BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR

K092144 · Endochoice, Inc. · ESW · Feb 22, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K092144
• Device Name: BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR
• Applicant: Endochoice, Inc.
• Product Code: ESW · General, Plastic Surgery
• Decision Date: Feb 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3610
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The BONASTENT™ Esophageal Stent System is indicated for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and occlusion of concurrent esophageal fistula.

Device Story

Bonastent™ Esophageal is a covered, self-expanding tubular prosthesis; maintains patency of esophageal strictures caused by malignant tumors; treats concurrent esophageal fistula. Device consists of Nitinol wire stent pre-loaded on a delivery system. Physician operates delivery device over a guide-wire through an endoscope working channel. Stent features hook & cross wire construction for reduced diameter, radiopaque markers for visualization, and retrieval lassos for removal or repositioning. Designed to resist migration from peristalsis and tumor in-growth. Used in clinical settings by gastroenterologists.

Clinical Evidence

Bench testing only. Performance testing conducted per FDA guidance for esophageal and tracheal prostheses to verify safety and effectiveness compared to predicate devices.

Technological Characteristics

Nitinol wire construction; hook & cross weave pattern; self-expanding; radiopaque markers; retrieval lassos; delivery system available in 5mm and 6mm diameters.

Indications for Use

Indicated for patients with esophageal strictures caused by intrinsic or extrinsic malignant tumors and occlusion of concurrent esophageal fistula.

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)
• Wallflex Partially Covered Esophageal Stent System (K073266, K091510)
• Choostent™ covered Esophageal Stent (K072094)
• Niti-S Esophageal Stent (K080782, K041648)

Submission Summary (Full Text)

{0}------------------------------------------------

K092144/51
Page 1 of 2

# 510(K) Summary

[as required by section 807 .92(c)]

# Bonastent™ Esophageal

FEB 2 2 2010

#### 510(k) Number K092144

## Applicant's Name:

EndoChoice Inc. 11800 Wills Rd. Suite 100Alpharetta, GA 30009 Telephone: [phone] Fax: [phone]

#### Contact Person:

Name: Shoshana (Shosh) Friedman Telephone: [phone] Fax: [phone] Email: [e-mail]

#### Trade Name:

1. Bonastent™ Esophageal

| Classification Name: | Esophageal prosthesis |
|----------------------|--------------------------|
| Regulation Number: | 878.3610 |
| Product Code: | ESW |
| Classification: | Class II |
| Review Panel: | Gastroenterology/Urology |

### Predicate Devices:

- Ultraflex™ . Esophaqeal Stent System by Boston Scientific Corporation, K012883.
- Wallflex Partially Covered Esophageal Stent System by Boston . Scientific Corporation, K073266, K091510.
- Choostent™ covered Esophageal Stent by M.I. Tech Co., Ltd., . K072094.
- Niti-S Esophageal Stent by Taewoong Medical Co., Ltd., K 080782, ● K041648)

#### Device Description:

The Bonastent™ Esophageal Stent is a covered, self-expanding tubular prosthesis designed to maintain patency of esophageal strictures caused by malignant tumors. The Bonastent™ Esophageal stent is pre-loaded on a delivery device. The delivery device is placed over a guide-wire and through the working channel of an endoscope to deliver the stent. The

Bonastent™ Esophageal - Page 5-2

{1}------------------------------------------------

K092144/51
Page 2 of 2

delivery device is available in two sizes: 5mm and 6mm diameter. The stents are made of Nitinol wire, and are designed to prevent stent migration due to peristaltic motion and tumor in-growth. The stents are available in a variety of diameters and lengths.

### Intended Use:

The Bonastent™ Esophageal Stent System is indicated for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and occlusion of concurrent esophageal fistula.

## Comparison Characteristics:

The Bonastent™ Esophageal is substantially equivalent to the legally marketed predicate devices mentioned above. The stent is weaved using a hook & cross wire construction which reduces the delivery desvice diameter. The stent includes 3 groups of 4 radiopaque markers located at the center of the stent as well as at both ends of the stent and two retrieval lassos at both ends of the stent to allow for stent removal/repositioning.

#### Performance Data:

Performance testing was carried out per FDA document "Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses" to determine the equivalence of the Bonastent™ Esophageal Stent Systems to the predicate devices and to verify the safety and effectiveness.

#### Conclusion:

Endochoice Inc. believes that, based on the information provided in this submission the Bonastent™ Esophageal is substantially equivalent to its predicate devices without raising any new safety and/or effectiveness issue.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circle around the figure. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue. Document Mail Center - WO66-G6 Silver Spring, MD 20993-0002

EndoChoice, Inc. c/o Shoshana Friedman, RAC President & CEO Push-Med, LLC 1914 J.N. Pease Place CHARLOTTE NC_28262

FEB 2 2 2010

Re: K092144

Trade/Device Name: BONASTENT™ Esophageal Regulation Number: 21 CFR §878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: ESW Dated: February 1, 2010 Received: February 1, 2010

Dear Ms. Friedman:

We have reviewed your Section 510(k) prematket 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: 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 of medical device-related

{3}------------------------------------------------

Page 2 -

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,

Janine M. Morris

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

Enclosure

{4}------------------------------------------------

K092144/51
Page 1 of 1

# INDICATIONS FOR USE

## 510(k) Number (if known): K092144

Device Name: BONASTENT™ Esophageal

## Indications for Use:

The BONASTENT™ Esophageal Stent System is indicated for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and occlusion of concurrent esophageal fistula.

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) |
|--------------------------------------------------------|
|--------------------------------------------------------|

(Division Sign Off) Division of Reproductive, Apdominal Radiological Devices 510(k) Number

Page 1 of 1