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.

AI/ML Overview

Acceptance Criteria and Device Performance for NIROYAL® Biliary Premounted Stent System

This document outlines the acceptance criteria and the summary of the study performed to demonstrate that the NIROYAL® Biliary Premounted Stent System (with a modified balloon size) meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The following table details the functional testing performed on the modified NIROYAL® Biliary System and the corresponding acceptance criteria. The document states that "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." and implies that the device met these criteria, as substantial equivalence was determined.

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

2. Sample Size and Data Provenance

The document does not specify the exact sample size used for each functional test. The study appears to be a non-clinical bench test and therefore does not involve human subjects or data from a specific country of origin in the context of clinical trials. The data provenance is internal to Boston Scientific Scimed, Inc. and is generated during product development and modification. This is a retrospective analysis of the modified features against pre-defined engineering specifications.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This study involves functional, non-clinical bench testing of a medical device, not a diagnostic or AI-driven system that requires expert consensus for ground truth.

4. Adjudication Method

Not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth in diagnostic accuracy studies. This document describes non-clinical functional testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a submission for a modification to an existing medical device, involving non-clinical functional testing, not an MRMC comparative effectiveness study of a diagnostic AI system.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The "Non-Clinical Test Summary" section describes various functional tests performed on the device itself, independent of human interaction beyond the execution of the tests. This is a standalone (algorithm/device only) performance evaluation of the physical aspects of the stent system.

7. Type of Ground Truth Used

The "ground truth" for this study is based on engineering specifications and pre-defined performance limits established for the device's functional integrity and safety. These limits (e.g., maximum force, minimum pressure, maximum profile) serve as the objective standards against which the device's performance is measured.

8. Sample Size for the Training Set

Not applicable. This is a medical device modification submission based on non-clinical functional testing, not an AI/ML model that requires a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable. As noted above, this is not an AI/ML model; therefore, there is no training set or ground truth established for a training set in this context.

Summary

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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 Nameand Address	Boston Scientific Scimed, Inc.One Scimed PlaceMaple Grove, Minnesota 55311
Contact Person	Candice Burns(763) 494-2845
Classification Name	Biliary Catheter and AccessoriesProduct Code - 78 FGERegulation Number - 876.5010
Common or Usual Name	Biliary Stent
Proprietary Name	NIROYAL® Biliary Premounted StentSystem
Name of Predicate Devices	NIROYAL® Biliary Premounted StentSystem

III. Device Description

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 (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (301) 443-6597 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

Regulation Number and Section

§ 876.5010 Biliary catheter and accessories.

(a)
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.(b)
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.