CHANNEL BALLOON CATHETER

K970379 · Boston Scientific Corp · LIT · May 1, 1997 · Cardiovascular

Device Facts

• Record ID: K970379
• Device Name: CHANNEL BALLOON CATHETER
• Applicant: Boston Scientific Corp
• Product Code: LIT · Cardiovascular
• Decision Date: May 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The proposed Channel™ Balloon catheter is an over-the-wire balloon catheter with four lumens indicated for percutaneous transluminal angioplasty of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. A secondary function is the controlled selective regional infusion of contrast or therapeutic agents into the peripheral vasculature.

Device Story

Over-the-wire balloon catheter with four lumens; used for percutaneous transluminal angioplasty (PTA) of iliac, femoral, and renal arteries; treats obstructive lesions in native/synthetic arteriovenous dialysis fistulae; secondary function allows controlled selective regional infusion of contrast or therapeutic agents into peripheral vasculature. Operated by physicians in clinical settings. Device facilitates vessel dilation and targeted drug/contrast delivery.

Clinical Evidence

Bench testing only. In vitro functional tests: balloon burst, multiple inflation, compliance, inflation/deflation time, sheath withdrawal, tensile testing (proximal bond/shaft), flow rate, outer sleeve bond, and flow uniformity. Biocompatibility testing: intracutaneous reactivity, sensitization, cytotoxicity, acute systemic toxicity, haemocompatibility (hemolysis), pyrogenicity, and mutagenicity. Animal testing conducted for vessel depth of penetration.

Technological Characteristics

Over-the-wire balloon catheter; four-lumen design. Materials evaluated via biocompatibility standards (reactivity, sensitization, cytotoxicity, toxicity, hemolysis, pyrogenicity, mutagenicity). Mechanical performance verified via burst, compliance, tensile, and flow testing.

Indications for Use

Indicated for percutaneous transluminal angioplasty of iliac, femoral, and renal arteries and treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae. Also indicated for controlled selective regional infusion of contrast or therapeutic agents into peripheral vasculature.

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 -- Courier Balloon Dilatation Catheter
• BSC -- Ultra-thin Diamond Balloon Catheter
• BSC -- Katzen Thrombolysis Guidewire
• LocalMed Inc. - Kaplan Simpson InfusSleeve Catheter

Submission Summary (Full Text)

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MAY - 1 1997
K970379
Medi-tech Channel™ Balloon Catheter
January 31, 1997

# ATTACHMENT I

## 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 Channel™ Balloon Catheter is as follows:

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

- BSC -- Courier Balloon Dilatation Catheter
- BSC -- Ultra-thin Diamond Balloon Catheter
- BSC -- Katzen Thrombolysis Guidewire
- LocalMed Inc. - Kaplan Simpson InfusSleeve Catheter

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

**Device Description:**

The proposed Channel™ Balloon catheter is an over-the-wire balloon catheter with four lumens indicated for percutaneous transluminal angioplasty of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. A secondary function is the controlled selective regional infusion of contrast or therapeutic agents into the peripheral vasculature.

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Medi-tech Channel™ Balloon Catheter

January 31, 1997

# Safety and Performance:

The following in vitro functional tests were performed on the Channel™ Balloon Catheter:

1. Balloon Burst Testing
2. Multiple Inflation Testing
3. Balloon Compliance Testing
4. Inflation / Deflation Time Testing
5. Sheath Withdrawal Testing
6. Proximal Bond Tensile Testing
7. Shaft Tensile Testing
8. Flow Rate Testing
9. Outer Sleeve Distal and Proximal Bond Testing
10. Flow Uniformity Testing

In addition, the following Biocompatibility Testing was performed:

1. Intracutaneous Reactivity
2. Sensitization
3. Cytotoxicity
4. Acute Systemic Toxicity
5. Haemocompatibility (completed as Hemolysis)
6. Pyrogenicity
7. Mutagenicity

Animal testing was also conducted to establish the Vessel Depth of Penetration for the proposed device.

# Conclusion:

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

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