OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER

K973013 · Vas-Cath, Inc. · LIT · Jun 19, 1998 · Cardiovascular

Device Facts

• Record ID: K973013
• Device Name: OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER
• Applicant: Vas-Cath, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Jun 19, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Centurion Peripheral Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries, post-deployment dilatation of peripheral vascular stents and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The catheter is not for use in coronary arteries.

Device Story

Opti-Plast Centurion 5.5F PTA Catheter is a dual-lumen balloon dilatation catheter; one lumen for 0.035" guidewire insertion, one for balloon inflation/deflation with contrast media. Features two radiopaque gold marker bands for positioning. Used by physicians in clinical settings for peripheral vascular interventions. Device is inserted percutaneously; balloon is inflated to labeled diameter/length at 10 atm operating pressure to dilate stenotic vessels or stents. Output is mechanical force applied to vessel walls. Benefits include restoration of blood flow in peripheral arteries and dialysis fistulae. Performance verified via bench testing including burst strength, fatigue, and trackability.

Clinical Evidence

Bench testing only. Evaluated balloon burst strength, distensibility, inflation/deflation time, fatigue, joint/material strength, profile, sheath compatibility, flow rate, trackability, tip torque, puncture resistance, and scratch resistance. Testing included cycling to rated burst pressure and burst testing within a stent.

Technological Characteristics

Dual-lumen catheter; Nylon balloon; Nylon co-polymer shaft/tip/collar; Glissando coating; 5.5 French shaft diameter; 0.035" guidewire compatibility; Gold radiopaque marker bands; 10 atm operating pressure; 17-20 atm rated burst pressure.

Indications for Use

Indicated for patients requiring percutaneous transluminal angioplasty (PTA) of femoral, iliac, and renal arteries, post-deployment dilatation of peripheral vascular stents, and treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae. 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

• Opti-Plast® 5.5F PTA Catheter (K933483)
• Medi-Tech® Blue-Max™ Balloon Dilatation Catheter (K934191)

Submission Summary (Full Text)

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<973013

C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30209

# JUN 1 9 1998

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

C. R. Bard, Inc., Radiology Division Submitter Information: A. 13183 Harland Dr. Covington, GA 30014

| Contact Person: | Donna J. Wilson |
|----------------------------------------------|----------------------------------------------------------------|
| Contact Person's Address: | 8195 Industrial Blvd.<br>Covington, GA 30014 |
| Contact Person's Telephone: | 770-784-6135 |
| Contact Person's FAX: | 770-784-6419 |
| Date of Preparation: | June 17, 1998 |
| B. Device Name: | Opti-Plast® Centurion 5.5F PTA Catheter |
| C. Predicate Device: | Opti-Plast® 5.5F PTA Catheter (#K933483) |
| Predicate Device for<br>Indications for Use: | Medi-Tech® Blue-Max™ Balloon Dilatation<br>Catheter (#K934191) |

#### D. Device Description:

The Opti-Plast Centurion 5.5F PTA Catheter is a dual lumen catheter with a balloon mounted on its distal end. One lumen accommodates the insertion guidewire and the other provides a channel for inflation and deflation of the balloon with contrast media. The catheter is designed to be used in conjunction with a 0.035" diameter guidewire. There are two radiopaque marker bands secured on the catheter body to indicate the position of the balloon within the vasculature. The balloon inflates to the labeled diameter and length at a 10 atmosphere Operating Pressure. The Rated Burst Pressure of the device ranges from 17-20 atmospheres, depending on balloon diameter (see attached table).

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#### E. Indications for Use:

Centurion Peripheral Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries, post-deployment dilatation of peripheral vascular stents and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The catheter is not for use in coronary arteries.

### F. Technological Characteristics Summary:

Summarized in the attached table.

#### G. Performance Data:

Bench testing was conducted for the following characteristics: balloon burst strength, balloon distensibility, balloon inflation/deflation time, balloon fatigue, joints and material strength, catheter balloon profile, introducer sheath compatibility, catheter flow rate and maximum injection pressure, deflatability and trackability, tip torque performance, puncture resistance ("toughness"), balloon scratch resistance, balloon fatigue (cycling to rated burst pressure) within a stent and balloon burst within a stent. The test results indicate that the Opti-Plast Centurion 5.5F PTA Catheter is substantially equivalent to the stated predicate device, that there are no new safety or effectiveness issues, and that the device can be utilized for its stated indication.

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## Technological Characteristics Summary

.

| Features | Proposed Vas-Cath Opti-Plast®<br>Centurion 5.5F PTA Catheter | Vas-Cath Opti-Plast® 5.5F PTA<br>Catheter (K933483) | Medi-tech® Blue-Max™ Balloon<br>Dilatation Catheter (K934191) |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indicated Use | PTA of the femoral, iliac and renal<br>arteries, post-deployment dilatation<br>of peripheral vascular stents and for<br>the treatment of obstructive lesions of native<br>or synthetic arteriovenous dialysis fistulae. | PTA of vessels of the peripheral<br>vascular system | PTA of the Iliac, Femoral and Renal Arteries<br>and for the treatment of obstructive lesions of<br>native or synthetic arteriovenous dialysis fistulae |
| Balloon Material | Nylon | Nylon | Poly-5TM |
| Inflated Balloon Diameters | 4 mm - 10 mm | 4 mm - 10 mm | 4 mm - 10 mm |
| Inflated Balloon Length | 2 cm - 4 cm | 2 cm - 10 cm | 2 cm - 10 cm |
| Recommended Operating<br>Pressure | 10 atmospheres | 6 atmospheres - 8 atmospheres | NA |
| Rated Burst Pressure | 17 atmospheres - 20 atmospheres | 8 atmospheres - 12 atmospheres | 17 atmospheres |
| Material for catheter shaft,<br>tip, collar, and extensions | Nylon Co-polymer | Nylon Co-polymer | NA |
| Coating on shaft | Glissando | None | Medi-Glide |
| Radiopaque shaft | Yes | Yes | NA |
| Catheter Shaft Diameter | 5.5 French | 5.5 French | 5.8 French |
| Shaft Length | 50 cm - 140 cm | 50 cm - 120 cm | 40 cm - 120 cm |
| Shaft configuration | Double lumen | Double lumen | Double lumen |
| Marker Bands | Yes, Gold | Yes, Tantalum | Yes, material NA |
| Tip Length | 3 mm | 5 mm | 5 mm |
| Guidewire Capability | 0.035 inch diameter | 0.035 inch diameter | 0.035 inch diameter |

NA - Not available from promotional literature

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 9 1998

Ms. Donna J. Wilson Director, Requlatory Affairs C.R. Bard, Inc. 8195 Industrial Boulevard Covington, GA 30209

Re: K973013 Opti-Plast® Centurion 5.5F PTA Catheter Requlatory Class: II (two) Product Code: 74 LIT Dated: March 20, 1998 March 23, 1998 Received:

Dear Ms. Wilson:

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 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 requlations 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 Failure to comply with the GMP regulation may result in assumptions. regulatory 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 - Ms. Donna J. Wilson

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" (21 CFR 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/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. 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):

Device Name: Bard® Opti-Plast® Centurion 5.5 F PTA Catheter

Indications for Use:

Centurion Peripheral Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries, post-deployment dilatation of peripheral vascular stents and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The catheter is not for use in coronary arteries.

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

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

V Prescription Use (Per 21 CFR 801.109)

OR

Over-The Counter Use_

(Optional Format 1-2-96)

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Division Sign Off

(Division Sign-Off) Division of Cardiovascular, Resphalory, and Neurological Devices x 974013 510(k) Number -----