(525 days)
A physical barrier for mouth to mouth resuscitation between the victim (patient) and the rescuer. This device makes no "guarantee" of disease protection, but it is designed to help protect the rescuer against potentially contaminated secretions and back drafts emanating from the victim while eliminating actual mouth to mouth contact. This device is to be used only by persons trained in CPR and the use of this device. DO NOT USE THIS DEVICE ON INFANTS.
The CPRotector 2000 device is a mouth-to-mouth barrier that offers protection to the CPR administrator from vomitus and other oral secretions. It is to be used only by persons trained in the application of CPR. Each CPRotector 2000 comes prepackaged with complete instructions for use. It is labeled as a single-use device and therefore must be disposed of after each use, in accordance with applicable rules and requlations. The CPRotector 2000 includes a one-way valve that directs the breathing gas flow from the CPR administrator to the patient, and directs the exhaled gases away from the rescuer and into the atmosphere. The components used in the manufacture of this device are made from PVC compounds which have been tested to meet the requirements of USP XXII, 1990, and Supplement 5, 1991, for the Biological Test for Plastics, Class VI-70°C.
The provided text is a 510(k) summary for a CPRotector 2000 Mouth-to-Mouth Barrier. It outlines the device's classification, intended use, and substantial equivalence to a previously cleared device. However, it does not contain specific acceptance criteria or details of a study proving the device meets acceptance criteria in the format requested.
The document states:
- "The CPRotector 2000 device is a mouth-to-mouth barrier that offers protection to the CPR administrator from vomitus and other oral secretions."
- "The components used in the manufacture of this device are made from PVC compounds which have been tested to meet the requirements of USP XXII, 1990, and Supplement 5, 1991, for the Biological Test for Plastics, Class VI-70°C."
This indicates that the material biocompatibility was tested against a standard (USP Class VI), which could be considered an acceptance criterion for the material. However, this is not a performance study for the device's function as a barrier.
The filing relies on substantial equivalence to an existing predicate device (CPRotector, cleared under K934821) rather than presenting new performance study data for the CPRotector 2000 itself. Substantial equivalence generally implies that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate device without raising new questions of safety or effectiveness.
Therefore, most of the requested information cannot be extracted from this document as it pertains to a new performance study.
Here's what can be provided based on the text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Material Biocompatibility: Components meet USP XXII, 1990, and Supplement 5, 1991, for the Biological Test for Plastics, Class VI-70°C. | Components made from PVC compounds have been tested to meet these requirements. |
| New Performance Study: (Not applicable as reliance is on substantial equivalence to a predicate). | (No new performance study data provided in this summary). |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. No new device performance study is described for the CPRotector 2000.
- Data Provenance: Not applicable for device performance. The material biocompatibility testing would have been conducted on component samples, likely prospective testing for the manufacturing batch/materials. The document doesn't specify the country of origin for the material testing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No new performance study or ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No new performance study is described.
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 physical barrier, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No new performance study is described for the device's function. The "ground truth" for material biocompatibility is adherence to the USP Class VI standard.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. (See #8).
§ 868.5870 Nonrebreathing valve.
(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).