industry norms and regulatory requirements for such devices.

8. The sample size for the training set:

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The design, materials, and manufacturing processes would be developed based on engineering principles and knowledge of the predicate devices.

9. How the ground truth for the training set was established:

Not applicable. As there is no training set mentioned.

Summary

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K032587

OCT - 2 2003

Image /page/0/Picture/2 description: The image shows a logo with the word "Edwards" written in a serif font at the bottom. Above the word, there is a square grid pattern with a large letter "E" superimposed on it. A partial circle is behind the letter "E", adding a design element to the logo.

510(k) Summary

1. Submitter's Name and Address:

Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614

2. Contact:

Kevin Drisko Senior Manager, Regulatory Affairs Edwards Lifesciences LLC Phone: (949) 250-2416 Fax: (949) 250-3630 E-mail: kevin_drisko@edwards.com

3. Date Prepared:

August 21, 2003

4. Device Trade Name:

Edwards Peripheral Dilatation Catheter

5. Device Common Name:

Peripheral dilatation catheter

6. Device Classification Name:

Catheter, percutaneous (DQY), Class II

7. Predicate Devices:

Cordis MAXI LD Esophageal Dilator (K023907) Guidant AGILTRAC™ 035 Peripheral Dilatation Catheter (K023320)

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Image /page/1/Picture/0 description: The image shows a logo with the letter 'E' in a stylized font, set against a textured background that resembles a grid or a pattern of small squares. The letter 'E' is large and prominent, with some circular design elements incorporated into the background. Below the logo, the word 'Edwards' is printed in a serif typeface, with the first letter capitalized.

510(k) Summary (continued)

8. Device Description:

9. Intended Use:

The Edwards Peripheral Dilatation Catheter is intended to:

dilate stenoses in 10 14mm peripheral arteries, .
treat obstructive lesions of native or synthetic A-V fistulae and/or .
expand endoluminal stent graft elements in the aorta and iliac arteries .

10. Technological Characteristics:

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

11. Performance Data:

Edwards Lifesciences completed bench testing such as balloon burst strength, balloon compliance, balloon inflation, balloon fatigue, as well as tensile strength testing on applicable joints of the delivery system. The results indicate that the Edwards Peripheral Dilatation Catheter performed in a manner substantially equivalent to the predicate devices cited in item 7 above.

12. Conclusion:

Since the Edwards Peripheral Dilatation Catheter has similar intended use, design, materials, performance, safety, effectiveness and labeling, it may be considered substantially equivalent to the predicate devices cited in item 7 above.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 2 2003

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

Re: K032587

Trade Name: Edwards Peripheral Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: August 21, 2003 Received: August 22, 2003

Dear Mr. Drisko:

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 (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) that do not require approval of a premarket approval application (PMA). 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.

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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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Page 2 – Mr. Kevin Drisko

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 53) -542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Kalen TM

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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Page 1 of

510(k) Number (if known) _____________________________________________________________________________________________________________________________________________________

Device Name: Edwards Peripheral Dilatation Catheter

Indications for Use:

The Edwards Peripheral Dilatation Catheter is intended to:

dilate stenoses in 10 14mm 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 .

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Evaluation (CDE)

(Division Sign-Off Division of Cardio

510(k) Number K032587

Prescription Use
(per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Edwards Lifesciences 510(k) Application Edwards Peripheral Dilatation 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).