(87 days)
The Ultraflex Tracheobronchial Stent System is indicated for treatment of tracheobronchial strictures produced by malignant neoplasms.
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.
The provided text is a 510(k) premarket notification for a medical device (Ultraflex Tracheobronchial Stent System). It focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study that proves the device meets specific performance acceptance criteria.
Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document, as it describes a different regulatory pathway (510(k) clearance based on substantial equivalence) than one requiring extensive clinical performance studies with predefined acceptance criteria for AI or diagnostic devices.
However, I can provide the following based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or provide specific performance metrics in a table. The regulatory submission is for substantial equivalence to an existing predicate device (Boston Scientific Corporation's Wallstent Tracheobronchial Stent System) for the treatment of tracheobronchial strictures produced by malignant neoplasms.
The "performance" demonstrated is that the device has "similar" design characteristics and that bench testing was conducted to evaluate features and demonstrate substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable/not provided. This document states "Bench testing was conducted to evaluate the design features," implying in-vitro or simulated testing, not testing on human patient data with a "test set" in the context of diagnostic accuracy.
- Data Provenance: Not applicable/not provided. The device is a physical stent system, and the submission focuses on its physical characteristics and intended use in comparison to a predicate, not on a data-driven diagnostic or AI system.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/not provided. This is not a study involving expert-established ground truth for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a traditional medical device submission for a physical stent, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI-related effectiveness is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. As above, this is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" in this context would implicitly be the established safety and efficacy profile of the predicate device, against which the new device's engineering and performance characteristics were compared to demonstrate equivalence.
8. The sample size for the training set
- Not applicable. No training set is mentioned as this device is a physical stent and not an AI or machine learning model.
9. How the ground truth for the training set was established
- Not applicable.
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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
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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.
§ 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.”