(19 days)
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.
| Acceptance Criteria (Specification) | Reported Device Performance (Implied by testing) |
|---|---|
| Module Specifications | |
| Monitored Parameters | ECG, Heart Rate |
| Sampling Rate and Resolution | 500 Hz sampling rate, 20 bit resolution |
| Frequency Response (Diagnostic) | 0.05 to 150 Hz |
| Frequency Response (Monitor) | 0.5 to 40 Hz |
| Frequency Response (Exercise) | 1.0 to 25 Hz |
| Input Impedance | 47 megohms |
| Baseline Recovery | within 3 sec, 1 sec after lead switch |
| Input Dynamic Range | 700 mv. |
| Electrode offset tolerance | Electrode offset tolerance (value not specified, but device designed to tolerate it) |
| Pacemaker Detection and Rejection | 10,000 s/sec/channel used for pacemaker artifact detection |
| Heart Rate (HR) Counting | 20 to 300 BPM |
| HR Accuracy | ± 2 BPM. Values below 20 are recorded as zero |
| QRS Detection Range | 0.25 to 5.0 millivolt height, 70 to 120 milliseconds width |
| Leads analyzed for HR and Arrhythmia Configuration | Heart Rate and Arrhythmia Configuration; Top two displayed |
| HR Alarm Settings | 20 (Low) to 350 (High), non-overlapping |
| Lead Fault Sense | When ECG electrode is interrupted or becomes marginal |
| Defibrillation Pulse Protection | Defibrillator protected when used with OEM patient cable |
| Degree of protection against electrical shock | Transmitter is Type CF (fully isolated) |
| Alarm Indications | |
| ECG Alarm | Visual & Sound |
| Heart Rate Alarm | Visual & Sound |
| Display Functions | |
| Change ECG Lead Selection | Yes |
| Display of Arrhythmia Information | Yes |
| Data Review: Trends | Yes |
| Data Review: Tabular | Yes |
| User defined Configuration Setup | Yes |
| User defined Default Settings | Yes |
| Safety and EMC Standards Compliance | Compliance to applicable industry and safety standards (implied by independent testing laboratory verification) |
| IEC 60601-1, IEC 60601-1-2, IEC 60601-2-27, AAMI/ANSI ES1, AAMI/ANSI EC13 | Compliant (implied by independent testing laboratory verification) |
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.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.