Express SD Biliary Monorail Premounted Stent System

K162404 · Boston Scientific Corporation · FGE · Oct 12, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K162404
• Device Name: Express SD Biliary Monorail Premounted Stent System
• Applicant: Boston Scientific Corporation
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Oct 12, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Express SD Biliary Monorail Premounted Stent System is indicated for palliation of malignant neoplasms in the biliary tree.

Device Story

The Express SD Biliary Monorail Premounted Stent System is a balloon-expandable stent delivery system used to maintain patency of biliary strictures caused by malignant neoplasms. The device consists of a traditional Monorail catheter with a balloon at the distal tip, upon which the stent is premounted. It is intended for use by physicians in a clinical setting. The device is navigated to the site of the biliary stricture; the balloon is inflated to expand the stent, which then remains in place to keep the duct open. This procedure provides palliative relief for patients suffering from biliary obstruction. The device is a modification of a previously cleared system, featuring an updated corewire design.

Clinical Evidence

Bench testing only. Testing included first article inspection, shaft testing, and bond burst testing to validate the modified corewire design. No clinical data was required or provided.

Technological Characteristics

Balloon-expandable stent delivery system; Monorail catheter design; modified corewire. Materials, sterilization, and packaging are identical to the predicate device. No FDA-mandated performance standards apply.

Indications for Use

Indicated for palliation of malignant neoplasms in the biliary tree in patients requiring biliary stenting.

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

• Express® SD Biliary Monorail® Premounted Stent System (K152607)

Submission Summary (Full Text)

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

October 12, 2016

Boston Scientific Corporation Ka Zoua Xiong Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311-1566

Re: K162404

> Trade/Device Name: Express® SD Biliary Monorail® Premounted Stent System Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: FGE Dated: August 26, 2016 Received: August 29, 2016

Dear Ka Zoua Xiong:

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. 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.

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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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely,

# Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known)

#### K162404

#### Device Name

Express® SD Biliary Monorail® Premounted Stent System

Indications for Use (Describe)

The Express SD Biliary Monorail Premounted Stent System is indicated for palliation of malignant neoplasms in the biliary tree.

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

| <span style="text-decoration: underline;"></span> <span style="text-decoration: overline;"></span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|-------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
|-------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|

| X Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) Summary Per 21 CFR §807.92

| Common or Usual Name | Biliary Stent and Balloon Dilatation Catheter |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name(s) | Express® SD Biliary Monorail® Premounted Stent System |
| Product Code | FGE -Catheter, Biliary, Diagnostic |
| Classification of Device | Class II - 21 CFR 876.5010 |
| Submitter's Name and Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311-1566 |
| Contact Name and Information | Ka Zoua Xiong<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared | 11 October 2016 |
| Section 514 of the Act<br>Performance Standards | Currently no FDA mandated or voluntary performance<br>standards exist for this device. |
| Establishment Registration Numbers | Owner/Operator:<br>Boston Scientific Corporation<br>300 Boston Scientific Way<br>Marlborough, MA 01752<br>ERN: 9912058<br><br>Manufacturing Facility:<br>Boston Scientific Corporation<br>Two Scimed Place<br>Maple Grove, MN 55311<br>ERN: 2134265<br><br>Sterilization Facilities:<br>BSC Coventry<br>8 Industrial Drive<br>Coventry, RI 02816<br>USA<br><br>Synergy Health (Tullamore)<br>IDA Business & Technology Park<br>Tullamore<br>County Offaly<br>Ireland |

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| Predicate<br>Devices | K152607 - Express® SD Biliary Monorail® Premounted Stent<br>System, cleared 27 October 2015 |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description | The Express® SD Biliary Monorail® Premounted Stent System<br>(Express SD Biliary) is a traditional Monorail catheter with a<br>balloon near the distal tip. Express SD Biliary consists of a<br>delivery system and a stent that is balloon expandable<br>intended to maintain patency of biliary strictures produced by<br>malignant neoplasms. |
| Intended Use/<br>Indications for<br>Use | The Express SD Biliary Monorail Premounted Stent System is<br>indicated for palliation of malignant neoplasms in the biliary<br>tree. |
| Comparison of<br>Required<br>Technological<br>Characteristics | The proposed Express SD Biliary is substantially equivalent to<br>the existing Express SD Biliary cleared by FDA under<br>premarket notification K152607 (27Oct2015). Express SD<br>Biliary has the same intended use, scientific technology,<br>design (with the exception of the corewire design), materials,<br>sterilization method, and packaging materials as the<br>applicable predicate device. |
| Summary of<br>Non-Clinical Test<br>Summary | First article and shaft and bond burst testing were performed<br>to support a determination of substantial equivalence. The<br>results of these tests provide reasonable assurance that the<br>proposed device with the modified corewire have been<br>designed and tested to assure conformance to the<br>requirements for its intended use. No new safety or<br>performance issues were raised during the device testing. |
| Conclusion | Based on the indications for use, technological characteristics,<br>and safety and performance testing, the proposed Express<br>SD Biliary with the modified corewire has been shown to be<br>appropriate for its intended use and is considered to be<br>substantially equivalent to its predicate (K152607). |