The PowerFlex Plus PTA balloon catheter is intended to dilate stenoses in iliac, femoral, iliofemoral, popliteal, infra popliteal and renal arteries, and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Description

The Cordis PowerFlex Plus PTA balloon catheter is a dual lumen design with a distal inflatable balloon. Two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. The balloon inflation lumen is used to inflate and deflate the balloon. The nominal balloon size is printed on the hub. The guidewire lumen is used to track the catheter over a prepositioned guidewire or to inject contrast medium and/or saline. The maximum injection pressure is 450 psi. The compatible guidewire size, catheter shaft French size and catheter length are printed on the hub. The radiopaque marker bands indicate the stated nominal length of the balloon.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving device performance as typically understood in the context of AI/ML medical devices. This document is a 510(k) Premarket Notification for a PTA Balloon Catheter from 1997, focusing on demonstrating substantial equivalence to predicate devices rather than novel performance claims supported by clinical studies with specific acceptance criteria.

Therefore, I cannot populate the requested table or answer the questions related to test sets, ground truth establishment, expert adjudication, or MRMC studies.

Here's why this information is absent in your input:

Device Type: This document is for a physical medical device (a balloon catheter), not a software or AI/ML device that would typically have performance metrics like accuracy, sensitivity, specificity, and require a test set with established ground truth.
Regulatory Pathway: A 510(k) is primarily about demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing design, materials, and intended use, and may include some bench testing or limited clinical data if necessary to support equivalence, rather than a full-scale performance study with predefined acceptance criteria for AI output.
Date: The document is from 1997, predating the widespread use of AI/ML in medical devices and the associated regulatory expectations and study designs.

If you have a different document related to an AI/ML medical device, I would be happy to analyze it for the requested information.

Summary

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SUMMARY OF SAFETY EFFECTIVENESS

I. General Provisions

PTA Balloon Catheter Common or Usual Name:

JUL 2 3 1997

PowerFlex™ Plus PTA Balloon Catheter Proprietary Name:

II. Name of Predicate Devices

Cordis PowerFlex PTA Balloon Catheter
Cordis Opta5 PTA Balloon Catheter
Cordis Small Vessel PTA Balloon Catheter
Cordis Savyy PTA Balloon Catheter
Cordis Mega PTA Balloon Catheter
Meditech UltraThin Balloon Catheter

III. 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

All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure.

The balloon inflation lumen is used to inflate and deflate the balloon. The nominal balloon size is printed on the hub.

The guidewire lumen is used to track the catheter over a prepositioned guidewire or to inject contrast medium and/or saline. The maximum injection pressure is 450 psi. The compatible guidewire size, catheter shaft French size and catheter length are printed on the hub. The radiopaque marker bands indicate the stated nominal length of the balloon.

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VI. Biocompatibility

All materials used in the PowerFlex Plus PTA balloon catheter are biocompatible.

VII. Summary of Substantial Equivalence

The Cordis PowerFlex Plus PTA balloon catheter and the referenced Cordis PowerFlex PTA balloon catheter, Cordis Opta5 PTA balloon catheter, Cordis Small Vessel PTA balloon catheter, Cordis Savvy PTA balloon catheter, Cordis Mega PTA balloon catheter and Meditech UltraThin balloon catheter are similar in their basic design, construction, indication for use and performance characteristics.

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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 with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUM SERVICES • USA" are arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 3 1997

Ms. Jan Pieter Kappelle Cordis Corporation 14201 N.W. 60th Avenue ... . Miami Lakes, Florida 33014

Re: K971516 PowerFlex™ PTA Balloon Catheter Regulatory Class: II (two) Product Code: 74 LIT Dated: April 25, 1997 Received: April 28, 1997

Dear Ms. Kappelle:

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 aqainst 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 requlations.

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Page 2 - Ms. Jan Pieter Kappelle

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 leqally 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) 594-4639. 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, "Misbrandinq 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 Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Cordis PowerFlex™ Plus PTA Balloon Catheter

Indications for Use:

The PowerFlex Plus PTA Balloon Catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries, and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

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(Division Sign -Division of C and Neurolo¿ and Neurolog
510(k) Numbe: ..... 179 715112

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS 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).