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.

Device Description

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.

AI/ML Overview

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.

Summary

{0}------------------------------------------------

DEC 0 3 2002

Image /page/0/Picture/1 description: The image shows the text "Food and Drug Administration". The text is in a simple, sans-serif font and is left-aligned. The text is likely a heading or title, possibly indicating the source or subject of a document or website.

ENVOY Patient Monitor – Device Modification: Special 510(k) for new 12L ECG/Telemetry module

Image /page/0/Picture/3 description: The image shows the logo for "mennenmedical". The logo consists of a lowercase "m" inside of a black circle on the top left. The word "mennen" is in bold font, and the word "medical" is in a regular font.

Mennen Medical Ltd., 4 Hayarden Street, Yavne PO Box 102, Rehovot 76100 Israel

Page 1 of

Tel.: +972-8-9323333 Fax: +972-8-9328510

Date:

2002

Topic: 510(k) Safety and Effectiveness Summary as per 21 CFR Section 807.92(c) Envoy Patient Monitor - Device Modification: Special 510k for new ECG/Telemetry module

Establishment Name, Registration Number and Address:

Name:	Mennen Medical Ltd.
Registration Number	9611022
Operator Number:	9011766
Address:	4 Hayarden Street, Yavne, 81228, Israel
Postal Address:	PO Box 102,Rehovot, 76100, Israel
Tel:	+972-8-9323333
Fax:	+972-8-9328510
Contact person:	Asher Kassel, Director of Regulatory Affairs
To:	Food and Drug AdministrationCenter for Devices and Radiological HealthDocument Mail Center (HFZ-401)9200 Corporate BoulevardRockville MD, 20850
Attn.:	Document Control Clerk
From:	Asher Kassel, Director of Regulatory Affairs
Product Name:
Proprietary:	ENVOY
Common:	Physiological Patient Monitor
Mennen Medical Part Number:	550-010-000 (full system)554-000-010 (CPU only)
12L ECG/Telemetry module (receiver):	P/N: 551-119-000
12L ECG/Telemetry module (transmitter):	P/N: 551-119-100

{1}------------------------------------------------

FDA Classification of Envoy Patient Monitor:

Classification Name:	Arrhythmia Detector and Alarm
Classification Number:	21 CFR 870.1025
Classification:	Class III
Product Code:	74 DSI

FDA Classification of ECG/Telemetry Module:

Classification Name:	Arrhythmia detector and alarm
Classification Number:	21 CFR 870.1025
Classification:	Class III
Product Code:	DSI

Performance Standards:

None promulgated

Voluntary Standards:

.
IEC 60601-1: Medical Electrical Equipment General Requirements for Safety
IEC 60601-1-2: General Requirements for Safety. Collateral Standard: Electromagnetic . compatibility - Requirements and tests
IEC 60601-2-27: Safety of Electrocardiographic monitoring .
AAMI/ANSI ES1: Safe Current Limits for Electromedical Apparatus, and ●
AAMI/ANSI EC13: Cardiac Monitors, Heart Rate Meters and Alarms. .

Predicate Device:

MENNEN MEDICAL ENVOY PATIENT MONITOR (K011784).

Device Description - Envoy Patient Monitor:

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

{2}------------------------------------------------

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.

Functional Description and intended use of of the ECG/Telemetry module:

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.

{3}------------------------------------------------

This application is typical to Cardiology Step Down units and to post Open Heart Surgery units, where the patient is connected to a multi parameter monitor at the first stage of hospitalization, and as his condition improves, he is encouraged to be ambulatory with only ECG monitoring by telemetry

ENVOY Intended Use:

Food and Drug Administration

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 ●

{4}------------------------------------------------

Summary of the technological characteristics of the new ECG/Telemetry module (OEM Mortara technology):

The following tables summarize data on the Mennen Medical Envoy 12L ECG/Telemetry module (modified device):

Envoy12 L ECG/Telemetry module
Part Number:	551-119-000 (module with receiver)551-119-100 (transmitter)
MonitoredParameters:	• ECG• Heart Rte
Module size:	Single slotHeight: 10.0cm (4.0 in)Width: 4.0 cm (1.6 in)Depth: 14.0 cm (5.5 in)

Features	Envoy 12L ECG/Telemetry module
Monitored Leads	Single block 10 lead (12L)
Sampling Rate and Resolution	500 Hz sampling rate20 bit resolution
Frequency Response -analog output	Diagnostic: 0.05 to 150 HzMonitor: 0.5 to 40 HzExercise: 1.0 to 25 Hz
Input Impedance	47 megohoms
Baseline Recovery	within 3 sec, 1 sec after lead switch
Input Dynamic Range	700 mv.
Electrode offset tolerance	Electrode offset tolerance
Pacemaker Detection andRejection	10,000 s/sec/channel used for pacemaker artifact detection
Patient Isolation	Transmitter is battery operated (internally powered) andfully isolated
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 height70 to 120 milliseconds width

{5}------------------------------------------------

Features	Envoy 12L ECG/Telemetry module
Leads analyzed for	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
Defib. Pulse Protection	Defibrillator protected when used with OEM patient cable
Degree of protection againstelectrical shock	Transmitter is Type CF

Alarm Indications:	Envoy 12L ECG/Telemetry module
ECG	Visual & Sound
Heart Rate	Visual & Sound
Display Functions	Envoy 12L ECG/Telemetry module
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

Conclusion of comparison of technological characteristics:

We consider the Envoy ECG/Telemetry module to be substantially equivalent to the Envoy 12 Lead ECG/Resp. module and we submit that any differences between the two modules:

fall within the scope of a Special 510(k) Device Modification and
. do not raise any new issues of safety and effectiveness

{6}------------------------------------------------

Testing

The Envoy 12L ECG/Telemetry 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. Safety testing and EMC testing were performed by an independent testing laboratory to ensure that the device complies to applicable industry and safety standards.

{7}------------------------------------------------

NEWEND OF HARFER & HUMAN SERVICES

Image /page/7/Picture/1 description: The image contains blurry text that is difficult to read. The text appears to be in a sans-serif font. Due to the poor image quality, it is not possible to provide a more detailed description.

Food and Drug Administra 9200 Corporate Boulevare Rockville MD 20850

Mennen Medical Ltd. c/o Mr. Asher Kassel Regulatory Affairs P.O. Box 102 Rehovot 76100 ISRAEL

Re: K023798

Trade Name: The Envoy Regulation Name: Arrhythmia Detector & Alarm Regulation Number: 21 CFR 870.1025 Regulatory Class: Class III (three) Product Code: DSI Dated: November 12, 2002 Received: November 14, 2002

Dear Mr. Kassel:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{8}------------------------------------------------

Page 2 -- Mr. Asher Kassel

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Kaitlin

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{9}------------------------------------------------

INDICATIONS FOR USE

The Envoy is intended for use as a multiparameter monitoring system.

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

Division of Cardiovascular & Respiratory Devices
510(k) Number K023798

Prescription Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 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.