(113 days)
Not Found
No
The provided text explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any functions or components that would suggest the presence of an AI model, such as image analysis for diagnostic purposes.
Yes
The device is used to establish and maintain an artificial airway for patients requiring mechanical ventilation, which is a direct therapeutic intervention.
No
The device is primarily used for intubation procedures and for verifying endotracheal tube placement, which are procedural and confirmatory actions, not diagnostic.
No
My reasoning is based on the 'Device Description' section, which explicitly states that the device "comprises of two main components: The ProVu Reinforced Endotracheal tube and The ProVu Video Stylet". These are tangible hardware components. Additionally, the 'Summary of Performance Studies' includes biocompatibility testing, sterilization testing, electrical safety, and bench performance testing, all of which are characteristic of physical medical devices rather than solely software. The "Input Imaging Modality: Video camera" also indicates a hardware component.
No. The device is for intubation and airway management, not for examining specimens derived from the human body for diagnostic purposes.
N/A
Intended Use / Indications for Use
The ProVu Endotracheal Tube with Video Stylet is intended for intubation procedures. The ProVu Endotracheal Tube with Video Stylet is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral and nasal intubations.
The ProVu Endotracheal Tube with Video Stylet is indicated for viewing during non-difficult and difficult intubation procedures and for verifying endotracheal tube placement.
Product codes (comma separated list FDA assigned to the subject device)
BTR, BSR
Device Description
The ProVu Video Stylet with Reinforced ET Tube is a sterile, single-use, video-enabled stylet and ETT intubation system with malleable and directional control intended to assist with oral and nasal intubations and designed for use in adults in a hospital environment.
The device comprises of two main components:
- The ProVu Reinforced Endotracheal tube
- The ProVu Video Stylet (with a removable malleable rod)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video camera
Anatomical Site
Not Found
Indicated Patient Age Range
Adult
Intended User / Care Setting
Hospital
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)
The following performance data were provided in support of the substantial equivalence determination:
- Biocompatibility testing: Evaluated in accordance with FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices − Part 1: Evaluation and Testing Within a Risk Management Process," and ISO 18562-1" Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process". Tests included Cytotoxicity, Sensitization, Intracutaneous reactivity, Material Mediated Pyrogenicity, Subcutaneous Implantation, Chemical Characterisation, and Toxicological Risk Assessment. Gas Pathway Testing using methods in ISO 18562-2 and ISO 18562-3 was completed.
- Sterilization and shelf-life testing: Sterilization Process validated according to ISO 11135:2014. EO/ECH residual test performed according to ISO 10993-7:2008. Shelf-life is 0.5 year.
- Electrical safety and electromagnetic compatibility (EMC): Complies with IEC 60601-1 and IEC60601-2-18 for safety and IEC 60601-1-2 for EMC.
- Bench performance testing: Performed according to ISO 5361 and ISO 5356-1.
- Usability validation: Conducted according to FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices".
Clinical study: Not applicable.
Key results: Performance testing and compliance with voluntary standards demonstrate that the subject device is substantially equivalent to the predicate device.
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
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).
FDA 510(k) Clearance Letter - ProVu Single Use Video Stylet with Reinforced ET Tube
Page 1
May 20, 2025
Flexicare Medical Limited
Rebecca Funston
Director of Regulatory Affairs and Quality Assurance
Cynon Valley Business Park Mountain Ash.
Rhondda Cynon Taf, Wales CF45 4ER
United Kingdom
Re: K250243
Trade/Device Name: ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)
Regulation Number: 21 CFR 868.5730
Regulation Name: Tracheal Tube
Regulatory Class: Class II
Product Code: BTR, BSR
Dated: April 23, 2025
Received: April 23, 2025
Dear Rebecca Funston:
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 (the 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 available 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.
Page 2
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
Page 3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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,
Bradley Q. Quinn -S
Bradley Quinn
Assistant Director
DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K250243
Device Name
ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U);
ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U);
ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U);
ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)
Indications for Use (Describe)
The ProVu Endotracheal Tube with Video Stylet is intended for intubation procedures. The ProVu Endotracheal Tube with Video Stylet is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral and nasal intubations.
The ProVu Endotracheal Tube with Video Stylet is indicated for viewing during non-difficult and difficult intubation procedures and for verifying endotracheal tube placement.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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Page 5
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2025/03/20
1. Submission sponsor
Name: Flexicare Medical Limited
Address: Cynon Valley Business Park Mountain Ash. CF45 4ER. United Kingdom
Contact person: Rebecca Funston
Title: Director of Regulatory Affairs and Quality Assurance
Tel: +44 (0)1443 474647
2. Subject Device Information
| Trade/Device Name | ProVu Video Stylet and Reinforced Endotracheal Tube |
|---|---|
| Common Name | Endotracheal Tube |
| Regulatory Class | Class II |
| Classification | 21CFR 868.5730 / tube, tracheal (w/wo connector)/ BTR |
| Product code | BTR, BSR |
| Submission type | Traditional 510(K) |
3. Predicate Device
VIVASIGHT-SL (TVTTM) device manufactured by "ETView Ltd" at date of clearance (Now owned by Ambu) and cleared under "K152438".
