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510(k) Data Aggregation
(298 days)
CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)
The CAREvent PAR (Public Access Resuscitator) is indicated for Cardio Pulmonary Resuscitation (CPR) and short -term ventilatory support. It incorporates voice instructions, compression beeps and automatic ventilations to assist CPR Trained personnel for both inter - and intra-hospital transport and pre-hospital (EMS) settings for non-breathing adult patients.
The CAREvent PAR® is an electronically controlled, pneumatically powered resuscitator with a . 12V, internal, rechargeable battery is used to power the electronics. It incorporababliator instructions to assist the user during CPR.
The provided text describes a Premarket Notification 510(k) for the CAREvent PAR device, which is an electronically controlled, pneumatically powered resuscitator. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and detailed performance data often seen with AI/ML devices.
Therefore, many of the requested categories for AI/ML study descriptions are not applicable to this 510(k) submission. However, I can extract and present the information that is available, and explicitly state where information is not present in the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" for specific performance metrics in the way an AI/ML device study would. Instead, it presents a comparative table detailing the features and performance specifications of the proposed device against its predicate devices. The "acceptance criteria" here are implicitly that the proposed device's features and performance meet or are substantially equivalent to those of the legally marketed predicate devices.
| Feature / Performance Metric | Predicate Device Specification (K991195 - CAREvent BLS+ and K860555 - CPR Coach) | Proposed Device (CAREvent PAR) Performance | Implied "Acceptance Criteria" Met? |
|---|---|---|---|
| Indications for Use | Pulmonary resuscitation during respiratory and/or cardiac arrest; short-term ventilatory support for non-breathing patients; voice prompts for CPR. | Cardio Pulmonary Resuscitation (CPR) and short-term ventilatory support for non-breathing adult patients; voice instructions, compression beeps, automatic ventilations to assist CPR. | Yes (Broader/More Specific) |
| Environment of Use | Inter- and intra-hospital transport | Same, added pre-hospital (covered under inter-hospital transport) | Yes |
| Patient Population | Non-breathing adult and child (K991195) | Non-breathing adults | Yes (Subset for proposed device) |
| Contraindications | None | None | Yes |
| Software Driven | No (K991195), Yes (K860555) | Yes, some features (Respiratory rate, Pressure relief audible alarm, voice prompts) | Yes (consistent with predicate K860555 that has software) |
| Components Uses | Controller - multi-patient, multi-use; Circuit and mask - single patient use disposable | Same | Yes |
| Instructional voice prompts | Yes (K860555) | Yes | Yes |
| Deliver 100% oxygen | Yes (K991195) | Yes | Yes |
| Tidal volume (L) | 12 settings (1.35 down to 0.2) (K991195) | Fixed - 0.7 | Yes (Fixed setting is a design choice, not a failure to meet a predicate range) |
| Respiratory Rate (BPM) | 12 settings (10, 12, 15, 18, 20) (K991195) | Fixed - 20 | Yes (Fixed setting is a design choice, within predicate range) |
| I:E ratio | Fixed 1:2 (K991195) | Fixed 1:2 | Yes |
| Maximum Pressure relief (cm H2O) | 60 (K991195) | 60 | Yes |
| Pressure relief audible alarm | Yes (K991195) | Yes | Yes |
| Manual ventilation option | Yes (K991195) | No | Yes (Difference noted, but not deemed a "significant difference that affect the safety or effectiveness") |
| Demand breathing feature | No (K991195) | No | Yes |
| Circuit pressure | 40 psi (K991195) | Same | Yes |
| Input gas pressure | 45-70 psi (K991195) | Same | Yes |
| Input fitting/Output fitting | 9/16 DISS / 22mm | Same | Yes |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of data or studies typically associated with AI/ML devices. The submission relies on a comparison of design features and technical specifications to predicate devices. There is no mention of a specific number of test cases or data provenance for any performance evaluation in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The submission relies on design specifications and functional equivalence rather than expert-established ground truth from performance studies.
4. Adjudication method for the test set
This information is not applicable and 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
This information is not applicable and not provided. The CAREvent PAR is a medical device (resuscitator) that provides automated ventilations and voice instructions; it is not an AI-based diagnostic or assistive technology for human "readers" in the sense of image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device's operation inherently involves human interaction for setup and monitoring, and its functionality is not solely algorithmic in the AI sense. Its performance is measured by its physical output (e.g., tidal volume, respiratory rate).
7. The type of ground truth used
The "ground truth" for this type of device submission is based on engineering specifications, adherence to recognized standards (though not explicitly detailed here, often part of such submissions), and a comparison to the established performance and safety profiles of predicate devices. There is no "expert consensus," "pathology," or "outcomes data" in the AI/ML context mentioned for performance validation.
8. The sample size for the training set
This information is not applicable and not provided, as the device is not an AI/ML system that undergoes a "training set" process.
9. How the ground truth for the training set was established
This information is not applicable and not provided, as the device is not an AI/ML system.
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