The Maxi DS PTA balloon Catheter intended use is to dilate stenoses in iliac, femoral, ilio femoral, popliteal, infra-popliteal, and renal arteries and the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. In addition, the Maxi DS catheters are also indicated for deployment of Palmaz Balloon expandable stents for the biliary system.

Device Description

The Maxi DS PTA Balloon Catheters are indicated for dilatation of 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. In addition, certain sizes of the Maxi DS catheters are also indicated for deployment of Palmaz balloon expandable stents for the biliary system.

AI/ML Overview

This document is a 510(k) premarket notification for the Cordis Maxi DS PTA Balloon Catheter, seeking to establish substantial equivalence to previously cleared predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria beyond biocompatibility and a general statement of substantial equivalence to predicate devices.

Therefore, I cannot provide the requested information:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text. The document states "Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act." and focuses on demonstrating substantial equivalence to predicate devices rather than meeting new, specific performance criteria.

2. Sample sized used for the test set and the data provenance: Not applicable, as detailed performance testing data for a specific acceptance criterion is not provided. The substantial equivalence claim is based on the device design and intended use being similar 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.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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: Not applicable, as this is a medical device (balloon catheter) submission, not an AI-enabled diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for substantial equivalence is based on comparison to legally marketed predicate devices.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

Summary

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Attachment 4

Summary of Safety and Effectiveness JUN 15 1999 Trade Name: Cordis Maxi DS PTA Balloon Catheter General Provisions Common/Classification Name: Peripheral Transluminal Angioplasty Balloon Catheter Name of Cordis Opta5 PTA Balloon Catheter Cordis Maxi LD PTA Balloon Catheter Predicate Devices Class II. Classification Performance standards have not been established by the FDA under section 514 of Performance the Food, Drug and Cosmetic Act. Standards The Maxi DS PTA Balloon Catheters are indicated for dilatation of stenoses in iliac, Intended Use femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the and Device treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Description In addition, certain sizes of the Maxi DS catheters are also indicated for deployment of Palmaz balloon expandable stents for the biliary system. Biocompatibility All materials used in the Maxi DS PTA Balloon Catheters are biocompatible. Summary of The Maxi DS catheters are substantially equivalent to the previously cleared Opta5 and Maxi LD catheters. Substantial Equivalence

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three wavy lines that resemble a person. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.

Public Health Service

JUN 15 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ariel MacTavish, RAC Sr. Regulatory Affairs Associate Cordis Corporation P.O. Box 025700 Miami Lakes, FL 33014

Re: K991811 Cordis Maxi DS PTA Balloon Catheter Trade Name: Requlatory Class: II Product Code: LIT Dated: May 26, 1999 Received: May 27, 1999

Dear Ms. MacTavish:

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 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). 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, 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 In addition, FDA may publish further announcements concerning action. your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices

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Page 2 - Ariel MacTavish, RAC

under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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) 594-4586. 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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

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

Enclosure

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Attachment 2

Indications for Use Statement

510(k) Number (if known)
Device Name	Maxi DS PTA balloon Catheter
Indications for Use	The Maxi DS PTA balloon Catheter intended use is to dilate stenoses in iliac, femoral, ilio femoral, popliteal, infra-popliteal, and renal arteries and the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. In addition, the Maxi DS catheters are also indicated for deployment of Palmaz Balloon expandable stents for the biliary system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number K991811
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Prescription Use ✓(Per 21 CFR 801.109)	OR	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).