(22 days)
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 arteriovenous dialysis fistulae.
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.
The provided text describes a 510(k) premarket notification for the PolarCath™ Peripheral Dilatation System, which is a Percutaneous Transluminal Angioplasty Catheter. The document is a regulatory submission, not a study report, and therefore does not contain the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device performance.
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 traditional device testing (bench testing, design controls) was performed, not clinical studies involving AI performance metrics.
Therefore, I cannot provide the requested table and study details as they are not present in the provided document.
This document is from 2004, a period before AI/ML-driven medical devices were commonly evaluated in the same manner as described in your request. The evaluation framework for devices like this involved demonstrating substantial equivalence to a predicate device through engineering design, material specifications, manufacturing processes, and bench testing, rather than through extensive clinical performance studies with AI components.
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OCT 1 2 2004
K042541
page 1 of 1
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: | September 10, 2004 |
| Trade Name: | PolarCath™ Peripheral Dilatation System |
| Common Name: | Percutaneous Transluminal Angioplasty Catheter |
| Classification: | II |
| Product Code: | LIT/DQY21 CRF 870.1250 |
PolarCath Peripheral Dilatation System Predicate Devices:
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.
Indications for Use
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 arteriovenous dialysis fistulae.
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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its back, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.
OCT 1 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CryoVascular Systems, Inc. c/o Ms. Kim Tompkins Sr. Director, Clinical and Regulatory Affairs 160 Knowles Drive Los Gatos, CA 95032
Re: K042541
K042.941
Trade Name: PolarCath™ Peripheral Dilatation System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II (two) Product Code: DQY Dated: September 17, 2004 Received: September 20, 2004
Dear Ms. Tompkins:
We have reviewed your Section 510(k) premarket notification of intent to market the andication We have reviewed your Section 510(x) premaint is substantially equivalent (for the indications
referenced above and have determined the device marketed in interstate referenced above and nave determined the arrested predicate devices marketed in interstate for use stated in the enclosure) to regally manced provice Americal Device Ameridae, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the chacinent auto the Federal Food, Drug, 1994, Drug, devices that have been reciassified in accordance what approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general masisterstion, lightin You may, therefore, market the device, basjon to the enterests for annual registration, listing of
general controls provisions of the Act include requirements for annual regi general controls provisions of the receiners requires against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (Scc above) mis exist major regulations affecting your device can
may be subject to such additional controls. Existems may be subject to such additional controller Entitutions, Title 21, Parts 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 t be found in the Code of Peacharts concerning your device in the Federal Register.
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Page 2 -- Ms. Kim Tompkins
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase be advised that I Dris issues that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any I cacal statutes and regarantents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It Fat 6077, labeling (21 CFR Part 820); and if applicable, the electronic form in the quant) by sections (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro herems (seting your device as described in your Section 510(k) This letter with anow you're out a finding of substantial equivalence of your device to a legally premaince notification: "The Pro 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 if you desire 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 other general 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/cdrl/dsma/dsmamain.html
Sincerely yours,
Blumimar for
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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Indications for Use
510(k) Number (if known):_K042541
Device Name:__PolarCath™ Peripheral Dilatation System
Indications For Use:
The PolarCath Peripheral Dilatation System is indicated to dilates tenosis in the peripheral The PolarCath Peripheral Dhataton Oystem is indical, and renal arteries) and for the treatment of
vasculature (iliac, femoral, popliteal, infrapopliteal, and renal arteries) vasculature (inac, ichiorar, popileda), marke opening of the mative arteriovenous dialysis fistulae.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blumima
n Slan-Off Olvision of Cardlov vices 510(k) Number
§ 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).