NITI-S STENT & INTRODUCER, MODEL EOXXXX

K041648 · Taewoong Medical Co., Ltd. · ESW · Apr 28, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K041648
• Device Name: NITI-S STENT & INTRODUCER, MODEL EOXXXX
• Applicant: Taewoong Medical Co., Ltd.
• Product Code: ESW · General, Plastic Surgery
• Decision Date: Apr 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3610
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Niti-S Esophageal Non-covered Stent & Introducer is intended for maintaining luminal patency in esophageal structures caused by intrinsic and/or extrinsic malignant tumors.

Device Story

Niti-S Esophageal Non-covered Stent & Introducer is a self-expanding, tubular prosthesis constructed from Nitinol (Nickel Titanium alloy) wire. The device is designed to be implanted within the esophagus to restore structure and function by exerting outward radial force on the luminal surface, thereby establishing patency in the presence of malignant tumors. The system includes a delivery introducer for deployment. It is intended for use by clinicians in a medical setting. By maintaining esophageal patency, the device facilitates the passage of food and liquids, potentially improving patient quality of life.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Self-expanding tubular stent made of Nitinol (Nickel Titanium alloy) wire. Includes a delivery introducer system. Dimensions range from 16-18mm trunk diameter and 30-120mm trunk length. Mechanical expansion principle via radial force.

Indications for Use

Indicated for maintaining luminal patency in the esophagus for patients with esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.

Regulatory Classification

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.

Special Controls

The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”

Predicate Devices

• Ultraflex Esophageal NG Stent System (K032930)

Submission Summary (Full Text)

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K041648, Puzz INC

## 510(k) Summary

Date: Jan 31, 2005

## Company and Submission Correspondent making the submission: 1.

| Name | Taewoong Medical Co., Ltd.<br>610 Ilsan-Technotown<br>1141-1 Backsuk-doing<br>Ilsam-Ku, Koyang-si<br>Kyunggi-do<br>Korea | or | Correspondent (contract):<br>Delphi Consulting Group<br>11874 South Evelyn Circle<br>Houston, Texas 77071-3404 |
|-----------|--------------------------------------------------------------------------------------------------------------------------|----|----------------------------------------------------------------------------------------------------------------|
| Telephone | 82-31-811-9111 | | 832-285-9423 |
| Contact | J.H. Nam /Director | | J. Harvey Knauss |

#### 2. Device:

| Proprietary Name: | Niti-S Esophageal Non-covered Stent & Introducer |
|----------------------|--------------------------------------------------|
| Common Name: | Esophageal Stent |
| Classification Name: | Prosthesis, Esophageal |
| Classification: | 21 CFR 878.3610 |
| Product Code: | ESW |

## Predicate Device: 3.

Ultraflex Esophageal NG Stent System, Boston scientific Corp, K032930

## 4. Description:

Niti-S Esophageal Non-covered Stent & Introducer is a rigid, flexible, and expandable tubular device made of a self-expanding Nickel Titanium alloy (Nitinol) wire that is intended to be implanted to restore the structure and/or function of the esophagus. This device also includes a device delivery system for deployment. Upon deployment, the stent imparts an outward radial force on the luminal surface of the lumen to establish patency.

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#### ട്. Review:

The Niti-S Esophageal Non-covered Stent & Introducer has the similar device characteristics as the predicate device. Material, design and use concepts are similar.

The Niti-S Esophageal Non-covered Stent & Introducer has been subjected to extensive safety, performance, and validations prior to release. Safety and performance tests have been further performed to ensure the devices comply with applicable industry and US regulations.

#### Dimensions 6.

| Product | Art. No. | Stent | | Head | | | Introducer | | | |
|----------------------------------------------|----------|---------------------|-------------------|--------------------|-----------------|--------|---------------|--------------------|-------------------|--|
| | | Trunk Diameter (mm) | Trunk Length (mm) | Head Diameter (mm) | Head Length(mm) | | Diameter (mm) | Usable Length (cm) | Total Length (cm) | |
| Niti-S<br>Esophageal<br>Non-covered<br>Stent | E01606 | | 30±0.6 | | | | | | 95±9.5 | |
| | E01608 | | 50±1.0 | | | | | | 98±9.8 | |
| | E01610 | 16±0.32 | 70±1.4 | | | | | | 24±0.48 | |
| | E01612 | | 90±1.8 | | | | | | 105±10.5 | |
| | E01615 | | 120±2.4 | | | | | | 107±10.7 | |
| Niti-S<br>Esophageal<br>Non-covered<br>Stent | E01806 | | 30±0.6 | | 15±0.3 | 15±0.3 | | | 5.3±0.1 | |
| | E01808 | | 50±1.0 | | | | | | 98±9.8 | |
| | E01810 | 18±0.36 | 70±1.4 | | 26±0.52 | | | | 101±10.1 | |
| | E01812 | | 90±1.8 | | | | | | 105±10.5 | |
| | E01815 | | 120±2.4 | | | | | | 107±10.7 | |

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## Indications For Use: 7.

Niti-S Esophageal Non-covered Stent & Introducer is intended for maintaining Nit & Edophageal Nortested in esophageal structures caused by intrinsic and/or extrinsic malignant tumors.

## Conclusions: 8.

Niti-S Esophageal Non-covered Stent & Introducer is substantially equivalent fo Ultraflex Esophageal NG Stent System.

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Image /page/3/Picture/2 description: The image is a black and white circular logo. The logo features a stylized bird in flight, with three curved lines representing its wings. The bird is facing to the left. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all capital letters. The text is arranged along the upper half of the circle.

APR 2 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

TaeWoong Medical Co., Ltd. c/o James Harvey Knauss Contract Consultant Delphi Consulting Group 11874 South Evelyn Circle HOUSTON TX 77071

K041648 Re:

Ko410+0
Trade/Device Name: Niti-S Esophageal Non-Covered Stent(s) & Introducer Regulation Number: 21 CFR §878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: ESW Dated: March 28, 2005 Received: March 31, 2005

Dear Mr. Knauss:

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 do not require approvisions 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 (Premarket 11 your al), it may be subject to such additional controls. Existing major regulations affecting your Apple rary, it 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 I todo o a rison 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 I cacal statues and regulating, 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) (21 CFR Part 8017, good and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing of substantial equivalence of your device to a legally premarket notification. The FDA midtig of sucstantial of a more of the promits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleased If you desire specific advice for your device of our habers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 | |

Also, please note the regulation entitled, "Misbranding by reference to premaiket notification" (21 CFR Also, please fibe the regulation entitled, "Thereasons on your responsibilities under the Act from the 807.97). You may outain other general meetical and Consumer Assistance at its toll-free number (800).
Division of Small Manufacturers, International and Consumer del Idemalde Division of Small Manufacturers, Internet address http://www.fda.gov/cdrb/dsmadsmamain.html

Sincerely yours,

Nancy C. brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K04/648
page 10+1

# Indications for Use

510(k) Number (if known): KO4 | 648

Niti-S Esophageal Non-covered Stent & Introducer Device Name:

Indications For Use: Niti-S Esophageal Non-covered Stent & Introducer is intended for Nill-J Esophageal No.1 Suminal patency in esophageal structures maintaining consic and/or extrinsic malignant tumors.

Prescription Use
(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)

Nancy brigdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number

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