RX VIATRAC 18 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER

K993639 · Guidant Corp. · LIT · Jan 27, 2000 · Cardiovascular

Device Facts

• Record ID: K993639
• Device Name: RX VIATRAC 18 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER
• Applicant: Guidant Corp.
• Product Code: LIT · Cardiovascular
• Decision Date: Jan 27, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RX VIATRAC™ 18 Peripheral Dilatation Catheter is intended: - To dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, . popliteal, infra popliteal, renal arteries) - For the treatment of obstructive lesions of native or synthetic . arteriovenous dialysis fistulae. - For post deployment optimization of the 28 mm GUIDANT . MEGALINK™ Biliary Stent (6.0 to 10.0 mm diameters). The OTW VIATRAC™ 18 Peripheral Dilatation Catheter is intended: - . To dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries) - For the treatment of obstructive lesions of native or synthetic . arteriovenous dialysis fistulae. - For post deployment optimization of the 28 mm GUIDANT . MEGALINK™ Biliary Stent (6.0 to 10.0 mm diameters).

Device Story

RX and OTW VIATRAC 18 Peripheral Dilatation Catheters are balloon angioplasty devices. RX platform features integrated shaft for rapid exchange; OTW platform features coaxial design with full-length inner member. Both utilize XCELON balloon with two radiopaque markers for positioning. Operated by physicians in clinical settings to dilate peripheral artery stenoses, treat arteriovenous dialysis fistula lesions, or optimize biliary stent deployment. Balloon provides expandable segment of known diameter/length at specific pressures. Output is mechanical dilation of target vessel/lesion. Benefits include restoration of blood flow or stent apposition.

Clinical Evidence

Bench testing only. Tests included accelerated aging, catheter preparation, crossing/collapsed profile, balloon compliance, inflation/deflation times, balloon fatigue, balloon rupture, soft tip tensile, catheter tensile, bend integrity, shaft pressure, inner member collapse, wall/mandrel penetration, support mandrel pull, and in-stent balloon rupture/fatigue. Results demonstrated performance equivalent to predicate devices.

Technological Characteristics

PTA catheters with XCELON balloon; 75 and 135 cm lengths; 6.0-10.0 mm diameters. RX platform (integrated shaft) and OTW platform (coaxial). Features two radiopaque markers. Materials, biocompatibility, and sterilization are equivalent to predicates.

Indications for Use

Indicated for patients requiring dilation of stenoses in peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra-popliteal, renal) or treatment of obstructive lesions in native/synthetic arteriovenous dialysis fistulae; also indicated for post-deployment optimization of 28 mm GUIDANT MEGALINK Biliary Stents (6.0-10.0 mm diameters).

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

• RX VIATRAC™ 14 Peripheral Dilatation Catheter (K983055)
• Cordis OPTA 5™ PTA Catheter (K972825)

Submission Summary (Full Text)

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JAN 2 7 2000

510(k) SUMMARY

K993639

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™ 14 Peripheral Dilatation Catheter |
| | Device Common Name: | Percutaneous Transluminal Angioplasty Catheter |
| | Device Classification Name: | LIT |
| 3. | | Predicate Devices: RX VIATRAC™ 14<br>Peripheral Dilatation Catheter (K983055) |

#### 4. Device Description:

The RX VIATRACTM 18 and the OTW VIATRACTM 18 Peripheral Dilatation Catheters were developed in parallel as two platforms, a Rapid Exchange (RX) platform and an Over-the-Wire (OTW) platform. The distal 20 cm of both catheters are identical however, the proximal portions are modified to accommodate either the RX or OTW platform.

Cordis OPTA 5TM PTA Catheter (K972825)

The RX catheter is a rapid exchange catheter with an integrated shaft system. The design is based upon the RX VIATRACTM 14 Peripheral Dilatation Catheter, manufactured by Guidant (K983055, 12/30/98). The RX VIATRAC™ 18 Peripheral Dilatation Catheter has catheter lengths of 75 and 135 cm, with balloon diameters of 6.0, 7.0, 8.0, 9.0 and 10.0 mm.

The OTW platform is an over-the-wire, coaxial design catheter that is similar to that of the RX catheter. However, the OTW catheter has an inner member extending the entire length of the catheter, and therefore has no mid-catheter junction. The OTW VIATRAC™ 18 Peripheral Dilatation Catheter has catheter lengths of 75 and 135 cm, with balloon diameters of 6.0, 7.0, 8.0, 9.0 and 10.0 mm.

