MODIFICATION TO FOX PTA CATHETER

K020854 · Jomed AG · LIT · Apr 11, 2002 · Cardiovascular

Device Facts

• Record ID: K020854
• Device Name: MODIFICATION TO FOX PTA CATHETER
• Applicant: Jomed AG
• Product Code: LIT · Cardiovascular
• Decision Date: Apr 11, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fox 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.

Device Story

Double-lumen catheter with distal balloon; used for percutaneous transluminal angioplasty (PTA) to dilate arterial lesions and dialysis fistulae. Operated by physicians in clinical settings. Balloon diameters 3.0-12.0 mm; lengths 20-80 mm; catheter lengths 75 and 135 cm. Compatible with 0.035" guidewires. Device facilitates vessel patency by mechanical dilation.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Double-lumen catheter; balloon-tipped; 3.0-12.0 mm diameter; 20-80 mm length; 75/135 cm catheter length; 0.035" guidewire compatibility. Mechanical dilation principle.

Indications for Use

Indicated for dilatation of lesions in femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae.

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

• Jomed Fox PTA Catheter (K010838)
• Guidant VIATRAC PTA Catheter (K000101)
• NuMED Ghost II PTA Catheter (K003972)

Submission Summary (Full Text)

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APR 1 1 2002

Sponsor:
JOMED

## 510(k) SUMMARY -- Fox PTA Catheter

| Submitter Name: | Jomed AG | | |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Submitter Address: | Ampthauptstrasse, Postfach<br>CH-8222 Beringen, Switzerland | | |
| Contact Person: | Rudi Ott | | |
| Phone Number: | + 41 52 674 8505 | | |
| Fax Number: | [phone] | | |
| Date Prepared: | 15 March 2002 | | |
| Device Trade Name: | Fox PTA Catheter | | |
| Device Common Name: | Peripheral Transluminal Angioplasty Catheter | | |
| Classification Name: | 21 CFR 870.1250 Percutaneous Catheter | | |
| Predicate Devices: | • Jomed Fox PTA Catheter, K010838<br>• Guidant VIATRAC PTA Catheter, K000101<br>• NuMED Ghost II PTA Catheter, K003972 | | |
| Device Description: | The JOSTENT® Fox PTA Catheter consists of a double<br>lumen catheter with a balloon located at the distal tip.<br>The catheter will be available with balloon diameters of<br>3.0 - 12.0 mm and balloon lengths of 20 - 80 mm. The<br>catheter will be available in lengths of 75 and 135 cm.<br>The catheter is compatible with 0.035" diameter<br>guidewires. | | |
| Intended Use: | The Fox PTA Catheter is intended for dilatation of<br>lesions in the femoral, renal, iliac, popliteal, peroneal,<br>and profunda arteries and native or synthetic<br>arteriovenous dialysis fistulae. | | |
| Device Technological | The Fox PTA Catheter is made of similar materials, is | | |

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| Characteristics and<br>Comparison to<br>Predicate Device(s): | available in similar diameters and lengths, has a similar<br>design, and the same indications for use as the predicate<br>devices and other currently marketed PTA Catheters. |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data: | Bench, biocompatibility, and design control activities<br>demonstrate the safety and effectiveness of the Fox PTA<br>Catheter. |
| Conclusion: | The Fox PTA Catheter is substantially equivalent to the<br>claimed predicate devices and other currently marketed<br>PTA Catheters. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is written around the upper portion of the circle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 1 2002

Mr. Glenn N. Byrd, MBA, RAC Director, Regulatory Affairs Eminent Research Systems, Inc 1700 Rockville Pike, Suite 400 Rockville, MD 20852

Re: K020854

> JoMed Fox PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: 74 LIT Dated: April 2, 2002 Received: April 2, 2002

Dear Mr. Byrd:

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. Iisting 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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour device complies with other requirements of the Act

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## Page 2 - Mr. Glenn N. Byrd, MBA, RAC

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 vours.

AedacMoyn

for

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known): | j020854 |
|---------------------------|---------|
|---------------------------|---------|

Device Name:

Fox PTA Catheter

Indications for Use:

The Fox 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.

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Concurrence of CDRH; Office of Device Evaluation (ODE)
*Division Sign-Off* for Donna. Bee Tillman
Division of Cardiovascular, Respiratory, and Neurological Devices

| 510(k) Number | K020554 |
|---------------|---------|
|---------------|---------|

| Prescription Use (Per 21 CFR 801.109) | <div>OR</div> | Over-The-Counter Use |
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