(75 days)
Not Found
No
The description focuses on the mechanical properties and deployment of a metallic stent and introducer system. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is described as an "implantable metallic stent" that "imparts an outward radial force on the luminal surface esophagus to establish patency" in esophageal strictures caused by malignant tumors, indicating it is used to treat a medical condition.
No
The device is an esophageal stent used to maintain patency in the esophagus due to malignant tumors. It is a therapeutic device, not a diagnostic one, as it treats a condition rather than identifying or characterizing it.
No
The device description explicitly states it consists of an implantable metallic stent and a flexible introducer system, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for treating esophageal strictures caused by malignant tumors. This is a therapeutic intervention performed in vivo (within the body) to restore patency of the esophagus.
- Device Description: The device is an implantable metallic stent designed to exert radial force on the esophageal wall. This is a physical device used for mechanical support and opening of a lumen.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any such use or interaction with biological specimens outside the body.
Therefore, this device falls under the category of a therapeutic medical device, specifically an implantable stent, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.
Product codes
ESW
Device Description
The Esophageal TTS Stent consists of an implantable metallic stent and a flexible introducer system. The stent is a flexible, expandable tubular device made of Nitinol wire and covered with silicone. This device also includes a disposable introducer. Upon deployment, the stent imparts an outward radial force on the luminal surface esophagus to establish patency.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophagus
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
Per FDA "Guidance for Industry – Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses," the following tests were conducted:
- . Deployment Testing
- Expansion Force Testing .
- Compression Force Testing .
- Dimensional Testing .
- Tensile Strength Testing .
The following testing was also conducted:
- Packaging Adhesive Testing .
- . MR Compatibility
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
510(k) Premarket Notification
Taewoong Medical Esophageal TT
5.0 510(k) Summary
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the TTS Esophageal Stent device is provided below.
| Device Common Name: | Esophageal Prosthesis |
|---|---|
| Device Proprietary Name: | Esophageal TTS Stent |
| Submitter: | Taewoong Medical Co., Ltd. |
| 1-5, Gomak-ri, Wolgot-myeon, Gimpo-si, Gyeonggi- | |
| do, Korea 415871 | |
| TEL: +82-31-996-0641 | |
| FAX: +82-31-996-0645 | |
| Contact: | Stephen P. Rhodes |
| Senior Consultant, Medical Devices | |
| Biologics Consulting Group, Inc. | |
| Phone: (301) 579-3700 | |
| Email: srhodes@bcg-usa.com | |
| Fax: 720-293-0014 | |
| Classification | |
| Regulation: | 21 CFR 878.3610 |
| Panel: | General & Plastic Surgery Devices |
| Product Code: | ESW |
| Predicate Devices: | K080782 - Taewoong Niti-S Esophageal Stent |
| K073667 - Taewoong Niti-S Biliary Stent |
Indication for Use:
For use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.
Device Description:
The Esophageal TTS Stent consists of an implantable metallic stent and a flexible introducer system. The stent is a flexible, expandable tubular device made of Nitinol wire and covered with silicone. This device also includes a disposable introducer. Upon deployment, the stent imparts an outward radial force on the luminal surface esophagus to establish patency.
Comparison to the Predicates
The Esophageal TTS Stent is substantially equivalent to the Niti-S Esophageal Stent cleared in K080782 with respect to the materials, design, and range of available sizes.
1
K113331
page 2 of 2
The introducer used to deliver the Esophageal TTS Stent is the same as the introducer cleared for use with the Niti-S Biliary Stent (K073667), except that the diameter is slightly larger to match the diameter of the esophageal stent. The materials, length and manufacturing are the same as previously cleared introducer.
Performance Data:
Per FDA "Guidance for Industry – Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses," the following tests were conducted:
- . Deployment Testing
- Expansion Force Testing .
- Compression Force Testing .
- Dimensional Testing .
- Tensile Strength Testing .
The following testing was also conducted:
- Packaging Adhesive Testing .
- . MR Compatibility
Summary of Substantial Equivalence:
Based on the indications for use, technological characteristics and performance test results, the Esophageal TTS Stent is substantially equivalent to the predicate Niti-S Esophageal Stent and Niti-S Biliary Stent.
2
Image /page/2/Picture/1 description: The image is a black and white seal for 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.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Taewoong Medical Co., Ltd. % Mr. Stephen P. Rhodes Senior Consultant Biologics Consulting Group, Inc. 400 N. Washington St. Suite 100 ALEXANDRIA VA 22314
FEB 1 4 2012
Re: K113551
Trade/Device Name: Esophageal TTS Stent Regulation Number: 21 CFR§ 878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: ESW Dated: December 1, 2011 Received: December 1, 2011
Dear Mr. Rhodes:
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 10 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical
3
Page 2 -
device-related adverse events) (21 CFR 803); 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 advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Benjamin K-tivko
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement 4.0
KII3551 510(k) Number (if known):
Device Name: Esophageal TTS Stent
Indications For Use:
For use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helen Remm
Division Sign-Off) ivision of Reproductive, Gastro-Renal, and Urological Devices Page 1 of 1 510(k) Number