NIROYAL BILIARY PREMOUNTED STENT SYSTEM

K012216 · Boston Scientific Scimed, Inc. · FGE · Aug 17, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K012216
• Device Name: NIROYAL BILIARY PREMOUNTED STENT SYSTEM
• Applicant: Boston Scientific Scimed, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Aug 17, 2001
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NIROYAL® Biliary Premounted Stent System is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.

Device Story

The NIROYAL® Biliary Premounted Stent System consists of a gold-plated stainless steel stent mounted on a 0.018" balloon delivery catheter. It is used by clinicians to treat biliary strictures resulting from malignant neoplasms. The device is deployed via the balloon catheter; the balloon is inflated to expand the stent within the biliary duct to maintain patency. This modification involves increasing the delivery balloon length from 15 mm to 20 mm for the 7 mm x 14 mm stent size. The device is intended for professional use in a clinical setting. The output is the mechanical placement of the stent to relieve biliary obstruction, which aids in patient symptom management.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical functional bench testing, including tracking force, stent deployment pressure, balloon burst pressure, stent profile, expansion uniformity, foreshortening, and stent securement.

Technological Characteristics

Gold-plated stainless steel stent; 0.018" balloon delivery catheter. Modification: 20 mm balloon length for 7 mm x 14 mm stent. Mechanical expansion via balloon inflation. Sterilization method not specified.

Indications for Use

Indicated for patients with biliary strictures caused by malignant neoplasms. Not for use in the vascular system.

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

• NIROYAL® Biliary Premounted Stent System (K003929)

Submission Summary (Full Text)

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Special 510(k) : Device Modification NIROYAL® Biliary Premounted Stent System Balloon Size Change for the 7 mm x 14 mm Stent

# AUG 1 7 2001

K012216
Page 1 of 2

### Section 4

### Summary of Safety and Effectiveness

# (Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)

#### General Provisions II.

| Submitter's Name<br>and Address | Boston Scientific Scimed, Inc.<br>One Scimed Place<br>Maple Grove, Minnesota 55311 |
|---------------------------------|-------------------------------------------------------------------------------------------|
| Contact Person | Candice Burns<br>[phone] |
| Classification Name | Biliary Catheter and Accessories<br>Product Code - 78 FGE<br>Regulation Number - 876.5010 |
| Common or Usual Name | Biliary Stent |
| Proprietary Name | NIROYAL® Biliary Premounted Stent<br>System |
| Name of Predicate Devices | NIROYAL® Biliary Premounted Stent<br>System |

### III. Device Description

The NIROYAL® Biliary Premounted Stent System (NIROYAL® Biliary System) is a stent system consisting of a 0.018" balloon delivery catheter and a gold plated stainless steel stent. The modified NIROYAL® Biliary System is the same as the NIROYAL® Biliary System cleared under K003929, with the exception of the delivery balloon size for the 7 mm x 14 mm stent. The 7 mm x 14 mm stent will be mounted on a 20 mm balloon, instead of a 15 mm balloon as described in K003929.

#### IV. Intended Use

The NIROYAL® Biliary System is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.

### Summary of Technological Characteristics V. Same as the NIROYAL® Biliary System cleared under K003929.

#### VI. Non-Clinical Test Summary

Functional testing was conducted to verify the integrity of the modified balloon length of 20 mm for the 7 mm x 14 mm NIROYAL® Biliary System.

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K012216
Page 2 of 2

### Section 4

# Summary of Safety and Effectiveness (cont.)

# IV. Non-Clinical Test Summary (cont.)

The functional testing included:

| Test | Acceptance Criteria |
|----------------------------------------------------------|---------------------|
| Tracking Force | 1.5 lbf maximum |
| Stent Deployment Pressure | 103 psi maximum |
| Balloon Burst Pressure Within the Stent | 176 psi minimum |
| Stent Profile | 0.075" maximum |
| Stent Expansion Uniformity at Nominal and Rated Pressure | 5% maximum |
| Stent Foreshortening at Nominal and Rated Pressure | 20% maximum |
| Balloon Burst Pressure Out of the Stent | 176 psi minimum |
| Stent Securement | 0.30 lbf minimum |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 7 2001

Ms. Candice Burns Regulatory Affairs Specialist Boston Scientific SCIMED One Scimed Place MAPLE GROVE MN 55311-1566

Re: K012216 NIROYAL® Biliary Premounted Stent System Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: July 13, 2001 Received: July 16, 2001

Dear Ms. Burns:

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 legally marketed predicate 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 and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

The safety and effectiveness of this device for use in the vascular system have not been established.

Furthermore, the indication for biliary use must be prominently displayed in all labeling, including pouch, box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.

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Page 2 - Ms. Candice Burns

If your device is classified (see above) into either class II (Special Controls) or class III II your device is classified (see acore) and additional controls. Existing major regulations (Premarket Apploval), it they of Subject Code of Federal Regulations, Title 21, Parts 800 to 895. alrecting your ac rise can determination assumes compliance with the Current Good A substantially equirements, as set forth in the Quality System Regulation (QS) for Manufacturing Fractice regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to inspections, the Food and Drag result in regulatory action. In addition, FDA may publish comply with the GMT regulation inderice in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might response to your premarter no most 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device The IDA midning of substancial squrinesand permits your device to proceed to the market. This results in a classified.com rearketing your device as described in your 510(k) premarket notification if the limitation statement above is added to your labeling, as described.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. I heast note that the above re these limitations are modified in any way or removed from the device's labeling.

If you desire specific information about the application of other labeling requirements to your 11 you desire openits misund 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, ad vernants or your as issues in the branding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be (21 OF IC 6017) | Small Manufacturers, International and Consumer Assistance at its obtained from and 200) 638-2041 or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Bernard E. Statland, M.D., Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K012216

Device Name: NIROYAL® Biliary Premounted Stent System

FDA's Statement of the Indications For Use for device:

The NIROYAL® Biliary Premounted Stent System is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.

OR Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Nancy C. Brogdon
**(Division Sign-Off)**

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K0/2216