FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES)

K051519 · Abbott Laboratories (Perclose, Inc.) · LIT · Jun 21, 2005 · Cardiovascular

Device Facts

• Record ID: K051519
• Device Name: FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES)
• Applicant: Abbott Laboratories (Perclose, Inc.)
• Product Code: LIT · Cardiovascular
• Decision Date: Jun 21, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

Fox SV PTA Catheter is an over-the-wire percutaneous transluminal angioplasty (PTA) catheter. Device features double-lumen design with balloon at distal tip; one lumen for balloon inflation, second lumen for guidewire access (max 0.018"). Balloon expands to known diameter at specific pressure. Used by physicians in clinical settings for arterial and dialysis fistula lesion dilatation. Output is mechanical dilation of stenotic vessels. Benefits patient by restoring vessel patency.

Clinical Evidence

Bench testing only.

Technological Characteristics

Over-the-wire PTA catheter; double-lumen design; balloon at distal tip; guidewire compatibility up to 0.018"; balloon expands to known diameter at specific pressure.

Indications for Use

Indicated for dilatation of lesions in femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae. Not for stent delivery or expansion.

Regulatory Classification

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.

Predicate Devices

• Fox Plus PTA Catheter (K040954)

Submission Summary (Full Text)

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JUN 2 1 2005

Special 510(k): Device Modification CONFIDENTIAL

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## APPENDIX A. 510(k) SUMMARY

| Sponsor/Submitter: | Abbott Laboratories (Perclose, Inc.)<br>Abbott Vascular Devices<br>400 Saginaw Drive<br>Redwood City, CA 94063 |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ann E. Leonard Ph.D. R.A.C.<br>Regulatory Affairs Coordinator<br>Phone:[phone]<br>Fax:[phone] |
| Date of Submission: | June 7, 2005 |
| 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 Plus PTA Catheter (K040954) |
| Intended Use: | The Fox SV PTA Catheter is intended for dilatation of lesions in the<br>femoral, renal, iliac, popliteal, peroneal, and profunda arteries and<br>native or synthetic arteriovenous dialysis fistulae. This catheter is<br>not intended for the delivery or expansion of stents. |
| Device Description: | The Fox SV PTA Catheter is a standard over-the-wire PTA catheter.<br>The double lumen catheter has a balloon located near the distal tip.<br>One lumen is used for inflation of the balloon, while the second<br>lumen allows access to the distal tip of the catheter for guidewire<br>insertion (max 0.018"). The balloon material expands to a known<br>diameter at specific pressure. |
| Summary of Substantial<br>Equivalence: | The Fox SV PTA Catheter is substantially equivalent to the<br>predicate device. Substantial equivalence was confirmed through<br>non-clinical testing. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.

JUN 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Abbott Vascular Devices c/o Ann E. Leonard, Ph.D. Regulatory Affairs Coordinator 400 Saginaw Drive Redwood City, CA 94063

Re: K051519 Fox SV PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: LIT Dated: June 7, 2005 Received: June 8, 2005

Dear Ms. Leonard:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > I o(x) premaince is substantially equivalent (for the indications
referenced above and have determined the device merketed in interstate referenced above and nave delemined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices of mendments for use stated in the enclosure) to tegally manced to of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Drug. commerce prior to May 28, 1970, the chaculience with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance with as proval application (PMA).
and Cosmetic Act (Act) that do not require approval assured a provisions of the Act . The and Cosmetic Act (Act) that do not require approvate of the general controls of the Act. The Act. The Act. The You may, therefore, market the device, subject of the gents for annual registration, listing of
general controls provisions of the Act include requirements for annual registr general controls provisions of the Act mende roquirement of the seainst 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 (see above) nito exist east in the state the your device can
may be subject to such additional controls. Existing major regulations FDA may may be subject to such additional controlist Existing major regalate and on addion, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 . be found in the Couc of Peacharts, In the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuality of a substitive complies with other requirements of the Act
that FDA has made a determination that your device areasonaias . You must that FDA has made a delerimhation that your as roses by other Federal agencies. You must or any Federal statules and regulations administed to: registration and listing (21
comply with all the Act's requirements, including, but not as sepiraments as set comply with all the Act S requirements, moradice requirements as set
CFR Part 807); labeling (21 CFR Part 801); end if englicable, the electronic CHR Part 807); labeling (21 CFR Part 820); god frances 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (Q5) roganation (Sections 531-542 of the Act); 21 CFF 1000-1050.
Product radiation control provisions (Sections 531-542 of the Actile in rever Se product faction control provisions (Sections 50 - C vice as described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to Jegal I his letter will anow you to ocgin maneting your in the may be and the species to a legally premarket notification. The PDA miding 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 Pair 801), please if you desire specific advice for your ac not 100 - Also, please note the regulation entitled, contact the Office of Complanes as (210) 21 St Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your responsion.com and its toll-free number [phone] or 1 Manufacturers, International and Ochsaniti v.loww.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Dunn R. Kirchner

Duna R. Vichne

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

K051519 ______________________________________________________________________________________________________________________________________________________________________ 510(k) Number (if known):

Fox SV PTA Catheter Device Name:

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 (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use [] (Part 21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Dune R. Vachon

(Division Sign-Off) Division of Cardiovascular Devices

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