CHOOSTENT

K072094 · M.I.Tech Co., Ltd. · ESW · Sep 25, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K072094
• Device Name: CHOOSTENT
• Applicant: M.I.Tech Co., Ltd.
• Product Code: ESW · General, Plastic Surgery
• Decision Date: Sep 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3610
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CHOOSTENT™ covered esophageal stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and or extrinsic malignant tumors only and occlusion of concurrent esophageal fistula.

Device Story

Self-expanding tubular esophageal prosthesis; maintains luminal patency in malignant strictures; occludes esophageal fistulae. Device features Nitinol wire frame, Nusil silicone membrane, and gold radiopaque markers. Includes retrieval lassos at both ends for repositioning or removal. Deployed by physician in clinical setting. Stent structure connects segments to increase flexibility, prevent migration, and inhibit tumor in-growth. Larger bands at both ends provide fixation within esophagus. Output is physical mechanical support of esophageal wall. Benefits patient by restoring patency and managing fistula complications.

Clinical Evidence

Bench testing only. Comparison of deployment time, expansion force, compression force, dimensions, corrosion resistance in simulated gastric fluid, and tensile strength against predicate device. No clinical data provided.

Technological Characteristics

Self-expanding tubular prosthesis. Materials: Nitinol wire, gold markers, Nusil silicone membrane. Dimensions: 18mm body diameter, 24mm end bands; lengths 80-170mm. Sensing/actuation: Mechanical self-expansion. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients with esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and concurrent esophageal fistula requiring maintenance of esophageal luminal patency.

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 Stent System (K012883)

Submission Summary (Full Text)

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#### 510(K) Summary M. I. Tech Co., Ltd. 241-3 Habuk-ri, Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do 451-864 KOREA Tel.) 82 31 662 5645 Fax) 82 31 662 5648 www.mitech.co.kr Date Prepared: July 7, 2007 Aeyoung Heo, Regulatory Affairs Manager Contact:

- 1. Identification of the Device: Proprietary-Trade Name: CHOOSTENT™ covered Esophageal Stent Classification Name: Prosthesis, esophageal Product Code ESW Common/Usual Name: Esophageal Stent
- 2. Equivalent legally marketed devices: Ultraflex™ Esophageal Stent System (K012883, Boston scientific corporation)
- 3. Indications for Use (intended use) The CHOOSTENT™ covered esophageal stent is intended for maintaining esophageal luminal patcncy in esophageal strictures caused by intrinsic and or extrinsic malignant turnors only and occlusion of concurrent esophageal fistula.
- 4. Description of the Device:. This stent is a self-expanding tubular prosthesis designed to maintain patency of esophageal stricture caused by malignant tumors. The unique structure of the membrane connects the several segments to increase the flexibility of the stent and to prevent migration and tumor in-growth. Since the both ends of stent have larger bands, the stent can be fixed firmly within the esophagus. There are totally 12 excellent radiopaque markers made of gold wires; 4 each on both ends of the stents and another 4 at the center. Two retrieval lassos attached to the both ends play a role in removing the stent when necessary or pulling the stent up to the right position in case the stent has been deployed deeply down the stricture. The fully expanded diameter is 18mm for the body and 24mm for both larger bands. There are four standard lengths: 80mm, 110mm, 140mm, 170mm.
- 5. Safety and Effectiveness, comparison to predicate device. The results of bench and test laboratory testing indicates that the new device is as safe and effective as the predicate devices.

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| Manufacturer | Boston Scientific | M. I. Tech Co., Ltd. |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Ultraflex™ | CHOOSTENT™ |
| 510(k) | K012883 | -- |
| Indication for use | The proposed Ultraflex Esophageal Stent<br>System is intended for use in esophageal<br>strictures caused by intrinsic and/or<br>extrinsic malignant tumors. | The CHOOSTENT™ covered<br>esophageal stent is intended for<br>maintaining esophageal luminal<br>patency in esophageal strictures<br>caused by intrinsic and or extrinsic<br>malignant tumors only and occlusion<br>of concurrent esophageal fistula. |
| Specification comparison | | |
| Deployment time | 21 Sec | 11-17 Sec |
| Expansion force | 0.81 lb. | 0.83 lb. |
| Compression force | 2 lb | 2 lb |
| Dimension: diameter | 18 mm | 18 mm |
| Corrosion (in simulated<br>gastric fluid) | No corrosion after 90 days | SAME |
| Tensile strength | >90 lb (more than adequate for safe<br>removal) | >15 lb. (more than adequate for safe<br>removal) |
| Construction materials | Nitinol wire and Polyurethane | Nitinol wire, gold, and Nusil silicone |

## 6. Substantial Equivalence Chart

7. Conclusion After analyzing both bench as well as laboratory testing to applicable standards, it is the conclusion of M. I. Tech Co., Ltd. that the CHOOSTENT™ covered Esophageal Stent is as safe and effective as the predicate devices, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices.

.

:

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## 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 features a stylized eagle with three curved lines representing its wings. The eagle is facing left and is enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP % 5 2008

M.I. Tech Co., Ltd. c/o Daniel Kamm. P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015

Re: K072094

Trade/Device Name: CHOOSTENT™ covered Esophageal Stent Regulation Number: 21 CFR §878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: ESW Dated: July 11, 2008 Received: July 21, 2008

Dear Mr. Kamm:

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. Bxisting 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.

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#### 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 of 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 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/odrh/industry/support/index.html.

Sincerely vours.

Jozue M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

K072094

Device Name: CHOOSTENT™ covered Esophageal Stent

Indications For Use:

The CHOOSTENT™ covered esophageal stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and or extrinsic malignant tumors only and occlusion of concurrent esophageal fistula.

Prescription Use X (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)

Hakeh Lewin

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _

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