(317 days)
Niti-S Esophageal Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.
The proposed Niti-S Esophageal 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 esophagus. 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.
The provided text is a 510(k) summary for the Niti-S Esophageal Stent, focusing on its substantial equivalence to predicate devices. It describes the device, its intended use, and technological characteristics. However, it does not contain the detailed performance data or study information required to fill out the requested table and answer many of your questions.
Specifically, this document is a regulatory submission for premarket notification, which often relies on demonstrating substantial equivalence to existing devices rather than extensive new clinical trials or detailed performance studies with acceptance criteria in the same way an AI/ML device might.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document states: "Laboratory testing regarding characteristics was performed on the Niti-S Esophageal Stent to verify its safety and performance." and "A biocompatibility assessment was performed on the patient contact materials." However, it does not provide any specific acceptance criteria (e.g., in terms of sensitivity, specificity, accuracy, or a specific metric) or the reported performance metrics (e.g., actual values from tests like radial force, fatigue, etc.).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The general statement "Laboratory testing regarding characteristics was performed" does not specify sample sizes or data provenance.
3. 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)
This information is not provided. The document describes physical device testing (laboratory testing and biocompatibility), not studies involving expert evaluation to establish ground truth for a test set in the way an AI/ML device would require.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
This information is not provided. This device is an esophageal stent, not an AI-powered diagnostic or assistive tool, so an MRMC study comparing human readers with and without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical stent, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a physical medical device like an esophageal stent, "ground truth" would typically relate to predefined engineering specifications, material properties, and biological compatibility standards. The document mentions "Laboratory testing regarding characteristics" and "biocompatibility assessment," implying that the device was evaluated against these types of established standards, but it does not explicitly detail the "type of ground truth" in a way that aligns with AI/ML device evaluations.
8. The sample size for the training set
This is not applicable. This document is for a physical medical device and discusses laboratory testing and biocompatibility, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable.
In summary:
This 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and general safety/performance statements from laboratory testing and biocompatibility. It does not provide the detailed performance metrics, study designs, expert involvement, or AI-specific information requested in your prompt. This type of submission generally relies on demonstrating that the new device is as safe and effective as a legally marketed predicate, rather than presenting novel clinical trial data with specific acceptance criteria and ground truth establishment, as would be expected for a new AI/ML device.
{0}------------------------------------------------
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: March 12, 2008
1. Submitter:
JAN 30 2009
0807 82
| 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 Esophageal Stent |
|---|---|
| Common Name: | Prosthesis, Esophageal |
| Classification Name: | Esophageal Prosthesis |
| Classification: | 21 CFR 878.3610 |
| Product Code: | ESW |
| Third Party Reviewed: | NO |
3. Predicate Device:
Microvasive Ultraflex Esophageal Stent System Boston Scientific Corporation K940838
Niti-S Stent & Introducer, Model Esophageal, Taewoong Medical Co., Ltd K041648
Cook Esophageal Z Stent with DUA Anti-Reflux Wilson-Cook Medical K011591
4. Description:
The proposed Niti-S Esophageal Stent consists of an implantable metallic stent and a flexible introducer system. The stent is a rigid, flexible, and expandable tubular device
Taewoong Medical Co., Ltd.
11
{1}------------------------------------------------
produ made of a Nitinol wire that is intended to be implanted to restore the structure and/or function of the esophagus. 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.
5. Indications for use:
Niti-S Esophageal Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.
Technological Characteristics: 6.
The proposed Niti-S Esophageal Stent is a self-expanding Nickel Titanium alloy (Nitinol) stent mounted on an introducer. The stent is available in multiple sizes. The proposed stent's body diameter is 16, 18 or 20 mm with a 30, 50, 70, 90, or 120 mm length and each head's diameter is 24, 26 or 28 mm and 15 mm in length. Physician preference and individual patient condition and/or anatomy will determine the appropriate size.
Niti-S Esophageal Stent is substantially equivalent to Microvasive Ultraflex Esophageal Stent System, Boston scientific Corporation K940838, Cook Esophageal Z Stent with DUA Anti-Reflux, Wilson-Cook K011591 and Niti-S Stent & Introducer, Model Esophageal, Taewoong Medical Co., Ltd K041648. The devices have the same intended use and self-expanding stents constructed of Nitinol. The stents are mounted on an introducer system; however the designs are different. The predicate Microvasive Ultraflex Esophageal Stent System is constrained onto the introducer system with knitted loop by pulling string. The Niti-S Stent & Introducer, Model Esophageal and the proposed Niti-S Esophageal Stent utilized a co-axial tube and the stents are constrained onto the introducer system shaft by the outer sheath by pulling outer sheath.
7. Performance Data:
Laboratory testing regarding characteristics was performed on the Niti-S Esophageal Stent to verify its safety and performance. A biocompatibility assessment was performed on the patient contact materials of the Niti-S Esophageal Stent.
8. Conclusions:
Taewoong Medical Co., Ltd. concludes that the Niti-S Esophageal Stent is safe and effective. It is substantially equivalent to the predicate devices, Microvasive Ultraflex Esophageal Stent System, Cook Esophageal Z Stent with DUA Anti-Reflux and Niti-S Stent & Introducer, Model Esophageal.
END
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Taewoong Medical Co., Ltd. c/o Cathryn N. Cambria, RAC Consultant Arkin Consulting Group, LLC 5536 Trowbridge Drive DUNWOODY GEORGIA 30338
JAN 3 0 2009
Re: K080782
Trade/Device Name: Taewoong Niti-S Esophageal Stent System Regulation Number: 21 CFR §878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: FGE Dated: December 23, 2008 Received: December 30, 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
{3}------------------------------------------------
Page 2
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, 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.suppor/index.html.
Sincerely yours.
Laura B. Merrill
anine M. M. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
10
510(k) Submission - Niti-S Esophageal Stent
510(k) Number K
080782
Device Name: Niti-S Esophageal Stent
Indication for use: Niti-S Esophageal Stent is intended for use in esophageal w strictures caused by intrinsic and/or extrinsic malignant tumors.
Prescription Use (Per 21CFR801 Subpart D) Over-The-Counter Use (Per 21CFR807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Arvito Whay
Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices 8079 510(k) Number
Taewoong Medical Co., Ltd.
§ 878.3610 Esophageal prosthesis.
(a)
Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”