K Number
K152842
Device Name
WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL
Date Cleared
2016-05-19

(233 days)

Product Code
Regulation Number
878.3720
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
The WALLSTENT RP Endoprosthesis Tracheobronchial and WALLSTENT Endoprosthesis Tracheobronchial are comprised of two components: The implantable metallic stent and the UNISTEP Plus delivery system. The stent is composed of biomedical superalloy wire, braided in a tubular mesh configuration. This design configuration results in a stent that is flexible, compliant, and self-expanding. The delivery system consists in part of coaxial tubes. The exterior tube serves to constrain the stent until retracted during delivery. Radiopaque marker bands situated on the interior and exterior tubes aid in imaging during deployment. Small stent sizes (5mm-12mm) may have a radiopaque core to improve radiopacity. The interior tube of the coaxial system contains a central lumen that accommodates a 0.035 in (0.89mm) guidewire.
More Information

Not Found

No
The summary describes a mechanical stent and delivery system with no mention of AI or ML in its function, design, or testing.

Yes
The device is used for "treatment of tracheobronchial strictures," which indicates a therapeutic purpose.

No

This device is a tracheobronchial stent, indicated for the treatment of strictures, which is a therapeutic rather than diagnostic function.

No

The device description explicitly states it is comprised of two components: an implantable metallic stent and a delivery system, both of which are hardware components.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is the treatment of tracheobronchial strictures produced by malignant neoplasms. This is a therapeutic intervention performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body) on biological samples.
  • Device Description: The device is an implantable metallic stent and a delivery system. This is a medical device designed for physical placement within the body to treat a condition.
  • No mention of analyzing biological samples: The description focuses on the physical properties and deployment of the stent, not on the analysis of blood, tissue, or other biological specimens.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

N/A

Intended Use / Indications for Use

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

Product codes

JCT

Device Description

The WALLSTENT RP Endoprosthesis Tracheobronchial and WALLSTENT Endoprosthesis Tracheobronchial are comprised of two components: The implantable metallic stent and the UNISTEP Plus delivery system. The stent is composed of biomedical superalloy wire, braided in a tubular mesh configuration. This design configuration results in a stent that is flexible, compliant, and self-expanding. The delivery system consists in part of coaxial tubes. The exterior tube serves to constrain the stent until retracted during delivery. Radiopaque marker bands situated on the interior and exterior tubes aid in imaging during deployment. Small stent sizes (5mm-12mm) may have a radiopaque core to improve radiopacity. The interior tube of the coaxial system contains a central lumen that accommodates a 0.035 in (0.89mm) guidewire.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Tracheobronchial

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Bench testing was performed in accordance with FDA guidance document Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, dated December 11, 2014) to support labeling as MR Conditional. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the device testing.

Key Metrics

Not Found

Predicate Device(s)

K992510

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 878.3720 Tracheal prosthesis.

(a)
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.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem featuring three human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
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

May 18th, 2016

| Common or Usual

NameSelf-Expanding Stent
Trade Name(s)WALLSTENT™ RP Endoprosthesis Tracheobronchial and
WALLSTENT™ Endoprosthesis Tracheobronchial
Product CodeJCT – Prosthesis, Tracheal, Expandable
Classification of
DeviceThe WALLSTENT Endoprosthesis Tracheobronchial device has been
classified as Class II devices according to 21 CFR 878.3610 –
Esophageal Prosthesis.
Submitter's Name
and AddressBoston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311-1566
Contact Name and
InformationCarah Kucharski
Regulatory Affairs Specialist
Phone: 763-494-1683
Fax: 763-255-0738
Email: carah.kucharski@bsci.com
Section 514 of the
Act Performance
StandardsCurrently no FDA mandated or voluntary performance standards exist
for this device.
Establishment
Registration
NumbersOwner /Operator: Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA 01752
ERN: 3005099803
Manufacturing
Facility: Boston Scientific Ireland Ltd. (BSIL)
Ballybrit Business Park
Galway, Ireland
ERN: 9681260
Predicate DevicesWALLSTENT™ Tracheobronchial Endoprosthesis K992510 cleared
November 18, 1999
Intended Use/
Indications for UseThe WALLSTENT™ RP Endoprosthesis and WALLSTENT™
Endoprosthesis Tracheobronchial are indicated for use in the
treatment of tracheobronchial strictures produced by malignant
neoplasms.
Description of
DeviceThe WALLSTENT RP Endoprosthesis Tracheobronchial and
WALLSTENT Endoprosthesis Tracheobronchial are comprised of two
components: The implantable metallic stent and the UNISTEP Plus
delivery system. The stent is composed of biomedical superalloy wire,
braided in a tubular mesh configuration. This design configuration
results in a stent that is flexible, compliant, and self-expanding. The
delivery system consists in part of coaxial tubes. The exterior tube
serves to constrain the stent until retracted during delivery.
Radiopaque marker bands situated on the interior and exterior tubes
aid in imaging during deployment. Small stent sizes (5mm-12mm) may
have a radiopaque core to improve radiopacity. The interior tube of the
coaxial system contains a central lumen that accommodates a 0.035
in (0.89mm) guidewire.
Comparison of
Required
Technological
CharacteristicsThe proposed WALLSTENT RP Endoprosthesis Tracheobronchial
and WALLSTENT Endoprosthesis Tracheobronchial is substantially
equivalent to the existing Wallstent Endoprosthesis Tracheobronchial
cleared by FDA under premarket notification K992510 (November 18,
1999). WALLSTENT RP Endoprosthesis Tracheobronchial and
WALLSTENT Endoprosthesis Tracheobronchial has the same
intended use, scientific technology, design, sterilization method, and
packaging as the applicable predicate device. The only difference is to
the MR Safety labeling information within the Directions for Use.
Bench testing in accordance with current FDA guidance supports a
labeling as MR Conditional.
Summary of Non-
Clinical Test
SummaryBench testing was performed in accordance with FDA guidance
document Establishing Safety and Compatibility of Passive Implants in
the Magnetic Resonance (MR) Environment, dated December 11,
  1. to support labeling as MR Conditional. The results of these
    tests provide reasonable assurance that the proposed device has
    been designed and tested to assure conformance to the requirements
    for its intended use. No new safety or performance issues were
    raised during the device testing. | |
    | Conclusion | Based on the indications for use, technological characteristics, and
    safety and performance testing, the proposed WALLSTENT RP
    Endoprosthesis Tracheobronchial and WALLSTENT Endoprosthesis
    Tracheobronchial has been shown to be appropriate for its intended
    use and is considered to be substantially equivalent to the
    WALLSTENT Endoprosthesis Tracheobronchial (K992510). | |

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