The PolarCath Peripheral Dilatation System is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal and renal arteries) and for the treatment of obstructive lesions of PTFE access grafts or artcriovenous dialysis fistulae.

Device Description

The PolarCath Peripheral Dilatation System consists of a Catheter, Inflation Unit, connecting cable and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cartridge.

AI/ML Overview

The provided text describes the 510(k) summary for the PolarCath™ Peripheral Dilatation System. However, it does not include detailed acceptance criteria or a study proving that the device meets those criteria.

The "Performance Data" section explicitly states: "The safety and effectiveness of the modified PolarCath Peripheral Dilatation System is demonstrated with design control activities and bench testing on file at CryoVascular Systems, Inc." This indicates that the supporting data is held internally by the company and is not detailed in the provided 510(k) summary.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer the specific questions about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a study that is not described in this document.

The document focuses on:

Device Description: What the PolarCath Peripheral Dilatation System is.
Indications for Use: What the device is intended for.
Substantial Equivalence: How it is similar to predicate devices.
Regulatory Information: Sponsor, contact person, product codes, classification, and the FDA's letter of clearance.

In summary, based on the provided text, the specific study details and acceptance criteria you've requested are not available.

Summary

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4. 510(k) Summary

Sponsor:	CryoVascular Systems, Inc.160 Knowles DriveLos Gatos, CA 95032
Contact Person:	Kim Tompkins
Phone Number:	408 866 3203
Fax Number:	408 376 3677
Prepared:	November 17, 2003
Trade Name:	PolarCath™ Peripheral Dilatation System
Common Name:	Percutaneous Transluminal Angioplasty Catheter
Classification:	II
Product Code:	LIT21 CRF 870.1250

Predicate Devices: PolarCath Peripheral Dilatation System

Device Description

Indications for Use

Substantial Equivalence

The PolarCath Peripheral Dilatation System design, materials, manufacturing process and intended use are substantially equivalent to the predicate device and other marketed PTA catheters.

Performance Data

The safety and effectiveness of the modified PolarCath Peripheral Dilatation System is demonstrated with design control activities and bench testing on file at CryoVascular Systems, Inc.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized, parallel lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 2004

Cryovascular Systems, Inc. c/o Ms. Kim Tompkins Sr. Director, Clinical and Regulatory Affairs 160 Knowles Drive Los Gatos, CA 95032

Re: K033622

PolarCath™ Peripheral Balloon Catheter System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: January 9, 2004 Received: January 22, 2004

Dear Ms. Tompkins:

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 adultcration.

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.

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

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Page 2 – Ms. Kim Tompkins

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QS) regulation (21-52 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action S product radiation control provisions (Scctions 35 - 3 - 5 - 5 - 12 - 17 - 12 - 12 - 12 - 12 - 12 - 12 -This letter will allow you to begin marketing your actives of your device of your device to a legally premarket notification. The FDA Imaling of substantial equive 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
rs the regulation and 1991 - 1991 - 144 (446) - Alass maters note the regul If you desire specific advice for your de nec on 646. Also, please note the regulation entitled,
contact the Office of Compliance at (301) 594-4646. Also, please note the reg contact the Office of Comphalico at (301) 577 1707 (21CFR Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97) "Misbranding by reference to prematics nonification (certeen the Division of Small)
other general information on your responsibilities under (sites number (800) 638-204 other general information on your responsionnes and the research of the number (800) 638-2041 or (301) 443-6597 or at its Internet address

(301)443-0597 or al its intono.usus and smamain. html

Sincerely yours,

Dana R. Vochner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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3. 510(k) Indications for Use

Page 1 of 1

510(k) Number (if known):

Device Name: PolarCathTM Peripheral Dilatation System

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 J OR Over-the-Counter Use (per 21 CFR 801.109)

Dana R.Vachner
(Division Sign-Off)
Division of Cardiovascular Devices

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).