The Bonastent® Biliary stent is a self-expanding polygon mesh surface, tubular prosthesis designed to maintain patency of bile duct strictures caused by malignant tumors. The stent is made of Nitinol wire and is designed in such a way as to prevent migration and tumor in-growth. The stent is provided preloaded on a delivery device and is available in 2 different diameters (8mm and 10mm) in various lengths.

AI/ML Overview

This document describes the Bonastent® Biliary stent, addressing its substantial equivalence to predicate devices for the palliation of malignant strictures in the biliary tree. However, it does not contain information regarding specific acceptance criteria for performance metrics (such as accuracy, sensitivity, or specificity), nor does it describe any study designed to prove the device meets such criteria.

The document is a 510(k) summary for a medical device cleared by the FDA, which typically focuses on demonstrating substantial equivalence to pre-existing devices rather than independent performance validation studies with acceptance criteria.

Therefore, I cannot provide the requested information from the provided text for the following points:

A table of acceptance criteria and the reported device performance: This information is not present in the document. The document focuses on regulatory clearance through substantial equivalence, not on specific performance data against predefined acceptance criteria from a clinical study.
Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not described. This is a physical medical device (stent), not an AI diagnostic/assistive technology, so such a study would not be applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not described.
The sample size for the training set: Not applicable, as this is a physical medical device, not an AI/algorithm where a training set size would be relevant.
How the ground truth for the training set was established: Not applicable.

Summary of what is available in the document:

Device Name: Bonastent® Biliary
Intended Use: Palliation of malignant strictures in the biliary tree.
Device Description: Self-expanding polygon mesh surface, tubular prosthesis made of Nitinol wire. Designed to prevent migration and tumor in-growth. Available in 8mm and 10mm diameters in various lengths.
Technological Characteristics: Weaved using hook & cross wire construction (reduces delivery device diameter). Includes 3 groups of 4 radiopaque markers at the center and both ends.
Predicate Devices:
- Niti-S Biliary Stent by Taewoong Medical Co., Ltd, K073667
- WallFlex™ Biliary RX Stent System by Boston Scientific Corporation, K081733
Regulatory Conclusion: EndoChoice believes the device is substantially equivalent to its predicate devices without raising new safety or effectiveness issues.
FDA Clearance: K093003, cleared on March 24, 2010.
FDA Imposed Limitations: A warning must appear in the labeling: "The safety and effectiveness of this device for use in the vascular system have not been established." Additionally, the indication for biliary use must be prominently displayed in all labeling.

Summary

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MAR 2 4 ZOLO

510(K) Summary

[as required by section 807.92(c)]

Bonastent® Biliary

510(k) Number K_ 09 3003

Applicant's Name:

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EndoChoice Inc. 11800 Wills Rd. Suite 100Alpharetta, GA 30009 Telephone: 770-682-8700 Fax: 770-962-6981

Contact Person:

Name: Shoshana (Shosh) Friedman Telephone: 704-899-0092 Fax: 704-899-0098 Email: shosh@pushmed.com

Trade Name:

Bonastent® Biliary

Classification Name: Regulation Number: Product Code: FGE Classification: Review Panel:

Biliary catheter and accessories 876.5010 Class II Gastroenterology/Urology

Predicate Devices:

Niti-S Biliary Stent by Taewoong Medical Co., Ltd, K073667 ●
WallFlex™ Biliary RX Stent System by Boston Scientific Corporation . K081733

Device Description:

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Intended Use:

The Bonastent® Biliary is indicated for the palliation of malignant strictures in the biliary tree.

Technological Characteristics:

The Bonastent® Biliary is weaved using hook & cross wire construction which reduces the delivery device diameter. The stent includes 3 groups of 4 radiopaque markers located at the center of the stent as well as at both ends of the stent.

Conclusion:

EndoChoice believes that, based on the information provided in this submission, the Bonastent® Biliary stent system is substantially equivalent to its predicate devices without raising any new safety and/or effectiveness issue.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of a human figure with outstretched arms, representing health and well-being. The symbol is black and white.

Public Health Service

MAR 2 4 2010

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ms. Shoshana Friedman, RAC Regulatory Consultant EndoChoice, Inc. 11800 Wills road. Suite 100 ALPHARETTA GA 30009

Re: K093003

Trade/Device Name: BONASTENT® Biliary Stent Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: March 16, 2010 Received: March 18, 2010

Dear Ms. Friedman:

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 - Ms. Shoshana Friedman, RAC

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 (QS) 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 (301) 796-5484. 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 (301) 796-5857 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

B/Yemmer for

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): K093003

Device Name: BONASTENT® Biliary Stent

Indications For Use: The BONASTENT® Biliary 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 __K 09 30 30 3

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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.