RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003

K983055 · Guidant Corp. · LIT · Dec 30, 1998 · Cardiovascular

Device Facts

• Record ID: K983055
• Device Name: RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003
• Applicant: Guidant Corp.
• Product Code: LIT · Cardiovascular
• Decision Date: Dec 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The RX VIATRAC™ 14 Peripheral Dilatation Catheter is indicated for dilatation of stenoses in the peripheral vasculature (iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries) and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. In addition, the RX VIATRAC 14 Peripheral Dilatation Catheter is indicated for balloon dilatation of the PALMAZ™ P204 stent following implantation. It is not intended for use in the coronary vasculature.

Device Story

Rapid exchange peripheral dilatation catheter; integrated shaft system with XCELON (nylon blend) balloon at distal end. Proximal shaft features single lumen for contrast inflation; distal lumen accommodates guide wire for catheter advancement through stenosis. Tapered stainless steel mandrel provides shaft support and flexibility. Two radiopaque markers on balloon aid positioning. Single arm adaptor with luer-lock fitting at proximal end connects to inflation device. Used by clinicians in clinical settings to dilate peripheral vascular stenoses, treat arteriovenous dialysis fistulae, and post-dilate PALMAZ P204 stents. Output is mechanical expansion of balloon at specific pressures to restore vessel patency.

Clinical Evidence

Bench testing only. Testing demonstrated that the device met acceptance criteria and performed equivalently to predicate Cordis Jupiter and OPTA 5 PTA catheters.

Technological Characteristics

Rapid exchange catheter; XCELON (nylon blend) balloon; stainless steel mandrel; single lumen proximal/coaxial distal design. Radiopaque markers for positioning. Luer-lock inflation interface. Sterilized.

Indications for Use

Indicated for dilatation of stenoses in peripheral vasculature (iliac, femoral, ilio-femoral, popliteal, infra-popliteal, renal arteries), treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae, and balloon dilatation of PALMAZ™ P204 stents. Not for use in coronary vasculature.

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

• Cordis Jupiter™ PTA Catheter (K970299)
• Cordis OPTA 5™ PTA Catheter (K972825)

Reference Devices

• PALMAZ™ P204 stent

Submission Summary (Full Text)

{0}------------------------------------------------

DEC 30 1998

Image /page/0/Picture/1 description: The image shows a sequence of alphanumeric characters, seemingly handwritten. The sequence starts with the letter 'K', followed by the number '9830', and ends with the letters 'JJ'. The characters are written in a dark color, possibly black or dark blue, against a light background.

## 510(k) SUMMARY

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

| 1. Submitter's Name: | Guidant Corporation<br>Advanced Cardiovascular Systems, Inc. |
|-----------------------------|-----------------------------------------------------------------------------------------------------------|
| Submitter's Address: | 3200 Lakeside Drive<br>Santa Clara, CA 95054 |
| Telephone: | 408-235-3995 |
| Fax: | 408-235-3743 |
| Contact Person: | Susan Silavin, Ph.D. |
| Date Prepared: | August 28, 1998 |
| 2. Device Trade Name: | RX VIATRAC ^TM 14 Peripheral Dilatation Catheter |
| Device Common Name: | Percutaneous Transluminal Angioplasty Catheter |
| Device Classification Name: | LIT |
| 3. Predicate Devices: | Cordis Jupiter ^TM PTA Catheter (K970299)<br>Cordis OPTA 5 ^TM PTA Catheter (K972825) |

- 4. Device Description:
The RX VIATRACTM 14 Peripheral Dilatation Catheter is a rapid exchange catheter with an integrated shaft system and an XCELON™ (nylon blend) balloon bonded at the distal end. The shaft has a combination of a single lumen design at the proximal end and a coaxial lumen at the distal end. The proximal lumen provides for inflation of the balloon with contrast medium. The distal lumen permits use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The proximal shaft has a tapered stainless steel mandrel which provides support and flexibility to the shaft and is attached at the proximal end.

The balloon, which has 2 radiopaque markers to aid in positioning the balloon in the stenosis, is designed to provide an expandable segment of know diameter and length at specific pressures.

The proximal end of the catheter has a single arm adaptor that provides access to the inflation lumen. It is designed with a luer-lock fitting for connection with an inflation device.

{1}------------------------------------------------

The RX VIATRAC™ 14 Peripheral Dilatation Catheter is available in 75 cm and 135 cm catheter lengths and with balloon diameters of 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 and 7.0 mm.

- 5. Intended Use:
The RX VIATRAC™ 14 Peripheral Dilatation Catheter is indicated for dilatation of stenoses in the peripheral vasculature (iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries) and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. In addition, the RX VIATRAC 14 Peripheral Dilatation Catheter is indicated for balloon dilatation of the PALMAZ™ P204 stent following implantation. It is not intended for use in the coronary vasculature.

- 6. Technological Characteristics:
Comparisons of the new and predicate devices show that technological characteristics such as materials, biocompatibility, performance properties (see below), sterilization, and packaging are identical or substantially equivalent to the currently marketed predicate devices.

- 7. Performance Data:
Bench testing was performed to demonstrate that the met the acceptance criteria and performed similar to the predicate Cordis Jupiter™ and OPTA 5™ PTA Catheters. The following tests were performed:

{2}------------------------------------------------

The results from the bench tests showed that the new RX VIATRAC™ 14 Peripheral Dilatation Catheter met acceptance criteria and performed in a manner equivalent to the predicate Cordis Jupiter™ and Cordis OPTA 5™ PTA Catheters. No new safety or effectiveness issues were raised during the testing program.

- 8. Conclusions:
Since the new RX VIATRAC™ 14 Peripheral Dilatation Catheter has the same intended use, similar design and technological characteristics, equivalent performance properties, identical sterilization and packaging, and no new safety or effectiveness issues, the RX VIATRAC™ 14 Peripheral Dilatation Catheter may be considered substantially equivalent to the predicate Cordis Jupiter™ and Cordis OPTA 5TM PTA Catheters.

{3}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three birds in flight, arranged in a row.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 30 1998

Sudan Silavin, Ph.D. Senior Regulatory Affairs Coordinator Guidant Corporation 3200 Lakeside Drive P.O. Box 58167 Santa Clara, CA 95054

Re : K983055

Trade Name: RX VIATRAC™ 14 Peripheral Dilatation Catheter Regulatory Class: II Product Code: LIT Dated: November 20, 1998 November 23, 1998 Received:

Dear Dr. Silavin:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to

{4}------------------------------------------------

Page 2 - Dr. Susan Silavin

your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callehan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory And Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use Statement

510(k) Number (if known):

Device Name: RX VIATRAC™ 14 Peripheral Dilatation Catheter

## Indications for Use:

The RX VIATRAC™ 14 Peripheral Dilatation Catheter is indicated for dilatation of stenoses in the peripheral vasculature (iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries) and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. In addition, the RX VIATRAC™ 14 Peripheral Dilatation Catheter is indicated for balloon dilatation of the PALMAZ™ P204 stent following implantation. It is not intended for use in the coronary vasculature.

Tara A. Ry

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K983055

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | |
|------------------------------------------|--|
|------------------------------------------|--|

OR

| Over-The-Counter | |
|------------------|--|
|------------------|--|

(Optional Format 1-1-96)