Search Results

The Envoy is intended for use as a multiparameter physiological patient 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 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 remote monitoring and recording patient information or any in-hospital application requiring remote 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 sale of and use of the Envoy is restricted to qualified medical personnel only.

The 12L ECG telemetry module can be used instead of the regular ECG module to monitor the ECG of patients whose condition enables them to be mobile. ECG is monitored by attaching electrodes to the patient's chest and by connecting the electrodes via a cable to the ECG module in the patient monitor. A 10-wire cable enables ECG monitoring via 12 ECG leads, while a 5-wire cable enables the display of 7 ECG leads. The ECG signal is used to detect the QRS complex, and for the detection and alarm of Heart Rate, Arrhythmia and ST changes. The ECG telemetry does away with the need to connect the patient cable to the bedside monitor: instead, the patient cable is connected to a lightweight transmitter (240 gram) carried by the patient. This enables the patient to move around freely while being monitored by the Envoy patient monitor. The telemetry operating range is 15 meters (with no barrier) from the receiver. For a longer operating distance, you need to add an optional Antenna network. The Telemetry system can use up to 256 channels working in parallel. Each telemetry transmitter is coupled to one telemetry receiver. The telemetry receiver is located in a ECG Telemetry module connected to the Envoy module rack. The single width ECG Telemetry module is intended to be used to monitor 12 lead ECG for patients monitored by the bedside Envoy monitor. Telemetry monitoring is used when the condition of the patient enables him/her to move around.

Here's an analysis of the provided text regarding the Envoy Patient Monitor and its new 12L ECG/Telemetry module, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device. While it mentions "extensive safety and performance testing," it does not provide detailed quantitative acceptance criteria or specific study results showing the device meets those criteria, especially in a clinical performance context. The document primarily lists performance specifications and states that testing was performed to ensure compliance. Therefore, many sections of your request, particularly those related to clinical study design, will be answered with "Not explicitly stated" or "Not applicable" based on the limited information provided in this regulatory submission.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance specifications, which can be interpreted as the acceptance criteria that the device was designed to meet. The "reported device performance" is implied to meet these specifications as per the testing mentioned.

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

• Sample size used for the test set: Not explicitly stated in the provided document. The document mentions "various performance tests" and "Final testing for the system," but no specific patient or data sample sizes are given.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not explicitly stated. The manufacturer is based in Israel, so some testing may have occurred there, but this is not confirmed for a "test set." The nature of the testing described (performance, safety, EMC) suggests laboratory-based rather than clinical, patient-derived data directly.

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

Not applicable. The document describes engineering and safety testing against defined specifications and voluntary standards, not a clinical study involving expert interpretation of medical images or signals to establish a "ground truth."

4. Adjudication Method for the Test Set

Not applicable. As this was not a clinical study requiring expert consensus or adjudication on medical findings, no such method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This document does not describe a clinical study comparing human reader performance with or without AI assistance. The device is a physiological monitor, not an AI diagnostic tool that requires human interpretation.

6. Standalone (Algorithm Only) Performance Study

Not explicitly described as a separate study with specific metrics. The "performance tests" mentioned are for the device as a whole, including its algorithms for ECG/HR and arrhythmia detection, but a dedicated "standalone" study demonstrating algorithm performance in isolation from the hardware and complete system is not detailed. The listed specifications for HR accuracy and QRS detection range imply algorithmic performance metrics.

7. Type of Ground Truth Used

The "ground truth" for the performance specifications would be established by:

• Engineering measurements against known electrical signals (for parameters like frequency response, input impedance, QRS detection range, HR accuracy).
• Compliance testing against the requirements of cited industry standards (IEC, AAMI/ANSI).
• Controlled scenarios for safety (e.g., defibrillation pulse protection) and EMC (electromagnetic compatibility) testing.

These are not "expert consensus," "pathology," or "outcomes data" in the traditional clinical sense, but rather defined engineering and regulatory test conditions.

8. Sample Size for the Training Set

Not applicable. This device is a physiological monitor, not a machine learning or AI algorithm that relies on a "training set" of data in the way, for example, an image analysis AI would. Its functionality is based on established signal processing principles and hardware design.

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

Not applicable, as there is no "training set" for this type of device.

Ask a specific question about this device

ENVOY is intended for use as a multiparameter physiological patient 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.

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 and EtCO2 Modules incorporate software and/or hardware technology developed by vendors whose products are marketed in the USA.

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.

Operation of the ENVOY 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.

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.

