BIPORE BALLOON DILATATION CATHETER

K973563 · Bipore, Inc. · LIT · Apr 1, 1998 · Cardiovascular

Device Facts

• Record ID: K973563
• Device Name: BIPORE BALLOON DILATATION CATHETER
• Applicant: Bipore, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Apr 1, 1998
• 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 within Cardis Palmaz™ stent. All stents must be implanted and deployed according to the stent manufacturer's indications, contraindications, and instructions for use.

Device Story

Double lumen balloon dilatation catheter for percutaneous transluminal angioplasty (PTA). One lumen facilitates balloon inflation/deflation; second lumen allows tracking over a guidewire to stenosis site. Used in peripheral vessels and for post-deployed stent expansion. Operated by physicians in clinical settings. Device expansion restores vessel patency or ensures proper stent apposition. Product line extension adds specific balloon diameters and lengths to existing catheter platform.

Clinical Evidence

Bench testing only. Tests included balloon burst, multiple inflation, compliance, inflation/deflation time, rated burst pressure within stent, and balloon fatigue within stent. Biocompatibility data (systemic toxicity, intracutaneous toxicity, implantation, hemolysis, cytotoxicity, sensitization) was previously established in K961980.

Technological Characteristics

Double lumen catheter design. Materials and biocompatibility established in K961980. Features include variable balloon diameters (4-6mm) and lengths (4-10cm) with 5Fr catheter size. Mechanical operation via inflation/deflation. No software or electronic components.

Indications for Use

Indicated for percutaneous transluminal angioplasty of iliac, femoral, and renal arteries, and treatment of obstructive lesions in autologous or synthetic arteriovenous dialysis fistulae. Also indicated for 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 (K961980)

Reference Devices

• Cardis Palmaz™ stent

Submission Summary (Full Text)

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K973563

## SUMMARY OF SAFETY AND EFFECTIVENESS BIPORE BALLOON DILATATION CATHETER March 24, 1998 Ref: 510(k) K973563

| Trade Name: | Bipore Balloon Dilatation Catheter |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Bipore, Inc.<br>31 Industrial Parkway<br>Northvale, NJ 07647<br>Tel [phone] Fax [phone] |
| Device Generic Name: | Balloon Dilatation Catheter |
| Classification: | Class II, Performance Standards |
| Predicate Devices: | Bipore Balloon Dilatation Catheter<br>510(k) K961980 |
| Description of Device: | The Bipore Balloon Dilatation Catheter is a double lumen balloon<br>catheter for percutaneous transluminal angioplasty in peripheral<br>vessel. One lumen is for inflation and deflation of the balloon; the<br>other lumen is used to pass the catheter over a guide wire to locate<br>the balloon at the sire of stenosis. This submission adds two balloon<br>sizes to the existing product line, as follows, and does not affect the<br>safety or effectiveness of the device. |

| Inflated<br>Balloon<br>Diameter<br>(mm) | Balloon<br>Length<br>(Cm) | Catheter<br>Size<br>(Fr) | Usable<br>Length<br>(cm) |
|-----------------------------------------|---------------------------|--------------------------|--------------------------|
| 4 | 4 | 5 | 100 |
| 5 | 4 | 5 | 100 |
| 5 | 10 | 5 | 100 |
| 6 | 10 | 5 | 100 |

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.

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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 within Cardis Palmaz™ stent. *

^Il stents must be implanted and deployed according to the stent manufacturer's indications, contraindications, and instructions for use.

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

Safety and Performance:

The following in vitro function tests were performed on the Bipore Balloon Dilatation Catheter product line extensions:

> Balloon Burst Balloon Multiple Inflation Balloon Compliance Balloon Inflation/Deflation Time Rated Burst pressure within the Stent Balloon Fatigue within the Stent

The following biocompatibility tests were performed on the Bipore Balloon Dilatation Catheter; 510(k) K961980:

> Systemic Toxicity Intracutaneous Toxicity Implantation Hemolysis Cytotoxicity Sensitization

Conclusions:

Based on the indications for use, technological characteristics, and safety and performance tests, it has been demonstrated that the Bipore Balloon Dilatation Catheter product line extensions are safe and effective for their intended use.

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Food and Drug Administration 9200 Carporate Boulevard Rockville MD 20850

APR - 1 1998

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

Re : K973563 Trade Name: Bipore Balloon Dilatation Catheter Requlatory Class: II Product Code: LIT Dated: January 6, 1998 January 7, 1998 Received:

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 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 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 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 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 - Mr. Koch

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/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callshan

Thomas J. CallaMan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

J

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510(k) Number (if known): _ K973563

Bipore Balloon Dilatation Catheter Device Name:

Indications For Use:

The Bipore PTA catheters are indicated for percutaneous transluminal angioplasty of the illac, femoral, and renal arteries, and for the treatment of obstructive lesions of autologous or synthetic arteriovenous dialysis fistulae.

The Birgore, Inc. PTA Balloon Dilatation Catheter is also indicated for post-deployed stent expansion. Use of the Signe Dilatation Catheter for post-deployment sten expansion was demonstrated on the bench with the Cordi's Palmaz™ stent *.

All sterts must be implanted and deployed according to the stent manufacturer's indications, contraindications, and instructions for use.

Testing included:

Rated Burst Pressure within the Stent Balloon Fatigue within the Stent

Tan A. Re

Division Sign-Off) Division of Carc.ovascular, Respiratory, and Neurological D 510(k) Number

/ prescription use only

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

Concurrence of CDRH, Office of Device Evaluation (ODE)