(242 days)
The intended use of this device is to provide manual, bag mask/tube pulmonary resuscitation.
The Mercury Medical Reusable CPR Bag uses the same technology as the Mercury CPR, Puntan Bennett PMR and most other manual resuscitators in the market. The bag is compressed by hand to move air into the patient. When released the bag re-expands with air flowing through the intake valve. Supplemental oxygen tubing may be connected to an oxygen source to allow intake of oxygen enriched air.
The provided text describes a 510(k) submission for the Mercury Medical Reusable CPR Bag. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than a detailed performance study with acceptance criteria often seen for novel devices or those with higher risk. Therefore, much of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not directly addressed in this document.
Here's an attempt to extract the closest relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria. Instead, it relies on a comparison to predicate devices and adherence to external standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Design Similarity to predicate devices (K911622 Mercury Medical single patient use CPR Bag, Puntan Bennett PMR, Laerdal Bag Mask Resuscitator). | The device is "similar in design" to the Mercury Medical single patient use CPR Bag. The "Table of Technological Comparison in Section 5 indicates that this device and predicate device are similarly designed with identical materials." It uses "the same technology as the Mercury CPR, Puntan Bennett PMR and most other manual resuscitators in the market." |
| Performance Characteristics similar to predicate devices and exceeding ASTM standards. | The "Table of Performance Comparison in Section 5 also demonstrates that this and the predicate devices all have similar performance characteristics exceeding the ASTM standards." (Specific ASTM standard not mentioned, and specific performance characteristics/metrics are not detailed in this summary). |
| Intended Use Equivalence | "The intended use of this device is to provide manual, bag mask/tube pulmonary resuscitation," which is directly comparable to the stated function of manual resuscitators. |
2. Sample size used for the test set and the data provenance
Not applicable. The submission is based on engineering design comparison and performance data against standards, not a clinical test set from human or simulated patients in the usual sense. The data provenance would be laboratory testing against ASTM standards and comparison to specifications of predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for a clinical test set is not established in this type of submission. Performance is assessed against engineering standards and comparison to predicate devices, presumably by the manufacturer's internal engineering team and later reviewed by FDA.
4. Adjudication method for the test set
Not applicable, as there is no specific clinical test set described that would require expert adjudication.
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 manual resuscitator, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical, human-operated medical device, not an algorithm.
7. The type of ground truth used
For the performance comparison, the "ground truth" would be the established performance specifications of the predicate devices and the requirements of the relevant ASTM standards. These standards themselves are developed through expert consensus and scientific principles for medical device safety and efficacy.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or an "AI" component, so there is no training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 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).