The Cordis PTA Catheters are intended for balloon dilatation of lesions in peripheral arteries (iliac, renal, popliteal, infra popliteal, femoral, and ilio femoral) and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Description

Savvy PTA Catheters are designed for dilating stenotic atherosclerotic lesions in peripheral arteries (iliac, renal, popliteal, infra popliteal, femoral, and ilio femoral) and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Savvy PTA Catheters are similar in design, construction, indications for use, and performance characteristics as compared to commercially available PTA Catheters.

AI/ML Overview

This document, K971010, is a Premarket Notification 510(k) for the Cordis Corporation's Savvy PTA (Percutaneous Transluminal Angioplasty) Catheters. It asserts substantial equivalence to predicate devices rather than demonstrating performance against specific acceptance criteria through a clinical study.

Therefore, the requested information regarding acceptance criteria and a study proving device conformance cannot be provided as this 510(k) submission does not contain such a study.

Instead, the submission focuses on:

Intended Use and Device Description: Savvy PTA Catheters are designed for dilating stenotic atherosclerotic lesions in peripheral arteries (iliac, renal, popliteal, infra popliteal, femoral, and ilio femoral) and to treat obstructive lesions in native or synthetic arteriovenous dialysis fistulae.
Biocompatibility: All appropriate biocompatibility tests were successfully performed.
Substantial Equivalence: The Savvy PTA Catheters are claimed to be substantially equivalent to predicate devices (Cordis Corporation's Savyy PTA Catheters, Cordis Corporation's Opta 5 PTA Catheters, and Meditech's Ultra Thin PTA Catheter) based on similar design, construction, indications for use, and performance characteristics.

Without a performance study against predefined acceptance criteria, it's impossible to fill in the requested table and details about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set specifics. The 510(k) process often relies on demonstrating equivalence to existing, legally marketed devices rather than extensive new clinical performance data if the new device does not raise new questions of safety and effectiveness.

Summary

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K971010
June 18, 1997

PREMARKET NOTIFICATION 510(k) Cordis Corporation Savyy PTA Catheters March 19, 1997

SUMMARY OF SAFETY AND EFFECTIVENESS

General Provisions: l.

Common Name:

Percutaneous Transluminal Angioplasty Catheters

Savy PTA Catheters Proprietary Name:

Name of Predicate Devices: 11.

Savyy PTA Catheters Trade Name: 1. Cordis Corporation Manufacturer:
Opta 5 PTA Catheters 2. Trade Name: Cordis Corporation Manufacturer:
Ultra Thin PTA Catheter 3. Trade Name: Meditech Manufacturer:

111. Classification:

Class II

Performance Standards: IV.

Performance standards have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.

V. Intended Use and Device Description:

VI. Blocompatibility

All appropriate biocompatibility tests were successfully performed on Cordis Corporation's Savy PTA Catheters.

VII. Summary of Substantial Equivalence:

Savyy PTA Catheters are substantially equivalent to the predicate devices. Savy PTA Catheters are similar in design, construction, indications for use, and performance characteristics as compared to commercially available PTA Catheters.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 8 1997

Ms. Jodi Lynn Greenizen Requlatory and Clinical Affairs Associate Cordis Corporation P.O. Box 025700 Miami, Florida 33102-5700

Re: K971010 Cordis Savvy PTA Catheter Regulatory Class: II (two) Product Code: LIT Dated: March 17, 1997 Received: March 20, 1997

Dear Ms. Greenizen:

We have reviewed your Section 510(k) 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 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, Druq, 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, qood 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 (Premarket Approval), 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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PREMARKET NOTIFICATION 510(K) Cordis Corporation Savvy PTA Catheters

INDICATIONS FOR USE

510(k) Number: . . . . K971010 . . . . . . . .

Cordis Savvy PTA Balloon Catheter Device Name:

Indications for Use: The Cordis PTA Catheters are intended for balloon dilatation of lesions in peripheral arteries (iliac, renal, popliteal, infra popliteal, femoral, and 华 ilio femoral) and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Tim Ah

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 971010 510(k) Number

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

Prescription Use
(Per 21 CFR 801.109)

Over - The Counter Use_

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).