BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER

K012913 · C.R. Bard, Inc. · DQY · Sep 28, 2001 · Cardiovascular

Device Facts

• Record ID: K012913
• Device Name: BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER
• Applicant: C.R. Bard, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Sep 28, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bard® Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter is recommended for use in Percutaneous Transluminal Angioplasty of the renal, tibial, popliteal, femoral and peroneal vessels. This catheter is not for use in coronary arteries.

Device Story

The Bard Ultraverse is a dual-lumen PTA balloon dilatation catheter. One lumen facilitates guidewire insertion; the second enables balloon inflation/deflation. Two radiopaque marker bands on the distal tip assist in positioning within the vasculature. Used by clinicians in a clinical setting to perform angioplasty in peripheral vessels. The device is inserted percutaneously to dilate stenotic vessels, improving blood flow. It is a mechanical device; no electronic or software components are involved.

Clinical Evidence

Bench testing only.

Technological Characteristics

Dual-lumen catheter with distal balloon; 3.5 Fr shaft; 100 cm and 120 cm lengths; radiopaque marker bands for positioning; mechanical inflation/deflation mechanism.

Indications for Use

Indicated for patients requiring percutaneous transluminal angioplasty (PTA) of renal, tibial, popliteal, femoral, and peroneal vessels. Contraindicated for use in coronary arteries.

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

• Bard® Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter
• Bard® Opti-Plast™ PTA Catheter
• Boston Scientific Symmetry™ Balloon Dilatation Catheter

Submission Summary (Full Text)

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K012913

Bard Peripheral Technologies C.R. Bard, Inc. 13183 Harland Dr., N.E Covington, GA 30014

SEP 2 8 2001

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENES INFORMATION

A.. Submitter Information:

> C.R. Bard, Inc., Peripheral Technologies Division Submitter's Name: Submitter's Address: 13183 Harland Drive, Covington, GA 30014 Carol Vierling Contact Person: Contact Person's Telephone Number: [phone] Contact Person's FAX Number: [phone] Date of Preparation: August 30, 2001

Device Name: B.

Bard® Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter

#### C. Predicate Devices:

Bard® Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter Bard® Opti-Plast™ PTA Catheter Boston Scientific Symmetry™ Balloon Dilatation Catheter

D. Device Description:

> The Bard® Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter is a dual lumen catheter with a balloon mounted on its distal tip. One lumen accommodates the insertion guidewire and the second provides a channel for inflation/deflation of the balloon. There are two radiopaque marker bands placed beneath the balloon to indicate its position within the vasculature.

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#### E. Intended Use:

The Bard® Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter is recommended for use in Percutaneous Transluminal Angioplasty of the renal, tibial, popliteal, femoral and peroneal vessels. This catheter is not for use in coronary arteries.

### Technological Characteristics Summary: F.

The Bard® Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter has a 3.5 Fr shaft and is available in lengths of 100 and 120 cm. Various balloon diameters and lengths are available.

#### G. Performance Data:

The design, materials and manufacturing process for the predicate and the modified device are the same. Bench testing shows that the modified catheter is substantially equivalent to the predicate Ultraverse Catheter.

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Image /page/2/Picture/2 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures.

SEP 2 8 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

C.R. Bard, Inc. c/o Ms. Carol Vierling 13183 Harland Dr, NE Covington, GA 30014

Re: K012913

Trade Name: Bard Ultraverse Small Vessel PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DQY Dated: August 30, 2001 Received: August 30, 2001

Dear Ms. Vierling:

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. Carol Vierling

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 (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 yours,

signature

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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## ATTACHMENT 5

## Indications for Use Statement

Bard® Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter Device Name

The Bard® Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter Indications is recommended for use in Percutaneous Transluminal Angioplasty of the for Use renal, tibial, popliteal, femoral and peroneal vessels. This catheter is not for use in coronary arteries.

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K012913

V Prescription Use (Per 21 CFR 801.109

OR

Over-The-Counter Use