The X-Suit NIR® Biliary Metallic Stent is designed to maintain the patency of biliary ducts obstructed by malignant biliary strictures. The device is comprised of a self-expanding stent, which is pre-loaded on a delivery system. The stent is available in 8 and 10mm labeled diameters, and 40 - 100mm labeled lengths.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets them:

The provided text for the X-Suit NIR® Biliary Metallic Stent (K081956) does not contain specific acceptance criteria or details of a clinical study demonstrating device performance against such criteria in the way typically seen for AI/ML devices or clinical trials. Instead, it focuses on demonstrating substantial equivalence to predicate devices through functional testing and adherence to various standards.

Therefore, the requested table of acceptance criteria and device performance, as well as several other points, cannot be fully populated from the given information.

Here's an attempt to extract and infer what's available based on the provided text, and explicitly state what's missing:

Acceptance Criteria and Device Performance Study for X-Suit NIR® Biliary Metallic Stent (K081956)

Summary:
The X-Suit NIR® Biliary Metallic Stent received 510(k) clearance based on substantial equivalence to legally marketed predicate devices. The submission relied heavily on functional (laboratory) testing and adherence to recognized standards and guidance documents rather than a clinical study with specific performance endpoints and acceptance criteria against those endpoints. The primary "performance" demonstrated was that the device met the same performance requirements and was as safe and effective as the predicate devices, as assessed through bench testing and compliance with various specifications.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) summary, specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) and their corresponding device performance metrics from a clinical study are not provided. The "acceptance criteria" are broad and relate to meeting a range of functional and material standards to demonstrate equivalence.

Aspect of Performance/Acceptance Criterion	Reported Device Performance (as demonstrated by compliance)
Palliative Function	Designed to maintain patency of biliary ducts obstructed by malignant biliary strictures (Intended Use). Deemed as safe and effective as predicate devices.
Biocompatibility	Complies with ISO-10993 'Biological Evaluation of Medical Devices Part I: Evaluation and Testing'.
Sterility	Complies with FDA's Updated 510(k) Sterility Review Guidance (K90-1).
Material Specifications (Ni-Ti)	Complies with ASTM F 2063-05 (Wrought Nickel-Titanium Shape Memory Alloys).
Material Specifications (Tantalum)	Complies with ASTM F 560-05 (Unalloyed Tantalum).
MRI Safety/Compatibility	Complies with MRI Standards: ASTM F2503-05, ASTM F2213 -06, ASTM F2052-06e1, ASTM F2182-02a, ASTM F2119-07.
General Performance Requirements	Deemed to meet the same performance requirements as predicate devices, based on functional laboratory testing.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. This 510(k) relies on laboratory (functional) testing, not a clinical "test set" in the context of patient data. The "sample size" would refer to the number of devices or components tested in the lab, which is not detailed.
Data Provenance: The studies were laboratory (bench) tests, not involving patient data from specific countries. The testing was conducted to assess compliance with international standards (ISO, ASTM) and FDA guidance.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This device clearance did not involve a clinical study requiring experts to establish ground truth on patient cases. The evaluation was based on engineering and material standards, functional performance, and regulatory compliance.

4. Adjudication Method for the Test Set

Not Applicable. No clinical test set requiring adjudication was used.

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

No. An MRMC comparative effectiveness study was not done. The submission focused on demonstrating substantial equivalence to existing devices through a combination of engineering, material, and functional bench testing, rather than a clinical trial comparing performance with human readers (with or without AI assistance).

6. Standalone (Algorithm Only) Performance Study

Not Applicable. This is a physical medical device (stent), not an algorithm or AI software. Therefore, no standalone algorithm performance study was conducted.

7. Type of Ground Truth Used

Engineering Specifications and Standard Compliance: The "ground truth" for this submission was largely defined by the established performance characteristics of the predicate devices, along with the requirements laid out in various international standards (ISO, ASTM) and FDA guidance documents related to material properties, biocompatibility, sterility, and functional performance (e.g., expansion properties, resistance to fracture, MRI safety).

8. Sample Size for the Training Set

Not Applicable. As a physical medical device, there is no "training set" in the context of machine learning. The design and development of the stent would follow traditional engineering and R&D processes, using specifications and prototypes, not patient data for algorithm training.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. (See point 8).

Summary

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Ko8 1956 page lot 2

510(k) Summary X-Suit NIR® Biliary Metallic Stent

JAN - 9 2009

Submitter:

Medinol Ltd Kiryat Atidim, Bldg. 7 Entrance 1, 5th Floor Tel-Aviv, Israel 61581 Phone: +972-3-7679000

July 7, 2008

21 CFR 876.5010

78 FGE

Contact Person:

: ***************************************************************************************************************************************************************************

Leo Basta, Partner Boston Biomedical Associates, LLC Office: 508.351.8632 Fax: 508.351.8637

X-Suit NIR® Biliary Metallic Stent

Biliary catheter and accessories

Date Prepared:

Trade Name:

Regulation Name:

Classification Number:

Product Code:

Predicate Devices:

Cook Incorporated Zilver Biliary Stent - K010242

Wilson - Cook Medical Inc. Zilver Biliary Stent -K020788

Bard Luminexx Endoscopic Biliary Stent - K031186

Boston Scientific Wallstent Biliary Endoprostheses -K925406, K961262, K964119, K000308, K012752

Device Description:

Confidential

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K081956 page 2 of 2

Intended Use:

Functional Testing:

The X-Suit NIR® Biliary Metallic Stent has been designed for palliation of malignant strictures in the biliary tree.

Laboratory testing was performed. In some instances, legally marketed biliary stent systems were tested as control devices for the purpose of comparison with the X-Suit NIR® Biliary Metallic Stent device.

In addition, test results and information were also provided in accordance with the following:

Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents February 5, 1998;
International standards Organization's ISO-10993 'Biological Evaluation of Medical Devices Part I: Evaluation and Testing;
FDA's Updated 510(k) Sterility Review Guidance (K90-1); Final Guidance for Industry and FDA, August 30, 2002;
ASTM F 2063-05, Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants;
ASTM F 560-05, Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
MRI Standards, ASTM F2503-05, ASTM F2213 -06, ASTM F2052-06e1, ASTM F2182-02a, ASTM F2119-07.

Summary of Substantial Equivalence:

The design, material, components, fundamental technology and intended use of the X-Suit NIR® Biliary Metallic Stent device are substantially equivalent to those of the predicate devices cited above. Substantial equivalence is based upon descriptive characteristics of the various devices and upon the safety and performance testing completed. The information provided demonstrated that the proposed device meets the same performance requirements and is as safe and effective as the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Public Health Service

JAN - 9 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medinol, Ltd. c/o Mr. Leo L. Basta Partner Boston Biomedical Associates, LLC 386 West Main Street, Suite 7 NORTHBORO MA 01532

Re: K081956

Device Name: X-Suit NIR® Biliary Metallic Stent Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: December 18, 2008 Received: December 22, 2008

Dear Mr. Basta:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 - Mr. Leo Basta

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International, and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

V. O'Dell

Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K081956

Device Name: X-Suit NIR® Biliary Metallic Stent

Indications For Use: X-Suit NIR® Biliary Metallic Stent is indicated for the palliation of malignant strictures in the biliary tree.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(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 and
Radiological Devices
510(k) Number K081950

Page 1 of_

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.