BONASTENT BILIARY

K093003 · Endochoice, Inc. · FGE · Mar 24, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K093003
• Device Name: BONASTENT BILIARY
• Applicant: Endochoice, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Mar 24, 2010
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bonastent® Biliary is indicated for the palliation of malignant strictures in the biliary tree.

Device Story

Bonastent® Biliary is a self-expanding, tubular prosthesis constructed from Nitinol wire in a polygon mesh pattern. Designed to maintain patency of bile duct strictures caused by malignant tumors; prevents migration and tumor in-growth. Provided preloaded on a delivery device; available in 8mm and 10mm diameters with various lengths. Used by clinicians in a medical setting to treat biliary obstructions. Radiopaque markers at center and ends facilitate placement. Device functions as a mechanical stent; no software or electronic components.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarities to predicate devices.

Technological Characteristics

Self-expanding tubular prosthesis; Nitinol wire construction; hook & cross wire weave; 8mm and 10mm diameters; radiopaque markers (3 groups of 4) at center and ends; delivery system included.

Indications for Use

Indicated for the palliation of malignant strictures in the biliary tree. Not for use in the vascular system.

Regulatory Classification

Identification

A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.

Special Controls

*Classification.* Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• Niti-S Biliary Stent (K073667)
• WallFlex™ Biliary RX Stent System (K081733)

Submission Summary (Full Text)

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MAR 2 4 ZOLO

## 510(K) Summary

[as required by section 807.92(c)]

## Bonastent® Biliary

510(k) Number K_ 09 3003

### Applicant's Name:

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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:

Bonastent® Biliary

Classification Name: Regulation Number: Product Code: FGE Classification: Review Panel:

Biliary catheter and accessories 876.5010 Class II Gastroenterology/Urology

#### Predicate Devices:

- Niti-S Biliary Stent by Taewoong Medical Co., Ltd, K073667 ●
- WallFlex™ Biliary RX Stent System by Boston Scientific Corporation . K081733

#### Device Description:

The Bonastent® Biliary stent is a self-expanding polygon mesh surface, tubular prosthesis designed to maintain patency of bile duct strictures caused by malignant tumors. The stent is made of Nitinol wire and is designed in such a way as to prevent migration and tumor in-growth. The stent is provided preloaded on a delivery device and is available in 2 different diameters (8mm and 10mm) in various lengths.

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#### Intended Use:

The Bonastent® Biliary is indicated for the palliation of malignant strictures in the biliary tree.

#### Technological Characteristics:

The Bonastent® Biliary is weaved using hook & cross wire construction which reduces the delivery device 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.

#### Conclusion:

EndoChoice believes that, based on the information provided in this submission, the Bonastent® Biliary stent system is substantially equivalent to its predicate devices without raising any new safety and/or effectiveness issue.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of a human figure with outstretched arms, representing health and well-being. The symbol is black and white.

#### Public Health Service

# MAR 2 4 2010

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ms. Shoshana Friedman, RAC Regulatory Consultant EndoChoice, Inc. 11800 Wills road. Suite 100 ALPHARETTA GA 30009

Re: K093003

Trade/Device Name: BONASTENT® Biliary Stent Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: March 16, 2010 Received: March 18, 2010

Dear Ms. Friedman:

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

The safety and effectiveness of this device for use in the vascular system have not been established.

Furthermore, the indication for biliary use must be prominently displayed in all labeling. including pouch, box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.

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#### Page 2 - Ms. Shoshana Friedman, RAC

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

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); 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 information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

B/Yemmer for

Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K093003

Device Name: BONASTENT® Biliary Stent

Indications For Use: The BONASTENT® Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree.

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)

(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number __K 09 30 30 3

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