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The XCELON™ balloon, which is identical on both RX and OTW VIATRAC™ 18 Peripheral Dilatation Catheters 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.

### 5. Intended Use:

The RX VIATRACTM 18 Peripheral Dilatation Catheter is intended:

- To dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, . popliteal, infra popliteal, renal arteries)
- For the treatment of obstructive lesions of native or synthetic . arteriovenous dialysis fistulae.
- For post deployment optimization of the 28 mm GUIDANT . MEGALINK™ Biliary Stent (6.0 to 10.0 mm diameters).

The OTW VIATRAC™ 18 Peripheral Dilatation Catheter is intended:

- . To dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries)
- For the treatment of obstructive lesions of native or synthetic . arteriovenous dialysis fistulae.
- For post deployment optimization of the 28 mm GUIDANT . MEGALINK™ Biliary Stent (6.0 to 10.0 mm diameters).
- 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 RX VIATRAC™ 14 Peripheral Dilatation Catheter and the OPTA 5TM PTA Catheter. The following tests were performed:

| Accelerated Aging Testing |
|------------------------------------|
| Catheter Preparation Test |
| Crossing Profile/Collapsed Profile |
| Balloon Compliance Test |
| Balloon Inflation/Deflation Times |
| Balloon Fatigue Test |
| Balloon Rupture Test |
| Catheter Soft Tip Tensile Test |

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| Catheter Tensile Test |
|----------------------------------------|
| Catheter Bend Integrity Test |
| Catheter Shaft Pressure Test |
| Inner Member Collapse Test |
| Catheter Wall/Mandrel Penetration Test |
| Support Mandrel Pull Test |
| In-Stent Balloon Rupture Test |
| In-Stent Balloon Fatigue Test |

The results from the bench tests showed that the new RX and OTW VIATRAC™ 18 Peripheral Dilatation Catheters met acceptance criteria and performed in a manner equivalent to the predicate RX VIATRAC™ 14 Peripheral Dilatation Catheter and the Cordis OPTA 5TM PTA Catheter. No new safety or effectiveness issues were raised during the testing program.

- 8. Conclusions:
Since the new RX and OTW VIATRAC™ 18 Peripheral Dilatation Catheters have 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™ 18 Peripheral Dilatation Catheter and the OTW VIATRACTM 18 Peripheral Dilatation Catheter may be considered substantially equivalent to the predicate RX VIATRAC™ 14 Peripheral Dilatation Catheter and Cordis OPTA 5TM PTA Catheter.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that resembles a stylized eagle or bird-like figure with three curved lines representing its body and wings. The image is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 7 2000

Susan Silavin, Ph.D. Senior Regulatory Affairs Coordinator Guidant Corporation P.O. Box 58167 Santa Clara, CA 95052-8167

кадзеза Re: RX and OTW VIATRAC 18 Peripheral Dilatation Trade Name: Catheter Requlatory Class: II Product Code: LIT October 27, 1999 Dated: October 28, 1999 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 Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to 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.

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Page 2 - Susan Silavin, Ph.D.

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 Also, please note the regulation entitled, [phone]. "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,

Christopher

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological 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): K993639

# Device Name: RX VIATRAC™ 18 Peripheral Dilatation Catheter OTW VIATRACTM 18 Peripheral Dilatation Catheter

Indications for Use:

The RX VIATRAC™ 18 Peripheral Dilatation Catheter is intended:

- To dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, . popliteal, infra popliteal, renal arteries)
- For the treatment of obstructive lesions of native or synthetic arteriovenous . dialysis fistulae.
- For post deployment optimization of the 28 mm GUIDANT MEGALINK™ . Biliary Stent (6.0 to 10.0 mm diameters).

The OTW VIATRAC™ 18 Peripheral Dilatation Catheter is intended:

- To dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, . popliteal, infra popliteal, renal arteries)
- For the treatment of obstructive lesions of native or synthetic arteriovenous . dialysis fistulae.
- For post deployment optimization of the 28 mm GUIDANT MEGALINK™ . Biliary Stent (6.0 to 10.0 mm diameters).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <u>X</u> | OR | Over-The-Counter | <u></u> |
|----------------------|----------|----|------------------|--------------------------|
| (Per 21 CFR 801.109) | | | | (Optional Format 1-1-96) |

Christopher for Witten