The Opta5 catheters are intended for balloon dilatation of lesions in peripheral arteries (iliac, renal, popliteal, infra poplited, femoral and ilio femoral) and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Description

OPTA 5 PTA Catheters are designed for dilating stenoses in peripheral arteries (iliac, renal, popliteal, infra popliteal, femoral, and ilio femoral). OPTA 5 PTA Catheters are similar in design, construction, indications for use, and performance characteristics as compared to commercially available PTA Catheters.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Cordis Corporation OPTA 5 PTA Catheters from 1997. This document focuses on demonstrating substantial equivalence to predicate devices rather than conducting a de novo study to establish new acceptance criteria and prove device performance against them.

Therefore, the information required to populate the table and answer the specific questions about acceptance criteria, study details, expert involvement, and ground truth establishment, is not present in this document.

The document states:

"Performance standards have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act."
"OPTA 5 PTA Catheters are substantially equivalent to the predicate devices. OPTA 5 PTA Catheters are similar in design, construction, indications for use, and performance characteristics as compared to commercially available PTA Catheters."

This means the device's acceptance was based on its similarity to previously approved devices, not on meeting new, predefined performance metrics from a specific study outlined here.

Consequently, I cannot provide the requested table and answers based solely on the provided text.

Summary

{0}------------------------------------------------

PREMARKET NOTIFICATION 510(k) Cordis Corporation OPTA 5 PTA Catheters April 18, 1997

K971579

JUL 18 1997 SUMMARY OF SAFETY AND EFFECTIVENESS

l. General Provisions:

Percutaneous Transluminal Angioplasty Catheters Common Name:

OPTA 5™ PTA Catheters Proprietary Name:

Name of Predicate Devices: II.

1. Trade Name: OPTA 5 PTA Catheters Manufacturer: Cordis Corporation
JUPITER PTA Catheters 2. Trade Name: Manufacturer: Cordis Corporation

111. Classification:

Class II

IV. Performance Standards:

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:

OPTA 5 PTA Catheters are designed for dilating stenoses in peripheral arteries (iliac, renal, popliteal, infra popliteal, femoral, and ilio femoral).

VI. Biocompatibility

All appropriate biocompatibility tests were successfully performed on Cordis Corporation's OPTA 5 PTA Catheters.

VII. Summary of Substantial Equivalence:

OPTA 5 PTA Catheters are substantially equivalent to the predicate devices. OPTA 5 PTA Catheters are similar in design, construction, indications for use, and performance characteristics as compared to commercially available PTA Catheters.

{1}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Mirjam Barboza, M.D. Manager, Regulatory and Clinical Affairs Cordis Corporation P.O. Box 025700 Miami, Florida 33102-5700

JUL 18 1997

Re: K971579 Cordis Opta5 PTA Balloon Catheter Requlatory Class: II (two) Product Code: LIT Dated: April 18, 1997 Received: April 21, 1997

Dear Dr. Barboza:

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, Drug, 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, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations 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 requlation 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.

{2}------------------------------------------------

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. Callahan

Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

INDICATIONS FOR USE

510(k) Number: K971579

Cordis Opta5 PTA Balloon Catheter Device Name:

The Opta5 catheters are intended for balloon dilatation of Indications for Use: lesions in peripheral arteries (iliac, renal, popliteal, infra poplited, femoral and ilio femoral) and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE AS NEEDED

Prescription Use
(Per 21 CFR 801.109)

Ta A-R

(Division Sign-Off) Division of Cardiovascular, Respiratory, nd Neurological Devices

510(k) Number K971574

OR 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).