FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20, FOXCROSS .035 PTA CATHETER

K090509 · Abbott Vascular-Vascular Solutions · DQY · Mar 20, 2009 · Cardiovascular

Device Facts

• Record ID: K090509
• Device Name: FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20, FOXCROSS .035 PTA CATHETER
• Applicant: Abbott Vascular-Vascular Solutions
• Product Code: DQY · Cardiovascular
• Decision Date: Mar 20, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FoxCross 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 FoxCross PTA Catheter is an over-the-wire percutaneous transluminal angioplasty (PTA) catheter used by physicians to dilate arterial lesions and dialysis fistulae. The device features a double-lumen design: one lumen for balloon inflation and one for guide wire (max 0.035") insertion. A balloon at the distal tip, equipped with radiopaque markers for fluoroscopic positioning, expands to a specific diameter at controlled pressures. The device is used in clinical settings to improve blood flow by mechanically dilating stenotic vessels. It does not deliver or expand stents.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Over-the-wire double-lumen catheter; balloon with radiopaque markers; compatible with max 0.035" guide wires. Mechanical expansion via inflation lumen. No software or electronic components.

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

• FoxCross PTA Catheter
• Agiltrac .035 PTA Catheter

Submission Summary (Full Text)

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K090509 page 1 of 1

FoxCross PTA Catheter Special 510(k)

## 510(k) SUMMARY

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<br>Santa Clara, CA 95054 | MAR 20 2009 |
| Telephone: | 951-914-3311 | |
| Fax: | 951-914-0339 | |
| Contact Person: | Nadine Smith | |
| Date Prepared: | February 12, 2009 | |
| Device Trade Name: | FoxCross PTA Catheter (with 14mm balloon diameter) | |
| Device Common Name: | Percutaneous Catheter | |
| Device Classification Name: | Catheter | |
| Device Classification No.: | 21 CFR 870.1250 | |
| Device Classification: | Class II | |
| Device Product Code: | DOY | |

## Summary of Substantial Equivalence

The FoxCross PTA Catheter Line Extension (14mm balloon diameter) is substantially equivalent to the prodicate devices, the FoxCross PTA Catheter and the Agiltrac .035 PT A Catheter. The results of the in vitro bench tests and analyses demonstrate the safety and effectiveness of the FoxCross PTA Catheter Line Extension.

#### Device Description

The FoxCross 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 guide wire 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.

The FoxCross 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.

## Summary of Technological Characteristics Compared to Predicate Device

The FoxCross PTA Catheter Line Extension (with 14mm balloon diameter) is identical in technological characteristics, to the FoxCross PTA Catheter, with respect to product code, classification section, classification name, intended use, catheter lengths, introducer sheath size, and guide wire compatibility.

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od and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Abbott Vascular c/o Ms. Nadine Smith Regulatory Affairs 26531 Ynez Road Temecula, CA 92591

MAR 2 0 2009

Re: K090509

FoxCross PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: February 25, 2009 Received: February 26, 2009

Dear Ms. Smith:

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. Nadine Smith

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 (OS) 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 Biometrics' (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.

Z

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

Enclosure

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#### Abbott Vascular

# Indications For Use Statement

510(k) Number (if known)

KO90509

Device Name

FoxCross PTA Catheter

Indications for Use

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

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 (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

1-Off
Division of Cardiovascular Devices
for K090509

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