(87 days)
Not Found
Not Found
No
The summary describes a mechanical stent system and delivery catheter with no mention of AI/ML components or related performance metrics.
Yes
The device is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms, which is a therapeutic purpose.
No
The device is a stent system used for treating tracheobronchial strictures, which is a therapeutic function, not a diagnostic one. It's designed to treat a condition, not to identify or diagnose it.
No
The device description explicitly states it is comprised of a metallic expandable stent and a flexible delivery catheter, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Description: The Ultraflex Tracheobronchial Stent System is a device that is implanted into the body to treat a physical condition (tracheobronchial strictures). It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use is to treat strictures, not to diagnose a condition or analyze samples.
Therefore, based on the provided information, the Ultraflex Tracheobronchial Stent System is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Ultraflex Tracheobronchial Stent System is indicated for treatment of tracheobronchial strictures produced by malignant neoplasms.
Product codes
JCT
Device Description
The proposed Ultraflex Tracheobronchial Stent System is comprised of two components, a metallic expandable stent and a flexible delivery catheter. The stent is mounted on a delivery catheter. The delivery catheter is placed over a guidewire and through the working channel of an endoscope to deliver the stent. The stent is available in a variety of diameters and lengths.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was conducted to evaluate the design features of the Ultraflex Tracheobronchial Stent System and to demonstrate substantial equivalence of the proposed device to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Boston Scientific Corporation's Wallstent Tracheobronchial Stent System
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/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle image.
NOV - 3 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boston Scientific Corporation % Ms. Angela Byland Manager, Regulatory Affairs Cardiovascular Two Scimed Place Maple Grove. Minnesota 55311-1566
Re: K963241
Trade/Device Name: Ultraflex® Tracheobronchial Stent System Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: II Product Code: JCT Dated: August 16, 1996 Received: August 19, 1996
Dear Ms. Byland:
This letter corrects our substantially equivalent letter of November 14, 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
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Page 2 - Ms. Angela Byland
forth in 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.
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 Lemmer
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
510(k) Number (if known): K963241
Ultraflex™ Tracheobronchial Stent System Device Name:
Indications for Use:
The Ultraflex Tracheobronchial Stent System is indicated for treatment of tracheobronchial strictures produced by malignant neoplasms.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off Division of General, Restorative, Page 1 of 1 and Neurological Devices
510(k) Number K963241
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K963241 p. 1 of 2
Image /page/3/Picture/1 description: The image shows the logo for Boston Scientific. The logo is in a serif font and is black. The word "Boston" is on top of the word "Scientific".
510(K) SUMMARY K963241
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01545 Telephone: 508-683-4942 Fax: 508-683-5939
Contact: Kathleen Morahan Director Regulatory Affairs Original Date Prepared: August 16, 1996 Revision Date: July 14, 2006
- Device:
Trade Name: Ultraflex™ Tracheobronchial Stent System Common Name: Tracheal Prosthesis Classification Name: Tracheal Prosthesis Regulation Number: 878.3720 Product Code: JCT Classification: Class II
3. Predicate Device:
Boston Scientific Corporation's Wallstent Tracheobronchial Stent System
4. Device Description:
The proposed Ultraflex Tracheobronchial Stent System is comprised of two components, a metallic expandable stent and a flexible delivery catheter. The stent is mounted on a delivery catheter. The delivery catheter is placed over a guidewire and through the working channel of an endoscope to deliver the stent. The stent is available in a variety of diameters and lengths.
5. Intended Use:
The proposed Ultraflex Tracheobronchial Stent System is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
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K963241 p.2 of 2
6. Technological Characteristics:
The purpose of this 510(k) submission is to introduce the Ultraflex Tracheobronchial Stent System. The design characteristics are similar to the predicate Wallstent Tracheobronchial Stent System.
7. Performance Data:
Bench testing was conducted to evaluate the design features of the Ultraflex Tracheobronchial Stent System and to demonstrate substantial equivalence of the proposed device to the predicate device.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed Ultraflex Tracheobronchial Stent System is substantially equivalent to Boston Scientific Corporation's currently marketed Wallstent Tracheobronchial Endoprosthesis.