(340 days)
The ENVOY Monitor is a physiological patient monitor intended to be used for monitoring vital signs of critically ill adult and pediatric patients in the hospital environment, such as: ECG/Heart Rate, Invasive Blood Pressure, Respiration, Temperature, Noninvasive Blood Pressure, Pulse Oximetry and EtCO2. The ENVOY may be used to monitor a wide range of patient conditions in many different clinical specialties within the hospital. The device is intended for use by qualified health care providers, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
ENVOY EtCO2 is a hospital based module, for monitoring EtCO2 physiological patient vital signs.
ENVOY vital signs EtCO2 module acquires vital signs data from the patient, and displays the patients waveform and alarms indication on the ENVOY display unit. This information is displayed simultaneously on the ENVOY Display Unit.
All processing and alarm determination for EtCO2 is made using Pryon technology based on currently marketed Pryon monitoring devices.
Information from each vital sign is presented in a separate portion of the display. Each vital sign is labeled for identification and numeric value. Displayed Vital sign information can include: Primary Vital Sign Name, Waveform, Vital Sign Numeric Value, Alarm Status Message.
Selection of the EtCO2 functions is accomplished by interaction with front panel controls on the main processor unit. A quick-knob control allows direct interaction with displayed menus for direct parameter selection and setup. Where manual entry of alphanumeric information is required, a menu keyboard menu is display.
The provided document is a 510(k) summary for the MENNEN MEDICAL LTD. ENVOY Patient Monitor with an EtCO2 module. It outlines the device's description, indications for use, and a summary of its validation, focusing on substantial equivalence to predicate devices rather than detailed acceptance criteria against specific performance metrics for the EtCO2 module itself. Therefore, much of the requested information about acceptance criteria and a specific study proving the device meets them directly is not present in the provided text.
Based on the information available:
Acceptance Criteria and Reported Device Performance
The document does not provide a table of quantitative acceptance criteria for the EtCO2 module's performance (e.g., accuracy, precision) or specific reported performance values against such criteria. Instead, it focuses on functional substantial equivalence to predicate devices and general safety and effectiveness based on design and software validation.
The "Displayed Parameter Message" and "Alarm Indication" table suggests functional equivalence for displaying and alarming on various EtCO2 related parameters between the ENVOY and the MERCURY, but these are not performance metrics.
| Displayed Parameter Message | Alarm Indication | Mennen Medical ENVOY Patient Monitor | Mennen Medical MERCURY Patient Monitor |
|---|---|---|---|
| etCO2 | Yes | Yes | Yes |
| Respiration Rate | Yes | Yes | Yes |
| inCO2 | Yes | Yes | Yes |
| Apnea Information | Yes | Yes | Yes |
| EtCO2 Alarm Limits | Yes | Yes | Yes |
| Display Units | Yes | Yes | Yes |
| Display Labels | Yes | Yes | Yes |
| Sweep Speed | N/A | Yes | Yes |
| Grid | N/A | Yes | Yes |
The document states that the ENVOY EtCO2 was "tested against Mennen Medical's Design Specifications," and "Simulated inputs were used to test the vital signs monitored by the ENVOY." It also mentions testing "against voluntary industrial standards where appropriate, and Mennen Medical design standards where appropriate, or where industrial standards did not exist." However, the specific quantitative acceptance criteria and the numerical results of these tests for EtCO2 performance are not provided.
Study Information
The document describes a validation study, but it lacks the detail typically found in a clinical or performance study report.
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Sample size used for the test set and the data provenance:
- Test Set Size: Not explicitly stated. The validation used "simulated inputs" and "defined gas concentrations of CO2" for the EtCO2 module. This suggests a laboratory-based test with various CO2 concentrations rather than a patient-based test set, and therefore, typical "patient sample size" is not applicable in the usual sense.
- Data Provenance: The testing was done internally by Mennen Medical. The nature of "simulated inputs" and "defined gas concentrations of CO2" indicates lab data rather than retrospective or prospective patient data from a specific country.
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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. The ground truth for the "simulated conditions" was "defined gas concentrations of CO2," which would be established by the precise calibration of the gas mixing equipment, not by clinical experts.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no expert review or clinical adjudication is described for establishing ground truth in this type of simulation-based testing.
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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 patient monitor, not an AI-assisted diagnostic tool requiring human reader interpretation, nor does it describe human-in-the-loop performance improvement.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the validation described appears to be a standalone performance assessment of the EtCO2 module against simulated inputs and design specifications. The focus is on the device's ability to accurately measure and display EtCO2 levels.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): "Defined gas concentrations of CO2" for software validation. This is a controlled, objective physical ground truth established by calibrated equipment.
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The sample size for the training set: Not applicable. This document describes a traditional medical device validation using engineering and software testing, not a machine learning or AI algorithm that requires a training set.
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How the ground truth for the training set was established: Not applicable, as there is no training set for this device's validation as described.
§ 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).