The PolarCath Peripheral Balloon Catheter System is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, iliofemoral, popliteal, infrapopliteal and renal arteries) and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

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 native arteriovenous dialysis fistulae.

Device Description

The PolarCath Peripheral Balloon Catheter System consists of a Peripheral Balloon 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 cylinder.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria or the study that definitively proves the device meets those criteria.

However, based on the available text, here's what can be gathered regarding performance data:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
(Not specified in the provided text)	In vitro testing demonstrated that the PolarCath Peripheral Balloon Catheter System met all acceptance criteria.

2. Sample size used for the test set and data provenance:
The document states "In vitro testing" was performed. This generally refers to testing conducted in a controlled environment, often in a lab, using non-biological materials or simulations.

Sample Size for Test Set: Not specified.
Data Provenance: The nature of "in vitro testing" suggests a controlled laboratory setting, not related to specific countries or retrospective/prospective human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as the performance data is based on "in vitro testing" rather than expert-derived ground truth.

4. Adjudication method for the test set:
Not applicable, as the performance data is based on "in vitro testing" rather than expert 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:
Not applicable. The device described, the PolarCath Peripheral Balloon Catheter System, is a medical device for dilating stenosis, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical medical instrument, not an algorithm.

7. The type of ground truth used:
For "in vitro testing," the "ground truth" would typically refer to established engineering specifications, physical measurements, or validated standards against which the device's performance characteristics (e.g., burst pressure, inflation/deflation times, material compatibility, lumen integrity) are compared. The document does not specify these precise "ground truths."

8. The sample size for the training set:
Not applicable, as this device is not an AI/algorithm and therefore does not have a "training set."

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

Summary of available information:

The 510(k) summary for the PolarCath Peripheral Balloon Catheter System (K030742) indicates that "in vitro testing demonstrated that the PolarCath Peripheral Balloon Catheter System met all acceptance criteria." However, the document does not specify what those acceptance criteria were, nor does it provide details about the "in vitro testing" itself, such as methods, sample sizes, or specific results. The information provided is very high-level and focused on the regulatory submission process rather than a detailed scientific study report.

Summary

{0}------------------------------------------------

K030742

510(k) Summary 4.

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:	March 7, 2003
Trade Name:	PolarCath™
Common Name:	Percutaneous Transluminal Angioplasty Catheter
Classification:	II
Product Code:	79 LIT
Predicate Devices:	PolarCath Peripheral Balloon Catheter SystemRX Viatrac 14 Peripheral Dilatation CatheterVantage Dilatation CatheterCook PTA Balloon Catheter

Device Description

Indications for Use

Substantial Equivalence

The PolarCath Peripheral Balloon Catheter System design, materials, manufacturing process and intended use are substantially equivalent to the predicate devices.

Performance Data

In vitro testing demonstrated that the PolarCath Peripheral Balloon Catheter System met all acceptance criteria.

{1}------------------------------------------------

Image /page/1/Picture/2 description: The image shows a logo with three stylized birds in flight, enclosed within a circle. The birds are represented by curved lines, suggesting movement and freedom. The circle is not a solid line but appears to be made up of small, possibly dashed, segments, giving it a textured look. The logo is simple yet dynamic, conveying a sense of aviation or environmental themes.

AUG 2 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CryoVascular Systems, Inc. c/o Ms. KimTompkins Regulatory Affairs 160 Knowles Drive Los Gatos, CA 95032

Re: K030742

Trade Name: PolarCath™ Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: LIT Dated: June 9, 2003 Received: June 10, 2003

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 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.

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

{2}------------------------------------------------

Page 2 - Ms. KimTompkins

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 yours,

Jlos. OHAz fr

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

Enclosure

{3}------------------------------------------------

510(k) Number (if known): K030742

Device Name: PolarCath™ Peripheral Dilatation System

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Optional Format 3-10-98)

(Posted July 1, 1998)

510(k) Number K030742

Page 10 of 10

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).