WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary

K152853 · Boston Scientific Corp · FGE · Nov 20, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K152853
• Device Name: WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary
• Applicant: Boston Scientific Corp
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Nov 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The WALLSTENT RP Endoprosthesis Transhepatic Biliary and WALLSTENT Endoprosthesis Transhepatic Biliary are indicated for use in the treatment of biliary strictures produced by malignant neoplasms.

Device Story

Self-expanding metallic biliary stent; braided biomedical superalloy wire in tubular mesh configuration; delivered via coaxial Unistep Plus delivery system. Radiopaque marker bands on delivery tubes and optional radiopaque core (8 & 10mm sizes) assist physician during fluoroscopic deployment. Accommodates 0.035in guidewire. Used by physicians in clinical settings to treat malignant biliary strictures; stent provides radial force to maintain patency of bile duct. Device is MR Conditional.

Clinical Evidence

Bench testing only. Testing conducted per FDA guidance 'Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment' (2014) to validate MR Conditional labeling. No new safety or performance issues identified.

Technological Characteristics

Biomedical superalloy wire; braided tubular mesh; self-expanding. Coaxial delivery system with radiopaque marker bands. MR Conditional. Sterilization method not specified.

Indications for Use

Indicated for treatment of biliary strictures caused by malignant neoplasms 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

• WALLSTENT Biliary Endoprosthesis with Unistep Plus Delivery System (K993232)

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

November 20, 2015

Boston Scientific Corporation Carah Kucharski Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311-1566

Re: K152853

> Trade/Device Name: WALLSTENT RP Endoprosthesis Transhepatic Biliary and WALLSTENT Endoprosthesis Transhepatic Biliary Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: October 14, 2015 Received: October 15, 2015

Dear Carah Kucharski.

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 vours.

# Herbert P. Lerner -S

for 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) K152853

Device Name

WALLSTENT RP Endoprosthesis Transhepatic Biliary and WALLSTENT Endoprosthesis Transhepatic Biliary

Indications for Use (Describe)

The WALLSTENT RP Endoprosthesis Transhepatic Biliary and WALLSTENT Endoprosthesis Transhepatic Biliary are indicated for use in the treatment of biliary strictures produced by malignant neoplasms.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510k Summary

### Per 21 CFR §807.92

| Common or Usual<br>Name | Self-Expanding Biliary Stent |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name(s) | WALLSTENT™ RP Endoprosthesis Transhepatic Biliary and<br>WALLSTENT™ Endoprosthesis Transhepatic Biliary |
| Product Code | FGE— Catheter, Biliary, Diagnostic |
| Classification of<br>Device | The WALLSTENT™ RP Endoprosthesis Transhepatic Biliary and<br>WALLSTENT™ Endoprosthesis Transhepatic Biliary devices have<br>been classified as Class II devices according to 21 CFR 876.5010 –<br>Biliary Catheter and Accesories. |
| Submitter's Name<br>and Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311-1566 |
| Contact Name and<br>Information | Carah Kucharski<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Establishment<br>Registration<br>Numbers | <b>Owner / Operator:</b> Boston Scientific Corporation<br>300 Boston Scientific Way<br>Marlborough, MA 01752<br>ERN: 3005099803 |
| | <b>Manufacturing<br/>Facility:</b> Boston Scientific Ireland Ltd. (BSIL)<br>Ballybrit Business Park<br>Galway, Ireland<br>ERN: 9681260 |
| Predicate Devices | WALLSTENT™ Biliary Endoprosthesis with Unistep Plus Delivery<br>System (Since changed to “WALLSTENT™ Endoprosthesis<br>Transhepatic Biliary”) K993232 cleared September 24, 1999. |
| Intended Use/<br>Indications for Use | The WALLSTENT™ RP Endoprosthesis Transhepatic Biliary and<br>WALLSTENT™ Endoprosthesis Transhepatic Biliary are indicated for<br>use in the treatment of biliary strictures produced by malignant<br>neoplasms. |
| Description of<br>Device | The WALLSTENTTM RP Endoprosthesis Transhepatic Biliary and<br>WALLSTENTTM Endoprosthesis Transhepatic Biliary are comprised of<br>two components: The implantable metallic stent and the Unistep Plus<br>delivery system. The stent is composed of biomedical superalloy wire,<br>braided in a tubular mesh configuration. This design configuration<br>results in a stent that is flexible, compliant, and self-expanding. The<br>delivery system consists in part of coaxial tubes. The exterior tube<br>serves to constrain the stent until retracted during delivery.<br>Radiopaque marker bands situated on the interior and exterior tubes<br>aid in imaging during deployment. Small stent sizes (8 & 10mm) may<br>have a radiopaque core to improve radiopacity. The interior tube of the<br>coaxial system contains a central lumen that accommodates a 0.035in<br>(0.89mm) guidewire. |
| Comparison of<br>Required<br>Technological<br>Characteristics | The proposed WALLSTENTTM RP Endoprosthesis Transhepatic<br>Biliary and WALLSTENTTM Endoprosthesis Transhepatic Biliary is<br>substantially equivalent to the existing WALLSTENTTM Biliary<br>Endoprosthesis with Unistep Plus Delivery System cleared by FDA<br>under premarket notification K993232 (September 24, 1999).<br>WALLSTENTTM RP Endoprosthesis Transhepatic Biliary and<br>WALLSTENTTM Endoprosthesis Transhepatic Biliary have the same<br>intended use, scientific technology, design, sterilization method, and<br>packaging as the applicable predicate device. The only difference is to<br>the MR Safety labeling information within the Directions for Use.<br>Bench testing in accordance with current FDA guidance supports a<br>labeling as MR Conditional. |
| Summary of Non-<br>Clinical Test<br>Summary | Bench testing was performed in accordance with FDA guidance<br>document <i>Establishing Safety and Compatibility of Passive Implants in<br/>the Magnetic Resonance (MR) Environment</i> , dated December 11,<br>2014) to support labeling as MR Conditional. The results of these<br>tests provide reasonable assurance that the proposed device has<br>been designed and tested to assure conformance to the requirements<br>for its intended use. No new safety or performance issues were<br>raised during the device testing. |
| Conclusion | Based on the indications for use, technological characteristics, and<br>safety and performance testing, the proposed WALLSTENTTM RP<br>Endoprosthesis Transhepatic Biliary and WALLSTENTTM<br>Endoprosthesis Transhepatic Biliary has been shown to be<br>appropriate for its intended use and is considered to be substantially<br>equivalent to the WALLSTENTTM Biliary Endoprosthesis with Unistep<br>Plus Delivery System (K993232). |

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