(290 days)
EMMA® Capnograph measures, displays and monitors carbon dioxide partial pressure and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients.
The subject device, EMMA® Capnograph (EMMA), the same as the predicate, is a portable medical device capable of measuring, displaying, and monitoring carbon dioxide and respiratory rates from exhaled air. The difference between the subject device and the predicate device is the addition of the wireless capability to allow for the wireless transmission of data. The intended use and measurement functions have not changed from the previous clearance.
Masimo Corporation sought 510(k) clearance for their EMMA Capnograph with added wireless capabilities. The device measures and monitors carbon dioxide partial pressure and respiratory rates for adult, pediatric, and infant patients across various clinical settings.
Here's an analysis of the acceptance criteria and supporting studies:
- Table of Acceptance Criteria and Reported Device Performance:
| Feature | Acceptance Criteria (EMMA Specification) | Reported Device Performance (Subject Device) |
|---|---|---|
| CO2 Accuracy | 0-40 mmHg: +/- 2 mmHg | 0-40 mmHg: +/- 2 mmHg (Same as predicate) |
| 41-99 mmHg: 6% of reading | 41-99 mmHg: 6% of reading (Same as predicate) | |
| Respiration Rate Accuracy | 3-150 breaths/min: ± 1 breaths/min | 3-150 breaths/min: ± 1 breaths/min (Same as predicate) |
| Total System Response Time |
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).