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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, CO, 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.

The Mennen Medical Envoy BIS module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals.

The BIS Index, a processed parameter may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

• The Bispectral Index is a complex technology, intended for use only as an adjunct to clinical judgment and training.
• In addition, the clinical utility, risk/benefit, and application of this device have not undergone full evaluation in the pediatric population.

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 .
• Spirometry ●
• EEG ●
• BIS module (new subject of this application) .

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 vital signs modules interface with readily available physiologic transducers through electrically isolated patient input connections. After amplification, the signals are digitized, analyzed and displayed. All processing and alarm determination for ECG, Respiration and Invasive Blood Pressure is made using proprietary algorithms and software based on previously marketed Mennen Medical monitoring devices tested against well known and accepted data bases that present representative examples of waveform artifact to be encountered in real case conditions. The SpO2, Non-Invasive Blood Pressure, ExCO2 and Spirometry modules incorporate software and/or hardware technology developed by vendors whose products are marketed in the USA.

The BIS Module is used to monitor dual channel EEG waveform and the BIS index, used to estimate the level of conciseness of patient under anesthesia, or patients in the ICU that may be with limited conciseness.

The BIS index together with several quality parameters are displayed and stored by the Envoy monitor.

The Mennen Medical Envoy BIS module is a modification to the existing Envoy Patient Monitor, adding Bispectral Index (BIS) monitoring capabilities. The device claims substantial equivalence to the predicate device, the Spacelab Medical Bispectral Index (BISx) Analysis Module 91482 (K060900).

The provided text outlines the functional description of the new BIS module and its comparison to the predicate device, focusing on display formats, data storage, and alarm functionalities. It also references "performance testing" and "SW Validation" but lacks specific details regarding acceptance criteria and the results of these studies.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly present a table of acceptance criteria with corresponding reported device performance values. Instead, it relies on demonstrating substantial equivalence by comparing the functional and technical specifications of the Envoy BIS module with the predicate device. The primary claim for acceptance is that the Envoy BIS module's function to display BIS parameters and quality parameters, and its alarm capabilities, are equivalent to the predicate device.

The document highlights the following parameters and their ranges as displayed and stored by the Envoy monitor, which are derived from the BISx unit:

The "Similarities" and "Differences" sections (Page 9) act as an indirect comparison of performance criteria, stating that differences in display options between the two devices "do not change the efficiency of BIS and EEG displays of both monitors," implying an equivalence in performance.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide details on the sample size used for any specific test set related to the BIS module. There is no mention of human subject data, country of origin, or whether it was retrospective or prospective. The testing described primarily appears to be technical validation against the predicate device's performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

No information is provided regarding the number or qualifications of experts used to establish ground truth for any test set. The validation primarily focuses on comparing technical specifications and functional equivalence.

4. Adjudication Method for the Test Set

No information on an adjudication method for a test set is provided.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study is mentioned, nor is any effect size for human reader improvement with or without AI assistance. The device is a patient monitor, not an AI diagnostic tool involving human reader interpretation. The BIS module aids in monitoring the effects of anesthetic agents to help guide administration and potentially reduce awareness with recall, but this is a clinical utility, not a reader study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The BIS module itself processes EEG signals to generate the BIS index and related parameters. This processing can be considered "standalone" in the sense that the algorithm generates these outputs without direct human intervention in the calculation process. The device functions to "display the BIS parameter and the quality parameters" and to "provide alarm limits for the BIS index and provide visual and audible alarms." These outputs are generated by the device's algorithms based on the input from the BISx unit. However, the context of the question often implies a comparison to a clinical ground truth, which is not detailed here.

7. The Type of Ground Truth Used

The "ground truth" implicitly used in this submission is the established performance and output of the predicate device, the Spacelab Bispectral Index (BISx) Analysis Module 91482. The entire submission is built on demonstrating substantial equivalence to this legally marketed device. The "Substantial Equivalence Discussion" (Page 5) directly compares the Envoy BIS module's specifications and functionality to the predicate.

8. The Sample Size for the Training Set

No information is provided regarding a training set sample size. The device is not described as utilizing machine learning or AI that would typically involve a training set for model development. Its function appears to be based on established algorithms for processing EEG signals and deriving the BIS index, which are derived from the OEM (Aspect BISx).

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned for the Envoy BIS module itself, there is no information on how its ground truth was established. The core processing capabilities for the BIS index are derived from the Aspect BISx unit (OEM agreement), suggesting that any fundamental ground truth for the BIS algorithm would have been established during the development and clearance of the original BISx device (K040183 and subsequently K060900 for the predicate).

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