COURIER ST BALLOON DILATATION CATHETER

K973008 · Boston Scientific Corp · FGE · Dec 15, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K973008
• Device Name: COURIER ST BALLOON DILATATION CATHETER
• Applicant: Boston Scientific Corp
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Dec 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Marshal Balloon Dilatation Catheter is indicated for deployment The Palmaz and the Palmaz-Schatz Balloon-Expanded Stents for the Biliary System. Marshal Gatheters are not indicated for use in coronary arteries or the neurovasculature.

Device Story

Over-the-wire balloon dilatation catheter; compatible with guidewires ≤ .035" diameter. Used for deployment of Palmaz and Palmaz-Schatz balloon-expanded stents within the biliary system. Operated by clinicians in a clinical setting. Device facilitates stent placement; provides mechanical expansion of stents to maintain biliary patency. Benefits patient by enabling minimally invasive biliary stenting.

Clinical Evidence

Bench testing only. Functional and integrity testing performed. Biocompatibility testing conducted per ISO 10993 standards.

Technological Characteristics

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

Indications for Use

Indicated for deployment of Palmaz and Palmaz-Schatz balloon-expanded stents in the biliary system. Not indicated for use in coronary arteries or neurovasculature.

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 Courier 1 Balloon Catheter

Submission Summary (Full Text)

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K973008

Medi-toch Marshal™ Balloon Dilatation Cathorer September 12, 1996

## ATTACHMENT H

## DEC 1 5 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 un " ... adequate summary of aay 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 summery of information respection safety and offectiveness. According to §.13(i)(3)(B), "Any summary under subparagraph (A) respecting a dovice shall contain detailed information regarding data concerning adverse health effects ...

The summary regarding the adverse bealth effects of the proposed Marshal™ Balloon Dilatation Catheter is as follows:

| Trade Name: | MarshalTM 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 Marshal™ Balloon Dilatation Catheter:

> BSC -- PEMT-5 Balloon Dilatation Catheter BSC -- Courier 1 Balloon Catheter

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

Device Description:

The Marshal™ Balloon Dilatation catherer is an over-the-wire catherer designed to be placed over guidewires which have outer diameters of .035" or smaller.

Indications for Use:

The Marshal™ Balloon Dilatation Cutheter is indicated for deployment of the Palmaz™ and the Palmaz-Shatz™ Balloon-Expanded Stents for the Biliary system

Safety and Performance:

Functional and integrity beach testing and hiocompatibility testing (according to the FDA guidance document, ODE Blue Book Memorandum #G95-1, May 1, 1995, Use of International Standard ISO-

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## K973008

Medi-tech Marshal nu Ralloon Dilation Cather September 12, 1996

10993, "Biological Evaluation of Medical Devices Part I: Evaluation and Testing") were performed, and the data supported the substantial equivalence of the Marshall™ Balloon Dilatation Catheter to the Courier and PEMT-5 Balloon Dilatation Catherer.

Conclusion:

Based on the Indication for Use, technological characteristics and safety and performance testing, the Marshalled Balloon Dilation Catheter has beca shown to be safe und effective for its intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 5 1997

Ms. Mary P. LeGraw Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537 Re: K973008

Marshal™ Balloon Dilatation Catheter Dated: November 12, 1997 Received: November 14, 1997 Regulatory class: II 21 CFR §876.5010/Product code: 78 FGE

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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 misbranion.

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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections the Food and Drue Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. 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 Radiation Control provisions, or other Federal laws or regulations.

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,

h)liau Yu
Lillian Yin, Ph.D.

Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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| Page | Ol<br>Annual Property of Children and Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Chil | |
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| | | Carolina Antario Controllation Company of Children |

| 510(k) Number lif known)- | K973008 |
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Courier ST (Marshal) Balloon Dilatation Catheter Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Marshal Balloon Dilatation Catheter is indicated for deployment The Palmaz and the Palmaz-Schatz Balloon-Expanded Stents for the Biliary System.

Marshal Gatheters are not indicated for use in coronary arteries or the neurovasculature.

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

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