(164 days)
Not Found
No
The device description focuses on the mechanical properties and delivery system of a metal stent, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are bench tests related to MR compatibility, not algorithmic performance.
Yes
The device is intended for the treatment of tracheobronchial strictures, which means it addresses a medical condition or ailment.
No
The device is a stent system intended for treating tracheobronchial strictures, not for diagnosing them.
No
The device description clearly outlines a physical, implantable medical device (a stent) and its associated delivery system, which are hardware components. There is no mention of software being the primary or sole component of this device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Ultraflex™ Tracheobronchial Stent System is a permanently implanted medical device designed to physically open and support the airway in the tracheobronchial tree. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use is to treat tracheobronchial strictures produced by malignant neoplasms by providing intralumenal support. This is a direct intervention on the body, not an analysis of a specimen.
- Device Description: The description details a physical stent and delivery system for implantation, not equipment for analyzing biological samples.
The device's purpose is to provide mechanical support within the body, which is the function of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Ultraflex™ Tracheobronchial Stent System is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
Product codes (comma separated list FDA assigned to the subject device)
JCT
Device Description
The Ultraflex Tracheobronchial Stent System is a permanently implanted expandable metal stent designed to serve as an intralumenal support to keep open the inner lumen of the tracheobronchial tree. They consist of a flexible delivery catheter preloaded with an expandable metallic stent.
The stent is an open-ended cylindrical mesh constructed from a single strand of nitinol wire. The wire is configured into a series of circumferential interwoven loops, with the number of loops being dependent on the diameter of the stent. The stent is elongated and compressed onto a plastic delivery catheter. The stent is held onto the delivery catheter by a crocheted nylon suture wrapped around the stent. The delivery catheter has a flush taper tip at the distal end, and a round hub handle at the proximal end.
The partially covered stent has a single layer of silicone that covers the midsection of the stent. Partially covered stents are available with a distal release system only. The distal release system begins stent deployment from the lower (distal) end of the delivery catheter. The uncovered stents are available with a distal or proximal release system.
The radiopaque (RO) markers on the delivery system and stent facilitate fluoroscopic placement.
The uncovered stent has one pair of RO markers indicated the approximate locations of the margins of the deployed stent. The partially covered stent has four (4) RO markers. The outer two (2) RO markers indicate the estimated final position of the ends of the deployed stent. The inner two (2) RO markers indicate the estimated final position of the margins of the deployed stent cover.
The delivery system accepts a 0.035 in (0.89 mm) or 0.038 in (0.97 mm) guidewire. The delivery system is passed over the guidewire into the tracheobronchial lumen. The stent is positioned appropriately using the RO markers for guidance under fluoroscopy and by bronchoscopic visualization of the stent.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Tracheobronchial tree / tracheobronchial lumen
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)
Performance testing (bench) was completed to demonstrate compliance to the FDA Guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment issued on May 20, 2021. The testing included the following:
- Magnetically Induced Displacement Force . ASTM F2052, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- Magnetically Induced Torque . ASTM F2213, Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
- . Heating by Radio Frequency (RF) Fields ASTM F2182, Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging
- . Image Artifact ASTM F2119, Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
The performance (bench) testing demonstrated that the proposed Ultraflex™ Tracheobronchial Stent Systems comply with the FDA Guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment issued on May 20, 2021 and are considered substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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July 14, 2023
Boston Scientific Corporation Lingling Guo Senior Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, Massachusetts 01752
Re: K230269
Trade/Device Name: Ultraflex™ Tracheobronchial Stent System Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: Class II Product Code: JCT Dated: June 16, 2023 Received: June 16, 2023
Dear Lingling Guo:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ethan L. Nyberg -S
Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
| Submission Number (if known) | |
|---|---|
| ------------------------------ | -- |
Device Name
Ultraflex™ Tracheobronchial Stent System
Indications for Use (Describe)
The Ultraflex™ Tracheobronchial Stent System is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
Type of Use (Select one or both, as applicable)
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Summary for the Ultraflex™ Tracheobronchial Stent System
1. Submitter
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
| Primary Contact: | Lingling Guo |
|---|---|
| Sr. Regulatory Affairs Specialist | |
| Telephone: | 508-382-0456 |
| E-mail: | Lingling.guo@bsci.com |
| Secondary Contact: | Karin Desjardins |
| Director, Regulatory Affairs | |
| Telephone: | 508-683-0236 |
| E-mail: | Karin.Desjardins@bsci.com |
Date Prepared: June 6, 2023
2. Proposed Devices
Ultraflex™ Tracheobronchial Stent System Trade Name:
| Common Name: | Tracheal Prosthesis |
|---|---|
| Product Code: | JCT |
| Device Class and Panel: | Class II, General & Plastic Surgery |
| Classification Regulation: | 21 CFR 878.3720 |
3. Predicate Devices
| Trade Name: | Ultraflex™ Tracheobronchial Partially Covered Stent System |
|---|---|
| Clearance Number: | K141584 |
| Common Name: | Tracheal Prosthesis |
| Product Code: | JCT |
| Device Class and Panel: | Class II, General & Plastic Surgery |
| Classification Regulation: | 21 CFR 878.3720 |
| Trade Name: | Ultraflex™ Tracheobronchial Uncovered Stent System |
| Clearance Number: | K121048 |
| Common Name: | Tracheal Prosthesis |
| Product Code: | JCT |
| Device Class and Panel: | Class II, General & Plastic Surgery |
| Classification Regulation: | 21 CFR 878.3720 |
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4. Device Description
The Ultraflex Tracheobronchial Stent System is a permanently implanted expandable metal stent designed to serve as an intralumenal support to keep open the inner lumen of the tracheobronchial tree. They consist of a flexible delivery catheter preloaded with an expandable metallic stent.
