The proposed Niti-S Biliary Stent consists of an implantable metallic stent and a flexible introducer system. The stent is a rigid, flexible, and expandable tubular device made of a Nitinol wire that is intended to be implanted to restore the structure and/or function of the biliary. This device also includes the introducer. Upon deployment, the stent imparts an outward radial force on the luminal surface of the duct to establish patency. There are 2 different types of introducers; percutaneous or endoscopic. The Stent is available in two diameters (8, 10mm), and eight lengths (40mm, 50mm, 60mm, 70mm, 80mm, 90mm, 100mm, 120mm) of Nitinol Wire.

AI/ML Overview

The provided text describes a 510(k) summary for the Niti-S Biliary Stent, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full de novo study with detailed acceptance criteria and performance data as might be seen for a novel AI/software medical device.

Therefore, many of the requested categories related to AI/software performance studies (like sample sizes for test sets, expert qualifications, MRMC studies, standalone performance, training set details) are not applicable to this 510(k) submission for a physical medical device.

However, I can extract the relevant information from the provided text.

Here's the breakdown of the information that is applicable:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of physical medical device 510(k), the "acceptance criteria" is typically demonstrating substantial equivalence to a predicate device. The "reported device performance" refers to laboratory testing and biocompatibility assessments, rather than clinical performance metrics often seen in AI device submissions.

Acceptance Criterion (Implicit)	Reported Device Performance (as stated in the 510(k) Summary)
Safety and Effectiveness (Substantial Equivalence)	"Laboratory testing regarding characteristics was performed on Niti-S Biliary Stent to verify its safety and performance."
Biocompatibility	"A biocompatibility assessment was performed on the patient contact materials of Niti-S Biliary Stent."
Indication for Use	"The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree." (Confirmed substantially equivalent to predicate for this indication).
Technological Characteristics (matching/similar to predicate)	The device is a Nitinol, self-expanding Nickel Titanium alloy (Nitinol) mounted on an introducer, available in two types (Percutaneous and Endoscopic), two diameters (8, 10mm), and eight lengths. This matches the description of the predicate devices.

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is the overall 510(k) submission process, which demonstrates "substantial equivalence" to legally marketed predicate devices. This typically involves:

Comparison of technological characteristics: Comparing the Niti-S Biliary Stent's design, materials, and intended use to the identified predicate devices (Zilver Biliary Stent System USW, Wallstent RX Biliary Endoprostheses, Niti-S Stent & Introducer, Model Esophageal).
Non-clinical performance testing: Laboratory testing to verify safety and performance (e.g., radial force, fatigue resistance, stent integrity, deployment force, etc. - though specific details are not provided in this summary).
Biocompatibility testing: As stated, an assessment was performed on patient contact materials.

The conclusion from the submitter is: "Taewoong Medical Co., Ltd. concludes that the Niti-S Biliary Stent is safe and effective and substantially equivalent to the predicate devices." The FDA concurred with this determination, with the caveat of additional labeling requirements concerning use in the vascular system.

Information Not Applicable or Not Provided in the Document:

Since this is a 510(k) for a physical stent and not an AI or software device, the following points are not directly addressed in the provided summary:

2. Sample size used for the test set and the data provenance: Not applicable in the context of an AI/software device evaluation. Performance testing for a physical device would involve engineering tests (e.g., bench tests) rather than a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. 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 applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/software sense. The "ground truth" for a physical device's performance would be engineering specifications and safety standards met through bench testing.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary

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510(k) Summary

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: October 29, 2007

1. Submitter:

Name:	Taewoong Medical Co., Ltd.1-5 Gomak-ri, Wolgot-myeon,Gimpo-si, Gyeonggi-do,Republic of Korea 415871
Contact:	J.H. Nam /DirectorPhone +82 31 996-0641

2. Device:

Proprietary Name:	Niti-S Biliary Stent
Common Name:	Biliary Stent
Classification Name:	Biliary Catheter
Classification:	21 CFR 876.5010
Product Code:	FGE
Third Party Reviewed:	NO

3. Predicate Device:

1. Zilver Biliary Stent System USW, K040930
1. Wallstent RX Biliary Endoprostheses, K012752
1. Niti-S Stent & Introducer, Model Esophagea1, K041648

4. Description:

Taewoong Medical Co., Ltd.

NOV 1 9 600

2073667
pg 1 of 2

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Indications for use: 5.

The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree.

6. Technological Characteristics:

The proposed Niti-S Biliary Stent is a Nitinol, self-expanding Nickel Titanium alloy (Nitinol) mounted on an introducer. There are two types; Percutaneous and Endoscopic. The Stent is available in two diameters (8, 10mm), and eight lengths (40mm, 50mm, 60mm, 70mm, 80mm, 90mm, 100mm, 120mm). Preference and individual patient condition and/or anatomy will determine the appropriate type and size.

7. Performance Data:

Laboratory testing regarding characteristics was performed on Niti-S Biliary Stent to verify its safety and performance. A biocompatibility assessment was performed on the patient contact materials of Niti-S Biliary Stent.

8. Conclusions:

Taewoong Medical Co., Ltd. concludes that the Niti-S Biliary Stent is safe and effective and substantially equivalent to the predicate devices.

END

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 19 2008

Taewoong Medical Co., Ltd. c/o Ms. Cathryn N. Cambria Consultant Arkin Consulting Group, LLC 5536 Trowbridge Drive DUNWOODY GA 30338

Re: K073667

Device Name: Niti-S Biliary Stent Regulation Number: 21 CFR $876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: September 9, 2008 Received: September 11, 2008

Dear Ms. Cambria;

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. Cathryn Cambria

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,

В. Устинов

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): K073667

Device Name:_ Niti-S Biliary Stent

Indications For Use: Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree.

Prescription Use _ V (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)

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(Division S Division of Reproductive, Abdominal, and Radiological Devices

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

510(k) Number.

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.