ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER

K963397 · Boston Scientific Corp · FGE · Nov 25, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K963397
• Device Name: ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER
• Applicant: Boston Scientific Corp
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Nov 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Diamond™ 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. In addition, certain sizes of the Diamond balloon catheter are indicated for stent deployment / optimization of the J&J Palmaz Biliary Stent into the biliary ducts.

Device Story

Over-the-wire balloon dilatation catheter; compatible with guidewires ≤.035"; used by physicians in clinical settings for angioplasty and stent deployment. Device inserted into vasculature or biliary ducts; balloon inflated to dilate stenotic lesions or optimize stent placement. Mechanical expansion restores vessel patency or secures stent; improves blood flow or biliary drainage. No complex electronics or software.

Clinical Evidence

Bench testing only. Functional, integrity, and biocompatibility testing performed per ISO-10993 standards; no clinical data provided.

Technological Characteristics

Over-the-wire balloon dilatation catheter; compatible with guidewires ≤.035". Biocompatibility testing performed per ISO-10993.

Indications for Use

Indicated for patients requiring percutaneous transluminal angioplasty (PTA) of iliac, femoral, and renal arteries, treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae, and stent deployment/optimization in biliary ducts.

Regulatory Classification

Identification

A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.

Special Controls

*Classification.* Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• BSC PEMT-5 Balloon Dilatation Catheter
• BSC Ultra-thin™ Diamond Balloon Catheter

Submission Summary (Full Text)

{0}

NOV 25 1996
K963397
P192
Medi-tech Ultra-thin™ Diamond™ Balloon Dilatation Catheter
August 28, 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 -- PEMT-5 Balloon Dilatation Catheter
BSC -- Ultra-thin™ Diamond Balloon 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 designed to be placed over guidewires which have outer diameters of .035" or smaller.

**Indications for Use:**

The Diamond™ 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. In addition, certain sizes of the Diamond balloon catheter are indicated for stent deployment / optimization of the J&J Palmaz Biliary Stent into the biliary ducts.

000068

{1}

K96 3397
p2072
Medi-tech Ultra-thin™ Diamond™ Balloon Dilatation Catheter
August 28, 1996

# Safety and Performance:

Functional and integrity bench testing and biocompatibility testing (according to the FDA guidance document, ODE Blue Book Memorandum #G95-1, May 1, 1995, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing") were performed, and the data supported the substantial equivalence of the Ultra-thin™ Diamond™ Balloon Dilatation Catheter to the PEMT-5 Balloon Dilatation Catheter.

# 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.

000069