WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL

K152842 · Boston Scientific Corporation · JCT · May 19, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K152842
• Device Name: WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL
• Applicant: Boston Scientific Corporation
• Product Code: JCT · General, Plastic Surgery
• Decision Date: May 19, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The WALLSTENT RP Endoprosthesis and WALLSTENT Endoprosthesis Tracheobronchial are indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

Device Story

Self-expanding metallic stent; braided superalloy wire mesh; delivered via coaxial UNISTEP Plus delivery system. Radiopaque marker bands on delivery tubes aid fluoroscopic visualization; central lumen accommodates 0.035-inch guidewire. Used by physicians in clinical settings to treat malignant tracheobronchial strictures. Stent provides mechanical support to maintain airway patency; improves patient breathing by relieving obstruction. Device is MR Conditional.

Clinical Evidence

Bench testing only. Testing performed per FDA guidance 'Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment' (2014) to support MR Conditional labeling.

Technological Characteristics

Biomedical superalloy wire; braided tubular mesh configuration; self-expanding. Coaxial delivery system with radiopaque marker bands; small sizes (5mm-12mm) include radiopaque core. Accommodates 0.035-inch guidewire. Sterilization method consistent with predicate.

Indications for Use

Indicated for patients with tracheobronchial strictures caused by malignant neoplasms.

Regulatory Classification

Identification

The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal 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

• WALLSTENT™ Tracheobronchial Endoprosthesis (K992510)

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

May 19, 2016

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

Re: K152842

Trade/Device Name: WALLSTENT™ RP Endoprosthesis Tracheobronchial, WALLSTENTTM Endoprosthesis Tracheobronchial Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal Prosthesis Regulatory Class: Class II Product Code: JCT Dated: April 18, 2016 Received: April 19, 2016

Dear Ms. 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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 yours,

*Tejashri Purohit-Sheth, M.D.*

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K152842

Device Name

WALLSTENT™ RP Endoprosthesis Tracheobronchial/ WALLSTENT™ Endoprosthesis Tracheobronchial

Indications for Use (Describe)

The WALLSTENT RP Endoprosthesis and WALLSTENT Endoprosthesis Tracheobronchial are indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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### 510k Summary

## Per 21 CFR §807.92

May 18th, 2016

| Common or Usual<br>Name | Self-Expanding Stent | |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name(s) | WALLSTENT™ RP Endoprosthesis Tracheobronchial and<br>WALLSTENT™ Endoprosthesis Tracheobronchial | |
| Product Code | JCT – Prosthesis, Tracheal, Expandable | |
| Classification of<br>Device | The WALLSTENT Endoprosthesis Tracheobronchial device has been<br>classified as Class II devices according to 21 CFR 878.3610 –<br>Esophageal Prosthesis. | |
| 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] | |
| Section 514 of the<br>Act Performance<br>Standards | Currently no FDA mandated or voluntary performance standards exist<br>for this device. | |
| Establishment<br>Registration<br>Numbers | Owner /Operator: Boston Scientific Corporation<br>300 Boston Scientific Way<br>Marlborough, MA 01752<br>ERN: 3005099803 | |
| | Manufacturing<br>Facility: Boston Scientific Ireland Ltd. (BSIL)<br>Ballybrit Business Park<br>Galway, Ireland<br>ERN: 9681260 | |
| | Predicate Devices | WALLSTENT™ Tracheobronchial Endoprosthesis K992510 cleared<br>November 18, 1999 |
| | Intended Use/<br>Indications for Use | The WALLSTENT™ RP Endoprosthesis and WALLSTENT™<br>Endoprosthesis Tracheobronchial are indicated for use in the<br>treatment of tracheobronchial strictures produced by malignant<br>neoplasms. |
| Description of<br>Device | The WALLSTENT RP Endoprosthesis Tracheobronchial and<br>WALLSTENT Endoprosthesis Tracheobronchial are comprised of two<br>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 (5mm-12mm) may<br>have a radiopaque core to improve radiopacity. The interior tube of the<br>coaxial system contains a central lumen that accommodates a 0.035<br>in (0.89mm) guidewire. | |
| Comparison of<br>Required<br>Technological<br>Characteristics | The proposed WALLSTENT RP Endoprosthesis Tracheobronchial<br>and WALLSTENT Endoprosthesis Tracheobronchial is substantially<br>equivalent to the existing Wallstent Endoprosthesis Tracheobronchial<br>cleared by FDA under premarket notification K992510 (November 18,<br>1999). WALLSTENT RP Endoprosthesis Tracheobronchial and<br>WALLSTENT Endoprosthesis Tracheobronchial has 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 Establishing Safety and Compatibility of Passive Implants in<br>the Magnetic Resonance (MR) Environment, 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 WALLSTENT RP<br>Endoprosthesis Tracheobronchial and WALLSTENT Endoprosthesis<br>Tracheobronchial has been shown to be appropriate for its intended<br>use and is considered to be substantially equivalent to the<br>WALLSTENT Endoprosthesis Tracheobronchial (K992510). | |

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