(97 days)
Not Found
No
The device description focuses on the physical construction and mechanical function of a stent and its delivery system, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
Yes
The device is indicated for use in the treatment of tracheobronchial strictures, and its purpose is to increase or maintain the inner luminal diameter of the tracheobronchial passage, which are actions that alleviate or improve a pathological condition.
No
The device is a tracheobronchial endoprosthesis, indicated for the treatment of strictures, not for diagnosis. Its purpose is to increase or maintain the inner luminal diameter of the tracheobronchial passage, which is a therapeutic function.
No
The device description clearly states it is a physical prosthesis constructed of biomedical superalloy and an elastomeric polymer, which is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Device Description and Intended Use: The WALLSTENT® Tracheobronchial Endoprosthesis is a physical device that is implanted into the tracheobronchial passage to treat strictures. It directly interacts with the patient's anatomy.
- Lack of Specimen Examination: The description does not mention the examination of any biological specimens (blood, tissue, etc.) outside of the body.
The device is an implantable medical device used for a therapeutic purpose, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The WALLSTENT® Tracheobronchial Endoprosthesis is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
Product codes
JCT
Device Description
The WALLSTENT® Tracheobronchial Endoprosthesis is a self-expanding prosthesis constructed of biomedical superalloy and an elastomeric polymer. Smaller diameter models may utilize a radiopaque core. The prosthesis is a braided wire structure which may be covered with an elastomeric polymer in selected models. The outward radial force along with the ends of the device serve to stabilize the prosthesis after implanted. The prosthesis is offered in covered and uncovered versions to allow physicians to select the most appropriate model based on their preference and individual patient condition. The stent's purpose is to increase or maintain the inner luminal diameter of the tracheobronchial passage.
The stent is placed by means of a delivery system. The delivery system is a coaxial tubing assembly which constrains the prosthesis until it is released in a controlled manner. The release of the stent is accomplished by retracting the outer sheath. The prosthesis is packaged constrained on the delivery system ready for placement. The system is sterile and intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tracheobronchial passage
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
Not Found
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.”
0
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services - USA. The seal features an abstract image of an eagle with its wings spread. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 2006
Boston Scientific Corporation % Ms. Angela Byland Manager, Regulatory Affairs Cardiovascular Two Scimed Place Maple Grove, Minnesota 55311-1566
Re: K961296
Trade/Device Name: WALLSTENT® Tracheobronchial Endoprosthesis Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: III Product Code: JCT Dated: March 29, 1996 Received: April 4, 1996
Dear Ms. Byland:
This letter corrects our substantially equivalent letter of July 10, 1996.
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 (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.
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); good manufacturing practice requirements as set
1
Page 2 - Ms. Angela Byland
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.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Hubert Lenoir
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use Statement
| 510(k) Number
| (if known) | K961296 |
|---|---|
| Device Name | WALLSTENT® Tracheobronchial Endoprosthesis |
| Indications For Use | The WALLSTENT® Tracheobronchial Endoprosthesis is |
| indicated for use in the treatment of tracheobronchial | |
| strictures produced by malignant neoplasms. |
Prescription Use: × (Per 21 CFR §801 Subpart D)
ﻟﺘ
OR
Over-The-Counter Use: (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulut Lewy
(Division S ign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K961294
3
962296 p. 1 of 2
Image /page/3/Picture/1 description: The image shows the logo for Boston Scientific. The logo is in a bold, serif typeface. The word "Boston" is on the top line, and the word "Scientific" is on the bottom line. The logo is in black and white.
510(k) Summary
| Submitter's
Name and
Address | Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311 | | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------------|
| Contact Name
and Information | Angela Byland
Manager, Regulatory Affairs
Phone: 763-494-2887
Fax: 763-494-2981
e-mail: bylanda@bsci.com | | |
| Original Date
Prepared | March 29, 1996 | | |
| Date Prepared | July 14, 2006 | | |
| Proprietary
Name(s) | WALLSTENT® Tracheobronchial Endoprosthesis | | |
| Common Name | Tracheal Endoprosthesis | | |
| Product Code | JCT | | |
| Classification of
Device | Class III, 21 CFR Part 878.3720 | | |
| Predicate Device | WALLSTENT®
Tracheobronchial
Prosthesis | K934116 | June 2, 1994 |
| | WALLSTENT®
Tracheobronchial
Endoprosthesis | K945494 | March 3, 1995 |
| Device
Description | The WALLSTENT® Tracheobronchial Endoprosthesis is a
self-expanding prosthesis constructed of biomedical
superalloy and an elastomeric polymer. Smaller diameter
models may utilize a radiopaque core. The prosthesis is a
braided wire structure which may be covered with an
elastomeric polymer in selected models. The outward radial
force along with the ends of the device serve to stabilize the
prosthesis after implanted. The prosthesis is offered in
covered and uncovered versions to allow physicians to
select the most appropriate model based on their
preference and individual patient condition. The stent's
purpose is to increase or maintain the inner luminal
diameter of the tracheobronchial passage. | | |
: : : :
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
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961296 p. 2 of 2
| Device
Description
cont'd | The stent is placed by means of a delivery system. The
delivery system is a coaxial tubing assembly which
constrains the prosthesis until it is released in a controlled
manner. The release of the stent is accomplished by
retracting the outer sheath. The prosthesis is packaged
constrained on the delivery system ready for placement.
The system is sterile and intended for single use only. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The WALLSTENT® Tracheobronchial Endoprosthesis is
indicated for use in the treatment of tracheobronchial
strictures produced by malignant neoplasms. |
| Technological
Characteristics | This premarket notification deals with modification to the 12
and 14 mm stents to standardize the relative radial force.
This was accomplished by increasing the wire diameter
and/or number of wires used to fabricate the stent. |
| Conclusion | In summary, Boston Scientific Corporation has
demonstrated that the predicate devices and the
WALLSTENT® Tracheobronchial Endoprosthesis are
substantially equivalent based on design, materials,
methods of fabrication and indications for use. |
Carlos Concession
:
i
: