VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER

K012050 · Guidant Corp. · DQY · Sep 6, 2001 · Cardiovascular

Device Facts

• Record ID: K012050
• Device Name: VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
• Applicant: Guidant Corp.
• Product Code: DQY · Cardiovascular
• Decision Date: Sep 6, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VIATRAC™ 14 PLUS Peripheral Dilatation Catheter is indicated to dilate stenosis 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.

Device Story

Rapid exchange percutaneous transluminal angioplasty (PTA) catheter; features integrated shaft system with XCELON (nylon blend) balloon at distal end. Proximal shaft includes tapered stainless steel mandrel for support/flexibility; single lumen for balloon inflation; coaxial distal lumen for guide wire advancement. Radiopaque markers on balloon aid positioning; proximal shaft markers indicate catheter position relative to guiding catheter. Operated by physicians in clinical settings to dilate peripheral vascular stenoses or arteriovenous fistula lesions. Inflation device connects via luer-lock fitting. Output is mechanical expansion of balloon to restore vessel patency; benefits patient by improving blood flow in obstructed arteries or dialysis access sites.

Clinical Evidence

Bench testing only. Safety and effectiveness demonstrated through in vitro bench tests and analyses.

Technological Characteristics

Rapid exchange PTA catheter; XCELON (nylon blend) balloon; stainless steel mandrel; radiopaque markers; luer-lock inflation port. Sterilization and packaging consistent with predicate. No software or electronic components.

Indications for Use

Indicated for dilatation of stenoses in peripheral vasculature (iliac, femoral, ilio-femoral, popliteal, infra-popliteal, renal arteries) and treatment of obstructive lesions in 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

• RX VIATRAC™ 14 Peripheral Dilatation Catheter (K983055)
• RX VIATRAC™ 14 Peripheral Dilatation Catheter (K000101)

Submission Summary (Full Text)

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0/2050

## SEP = 6 2001

#### 510(k) SUMMARY

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

| Submitter's Name: | Guidant Corporation<br>Advanced Cardiovascular Systems, Inc. |
|-----------------------------|--------------------------------------------------------------|
| Submitter's Address: | 3200 Lakeside Drive<br>Santa Clara, CA 95052 |
| Telephone:<br>Fax: | 408/845-1067<br>408/845-3743 |
| Contact Person: | Saba Modjarrad |
| Date Prepared: | June 29, 2001 |
| Device Trade Name: | VIATRAC™ 14 PLUS Peripheral Dilatation Catheter |
| Device Common Name: | Percutaneous Transluminal Angioplasty Catheter |
| Device Classification Name: | LIT |
| Device Classification: | Class II |

#### Summary of Substantial Equivalence:

The design, materials, and intended use features of VIATRACTM PLUS Peripheral Dilatation Catheter are substantially equivalent with regard to these features in the predicate device, the RX VIATRACTM 14 Peripheral Dilatation Catheter (K983055 and K000101).

#### Device Description:

The VIATRAC™ 14 PLUS 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 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 known 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.

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The VIATRAC™ 14 PLUS Peripheral Dilatation Catheter is available with balloon diameters of 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 and 7.0 mm, with lengths of 15, 20, 30, and 40 mm and in catheter lengths of 80 cm and 135 cm.

On the 135 cm catheter length, there are two proximal shaft markers (95 cm and 105 cm from the distal tip). On the 80 cm catheter length, there is a single proximal marker (55 cm from the distal tip). Both indicate the relative position of the catheter to the end of a brachial, femoral or renal guiding catheter. An additional marker is located at the guide wire exit notch and aids in locating the guide wire exit notch.

#### Intended Use:

The VIATRAC™ 14 PLUS Peripheral Dilatation Catheter is indicated for dilatation of stenoses in the peripheral vasculature (iliac, femoral, popliteal, infra-popliteal and renal arteries) and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

#### Technological Characteristics:

Comparisons of the new and predicate devices show that technological characteristics such as materials, biocompatibility, performance properties, sterilization and packaging are substantially equivalent to the currently marketed predicate devices.

#### Performance Data:

The safety and effectiveness of the VIATRAC™ 14 PLUS Peripheral Dilatation Catheter has been demonstrated through data collected from in vitro bench tests and analyses.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. 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 abstract image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP = 6 2001

Ms. Saba Modjarrad Regulatory Affairs Coordinator Guidant Corporation 3200 Lakeside Drive Santa Clara, CA 95054-2807

Re: K012050

Trade Name: VIATRAC™ 14 PLUS Peripheral Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: August 10, 2001 Received: August 13, 2001

Dear Ms. Modjarrad:

We have reviewed your Section 510(k) premarket 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) 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. Saba Modjarrad

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast of advised and I DTP blishing of your device complies with other requirements of the Act that I Dri has made a covernment and inistered by other federal agencies. You must comply or all the Act's requirements, including, but not limited to: registration (21 CFR Part 807); with an the Hot Progant 807); labeling (21 CFR Part 801); good manufacturing practice nstilly (21 OF Icroover), as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in as qualify tion control provisions (section 531-542 of the Act, 21 CFR 1000-1050).

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 nothloate 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 If you desire specific diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in This alaguestions on the promotion and advertising of your device, (2017) 591-1010. Traditional [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 mormation on Jour responsal 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 yours,

Dala Tell

James E. Dillard III Director Division of Cardiovascular and Respiratory 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) | K012050 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | VIATRACTM 14 PLUS Peripheral Dilatation Catheter |
| Indications for Use | The VIATRACTM 14 PLUS Peripheral Dilatation Catheter is indicated to dilate stenosis 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. |

# PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Division of Cardiovascular & Respiratory Devices
510(k) Number K012050