FOX SV PTA CATHETER

• K Number: K062843
• Device Name: FOX SV PTA CATHETER
• Manufacturer: ABBOTT LABORATORIES
• Date Cleared: 2006-10-17 ( 25 days)
• Product Code: LIT
• Regulation Number: 870.1250
• Type: Special
• Panel: Cardiovascular
• Reference & Predicate Devices: K051519
• Predicate For: K072824

Intended Use

The Fox SV PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae. This catheter is not intended for the delivery or expansion of stents.

Device Description

The Fox SV PTA Catheter is a standard over-the-wire PTA catheter. The double lumen catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the second lumen allows access to the distal tip of the catheter for guidewire insertion (max 0.018"). The balloon material expands to a known diameter at specific pressure.

AI/ML Overview

Sorry, but this document does not contain the information required to answer your question. The document is a 510(k) summary for a medical device (Fox SV PTA Catheter) and focuses on regulatory approval and substantial equivalence to a predicate device. It does not include details about acceptance criteria, study methodologies, or performance data in the way you've outlined.

The provided document describes:

• The device trade name, classification, and regulation number.
• The intended use and device description.
• A statement of substantial equivalence based on non-clinical testing.
• FDA communication regarding the 510(k) premarket notification.

It lacks any mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication methods.
• MRMC comparative effectiveness studies or effect sizes.
• Standalone algorithm performance studies.
• Types of ground truth used (e.g., pathology, outcomes data).
• Training set sample sizes or how training set ground truth was established.

Summary

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APPENDIX A. 510(k) SUMMARY

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Sponsor/Submitter:	Abbott LaboratoriesAbbott Vascular Inc.400 Saginaw DriveRedwood City, CA 94063
Contact Person:	Kathryn MarchelRegulatory Affairs CoordinatorPhone:[phone]Fax:[phone]
Date of Submission:	September 21, 2006
Device Trade Name:	Fox SV PTA Catheter
Device Classification:	Class II
Regulation Number:	21 CFR 870.1250
Classification Name:	Percutaneous Transluminal Angioplasty Catheter
Product Code:	LIT
Predicate Device:	Fox SV PTA Catheter (K051519)
Intended Use:	The Fox SV PTA Catheter is intended for dilatation of lesions in thefemoral, renal, iliac, popliteal, peroneal, and profunda arteries andnative or synthetic arteriovenous dialysis fistulae. This catheter isnot intended for the delivery or expansion of stents.
Device Description:	The Fox SV PTA Catheter is a standard over-the-wire PTA catheter.The double lumen catheter has a balloon located near the distal tip.One lumen is used for inflation of the balloon, while the secondlumen allows access to the distal tip of the catheter for guidewireinsertion (max 0.018"). The balloon material expands to a knowndiameter at specific pressure.
Summary of SubstantialEquivalence:	The Fox SV PTA Catheter is substantially equivalent to thepredicate device. Substantial equivalence was confirmed throughnon-clinical testing.
OCT 17 2006

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is written around the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 17 2006

Kathryn Marchel Regulatory Affairs Coordinator 500 Saginaw Drive Redwood City. CA 9406 Ph: 650-474-6341 Fax: [phone]

Re: K062843

Trade/Device Name: Fox SV PTA Transluminal Angioplasty Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Angioplasty Catheter Regulatory Class: II (two) Product Code: LIT Dated: September 21, 2006 Received: September 22, 2006

Dear Ms. Marchel:

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 itestate 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, Or e. 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. Marchel

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dmna R. Vachner

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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APPENDIX B. INDICATIONS FOR USE STATEMENT

• Ko62843 510(k) Number (if known):

Device Name:

Fox SV PTA Catheter

Indications For Use:

The Fox SV PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae.

This catheter is not intended for the expansion or delivery of stents.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use [] (Part 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)

Dma R. Vochner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_KO 6 2

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).