CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA by CORDIS EUROPA N.V.

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

The POWERFLEX P3 PTA catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The OPTA PRO PTA catheter is intended to dilate stenoses in ilio-femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Description

The modified PTA catheters described in this submission are virtually identical to its original cleared devices, which received 510(k) concurrence.

The Cordis over-the-wire (OTW) PTA balloon catheters have a dual lumen design with a distal inflatable balloon. Two radiopaque marker bands indicate the dilatation section of the balloon and aid in balloon placement. The radiopaque marker bands indicate the nominal length of the balloon. The balloon inflation lumen is used to inflate and deflate the balloon. The guide wire lumen is used to track the catheter over a pre-positioned guide wire or to inject contrast medium and/or saline.

Compared to the previously cleared predicate devices, the devices in this submission are identical, except for the following feature: Polyamide hub instead of polycarbonate hub Injection molded hub instead of UV-glued hub Slight design configuration change for user preference.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for Cordis PTA Balloon Catheters, and it does not include information about a study proving the device meets specific acceptance criteria in the way a clinical trial or AI/ML performance study would.

Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices based on non-clinical design verification tests and analyses. This approach is typical for 510(k) submissions where the new device is very similar to an already approved one.

Therefore, many of the requested points related to acceptance criteria, ground truth, expert adjudication, MRMC studies, standalone performance, and training/test set details are not applicable or discoverable in this type of submission.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no explicit table of acceptance criteria and reported device performance in the context of a clinical performance study with defined metrics (e.g., sensitivity, specificity, accuracy).

Instead, the "performance" demonstrated is that the modified devices are "virtually identical" to their original cleared devices, with changes limited to non-clinical aspects like hub material and design configuration for user preference. The regulatory "acceptance criteria" here are implicitly that these minor design changes do not negatively impact the safety and effectiveness, and the device continues to meet the safety and performance of its predicate.

Acceptance Criteria (Implicit): The modified devices demonstrate biocompatibility, and their non-clinical performance (e.g., inflation/deflation, tracking over a guidewire, radiopacity) is equivalent to the predicate devices, and the changes do not introduce new safety concerns.
Reported Device Performance: "Safety and The safety and effectiveness of the affected PTA Balloon Catheters have been Performance demonstrated via data collected from non-clinical design verification tests and Data analyses. All materials used in these modified devices have been tested according to ISO 10993-Part 1 and were found biocompatible."

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

Test Set Size: Not applicable. This submission relies on non-clinical design verification tests, not a clinical test set with patient data.
Data Provenance: Not applicable, as there are no patient data. The "data" are from non-clinical laboratory tests.

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

Number of Experts: Not applicable. Ground truth as typically understood for clinical performance studies (e.g., diagnosis, lesion identification) is not established here.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

Not applicable. There is no clinical test set requiring adjudication.

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:

MRMC Study: No. This is a medical device (balloon catheter), not an AI/ML diagnostic or assistive device that would involve human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

Ground Truth: For biocompatibility, the "ground truth" is adherence to ISO 10993-Part 1 standards. For functional performance, the "ground truth" is equivalence in non-clinical bench testing to the predicate device. This is a technical (engineering/materials) ground truth, not a clinical ground truth.

8. The sample size for the training set:

Not applicable. There is no AI/ML component, so no training set.

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

Not applicable.

Summary

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K032737

510(k) Premarket Notification

Attachment 1		OCT - 2 2003
Summary of Safety and Effectiveness
Submitter & Contact person:	Cordis Europa, N.V., a Johnson & Johnson Company Oosteinde 8 NL-9300 LJ Roden, The Netherlands
	Harm Hovinga Senior Regulatory Affairs Associate Tel (+31) (5050) 22479 Fax: (+31) (5050)-22456 e-mail: hhovinga@crdnl.jnj.com
Date Prepared	October 1, 2003
Trade Name	Cordis PowerFlex TM Extreme PTA Balloon Catheter Cordis PowerFlex TM P3 PTA Balloon Catheter Cordis OPTA TM PRO PTA Balloon Catheter
Classification Name & Device Classification	Common Name: Peripheral Transluminal Angioplasty Balloon Catheter. Classification Name: 21 CFR 870.1250: Percutaneous Catheter. Class II; Product Code: #74LIT.

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Devicedescription	The modified PTA catheters described in this submission are virtually identical to its original cleared devices, which received 510(k) concurrence.
	The Cordis over-the-wire (OTW) PTA balloon catheters have a dual lumen design with a distal inflatable balloon. Two radiopaque marker bands indicate the dilatation section of the balloon and aid in balloon placement. The radiopaque marker bands indicate the nominal length of the balloon. The balloon inflation lumen is used to inflate and deflate the balloon. The guide wire lumen is used to track the catheter over a pre-positioned guide wire or to inject contrast medium and/or saline.
	Compared to the previously cleared predicate devices, the devices in this submission are identical, except for the following feature:Polyamide hub instead of polycarbonate hub Injection molded hub instead of UV-glued hub Slight design configuration change for user preference.
Name ofaffecteddevices	Cordis PowerFlex™ Extreme PTA Balloon CatheterCordis PowerFlex™ P3 PTA Balloon CatheterCordis OPTA™ PRO PTA Balloon Catheter
Performancestandards	The FDA under section 514 of the Food, Drug and Cosmetic Act has not established performance standards for these devices.
Conclusion	The Cordis PowerFlex Extreme, PowerFlex P3 and Opta Pro PTA balloon catheters are substantially equivalent to the predicate devices.

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The POWERFLEX EXTREME PTA catheter is intended for the treatment Intended Use of obstructive lesions of native or synthetic arteriovenous dialysis fistulae and to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries. The POWERFLEX P3 PTA catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The OPTA PRO PTA catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Safety and The safety and effectiveness of the affected PTA Balloon Catheters have been Performance demonstrated via data collected from non-clinical design verification tests and Data analyses. All materials used in these modified devices have been tested according to ISO 10993-Part 1 and were found biocompatible.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 2 2003

Cordis Corporation c/o Ms. Karen Wilk Manager, Regulatory Affairs 7 Powder Horn Drive Warren, NJ 07059

Re: K032737

Trade/Device Name: Cordis PowerFlex Extreme, PowerFlex P3, and OPTA PRO Percutaneous Transluminal Balloon Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DOY Dated: September 3, 2003 Received: September 4, 2003

Dear Ms. Wilk:

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.

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Page 2 - Ms. Karen Wilk

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 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 531-542 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 vours.

Dna Heuseler for
Brad D. Zuckerman, MD

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

Enclosure

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Special 510 (k) Number:

The Cordis POWERFLEX™ EXTREME Percutaneous Transluminal Angioplasty Device Names: (PTA) Catheter, the POWERFLEX™ P3 PTA Catheter and the OPTA™ PRO PTA Catheter

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)		OR	Over-The-Counter Use
			(Optional Format 1-2-96)

(Division Sign-Off)

Division of Cardiovascular, Respiratory and Neurological Devices

510(k) Number	K032737
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Special 510 (k) Number:

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).