The stent is an open-ended cylindrical mesh constructed from a single strand of nitinol wire. The wire is configured into a series of circumferential interwoven loops, with the number of loops being dependent on the diameter of the stent. The stent is elongated and compressed onto a plastic delivery catheter. The stent is held onto the delivery catheter by a crocheted nylon suture wrapped around the stent. The delivery catheter has a flush taper tip at the distal end, and a round hub handle at the proximal end.
The partially covered stent has a single layer of silicone that covers the midsection of the stent. Partially covered stents are available with a distal release system only. The distal release system begins stent deployment from the lower (distal) end of the delivery catheter. The uncovered stents are available with a distal or proximal release system.
The radiopaque (RO) markers on the delivery system and stent facilitate fluoroscopic placement.
The uncovered stent has one pair of RO markers indicated the approximate locations of the margins of the deployed stent. The partially covered stent has four (4) RO markers. The outer two (2) RO markers indicate the estimated final position of the ends of the deployed stent. The inner two (2) RO markers indicate the estimated final position of the margins of the deployed stent cover.
The delivery system accepts a 0.035 in (0.89 mm) or 0.038 in (0.97 mm) guidewire. The delivery system is passed over the guidewire into the tracheobronchial lumen. The stent is positioned appropriately using the RO markers for guidance under fluoroscopy and by bronchoscopic visualization of the stent.
5. Indications for Use
The Ultraflex™ Tracheobronchial Stent System is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
6. Technological Characteristics
The technological characteristics of proposed Ultraflex™ Tracheobronchial Stent System are identical to the predicate devices.
7. Substantial Equivalence
The Ultraflex™ Tracheobronchial Stent Systems do not have any change in material, design, specification, manufacturing technology, performance, biocompatibility or packaging to their respective predicate devices of Ultraflex™ Tracheobronchial Partially Covered Stent System (K141584) and Ultraflex™ Tracheobronchial Uncovered Stent System (K121048). The only change being introduced is to the MRI safety information in the Instruction for Use and the
5
addition of a Product Information for Patients and an implant card. The design requirements are not impacted by the labeling updates and the MRI safety status has not changed. Therefore, the subject devices are considered substantially equivalent to the predicate devices.
8. Performance Data
Performance testing (bench) was completed to demonstrate compliance to the FDA Guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment issued on May 20, 2021. The testing included the following:
- Magnetically Induced Displacement Force . ASTM F2052, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- Magnetically Induced Torque . ASTM F2213, Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
- . Heating by Radio Frequency (RF) Fields ASTM F2182, Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging
- . Image Artifact ASTM F2119, Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
The performance (bench) testing demonstrated that the proposed Ultraflex™ Tracheobronchial Stent Systems comply with the FDA Guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment issued on May 20, 2021 and are considered substantially equivalent to the predicate devices.
9. Conclusion
Boston Scientific Corporation has demonstrated that the proposed Ultraflex™ Tracheobronchial Stent Systems with updated labeling including MRI safety information are compliant with the FDA Guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment issued on May 20, 2021, and substantially equivalent to the currently cleared predicate devices of Ultraflex™ Tracheobronchial Partially Covered Stent System (K141584) and Ultraflex™ Tracheobronchial Uncovered Stent System (K121048).