BONASTENT BILIARY

K140760 · Endochoice, Inc. · FGE · Jun 16, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K140760
• Device Name: BONASTENT BILIARY
• Applicant: Endochoice, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Jun 16, 2014
• 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 surface; designed to maintain bile duct patency and prevent migration/tumor ingrowth. Device provided preloaded on a delivery system. Available in 8mm and 10mm diameters with various lengths. Used by clinicians in a medical setting to treat malignant biliary strictures. Radiopaque markers at center and ends facilitate placement. Material changes to delivery device enhance deployability and manufacturing efficiency.

Clinical Evidence

No clinical data. Evidence consists of bench testing and biocompatibility assessments, including cytotoxicity, sensitization, and irritation testing, alongside deployment and tensile strength verification.

Technological Characteristics

Nitinol wire self-expanding stent; hook & cross wire weave construction; radiopaque markers (3 groups of 4); 8mm and 10mm diameters. Delivery system modified for improved deployability.

Indications for Use

Indicated for palliation of malignant biliary tree strictures in patients requiring stent placement.

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

• BONASTENT® Biliary (K093003)

Submission Summary (Full Text)

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#### 510(K) SUMMARY

[as required by section 807.92(c)]

## Bonastent® Biliary

# 510(k) Number K140760

Prepared on (revised): April 10, 2014

#### Applicant's Name:

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

#### Contact Person:

Bosmat Friedman CO/MJ RAC 1208-12 Rockford Rd. Toronto, ON, M2R 3A2, Canada Phone: [phone] Fax: [phone] E-mail: [e-mail]

#### Trade Name:

Bonastent® Biliary

| Classification Name: | catheter, biliary, diagnostic |
|----------------------|-------------------------------|
| Regulation Number: | 876.5010 |
| Product Code: | FGE |
| Classification: | Class II |
| Review Panel: | Gastroenterology/Urology |

#### Predicate Devices:

BONASTENT® Biliary by EndoChoice Inc., K093003

#### 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 turnor ingrowth. The stent is provided preloaded on a delivery device and is available in 2 different diameters (8mm and 10mm) in various lengths.

#### Reason for Submission:

Material changes to delivery device.

Bonastent® Biliary - Page 5-2

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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.

The reason for this 510(k) submission is material changes in the delivery device.

#### Verification & Validation Activities:

Biocompatibility and bench tests were performed in order to ensure that the material changes do not affect the device performance. The results of Cytotoxicity, Sensitization and Irritation tests as well as deployment and tensile strength testing support our claim that the device is safe and effective.

#### Substantial equivalence:

BONASTENT® Biliary has been previously cleared by the agency under K093003. The only difference between the original cleared device and the subject of this submission are material changes that have been incorporated into the delivery device to enhance deployability and to make the manufacturing process more efficient. The performance and biocompatibility profile of the device have been evaluated; the results support that no new safetv and effectiveness issues are raised due to the changes.

#### 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

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Public Health Service

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

June 16, 2014

EndoChoice, Inc. % Bosmat Friedman Regulatory Consultant MJ RAC 1208-12 Rockford Road Toronto, ON M2R 3A2 Canada

Re: K140760

> Trade/Device Name: BONASTENT® Biliary Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: April 14, 2014 Received: April 15, 2014

Dear Bosmat 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. 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.

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 device's labeling:

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

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#### Page 2 - Bosmat Friedman

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.

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); 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

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Page 3 - Bosmat Friedman

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Christy L. Foreman -S

Christy Foreman Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K140760

Device Name

BONASTENT® Biliary

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Herbert P. Lerner -S 2014.06.16 15:18:29 -04'00'

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