(140 days)
The CAREvent Handheld CPAP System is intended to provide CPAP to spontaneously breathing patients in the hospital and pre-hospital (EMS) environments.
The proposed CAREvent Handheld CPAP System is a pneumatically powered device designed to provide CPAP (Constant Positive Airway Pressure) to spontaneously breathing patients who require respiratory support. The patient can breathe spontaneously through the device while the device provides constant positive airway pressure via a face mask. It has only one control for the adjustment of CPAP pressure from 0 to 20 cmH2O.
The device may be used in pre-hospital transport applications including accident scene, emergency rescue vehicles, hospital transport applications including emergency, surgery, post anesthesia/ recovery and air transport via helicopter or fixed wing.
The device is a restricted medical device intended for use by qualified medical personnel under the direction of a physician.
The main accessories for the proposed device are Patient Circuit, Face Mask and Airway Pressure Manometer. They are all disposable for single-patient use.
The CAREvent Handheld CPAP System (K093862) underwent non-clinical bench testing to demonstrate its safety and essential performance.
1. Table of Acceptance Criteria and Reported Device Performance:
| Scope | Standard Applied / Acceptance Criteria | Test Result |
|---|---|---|
| Safety & Essential Performance | ISO10651-5:2006 Product Specifications | Comply |
| Patient Valve function after contamination | ISO10651-5:2006 Clause 6.1.1 | Comply |
| Function Test after Reassembly | ISO10651-5:2006 Clause 6.1.3 | Comply |
| Mechanical Shock (Drop Test/Immersion) | ISO10651-5:2006 Clause 6.3.1, 6.3.3 | Comply |
| Mechanical Shock (Splash-proof) | ISO10651-5:2006 Clause 6.3.2 | Comply |
| Delivered oxygen concentration | ISO10651-5:2006 Clause 7.1.1 | Comply |
| Inadvertent PEEP & Continuing Expiratory Pressure | ISO10651-5:2006 Clause 7.1.3, 7.1.4 | Comply |
| Dead Space | ISO10651-5:2006 Clause 7.1.5 | Comply |
| Pressure limitation | ISO10651-5:2006 Clause 7.2.4, 7.2.5 | Comply |
| Demand Valve | ISO10651-5:2006 Clause 7.2.9 | Comply |
| Durability of Markings | ISO10651-5:2006 Clause 8.2.2 | Comply |
| Inspiratory & Expiratory Resistance | ISO10651-5:2006 Clause 7.1.2 | Comply |
| Expiratory flow characteristics | Adequately to reduce carbon dioxide rebreathing | Comply |
| Static pressure testing | +/- 10% | Comply |
| Accuracy of pressure gauge | +/- 4% of the full range | Comply |
| Environmental | ISO10651-5:2006 Clause 6.2 | Comply |
| Vibration (Sinusoidal) | IEC60068-2-6 Test Fc | Comply |
| Vibration (Random) | IEC60068-2-36 Test Fdb | Comply |
| Bump | IEC60068-2-29 Test Eb | Comply |
2. Sample size used for the test set and the data provenance:
The studies were non-clinical bench tests. The specific sample sizes for each test are not explicitly detailed in the provided summary, but it's implied that sufficient samples were tested to meet the "Comply" criteria for each standard. All testing was performed internally by O-Two Medical Technologies or by BET Service Inc. and Exova, indicating the data provenance is from laboratory testing of the device itself. The data is prospective in nature as it involves testing of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This was a non-clinical bench study assessing device performance against engineering standards and specifications, not clinical outcomes based on human expert assessment.
4. Adjudication method for the test set:
Not applicable. The tests were objective measurements against quantitative physical and performance standards.
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 device is a medical hardware device (CPAP system), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is not an algorithm or AI system. Its performance as a standalone medical device was evaluated through the non-clinical bench tests.
7. The type of ground truth used:
The ground truth used for these non-clinical tests were the established industry standards (ISO 10651-5:2006, IEC60068-2-6, IEC60068-2-36, IEC60068-2-29) and the device's own product specifications, along with specific quantitative criteria (e.g., +/- 10% for static pressure, +/- 4% for pressure gauge accuracy, adequately reducing carbon dioxide rebreathing).
8. The sample size for the training set:
Not applicable. There is no concept of a "training set" for this type of non-clinical device performance testing.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set, this question is not relevant.
§ 868.5925 Powered emergency ventilator.
(a)
Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).