(29 days)
The Envoy is intended for use as a multiparameter monitoring system.
The Envoy can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure and EtCO2. This effectively allows the Envoy to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital.
Functions include display of multiparameter waveforms, vital signs, alarm & status messages.
The Mennen Medical Envoy is intended for sale as a system for monitoring and recording patient information or any in-hospital application requiring patient monitoring.
The following are examples of intended clinical applications:
- Critical Care Patients
- Cardiac Step-down/Telemetry Units
- Emergency Departments
- Intra-operative (Anesthesia) Monitoring
- Post Anesthesia Care
The Envoy is a multiparameter physiological patient monitor, capable of monitoring:
- ECG/Heart Rate
- invasive blood pressure
- non-invasive blood pressure
- respiration
- pulse oximetry
- two temperature channels
- cardiac output
- eTCO2
The Envoy bedside patient monitor consists of a main processing unit, a mountable color monitor, and a module rack housing the various Mennen Medical plug-in vital signs modules. The modules monitor the patient's vital signs. Up to six internal modules can be plugged into a module rack. The Envoy can accommodate two module racks. The vital sign data derived from the modules by the Envoy are presented on the monitor as waveform and numeric displays. The Envoy vital signs modules acquire vital signs data from the patient, and display their waveforms and alarms indications on the Envoy display unit. Vital signs and waveform information are displayed simultaneously on the Envoy Display Unit. Up to 8 traces can be displayed at any one time.
The Envoy is a reusable, software driven, patient monitor, intended for use as part of a physiological monitoring system in a hospital environment. As such it is not a life supporting. nor life sustaining device; nor is it implantable and therefore sterility is not a consideration.
The Envoy is not a kit, does not contain any drug or biological products and is not for prescription use.
The SpO2 module is the source of all pulse oximetry data in the Envoy bedside monitor.
SpO2 is measured to determine a monitored patient's arterial oxygen saturation and pulse rate. Arterial oxygen saturation is the percentage of oxygenated hemoglobin in relation to the total hemoglobin. For example, if 95 percent of the hemoglobin molecules in the arterial red blood cells combine with oxygen, the blood has an oxygen saturation of 95 percent. The Sp02 numeric value represents the percentage of hemoglobin molecules that have combined with oxygen molecules to form oxyhemoglobin.
The SpO2 module is housed in the Envoy module rack, where it occupies a single slot.
The Envoy bedside monitor measures oxygen saturation using the Pulse Oximetry method. This continuous, non-invasive method measures the light absorption in the patient's tissue (for example, a finger of the hand or foot) to a receiver on the other side.
The provided text describes a special 510(k) for a device modification: a new SpO2 module (Masimo) for the ENVOY Patient Monitor. It claims the device meets performance specifications but does not detail a specific study with acceptance criteria in the format requested. However, based on the information provided, we can infer some acceptance criteria and reported performance values.
Here's an attempt to structure the information according to your request, acknowledging the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from reported performance) | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy (Adults) | SpO2 Accuracy: ± 2 digits for 70 % - 100 % SpO2 | 70 % - 100 % ± 2 digits |
| SpO2 Accuracy (Neonates) | SpO2 Accuracy: ± 3 digits for 70 % - 100 % SpO2 | 70 % - 100 % ± 3 digits |
| SpO2 Saturation Range | Saturation range: 1% to 100% SpO2 | 1% to 100% SpO2 |
| Pulse Rate Range | Pulse Rate range: 25 to 240 BPM ± 3 BPM | 25 to 240 BPM ±3 BPM |
| Low Saturation Alarm Limits | Low saturation alarm limits: 50% to 100% | 50% to 100% |
| Features/Functionality | Red & Infrared light Tissues absorption method | Present |
| Waveform display | Present | |
| Pulse rate derived from SpO2 with independent alarm limits | Present | |
| Pulse sound distinct in tone and pitch from QRS tone | Present | |
| Variation in the pulse sound pitch with SpO2 value | Present | |
| Signal strength display | Present | |
| Technical Alarms | "Cable out" and "Relocate probe" | Present |
2. Sample size used for the test set and the data provenance:
The document states, "The Envoy SpO2 Masimo module has been subject to extensive safety and performance testing. Final testing for the system included various performance tests designed to ensure that the device meets all functional requirements and performance specifications."
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified.
4. Adjudication method for the test set:
- Not specified.
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/Not mentioned. This device is a physiological patient monitor module, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The performance specifications listed in the table (SpO2 accuracy, pulse rate accuracy) are inherent to the device's algorithmic performance. The document describes "Final testing for the system included various performance tests designed to ensure that the device meets all functional requirements and performance specifications." This indicates standalone performance testing of the module itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For SpO2 and Pulse Rate accuracy, the ground truth would typically be established using a standardized reference method (e.g., CO-oximetry for SpO2, ECG for pulse rate).
- The document mentions "Red & Infrared light Tissues absorption method" for SpO2 measurement, which is the underlying principle. During testing, an independent, highly accurate reference measurement method would be used to establish ground truth for comparison.
8. The sample size for the training set:
- Not applicable/Not mentioned. This device is a hardware module with embedded algorithms for physiological measurement, not a machine learning model that typically requires a distinct "training set." Its algorithms are based on established physiological principles and signal processing.
9. How the ground truth for the training set was established:
- Not applicable/Not mentioned for the same reasons as point 8. The algorithms are likely developed based on known physiological models and validated through engineering principles and clinical testing, rather than being "trained" on a specific dataset.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).