The Opta LP PTA balloon catheters is intended to dilate stemoral, ilio-femoral, popliteal infra popliteal and renal arteries, and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Opta LP 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 Opta LP 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.

The working pressure range for the balloon is between the nominal size pressure and the rated burst pressure. 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 document is a 510(k) submission for the Cordis Opta LP PTA Balloon Catheter. It outlines the intended use, device description, and substantial equivalence to predicate devices, but does not contain information on acceptance criteria or a study proving the device meets said criteria. The document primarily focuses on regulatory approval based on substantial equivalence, rather than performance studies with specific metrics and acceptance criteria. Therefore, most of the requested information cannot be extracted from this document.

However, I can provide the following based on the available text:

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

Not available in the document. The document primarily addresses regulatory clearance through substantial equivalence, not detailed performance metrics against acceptance criteria.

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

Not applicable. No specific test set or clinical study data is reported in this 510(k) submission for the device itself. The submission relies on the substantial equivalence to predicate devices.

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

Not applicable. No test set requiring expert ground truth is described.

4. Adjudication method for the test set:

Not applicable. No test set is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This document is for a medical device (balloon catheter), not an AI-assisted diagnostic tool.

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

Not applicable. This document is for a medical device (balloon catheter), not an algorithm.

7. The type of ground truth used:

Not applicable. No performance study with ground truth is detailed in this document.

8. The sample size for the training set:

Not applicable. No training set for an algorithm is discussed.

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

Not applicable. No training set for an algorithm is discussed.

Summary

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SUMMARY OF SAFETY EFFECTIVENESS

" 3 1997 . || ||

I. General Provisions

PTA Balloon Catheter Common or Usual Name:

Opta LP™ PTA Balloon Catheter Proprietary Name:

II. Name of Predicate Devices

Cordis Opta5 PTA Balloon Catheter
Cordis PowerFlex PTA Balloon Catheter
Cordis Small Vessel PTA Balloon Catheter
Cordis Savvy 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

The Cordis Opta LP 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.

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

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VI. Biocompatibility

All materials used in the Opta LP PTA balloon catheter are biocompatible.

VII. Summary of Substantial Equivalence

The Cordis Opta LP PTA balloon catheter and the referenced Cordis Opta5 PTA balloon catheter, Cordis PowerFlex PTA balloon catheter, Cordis Small Vessel PTA balloon catheter, Cordis Savvy 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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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid with three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol, with "DEPARTMENT OF HEALTH & HUMAN" on the left side and "SERVICES - USA" on the top right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mirjam Barboza, M.D. Manager, Requlatory Affairs and Clinical Research Cordis Corporation P.O. Box 025700. - -----------------------------------------------------------------------------------------------------------------------------------------------------------

K971448 Re : Cordis Opta™ LP PTA Balloon Catheter Regulatory 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 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 requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 witro. ... 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. Callehan

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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510(k) Number (if known):

Device Name: Cordis Opta LPTM PTA Balloon Catheter

Indications for Use:

Tara t. Rh

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

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 ------

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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).