BLUE MAX - 20 BALLOON DILATATION CATHETER

K972357 · Boston Scientific Corp · LIT · Nov 19, 1997 · Cardiovascular

Device Facts

• Record ID: K972357
• Device Name: BLUE MAX - 20 BALLOON DILATATION CATHETER
• Applicant: Boston Scientific Corp
• Product Code: LIT · Cardiovascular
• Decision Date: Nov 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Blue Max 20 Balloon Dilatation Catheters are recommended 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.

Device Story

Over-the-wire, two-lumen balloon dilatation catheter; used for percutaneous transluminal angioplasty (PTA) of peripheral vasculature and arteriovenous dialysis fistulae. Operated by physicians in clinical settings. Device facilitates vessel dilation via balloon inflation; mechanical intervention to restore blood flow in obstructed vessels. Benefits include improved patency of dialysis access and peripheral arterial flow.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included balloon burst, multiple inflation, inflation/deflation time, balloon compliance, balloon proximal bond, and sheath withdrawal. Biocompatibility testing included cytotoxicity, irritation, hemolysis, acute systemic toxicity, mutagenicity, sensitization, implantation, pyrogenicity, and subchronic toxicity.

Technological Characteristics

Over-the-wire, two-lumen catheter design. Mechanical balloon dilatation. Biocompatible materials. No software or electronic components.

Indications for Use

Indicated for patients requiring percutaneous transluminal angioplasty of iliac, femoral, or renal arteries, or 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 Diamond Balloon Dilatation Catheter

Submission Summary (Full Text)

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K972357

Medi-tech Blue Max™ -20 Balloon Dilatation Catheter

June 24, 1997

### ATTACHMENT H

#### NOV 1 9 1997 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 Blue Max™ -20 Balloon Dilatation Catheter is as follows:

| Trade Name: | Blue Max™ -20 Balloon Dilatation Catheter |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Boston Scientific Corporation<br>One Boston Scientific Place<br>Natick, MA 01760 |
| Device Generic Name: | Balloon Dilatation Catheter |
| Classification: | According to Section 13 of the Federal Food, Drug and Cosmetic Act, the<br>device classification is Class II, Performance Standards. |

#### Predicate Devices:

The following devices are referenced in this premarket notification as predicate devices for the Blue Max™ -20 Balloon Dilatation Catheter:

> BSC -- Blue Max Balloon Dilatation Catheter BSC -- Ultra-thin Diamond Balloon Dilatation Catheter

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

#### Device Description:

The proposed Blue Max™ -20 Balloon Dilatation catheter is an over-the-wire catheter with two lumens indicated for percutaneous transluminal angioplasty of narrowed or obstructed vessels in the peripheral vasculature 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 Blue Max™ -20 Balloon Dilatation Catheter:

- Balloon Burst Testing
- . Multiple Inflation Testing
- . Inflation/Deflation Time Testing
- . Balloon Compliance Testing
- Balloon Proximal Bond Testing
- . Sheath Withdrawal Testing

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Medi-tech Blue Max™ -20 Balloon Dilatation Catheter

The following biocompatibility tests were performed:

- Cytotoxicity .
- Irritation .
- Hemolysis .
- Acute Systemic Toxicity .
- Mutagenicity .
- Sensitization .
- Implantation .
- Pyrogenicity .
- Subchronic Toxicity .

## Conclusion:

Based on the Indications for Use, technological characteristics and safety and performance testing, the Blue Max™ -20 Balloon Dilatation Catheter has been shown to be safe and effective for its intended use.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Career States

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HU. AN SERVICES. USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 19 1997

Ms. Mary P. LeGraw Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537

Re: K972357 Blue Max-20™ Balloon Dilatation Catheter Regulatory Class: II (two) Product Code: 74 LIT Dated: November 5, 1997 Received: November 6, 1997

Dear Ms. LeGraw:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to ,895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Mary P. LeGraw

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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New Application

510(k) Number (if known):

Blue Max 20 Balloon Dilatation Catheter Device Name:

Indications For Use:

Blue Max 20 Balloon Dilatation Catheters are recommended 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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-O Division of Cardiova and Neurological De 510(k) Numbe

Prescription Use
(Per 21 CFR 201.109)

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Over-The-Counter Use_

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