NIR BILIARY STENT

K973171 · Medinol, Ltd. · FGE · Nov 13, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K973171
• Device Name: NIR BILIARY STENT
• Applicant: Medinol, Ltd.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Nov 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The NIR Biliary Stent is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.

Device Story

NIR Biliary Stent is a balloon-expandable stent used with a balloon dilatation catheter; facilitates transhepatic access to biliary tree; maintains luminal patency of biliary strictures caused by malignant neoplasms. Used in clinical settings by physicians; stent deployed to support duct walls; benefits patient by relieving obstruction caused by malignancy.

Clinical Evidence

Bench testing only. Functional and integrity testing and biocompatibility testing (ISO 10993) were performed to support substantial equivalence.

Technological Characteristics

Balloon-expandable stent; used with balloon dilatation catheter; transhepatic delivery system. Biocompatibility evaluated per ISO 10993.

Indications for Use

Indicated for patients with biliary strictures caused by malignant neoplasms.

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

• Johnson & Johnson Palmaz™ Biliary Stent
• BSC Symphony™ Transhepatic Biliary Stent System

Submission Summary (Full Text)

{0}------------------------------------------------

NOV 13 1998

NIR™ Biliary Stent

K973174

August 22, 1997

# 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 NIR™ Biliary Stent is as follows:

| Trade Name: | NIR™ Biliary Stent |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Boston Scientific Corporation/ Ireland (BSIL)<br>Galway, Ireland |
| Device Generic Name: | Biliary Stent |
| Classification: | According to Section 13 of the Federal Food, Drug and Cosmetic Act, the<br>device classification is Class II, Performance Standards. |
| Predicate Devices: | Johnson & Johnson Palmaz™ Biliary Stent<br>BSC Symphony™™ Transhepatic Biliary Stent System |

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

## Device Description:

The proposed NIR™ Biliary Stent is a balloon expandable stent designed to be used with a balloon dilatation catheter. The delivery catheter facilitates transhepatic access to the biliary tree and the stent is designed to maintain luminal patency of biliary strictures produced by malignant neoplasms.

#### 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 NIRTM Biliary Stent to the predicate devices.

# Conclusion:

Based on the Indications for Use, technological characteristics and safety and performance testing, the NIR™ Biliary Stent has been shown to be safe and effective for its intended use.

{1}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 1 3 1998

Ms. Tami Abudi Clinical Research and Regulatory Affairs Medinol Ltd. POB.58165 Kiryat Atidim, Bldg. 3 Entrance 2, 4th Floor Tel Aviv 61581 ISRAEL

Re: K973171 NIR™ Biliary Stent Dated: August 11, 1998 Received: August 17, 1998 Regulatory Class: II 21 CFR 876.5010/Procode: 78 FGE

Dear Ms. Tami Abudi:

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 (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 OS 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.

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/odrh/dsmadsmam.html".

Sincerely yours

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

Enclosure

{2}------------------------------------------------

Page__________________________________________________________________________________________________________________________________________________________________________

ri

510(k) Number (if known):_______ New Application

Device Name:_____NIR Biliary Stent System

Indications For Use:

The NIR Biliary Stent is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.

·

.............................................................................................................................................................................. . -

(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 Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K973171/S ⁰⁰¹ |
| Prescription Use | <div style="display:inline-block; vertical-align:middle;"> ✓</div> |
| (Per 21 CFR 201.109) | |
| OR | |
| Over-The-Counter Use | |
| (Optional Format 1-2-96) | |