4. Device Description
The ProVu Video Stylet with Reinforced ET Tube is a sterile, single-use, video-enabled stylet and ETT intubation system with malleable and directional control intended to assist with oral and nasal intubations and designed for use in adults in a hospital environment.
The device comprises of two main components:
- The ProVu Reinforced Endotracheal tube
- The ProVu Video Stylet (with a removable malleable rod)
5. Intended use & Indication for use
The ProVu Endotracheal Tube with Video Stylet is intended for intubation procedures. The ProVu Endotracheal Tube with Video Stylet is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral and nasal intubations.
The ProVu Endotracheal Tube with Video Stylet is indicated for viewing during non-difficult and difficult intubation procedures and for verifying endotracheal tube placement.
Page 6
6. Comparison to the Predicate Device
| ProVu Video Stylet with Reinforced ET Tube | ETView Ltd.'s VIVASIGHT-SL (TVTTM) | Comparison | |
|---|---|---|---|
| 510(k) | K250243 | K152438 | / |
| Indications for use | The ProVu Video Stylet with Reinforced ET Tube is intended for intubation procedures. The ProVu Video Stylet with Reinforced ET Tube is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral and nasal intubations. The ProVu Video Stylet with Reinforced ET Tube is indicated for viewing during non-difficult and difficult intubation procedures and for verifying endotracheal tube placement. | The ETView VivaSight-SL (TVTTM) is intended for intubation procedures. The ETView VivaSight-SL (TVTTM) is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral and nasal intubations. The VivaSight-SL (TVTTM) System is indicated for viewing during non-difficult and difficult intubation procedures, for verifying endotracheal tube and endobronchial blocker placement and repositioning, for viewing during suctioning and for general inspection of the airway. | Equivalent |
| Product Code | BTR, BSR | BTR | Same |
| Regulation No. | 21 CFR 868.5730 | 21 CFR 868.5730 | Same |
| Classification | Class II | Class II | Same |
| Supplied/Use | Single use | Single use | Same |
| Method of sterilization | EtO | EtO | Same |
| Basic structure | Standard ETT | Standard ETT | Same |
| Endotracheal Tube Material | - Polyvinyl Chloride (PVC) |
- Polypropylene (PP) | - Polyvinyl Chloride (PVC)
- Polypropylene (PP) | Same |
Page 7
| ProVu Video Stylet with Reinforced ET Tube | ETView Ltd.'s VIVASIGHT-SL (TVTTM) | Comparison | |
|---|---|---|---|
| Imaging Sensor | Video camera | Video camera | Same |
| Video transfer | Colored real time image acquisition from the aperture of the tracheal lumen | Colored real time image acquisition from the aperture of the tracheal lumen | Same |
| Video Format | Motion Joint Photographic Experts Group | Composite Video Baseband Signal | Similar |
| Bevel | Opening to the bottom. The camera situates centrally within lumen. | Opening to the bottom with the camera on the top | Similar |
| Display system | Cable connection to ProVu 8" display | Cable connection to VivaSight-Max Monitor-7" monitor | Equivalent |
| Tube Dimensions: Internal Diameter | Four models: | ||
| • ID 6.5 mm | |||
| • ID 7.0 mm | |||
| • ID 7.5 mm | |||
| • ID 8.0 mm | Three models: | ||
| • ID 7.0 mm | |||
| • ID 7.5 mm | |||
| • ID 8.0 mm | Similar | ||
| Tube Dimensions: Outer Diameter | Four models: | ||
| • 9.0mm | |||
| • 9.4mm | |||
| • 10.1mm | |||
| • 10.8mm | Three models: | ||
| • OD 10.0 mm | |||
| • OD 10.5 mm | |||
| • OD 11.0 mm | Similar | ||
| Cuff | Medical grade PVC, High volume, low pressure | Medical grade PVC, High volume, low pressure | Same |
| Number of Murphy Eyes | 2 | 2 | Same |
| Shelf life | 0.5 year | 3 Years | Similar |
| Packaging | Rigid Blister tray, EO Permeable paper top | EO Permeable peel pouch | Same |
| Target population | Adult | Adult | Same |
| Emergency use | Emergency and elective | Emergency and elective | Same |
| Environment of use | Hospital | Hospital | Same |
| Duration of use |