(114 days)
Not Found
No
The device description focuses on the physical construction and mechanical function of a stent and its delivery system. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms, meaning it is used to manage or treat a medical condition.
No
The device is a tracheobronchial endoprosthesis, indicated for treating strictures by maintaining luminal diameter, not for identifying or diagnosing conditions.
No
The device description clearly states it is a physical prosthesis constructed of biomedical superalloy and an elastomeric polymer, and is delivered via a coaxial tubing assembly. This indicates it is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The WALLSTENT® Tracheobronchial Endoprosthesis is a physical device (a stent) that is implanted into the body to treat a physical condition (tracheobronchial strictures). It does not analyze samples taken from the body.
- Intended Use: The intended use is to treat a physical obstruction, not to diagnose or monitor a condition through laboratory analysis.
Therefore, based on the provided information, the WALLSTENT® Tracheobronchial Endoprosthesis is a medical device, specifically an implantable prosthesis, but not an in vitro diagnostic device.
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 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 that 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
Prescription Use
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 shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of an eagle, with three curved lines forming the body and wings. The logo is black and white.
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: K992510
K92510
Trade/Device Name: WALLSTENT® Tracheobronchial Endoprosthesis with Unistep™ Plus Delivery System Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis
Regulatory Class: III Product Code: JCT Dated: October 31, 1999 Received: November 3, 1999
Dear Ms. Byland:
This letter corrects our substantially equivalent letter of November 18, 1999.
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave ro roved your becaused the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the enactment date of 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, and Cosmedo Tect (110) that do neer equine general controls provisions of the Act. The general therefore, maintons of the Act include requirements for annual registration, listing of devices, condons provisions or actice, 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 or any I 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,
Herbert Lemmerus
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) | K992510 |
|---|---|
| Device Name | WALLSTENT® Tracheobronchial Endoprosthesis with Unistep™ Plus Delivery System |
| Indications For Use | The WALLSTENT® Tracheobronchial Endoprosthesis is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms. |
Prescription Use:_ X (Per 21 CFR §801 Subpart D) OR
Over-The-Counter Use: ر (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concerrence of CDRH, Office of Device Evaluation (ODE)
Hulda Gunn
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K992510
3
Boston
Scientific
510(k) Summary K992510
| 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 | July 26, 1999 |
| Date Prepared | July 14, 2006 |
| Proprietary
Name(s) | WALLSTENT® Tracheobronchial Endoprosthesis with
Unistep™ Plus Delivery System |
| Common Name | Tracheal Endoprosthesis |
| Product Code | JCT |
| Classification of
Device | Class III, 21 CFR Part 878.3720 |
| Predicate Device | WALLSTENT®
Tracheobronchial
Endoprosthesis
K964121
December 04, 1996 |
| 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 stent's purpose is to
increase or maintain the inner luminal diameter of the
tracheobronchial passage. |
| Device
Description
cont'd | The stent is placed by means of a delivery system. The
delivery system is a coaxial tubing assembly that 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 | The purpose of this 510(k) is to allow an alternate delivery
system. Compared to the present Unistep™ Plus Delivery
System (K964121), this version of the Unistep™ Plus
Delivery System has a reduced profile that is a smaller
diameter. |
| | The alternate delivery system can be found substantially
equivalent based on the results of in vitro testing that
demonstrates the deployment forces and handling
characteristics are comparable to the current delivery
systems. |
| Conclusion | In summary, Boston Scientific Corporation has
demonstrated that the WALLSTENT® Tracheobronchial
Endoprosthesis with Unistep™ Plus Delivery System with
reduced profile for the delivery system is substantially
equivalent based on design, test results, and indications for
use to the predicate devices. |
:
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