ENVOY complies with IEC 601-1 Medical Electrical Equipment, IEC 601-2-2-27 Safety of Electrocardiographic monitoring, IEC 601-2-30 Requirements for Automatic Cycling Indirect Blood Pressure monitoring, AAMI/ANSI SP-10/A1 Electronic or Automated Sphygmomanometers, IEC 601-2-34 Requirements for Invasive Blood Pressure monitoring, AAMI/ANSI ES1 Safe Current Limits for Electromedical Apparatus, and AAMVANSI EC13, Cardiac Monitors, Heart Rate Meters and Alarms. ENVOY is not a kit, does not contain any drug or biological products and is not for prescription use.

The ECG/Resp. module is the source of all ECG data in the Envoy bedside monitor. ECG is measured using a multi-lead cable via electrodes attached to the patient's chest.

Monitoring the ECG produces a continuous waveform of cardiac electrical activity to enable an accurate assessment of a patient's current physiological condition. With the ECG module, you can use a 3, 5 6 or 10 lead electrode ECG cable set to display up to 12 selectable ECG leads in up to three channels.

The 12 Lead ECG/Resp. module is housed in the Envoy module rack, where it occupies a single slot. It includes ECG and respiration monitoring.

{
  "1. A table of acceptance criteria and the reported device performance": {
    "ECG/HEART RATE": {
      "Monitored Leads": {
        "Acceptance Criteria": "Same as predicate (3/5/6-leads)",
        "Device Performance": "3/5/6/12 leads"
      },
      "Sampling Rate and Resolution": {
        "Acceptance Criteria": "641 Hz sampling rate, 22 bit resolution",
        "Device Performance": "The same"
      },
      "Frequency Response - analog output": {
        "Acceptance Criteria": "Diagnostic: 0.05 to 150 Hz; Monitor: 0.5 to 40 Hz; Exercise: 1.0 to 25 Hz (According to ANSI/AAMI EC11 para.3.2.7.2)",
        "Device Performance": "The same"
      },
      "Input Impedance": {
        "Acceptance Criteria": "20M ohm typical; 5M ohm differential, dc to 10Hz; 2.5M ohm differential 10 to 100 Hz (as per ANSI/AAMI EC13 para.3.2.9.2)",
        "Device Performance": "The same"
      },
      "Common Mode Rejection (CMR)": {
        "Acceptance Criteria": "120 dB, minimum; Lead Fault Detection based on impedance",
        "Device Performance": "The same"
      },
      "Baseline Recovery": {
        "Acceptance Criteria": "within 3 sec, 1 sec after lead switch",
        "Device Performance": "The same"
      },
      "Gain Levels": {
        "Acceptance Criteria": "250 - 8000",
        "Device Performance": "The same"
      },
      "Pacemaker Detection and Rejection": {
        "Acceptance Criteria": "Amplitude: 2 mV to 700 mV; Width: 0.1 ms to 2.0 ms (as per ANSI/AAMI EC13 para.3.1.4); Pacemaker flag inserted into displayed waveform",
        "Device Performance": "The same"
      },
      "Patient Isolation": {
        "Acceptance Criteria": "Meets ANSI/AAMI ESI-1985 standard for Safe Current Limits for Electromedical Apparatus (5kV dc, 2.5kV AC)",
        "Device Performance": "The same"
      },
      "Heart Rate (HR) Counting": {
        "Acceptance Criteria": "20 to 300 BPM",
        "Device Performance": "The same"
      },
      "HR Accuracy": {
        "Acceptance Criteria": "± 2 BPM. Values below 20 are recorded as zero",
        "Device Performance": "The same"
      },
      "QRS Detection Range": {
        "Acceptance Criteria": "0.25 to 5.0 millivolt height; 70 to 120 milliseconds width",
        "Device Performance": "The same"
      },
      "Leads analyzed for: Hear Rate and Arrhythmia Configuration": {
        "Acceptance Criteria": "Top two displayed",
        "Device Performance": "The same"
      },
      "HR Alarm Settings": {
        "Acceptance Criteria": "20 (low) to 250 (high), non-overlapping",
        "Device Performance": "The same"
      },
      "Lead Fault Sense": {
        "Acceptance Criteria": "when ECG electrode is interrupted or becomes marginal",
        "Device Performance": "The same"
      },
      "Defib. Pulse Protection": {
        "Acceptance Criteria": "5KV (as per ANSI/AAMI EC13, clause 3.2.2.2 and per IEC 601-2-27, clause 17,101 and 102)",
        "Device Performance": "The same"
      },
      "Degree of protection against electrical shock": {
        "Acceptance Criteria": "Type CF",
        "Device Performance": "The same"
      },
      "Electrosurgical Interference Suppression Provided": {
        "Acceptance Criteria": "Yes",
        "Device Performance": "The same"
      },
      "Dynamic Range": {
        "Acceptance Criteria": "differential voltage of up to ± 5mv at a rate up to ±320 mV/sec (as per ANSI/AAMI EC13, para. 3.2.9.1)",
        "Device Performance": "The same"
      },
      "Noise": {
        "Acceptance Criteria": "3K ohm",
