ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER

K960501 · Boston Scientific Corp · LIT · Apr 9, 1996 · Cardiovascular

Device Facts

• Record ID: K960501
• Device Name: ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER
• Applicant: Boston Scientific Corp
• Product Code: LIT · Cardiovascular
• Decision Date: Apr 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Diamond™ Vessel Balloon Dilatation Catheter is indicated for PTA of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Story

Over-the-wire balloon dilatation catheter; designed for use with guidewires ≤.035" diameter. Used by clinicians for percutaneous transluminal angioplasty (PTA) of iliac, femoral, and renal arteries; treatment of obstructive lesions in arteriovenous dialysis fistulae. Available with or without Glidex™ and Medi-Glide™ coatings. Device facilitates vessel dilation via balloon inflation; provides mechanical intervention to restore patency in stenotic vessels/fistulae.

Clinical Evidence

Bench testing only. In vitro functional tests: balloon burst, multiple inflation, inflation/deflation time, compliance, proximal bond, sheath withdrawal, wingfolded profile, coating slip/adhesion, coefficient of friction, particulate analysis, solvent residual. Biocompatibility: cytotoxicity, hemolysis, USP Class IV, mutagenicity, sensitization, thrombogenicity, pyrogenicity, 90-day muscle implantation.

Technological Characteristics

Over-the-wire balloon dilatation catheter; compatible with guidewires ≤.035". Features optional Glidex™ and Medi-Glide™ coatings. Biocompatible materials tested per USP Class IV and 90-day muscle implantation standards. Mechanical design includes balloon inflation/deflation mechanism for vessel dilation.

Indications for Use

Indicated for percutaneous transluminal angioplasty (PTA) of iliac, femoral, and renal arteries; 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

• BSC Blue Max Balloon Dilatation Catheter
• BSC Ultra-thin™ Balloon Catheter
• BSC Symmetry™ Small Vessel Balloon Dilatation Catheter
• BSC Courier™ Balloon Dilatation Catheter

Submission Summary (Full Text)

{0}

03/20/96 10.00 0000
BSC/CLINICAL RSH →→ CDRH ODE
003
Medi-tech Ultra-thin™ Diamond™ Balloon Dilatation Catheter
K. 966501
February 1, 1996

# ATTACHMENT H

## SUMMARY OF SAFETY AND EFFECTIVENESS

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification either an "... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation choose to submit a summary of information respecting safety and effectiveness. According to §513(i)(3)(B), "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects..."

The summary regarding the adverse health effects of the proposed Diamond™ Balloon Dilatation Catheter is as follows:

**Trade Name:** Diamond™ Balloon Dilatation Catheter

**Manufacturer:** Boston Scientific Corporation
One Boston Scientific Place
Natick, MA 01760

**Device Generic Name:** Balloon Dilatation Catheter

**Classification:** According to Section 13 of the Federal Food, Drug and Cosmetic Act, the device classification is Class II, Performance Standards.

**Predicate Devices:**

The following devices are referenced in this premarket notification as predicate devices for the Diamond™ Balloon Dilatation Catheter:

- BSC -- Blue Max Balloon Dilatation Catheter
- BSC -- Ultra-thin™ Balloon Catheter
- BSC -- Symmetry™ Small Vessel Balloon Dilatation Catheter
- BSC -- Courier™ Balloon Dilatation Catheter

All of the devices mentioned above have been determined substantially equivalent by FDA.

**Device Description:**

The proposed Diamond™ Balloon Dilatation catheter is an over-the-wire catheter indicated for percutaneous transluminal angioplasty of the iliac, femoral and renal arteries and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The proposed device is designed to be placed over guidewires which have outer diameters of .035" or smaller. The device is offered with and without Glidex™ and Medi-Glide™ coatings.

{1}

03/20/96 12:05 8SC, CLINICAL FSH ---> CDRH ODE 004

Medi-tech Ultra-thin™ Diamond™
Balloon Dilatation Catheter

February 1, 1996

## Indications for Use:

The Diamond™ Vessel Balloon Dilatation Catheter is indicated for PTA of the iliac, femoral and
renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis
fistulae.

## Safety and Performance:

The following in vitro frunctional tests were performed on the Diamond™ Balloon Dilatation
Catheter:

- Balloon Burst Testing
- Multiple Inflation Testing
- Inflation/Deflation Time Testing
- Balloon Compliance Testing
- Balloon Proximal Bond Testing
- Sheath Withdrawal Testing
- Wingfolded Balloon Profile Testing
- Coating Slip/Adhesion Testing
- Coating Coefficient of Friction Testing
- Particulate Analysis Testing
- Solvent Residual Testing

The following biocompatibility tests were performed:

- Cytotoxicity
- Hemolysis
- U.S.P. Class IV
- Mutagenicity
- Sensitization
- Thrombogenicity
- Pyrogenicity
- 90-Day Muscle Implantation

## Conclusion:

Based on the Indication for Use, technological characteristics and safety and performance testing, the
Diamond™ Balloon Dilatation Catheter has been shown to be safe and effective for its intended use.