(233 days)
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)
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
1
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
Name | Self-Expanding Stent | |
---|---|---|
Trade Name(s) | WALLSTENT™ RP Endoprosthesis Tracheobronchial and | |
WALLSTENT™ Endoprosthesis Tracheobronchial | ||
Product Code | JCT – Prosthesis, Tracheal, Expandable | |
Classification of | ||
Device | The WALLSTENT Endoprosthesis Tracheobronchial device has been | |
classified as Class II devices according to 21 CFR 878.3610 – | ||
Esophageal Prosthesis. | ||
Submitter's Name | ||
and Address | Boston Scientific Corporation | |
One Scimed Place | ||
Maple Grove, MN 55311-1566 | ||
Contact Name and | ||
Information | Carah Kucharski | |
Regulatory Affairs Specialist | ||
Phone: 763-494-1683 | ||
Fax: 763-255-0738 | ||
Email: carah.kucharski@bsci.com | ||
Section 514 of the | ||
Act Performance | ||
Standards | Currently no FDA mandated or voluntary performance standards exist | |
for this device. | ||
Establishment | ||
Registration | ||
Numbers | Owner /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 Devices | WALLSTENT™ Tracheobronchial Endoprosthesis K992510 cleared | |
November 18, 1999 | ||
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. | ||
Description of | ||
Device | 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. | ||
Comparison of | ||
Required | ||
Technological | ||
Characteristics | The 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 | ||
Summary | 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, |
- 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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