Who is the manufacturer of CHANNEL BALLOON CATHETER?

Boston Scientific Corp filed the 510(k) submission for CHANNEL BALLOON CATHETER (K970379).

What is the FDA product code for CHANNEL BALLOON CATHETER?

LIT. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for CHANNEL BALLOON CATHETER?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CHANNEL BALLOON CATHETER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CHANNEL BALLOON CATHETER

Q: What are the predicate devices for CHANNEL BALLOON CATHETER?

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

Related Devices

K051060 — ANGIODYNAMICS PROFILER PTA BALLOON CATHETER · AngioDynamics, Inc. · May 26, 2005
K960517 — BARD TRU-TRAC PERIPHERAL BALLOON DILATATION CATHETER · C.R. Bard, Inc. · Apr 9, 1996
K960501 — ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER · Boston Scientific Corp · Apr 9, 1996
K972357 — BLUE MAX - 20 BALLOON DILATATION CATHETER · Boston Scientific Corp · Nov 19, 1997
K062609 — MODIFICATION TO ANGIODYNAMICS PROFILER PTA BALLOON CATHETER · AngioDynamics, Inc. · Oct 6, 2006

Submission Summary (Full Text)

{0} 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. 000145 {1} 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. 000146