ESOPHAGEAL TTS STENT

• K Number: K123205
• Device Name: ESOPHAGEAL TTS STENT
• Manufacturer: TAEWOONG MEDICAL CO., LTD
• Date Cleared: 2013-10-09 ( 362 days)
• Product Code: ESW
• Regulation Number: 878.3610

Intended 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 are either fully silicone covered or partially silicone covered (the body is covered but both heads remains uncovered). This device also includes a disposable introducer. Upon deployment, the stent imparts an outward radial force on the luminal surface esophagus to establish patency.

Predicate Devices

K113551, K080782

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical properties and deployment of a metallic stent, with no mention of AI or ML technologies.

Therapeutic

Yes
The device is an implantable metallic stent used to establish patency in esophageal strictures, which is a therapeutic function.

Diagnostic

No
The device, an esophageal stent, is described as an "implantable metallic stent and a flexible introducer system" that "imparts an outward radial force on the luminal surface esophagus to establish patency." This indicates a therapeutic function by maintaining an open lumen, rather than a diagnostic one which would involve identifying or characterizing a condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it consists of an implantable metallic stent and a flexible introducer system, which are hardware components. The performance studies also focus on the physical properties and deployment of the stent.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
• Device Description: The description clearly states this is an "implantable metallic stent" used to "establish patency" in the esophagus. It's a physical device inserted into the body to treat a condition.
• Intended Use: The intended use is for treating esophageal strictures caused by tumors, which is a therapeutic intervention, not a diagnostic test performed on a specimen.

This device is a medical device, specifically an implantable prosthesis, used for treatment within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

For use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.

Product codes (comma separated list FDA assigned to the subject device)

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 are either fully silicone covered or partially silicone covered (the body is covered but both heads remains uncovered). 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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Per FDA "Guidance for Industry - Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses," the following tests were conducted:

• Expansion Force Testing
• Compression Force Testing
• Dimensional Testing
• Deployment Testing
• Deployment Force Testing
• Tensile Strength Testing.

The following testing was also conducted:

• Packaging Adhesive Strength Testing
• MR Compatibility.

The performance testing showed that the Esophageal TTS Stent with a larger body diameter of 20mm is as safe, as effective, and performs as well as or better than the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K113551, K080782

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.”

Summary

0

510(k) Summary

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Esophageal TTS Stent device is provided below.

Device Common Name:	Esophageal Prosthesis
Device Proprietary Name:	Esophageal TTS Stent
Submitter:	Y.J. Kim
Taewoong Medical Co., Ltd.
1-5, Gomak-ri, Wolgot-myeon, Gimpo-si, Gyeonggi-do, Korea
415871
TEL: [phone]
FAX: [phone]
Contact:	Calley Herzog
Consultant, Medical Devices
Biologics Consulting Group, Inc.
Phone: [phone]
Email: [e-mail]
Fax: [phone]
	OCT 0 9 2013
Date Summary Prepared:	October 10, 2012
Classification	21 CFR 878.3610
Regulation:
Panel:	General & Plastic Surgery Devices
Product Code:	ESW
Predicate Devices:	K113551 - Taewoong Esophageal TTS Stent
K080782 - Taewoong Niti-S Esophageal 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 are either fully silicone covered or partially silicone covered (the body is covered but both heads remains uncovered). This device also includes a disposable introducer. Upon deployment, the stent imparts an outward radial force on the luminal surface esophagus to establish patency.

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Comparison to the Predicates:

The Esophageal TTS Stent is substantially equivalent to the Esophageal TTS Stent cleared in K 113551 with the following exception: the submitted stent has a larger body diameter of 20mm. FDA has previously cleared a 20 mm diameter Esophageal stent with the same stent lengths as part of Taewoong's Niti-S stent system (K080782), so this new model does not raise any new types of safety and effectiveness questions.

The introducer used to deliver the Esophageal TTS Stent is the exact same introducer as the one cleared for use with the Esophageal TTS Stent (K113551). The matcrials, diameter, 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:

• Expansion Force Testing ●
• Compression Force Testing .
• Dimensional Testing 0
• . Deployment Testing
• Deployment Force Testing .
• Tensile Strength Testing .

The following testing was also conducted:

• . Packaging Adhesive Strength Testing
• MR Compatibility .

The performance testing showed that the Esophageal TTS Stent with a larger body diameter of 20mm is as safe, as effective, and performs as well as or better than the predicate device.

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 Esophageal TTS Stent.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609. Silver Spring, MD 20993-0002

October 9, 2013

Taewoong Medical Co., Ltd. % Calley Herzog Consultant Biologics Consulting Group, Inc. 400 N. Washington Street, Suite 100 Alexandria, VA 22314

Re: K123205

Trade/Device Name: Esophageal TTS Stent Regulation Number: 21 CFR$ 878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: ESW Dated: September 19, 2013 Received: September 23, 2013

Dear Calley Herzog,

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. Please note: CDRFI 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.

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Page 2 - Calley Herzog

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 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

for

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

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4.0 Indications for Use Statement

510(k) Number (if known): Kl23205

Device Name: Esophageal TTS Stent

Indications For Use:

For use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.

Prescription Use × (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)

Herbert P. Lerner -S 2013.10.09 15:51:17 -04'00'

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