(238 days)
The TNI softFlow 50 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases. The TNI softFlow 50 is for adult patients in hospitals and long-term care facilities. The flow may be from 10-50 L/min.
The TNI softFlow 50 is not indicated for life support measures.
The softFlow 50 system is a high flow heated humidifier for respiratory gases with integrated flow source and a heated breathing tube to deliver conditioned respiratory gases to a patient. The air or air/oxygen mixture is both humidified and heated. A nasal cannula serves as applicator, similar to the nasal cannula used during oxygen ventilation therapy. The nasal applicator is no compatible with a tracheostoma. The nasal applicator is sold separately as a disposable accessory that is replaced after 14 days (336 hours).
The softFlow 50 is for the treatment of spontaneously breathing adult patients in hospitals and long-term care facilities who would benefit from receiving high flow warmed and humidified respiratory gases. The flow may be from 10-50 L/min depending on the patient interface.
The humidifier clinic complete is sold separately so that the patient can replace the airlift, the humidification chamber, and the bacterial filter. The humidifier clinic is sold separately as a disposable accessory that is replaced weekly.
The document you provided is a 510(k) Pre-market Notification from the FDA for a medical device called "TNI softFlow 50," a respiratory gas humidifier. It focuses on demonstrating substantial equivalence to a predicate device, not on presenting results from a clinical study for a new AI/CAD device.
Therefore, the information requested in your prompt regarding acceptance criteria, study design, expert involvement, and performance metrics (especially those relevant to AI, like MRMC studies or effect sizes for human readers) cannot be extracted from this document.
This document describes:
- Device: TNI softFlow 50 (a respiratory gas humidifier)
- Predicate Device: AIRVO 2 HUMIDIFIER (K131895)
- Indications for Use: Treatment of spontaneously breathing adult patients in hospitals and long-term care facilities who would benefit from receiving high flow warmed and humidified respiratory gases (flow 10-50 L/min). Not indicated for life support.
- Comparison of Technical Characteristics: Focuses on similarities in intended use, materials, design, energy source, temperature range, operating principles, alarms, user interface, display, software/hardware controls, and performance testing (flow rates and humidity).
- Performance Data Provided:
- EN 62353:2014 Recurrent Test and Repair Test
- Air and Oxygen Flow Rate Test
- Mixing Chamber Test
- Humidifier Measurement Test
- FiO2 Measurement Test
- Sterilization & Shelf-life (4 years 10 months for device, 6 months for nasal applicator, weekly for humidifier clinic)
- Biocompatibility Testing (VOC emissions, genotoxicity, intracutaneous irritation, cytotoxicity, acute systemic toxicity, sensitization, chemical characterization, particulate matter)
- Software Verification and Validation (IEC 62304:2006, software usability risk analysis)
- Electrical Safety and EMC (IEC 60601-1:2005, MOD and IEC 60601-1-2:2014)
- Mechanical and Acoustic Testing (including alarms per IEC 60601-1-8:2006, and compliance to respiratory humidification systems per ISO 8185:2007)
- No Animal or Clinical Studies: Explicitly states that these were not required. The substantial equivalence is based on benchtop performance testing.
In summary, there is no information in the provided text that would allow me to answer your questions about acceptance criteria for an AI device, study design for AI evaluation, expert ground truth, or MRMC studies. The document describes a traditional medical device (humidifier) and its regulatory submission, not an AI or CAD device.
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).