BIPORE BALLOON DILATATION CATHETER

K983650 · Bipore, Inc. · LIT · Feb 17, 1999 · Cardiovascular

Device Facts

• Record ID: K983650
• Device Name: BIPORE BALLOON DILATATION CATHETER
• Applicant: Bipore, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Feb 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bipore Balloon Dilatation Catheter is recommended for percutaneous transluminal angioplasty of the iliac, femoral, and renal arteries, and for the treatment of obstructive lesions of autologous or synthetic arteriovenous dialysis fistulae. The Bipore PTA Balloon Dilatation Catheter is also indicated for post deployed stent expansion. Use of the Bipore Balloon Dilatation Catheter for post-deployed stent expansion was demonstrated on the bench with the Cordis Palmaz™ stent.

Device Story

Double lumen balloon catheter for percutaneous transluminal angioplasty; one lumen for balloon inflation/deflation; one lumen for guidewire tracking to stenosis site. Used by physicians in clinical settings for peripheral vessel dilation and post-stent expansion. Device expansion of balloon at stenosis site restores vessel patency; post-stent expansion ensures proper stent apposition. Submission adds two balloon sizes to existing product line.

Clinical Evidence

Bench testing only. Testing included rated burst pressure and balloon fatigue within the Cordis Palmaz™ stent to demonstrate safety for post-deployed stent expansion.

Technological Characteristics

Double lumen balloon catheter; percutaneous transluminal angioplasty design. No specific materials or standards provided. Mechanical inflation/deflation mechanism.

Indications for Use

Indicated for percutaneous transluminal angioplasty of iliac, femoral, and renal arteries; treatment of obstructive lesions in autologous or synthetic arteriovenous dialysis fistulae; and post-deployed stent expansion.

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

• Bipore Balloon Dilatation Catheter

Reference Devices

• Cordis Palmaz™ stent

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows a handwritten date, "2/17/99". The numbers are written in a simple, slightly slanted style. The handwriting appears to be done with a pen or marker, creating a clear and legible representation of the date.

(

## K983650

Summary of Safety and Effectiveness Bipore Balloon Dilatation Catheter

| Trade Name: | Bipore Balloon Dilatation Catheter | |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Manufacturer: | Bipore, Inc.<br>31 Industrial Parkway<br>Northvale, New Jersey 07647<br>Tel [phone] FAX [phone] | |
| Device Generic Name: | Balloon Dilatation Catheter | |
| Classification: | Class II, Performance Standards | |
| Predicate Devices: | Bipore Balloon Dilatation Catheter | |
| Description of Device: | The Bipore Balloon Dilatation catheter is a double lumen balloon catheter<br>for percutaneous transluminal angioplasty in peripheral vessel. One lumen is for<br>inflation and deflation of the balloon; the other lumen is used to<br>pass the catheter over a guide wire to locate the balloon at the site of stenosis.<br>This submission adds two balloon sizes to the existing product line, as follows,<br>and does not affect the safety or effectiveness of the device. | |
| Indications for Use: | The Bipore Balloon Dilatation Catheter is recommended for percutaneous<br>transluminal angioplasty of the iliac, femoral, and renal arteries, and for the<br>treatment of obstructive lesions of autologous or synthetic arteriovenous dialysis<br>fistulae. | |
| | The Bipore PTA Balloon Dilatation Catheter is also indicated for post deployed<br>stent expansion. Use of the Bipore Balloon Dilatation Catheter for post-<br>deployed stent expansion was demonstrated on the bench within Cordis<br>Palmaz™ stent. | |
| *Testing included: | Rated Burst pressure within the stent<br>Balloon Fatigue within the stent | |

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, composed of three curved lines that suggest the shape of a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 7 1999

Mr. Durmus Koch President Bipore, Inc. 31 Industrial Parkway Northvale, NJ 07647

K983650 Re: Trade Name: Bipore Balloon Dilatation Catheter Requlatory Class: II Product Code: LIT Dated: January 28, 1999 Received: January 29, 1999

Dear Mr. Koch:

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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 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

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

Page 2 - Mr. Durmus Koch

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 requlation (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. Callahan

Thomas J. Callahan, Ph Director Division of Cardiovascular, Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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

Page 1 of 1

510(k) Number (if known):

Device Name:

Indications For Use:

The Bipore Balloon Dilatation Catheter is recommended for percutaneous transluminal angioplasty of the iliac, femoral, and renal arteries, and for the treatment of obstructive lesions of autologous or synthetic arteriovenous dialysis fistulae.

The Bipore PTA Balloon Dilatation Catheter is also indicated for post deployed stent expansion. Use of the Bipore Balloon Dilatation Catheter for post-deployed stent expansion was demonstrated on the bench with the Cordis Palmaz™ stent*.

Rated Burst Pressure within the stent *Testing included: Balloon Fatigue within the stent

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Thomas J. Callahon

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number