        "Device Performance": "The same"
      },
      "Manual Threshold Mode": {
        "Acceptance Criteria": "0.2 ohm/1000 ohm (0.02%) to 5 ohm/1000 ohm (0.5%) at 20 BPM",
        "Device Performance": "0.2 ohm/1500 ohm (0.013%) to 5 ohm/1000 ohm (0.33%) at 20 BPM"
      },
      "Automatic Threshold": {
        "Acceptance Criteria": "0.35 ohm/1000 ohm (0.035%) to 5 ohm/1000 ohm (0.5%) at 20 BPM",
        "Device Performance": "The same"
      },
      "Alarm Settings": {
        "Acceptance Criteria": "Low rate: 0 - 150 BPM; High rate: 8 - 150 BPM",
        "Device Performance": "Low rate: 0 - 120 BPM; High rate: 8 - 120 BPM"
      },
      "Apnea Alarm Delay": {
        "Acceptance Criteria": "10 - 90 sec, selectable (default 10 sec.)",
        "Device Performance": "The same"
      },
      "Apnea Alarm Reset": {
        "Acceptance Criteria": "Automatic as defined by System administrator (default 3 breaths)",
        "Device Performance": "The same"
      }
    },
    "DISPLAYED PARAMETERS": {
      "ECG": {
        "Acceptance Criteria": "Yes",
        "Device Performance": "Yes"
      },
      "Heart Rate": {
        "Acceptance Criteria": "Yes",
        "Device Performance": "Yes"
      },
      "Respiration": {
        "Acceptance Criteria": "Yes",
        "Device Performance": "Yes"
      }
    },
    "ALARM INDICATIONS": {
      "ECG": {
        "Acceptance Criteria": "Visual & Sound",
        "Device Performance": "Visual & Sound"
      },
      "Heart Rate": {
        "Acceptance Criteria": "Visual & Sound",
        "Device Performance": "Visual & Sound"
      },
      "Respiration": {
        "Acceptance Criteria": "Visual & Sound",
        "Device Performance": "Visual & Sound"
      }
    },
    "DISPLAY FUNCTIONS": {
      "Change ECG Lead Selection": {
        "Acceptance Criteria": "YES",
        "Device Performance": "YES"
      },
      "Display of Arrhythmia Information": {
        "Acceptance Criteria": "YES",
        "Device Performance": "YES"
      },
      "Data Review: Trends": {
        "Acceptance Criteria": "YES",
        "Device Performance": "YES"
      },
      "Data Review: Tabular": {
        "Acceptance Criteria": "YES",
        "Device Performance": "YES"
      },
      "User Defined Configuration Setup": {
        "Acceptance Criteria": "YES",
        "Device Performance": "YES"
      },
      "User Defined Default Settings": {
        "Acceptance Criteria": "YES",
        "Device Performance": "YES"
      }
    }
  },
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The document states that the 12 Lead ECG/Resp. module 'has also been clinically tested and evaluated in a local hospital.' However, it does not specify the sample size of the test set nor the specific country of origin, or if it was retrospective or prospective.",
  "3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "This information is not provided in the document.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "This information is not provided in the document.",
  "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": "No MRMC comparative effectiveness study is mentioned. This device is a patient monitor, 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": "The device's proprietary algorithms for ECG, Respiration, and Invasive Blood Pressure are stated to be '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.' This suggests standalone testing of the algorithms was performed, but specific details of this testing are not provided for the modified device.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "For the algorithms, 'well known and accepted data bases that present representative examples of waveform artifact to be encountered in real case conditions' were used. This implies a ground truth based on established clinical examples and likely expert-validated data, though the exact method is not detailed.",
  "8. The sample size for the training set": "The document does not explicitly mention a training set, but refers to algorithms being 'based on previously marketed Mennen Medical monitoring devices tested against well known and accepted data bases'. The sample size of these databases is not specified.",
  "9. How the ground truth for the training set was established": "The ground truth for the underlying algorithms was established using 'well known and accepted data bases that present representative examples of waveform artifact to be encountered in real case conditions.' The specific methodology for establishing this ground truth (e.g., expert consensus, independent validation) is not detailed for the original databases."
}

Ask a specific question about this device

Ask a specific question about this device