INTRAVASCULAR INFUSION DEVICE

K963988 · Boston Scientific Corp · KRA · Dec 12, 1996 · Cardiovascular

Device Facts

• Record ID: K963988
• Device Name: INTRAVASCULAR INFUSION DEVICE
• Applicant: Boston Scientific Corp
• Product Code: KRA · Cardiovascular
• Decision Date: Dec 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2

Intended Use

The Intravascular Infusion Device is indicated for the infusion of diagnostic agents into the general vasculature including the peripheral, coronary and neurovasculature.

Device Story

Single-lumen intravascular catheter; progressively softer construction from proximal to distal end to facilitate selective vascular placement. Used by clinicians for infusion of diagnostic agents into peripheral, coronary, and neurovasculature. Device provides pathway for agent delivery; performance verified via bench testing (infusion rates, torque, tensile/torsion strength, tip flexibility) and biocompatibility assessments.

Clinical Evidence

Bench testing only. Performed infusion rate, dynamic infusion, static burst, tip flexibility, torque response, torsion strength, tensile strength, and coatings testing. Biocompatibility testing included cytotoxicity, hemolysis, acute systemic toxicity, intracutaneous toxicity, sensitization, pyrogenicity, and USP physiochemical testing. In vivo testing also conducted.

Technological Characteristics

Single-lumen catheter; progressively softer material construction from proximal to distal end. Class II device (CFR 870.1200).

Indications for Use

Indicated for patients requiring infusion of diagnostic agents into peripheral, coronary, or neurovasculature.

Regulatory Classification

Identification

A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

Predicate Devices

• Balt Magic Infusion Catheter
• Transend Steerable Guidewire (BSC/Scimed)

Submission Summary (Full Text)

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DEC 12 1996
K963988

510(k) Premarket Notification
Medi-tech Intravascular Infusion Device
October 3, 1996

## ATTACHMENT 1

## 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 Intravascular Infusion Device is as follows:

**Trade Name:** Intravascular Infusion Device

**Manufacturer:** BSC/SciMed Life Systems
6655 Wedgewood Road
Maple Grove, MN 55311-3646

**Device Generic Name:** Diagnostic Intravascular Catheter

**Classification:** According to Section 513 of the Federal Food, Drug and Cosmetic Act, the device classification is Class II, Performance Standards (CFR 870.1200)

**Predicate Device:**

**Balt Magic Infusion Catheter**
Manufactured by:
Target Therapeutics, Inc.
130 Rio Robles
San Jose, CA 95134

**Transend Steerable Guidewire**
Manufactured by
BSC/Scimed
6655 Wedgwood Road
Maple Grove, MN 55369

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{1}

510(k) Premarket Notification
Medi-tech Intravascular Infusion Device
October 3, 1996

## Product Description:

The Intravascular Infusion Device is a single lumen device constructed with progressively softer characteristics from proximal to distal end to aid in selective placement in the vasculature.

## Indications for Use:

The Intravascular Infusion Device is indicated for the infusion of diagnostic agents into the general vasculature including the peripheral, coronary and neurovasculature.

## Safety and Performance:

The following Functional Testing was performed on the proposed device:

1. Infusion Rate Testing
2. Dynamic Infusion Testing
3. Static Burst Testing
4. Tip Flexibility Testing
5. Torque Response Testing
6. Torsion Strength Testing
7. Tensile Strength Testing
8. Coatings Testing
9. In vivo Testing

In addition, the following Biocompatibility Testing was performed:

1. Cytotoxicity
2. Hemolysis
3. Acute Systemic Toxicity
4. Intracutaneous Toxicity
5. Sensitization
6. Pyrogenicity
7. USP Physiochemical Testing

## Conclusion:

Based on the Indications for Use, technological characteristics and safety and performance testing, the Intravascular Infusion Device has been shown to be safe and effective for its intended use.

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