COURIER ST BALLOON DILATATION CATHETER

K972744 · Boston Scientific Corp · LIT · Dec 11, 1997 · Cardiovascular

Device Facts

• Record ID: K972744
• Device Name: COURIER ST BALLOON DILATATION CATHETER
• Applicant: Boston Scientific Corp
• Product Code: LIT · Cardiovascular
• Decision Date: Dec 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Courier ST 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. Courier ST Catheters are not indicated for use in coronary arteries or the neurovasculature.

Device Story

Over-the-wire, three-lumen balloon dilatation catheter; used for percutaneous transluminal angioplasty (PTA) of peripheral arteries and arteriovenous dialysis fistulae. Device is inserted percutaneously by a physician to dilate obstructive lesions. Performance verified via in vitro functional testing (burst, inflation/deflation, compliance, bond strength, sheath withdrawal) and biocompatibility testing. Benefits include restoration of vessel patency in peripheral vasculature and dialysis access sites.

Clinical Evidence

No clinical data. Evidence consists of bench-top functional testing (balloon burst, multiple inflation, inflation/deflation time, compliance, proximal bond, sheath withdrawal) and biocompatibility testing (intracutaneous reactivity, sensitization, cytotoxicity, acute systemic toxicity, hemolysis, pyrogenicity, mutagenicity).

Technological Characteristics

Over-the-wire, three-lumen balloon dilatation catheter. Biocompatible materials verified via ISO/FDA standards. Mechanical design features include balloon inflation/deflation capabilities for vessel dilation. No software or electronic components.

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. Contraindicated for use in coronary arteries or neurovasculature.

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

Submission Summary (Full Text)

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444444

Medi-tech Courier™ ST Balloon Dilatation Catheter

July 21, 1997

## ATTACHMENT H

# DEC | | | |997

# 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 Courier™ ST Balloon Dilatation Catheter is as follows:

| Trade Name: | Courier™ ST 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 device for the Courier™ ST Balloon Dilatation Catheter:

BSC - Courier Balloon Dilatation Catheter

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

#### Device Description:

The proposed Courier™ ST Balloon Dilatation catheter is an over-the-wire catheter with three lumens. The Courer™ ST 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.

#### Safety and Performance:

The following in vitro frunctional tests were performed on the Courier™ ST 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 Courier™ ST Balloon Dilatation Catheter

The following biocompatibility tests were performed:

- Intracutaneous Reactivity .
- Sensitization .
- Cytotoxicity .
- Acute Systemic Toxicity .
- Haemocompatibility (completed as Hemolysis) .
- Pyrogenicity .
- Genotoxicity (completed as Mutagenicity) .

### Conclusion:

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

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Rockville MD 20857

DEC I I 1997

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

Re : K972744 Courier STTM Balloon Dilatation Catheter Regulatory Class: II (two) Product Code: LIT Dated: November 6, 1997 November 8, 1997 Received:

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 prìor 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 Requlations, 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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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 regulation (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,

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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Page__________________________________________________________________________________________________________________________________________________________________________

K972744 510(k) Number (if known):

Courier ST Balloon Dilatation Catheter Device Name:

Indications For Use:

Courier ST 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.

Courier ST Catheters are not indicated for use in coronary arteries or the neurovasculature.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|-------------------------------------------------------------------|--------------------------------------------|
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K972744 |
| Prescription Use<br>(Per 21 CFR 801.109) | <div style="display:inline-block;">✓</div> |
| OR | Over-The-Counter Use |

(Optional Format 1-2-96)

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