(35 days)
Disposable manual resuscitator with CO2 detection for use with patients requiring manual ventilatory support. The CO2 detector is located on the expiratory port. It may be supplied separately and attached to any resuscitator expiratory port. The CO2 detector assists in verification of the endotracheal tube placing during endotracheal or nasotracheal intubation. The CO2 detector detects approximate ranges of CO2 by color comparison. It is intended for use by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated such as in the hospital, transport, mobile or home settings.
The EMS Disposable Manual Resuscitator is a bag-valve-mask device with the capability of delivering supplemental oxygen. It incorporates a feature CO2 detection.
The provided text describes a 510(k) submission for the EMS Disposable Manual Resuscitator with CO₂ Detection. The submission focuses on demonstrating substantial equivalence to predicate devices rather than conducting a de novo study to establish new performance criteria. Therefore, several of the requested categories are not applicable or cannot be extracted directly from this type of document.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics from a formal study. Instead, it relies on demonstrating equivalence to predicate devices. The "Performance Standards / Specifications" section explicitly states "None applicable under Section 514," indicating that no specific performance standards were applied or tested against as part of this submission for the modified device.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Not explicitly defined as quantitative criteria for this submission. The submission focuses on substantial equivalence to predicate devices. | Functionally equivalent to predicates, specifically regarding CO₂ detection and manual resuscitation. | The device performs the same functions and has similar design attributes as already-cleared predicate devices. The "Performance Standards/Specifications" section indicates no specific standards were applicable under Section 514, implying performance was assessed based on comparison to predicates without needing new quantitative targets. |
Study Information:
Due to the nature of a 510(k) submission based on substantial equivalence, a traditional "study that proves the device meets acceptance criteria" as might be seen for a novel device or a de novo application is not detailed in this document. The focus is on comparison to predicates.
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Sample size used for the test set and the data provenance: Not applicable / Not specified in this 510(k) summary. The document compares the modified device to predicate devices based on attributes and materials, not on a formal test set with clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable / Not specified. Ground truth establishment would typically be for a de novo study involving clinical data, which is not detailed here.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable / None specified.
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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 manual resuscitator with a CO₂ detector, not an AI-powered diagnostic device involving human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The ground truth concept is generally for diagnostic or prognostic devices, where a reference standard is needed for comparison. This submission relies on substantial equivalence and material/design comparisons to predicate devices.
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The sample size for the training set: Not applicable / Not specified. This document does not describe a training set as it's not a machine learning or AI-based device.
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How the ground truth for the training set was established: Not applicable / Not specified.
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, 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).