MODIFICATION TO: FOX PLUS PTA CATHETER

K080264 · Abbott Vascular-Vascular Solutions · LIT · Mar 26, 2008 · Cardiovascular

Device Facts

• Record ID: K080264
• Device Name: MODIFICATION TO: FOX PLUS PTA CATHETER
• Applicant: Abbott Vascular-Vascular Solutions
• Product Code: LIT · Cardiovascular
• Decision Date: Mar 26, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fox Plus 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.

Device Story

The Fox Plus PTA Catheter is an over-the-wire percutaneous transluminal angioplasty (PTA) catheter used by physicians in clinical settings. It features a double-lumen design: one lumen for balloon inflation and one for guidewire insertion (up to 0.035"). The distal tip contains an inflatable balloon with two radiopaque markers for fluoroscopic positioning relative to arterial or fistula stenosis. The device is manually operated by the clinician to dilate stenotic lesions by expanding the balloon to a known diameter at specific pressures. It provides a mechanical means to restore vessel patency, benefiting patients with peripheral arterial disease or dialysis access complications.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness were demonstrated through in vitro bench tests and biocompatibility testing.

Technological Characteristics

Over-the-wire double-lumen PTA catheter. Features an inflatable balloon with two radiopaque markers. Compatible with guidewires up to 0.035". Balloon expands to specific diameters at defined pressures. Materials and design are substantially equivalent to predicate devices.

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 expansion or delivery.

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)
• Sailor Plus PTA Balloon Dilatation Catheter (K042538)

Submission Summary (Full Text)

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K080264

any lit 2

MAR 2 6 2008

## 510(k) Summary

### Summary Information

The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.

Submitter's Name: Abbott Vascular

Submitter's Address: 3200 Lakeside Drive Santa Clara, CA 95054

Telephone: [phone]

Fax: [phone]

Contact Person: Ivalee Cohen

Manager, Regulatory Affairs

Date Prepared:

Device Trade Name: Device Common Name: Device Classification: Device Classification Number: Device Product Code:

January 31, 2008

Fox™ Plus PTA Catheter PTA Catheter Class II 21 CFR 870.1250 LIT

#### Predicate Devices

The subject device is substantially equivalent to the Fox Plus PTA Catheter predicate device (K040954, cleared on May 11, 2004) and to the Sailor™ Plus PTA Balloon Dilatation Catheter predicate device (K042538, cleared on November 8, 2004).

#### Device Description

The Fox Plus 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 0.035"). The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The balloon material expands to a known diameter at specific pressures.

## Intended Use

The intended use for the device has not changed as a result of the modification.

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

## Summary of Technological Characteristics Compared to Predicate Devices

The Fox™ Plus PTA Catheter subject device is identical in technological characteristics, with the exception of balloon lengths, to the Fox Plus PTA Catheter predicate device. The subject device is also substantially equivalent to the Sailor™ Plus PTA Balloon Dilatation Catheter with respect to product code, classification section, classification name, intended use, catheter length, balloon diameters and lengths, introducer sheath size, and guidewire compatibility.

### Summary of Substantial Equivalence

The Fox Plus PTA Catheter subject device is substantially equivalent to the predicate devices. The results of the in vitro bench tests and analyses and biocompatibility testing demonstrate the safety and effectiveness of the Fox Plus PTA Catheter subject device.

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ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 6 2008

Abbott Vascular c/o Ms. Ivalee Cohen 3200 Lakeside Drive Santa Clara, CA 95054

Re: K080264

Trade Name: Fox 1M Plus PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Transluminal Angioplasty Catheter Regulatory Class: Class II (two) Product Code: LIT Dated: January 31, 2008 Received: February 1, 2008

Dear Ms. Cohen:

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.

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Page 2 - Ms. Ivalee Cohen

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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 Statement

510(k) Number (if known): K080264

Device Name: Fox™ Plus PTA Catheter

Indications for Use:

The Fox Plus 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.

OR

Prescription Use × (Per 21 CFR 801.109)

Over-The-Counter Use

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of

(Division Sign-Off) Division of Cardlovascular Devices 510(k) Number