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510(k) Data Aggregation
(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: $\pm$ 1 breaths/min | 3-150 breaths/min: $\pm$ 1 breaths/min (Same as predicate) |
| Total System Response Time | < 0.7 s | < 0.7 s (Specification met) |
| Operating Temperature | -5 to 50 °C (23 to 122 °F) | -5 to 50 °C (23 to 122 °F) (Same as predicate) |
| Storage/Transport Temperature | -40 to 70 °C (-40 to 158 °F) | -40 to 70 °C (-40 to 158 °F) (Extended from predicate: -30 to 70 °C, and verified. Test supports acceptability of lower temperature specification.) |
| Operating Humidity | 10 - 95%, non-condensing | 10 - 95%, non-condensing (Same as predicate) |
| Storage/Transport Humidity | 10 - 95%, non-condensing | 10 - 95%, non-condensing (Narrowed from predicate: 5 - 100%, and verified.) |
| Operating Atmospheric Pressure | 60 - 120 kPa | 60 - 120 kPa (Extended from predicate: 70 - 120 kPa, and verified. Test supports acceptability of lower atmospheric pressure specification.) |
| Electrical Safety/EMC | IEC 60601 compliant | IEC 60601-1-2:2014 compliant (Testing supports addition of wireless radio capabilities does not impact essential performance.) |
| Wireless Communication | Supports Bluetooth wireless communication | Bluetooth GFSK, 2402-2480 MHz, Max Peak Output Power -1 dBm, Antenna Peak Gain -7 dBi, Recommended Range ~10 feet (~3 meters) line-of-sight (Added capability, tested for radio co-existence). |
| Radio Co-existence | Quality of service of wireless connection maintained under normal and anticipated abnormal conditions | Testing supports the quality of the service of the wireless connection is maintained under normal and anticipated abnormal conditions. |
| Cybersecurity | Acceptable cybersecurity risks | Testing supports the acceptability of the cybersecurity risks. |
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Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for the test sets used in the engineering verification and validation. The studies mentioned (EMC, radio co-existence, cybersecurity, operational verification for temperature and atmospheric pressure) are typically engineering validation tests performed on the device itself, rather than clinical studies using human subjects or large datasets. As such, the data provenance is from laboratory testing of the manufactured device. -
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The ground truth for the engineering tests would be established by reference standards or highly calibrated equipment used for performance verification (e.g., precise gas mixtures for CO2 accuracy, controlled temperature/pressure chambers, standardized EMC/wireless testing setups). -
Adjudication Method for the Test Set:
Not applicable. These are engineering performance tests, not studies requiring expert adjudication of clinical outcomes. -
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. The submission focuses on substantial equivalence based on engineering changes (addition of wireless capabilities) to an already cleared predicate device, rather than a new clinical comparison. -
Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
While the EMMA Capnograph functions as a standalone device, the document does not detail a "standalone algorithm only" study in the context of AI without human interaction. The performance criteria listed (e.g., CO2 accuracy, respiration rate accuracy) inherently represent the standalone performance of the device's measurement functions. The core measurement algorithm itself has not changed from the predicate. -
Type of Ground Truth Used:
For the CO2 and respiration rate accuracy, the ground truth would be established by controlled gas mixtures with known CO2 concentrations and controlled respiration rates simulated in a laboratory setting, using highly accurate reference measurement systems. For environmental and electrical tests, ground truth is defined by established international standards (e.g., IEC 60601-1-2) and highly calibrated testing equipment. -
Sample Size for the Training Set:
Not applicable. This device is not an AI/Machine Learning device that requires a training set in the typical sense. It relies on established physical principles of infrared light absorption. -
How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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