(329 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and biocompatibility of a metallic stent and its introducer system. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The device is a stent intended to restore the structure and/or function of the biliary tree by establishing patency, which is a therapeutic action for malignant strictures.
No
This device is a stent, which is a therapeutic device used to restore structure and function, not a diagnostic device. Its purpose is to palliate malignant strictures, not to diagnose them.
No
The device description clearly states it consists of an implantable metallic stent and a flexible introducer system, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The Niti-S Biliary Stent is an implantable metallic stent designed to be placed inside the body (in vivo) to treat a physical condition (malignant strictures in the biliary tree).
- Intended Use: The intended use is to palliate malignant strictures within the biliary tree, which is a direct intervention on the patient's anatomy.
The device description and intended use clearly indicate that this is an implantable medical device used for a therapeutic purpose within the body, not for testing specimens outside the body.
N/A
Intended Use / Indications for Use
The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree.
Product codes
FGE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary tree
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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: 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 /Director
Phone +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:
-
- Zilver Biliary Stent System USW, K040930
-
- Wallstent RX Biliary Endoprostheses, K012752
-
- Niti-S Stent & Introducer, Model Esophagea1, K041648
4. Description:
Taewoong Medical Co., Ltd.
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.
NOV 1 9 600
2073667
pg 1 of 2
1
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
2
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.
3
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
4
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.