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

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.

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.

AI/ML Overview

{
  "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": "<30 microVp-p (ANSI/AAMI EC13, para.3.2.9.3)",
        "Device Performance": "The same"
      }
    },
    "RESPIRATION": {
      "Monitored Leads": {
        "Acceptance Criteria": "RA-LA (transthorac) or RA-LL (transabdominal)",
        "Device Performance": "The same"
      },
      "Frequency Response": {
        "Acceptance Criteria": "0.13 to 2.5 Hz (-3 dB)",
        "Device Performance": "The same"
      },
      "Impedance Range": {
        "Acceptance Criteria": "100 to 3000 ohm @ 100 kHz",
        "Device Performance": "100 to 1500 ohm @ 65 kHz"
      },
      "Respiration Sensitivity Range": {
        "Acceptance Criteria": "0.2 ohm to 5.0 ohm",
        "Device Performance": "The same"
      },
      "Respiration Rate Counting Range": {
        "Acceptance Criteria": "8 to 150 BPM",
        "Device Performance": "8 to 120 BPM"
      },
      "Overload Recovery Time": {
        "Acceptance Criteria": "typically 1 sec, max 10 sec",
        "Device Performance": "The same"
      },
      "Lead Fault Sense": {
        "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."
}

Summary

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

Food and Drug Administration

K011784

17 July, 2001

Food and Eagle
ENVOY Patient Monitor - Device Modification: Special 510 (k) for 12 Lead ECG/Resp. module

AUG 1 6 2001

MENNEN MEDICAL LTD.

Kiryat Weizmann Science Park P.O.B. 102 Rehovot 76100 Israel Tel: 972-8-9383030 Fax: 972-8-9406519

Date prepared: 17th July, 2001

Topic: 510(k) Safety and Effectiveness Summary as per 21 CFR Section 807.92 Special 510k Device Modification (K011784): Envoy Patient Monitor - 12Lead ECG/Resp. Module

Establishment Name, Registration Number and Address

Name:	Mennen Medical Ltd.
Registration Number:	9611022
Operator Number:	9011766
Address:	Kiryat Weizmann Science Park
	Rehovot 76100 Israel
	Tel: 972-8-938-3030
	Fax: 972-8-940-6519

Contact person:

Asher Kassel, Director of Regulatory Affairs

Food and Drug Administration To: Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville MD, 20850

Document Control Clerk Attn.: Asher Kassel, Director of Regulatory Affairs From:

Product Name

ENVOY Proprietary: Physiological Patient Monitor Common: 550-010-000 (full system) Mennen Medical Part Number: 554-000-010 (CPU only)

FDA Classification

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

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

KO11784

Food and Drug Administration

17 July, 2001

ENVOY Patient Monitor - Device Modification: Special 510 (k) for 12 Lead ECG/Resp. module

Performance Standards

None promulgated

Voluntary Standards

UL 2601-1, IEC 60601-1 for electrical safety for medical equipment AAMI/ EC 11 - Diagnostic electrocardiograph devices (1991) AAMI/ EC 13 - Cardiac monitors, heart-rate meters, alarms (1992) AAMI/ ES 1 - Safe current limits for electromedical apparatus (1993) IEC 60601-1: General Requirement for Safety for Medical Electrical Systems - part 1, (1988); Amendment 1 - 1991-11 Amendment 2 - 1995-03 IEC 60602-2-27: Medical electrical equipment, Part 2, (1994) Requirements for safety of electrocardiograph monitoring equipment.

Predicate Device

MENNEN MEDICAL ENVOY PATIENT MONITOR (K001120).

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}------------------------------------------------

ENVOY Patient Monitor - Device Modification: Special 510 (k) for 12 Lead ECG/Resp. module

ENVOY complies with IEC 601-1 Medical Electrical Equipment, IEC 601-2-27 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.

Functional Description of the Envoy 12Lead ECG/Resp. module

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.

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.

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

ENVOY Patient Monitor - Device Modification: Special 510 (k) for 12 Lead ECG/Resp. module

ENVOY Intended Use:

ENVOY is intended for use as a multiparameter physiological patient 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 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}------------------------------------------------

ENVOY Patient Monitor -- Device Modification: Special 510 (k) for 12 Lead ECG/Resp. module

Substantial Equivalency Information:

The following tables summarize and compare data on the Mennen Medical ENVOY 3/5/6 Lead ECG/Resp. module (predicate device - K001120) to the subject of this Special 510(k) submittal, the ENVOY 12 Lead ECG/Resp. module (modified device). We submit that the ENVOY 12 Lead ECG/Resp. module (modified device) is substantially equivalent to the Mennen Medical ENVOY 3/5/6 Lead ECG/Resp. module (predicate device - K001120), available in the U.S. market.

SE Comparison: 12 Lead ECG/Resp. module vs 3/5/6 Lead ECG/Resp. module

MonitoredParametersECG/HEART RATE	ENVOY3/5/6 Lead ECG/Resp. module	ENVOY12 Lead ECG/Resp. module
Part/Option Number	551-104-000	C51-112-000
Monitored Leads	Multi-lead ECG Module(3 /5/6-leads)	Multi-lead ECG Module(3/5/6/12 leads) -No Substantial Difference
Sampling Rate andResolution	641 Hz sampling rate22 bit resolution	the same
Frequency Response -analog output	Diagnostic: 0.05 to 150 HzMonitor: 0.5 to 40 HzExercise: 1.0 to 25 HzAccording to ANSI/AAMI EC11(10)para.3.2.7.2	the same
Input Impedance	20M ohm: typical5M ohm: differential, dc to 10Hz2.5M ohm: differential 10 to 100 Hzas per ANSI/AAMI EC13(9)para.3.2.9.2	the same
Common ModeRejection (CMR)	120 dB, minimumLead Fault Detection based onimpedance	the same
Baseline Recovery	within 3 sec,1 sec after lead switch	the same
MonitoredParametersECG/HEART RATE	ENVOY3/5/6 Lead ECG/Resp. module	ENVOY12 Lead ECG/Resp. module
Gain Levels	250 - 8000	the same
Pacemaker Detectionand Rejection	Amplitude: 2 mV to 700 mVWidth: 0.1 ms to 2.0 ms as perANSI/AAMI EC13(9) para.3.1.4Pacemaker flag inserted intodisplayed waveform	the same
Patient Isolation	Meets ANSI/AAMI ESI-1985standard for Safe Current Limits forElectromedical Apparatus(5kV dc, 2.5kV AC	the same
Heart Rate (HR)Counting	20 to 300 BPM	the same
HR Accuracy	$\pm$ 2 BPM. Values below 20 arerecorded as zero	the same
QRS Detection Range	0.25 to 5.0 millivolt height70 to 120 milliseconds width	the same
Leads analyzed for:	Heart Rate and ArrhythmiaConfigurationTop two displayed	the same
HR Alarm Settings	20 (low) to 250 (high),non-overlapping	the same
Lead Fault Sense	when ECG electrode is interruptedor becomes marginal	the same
Defib. Pulse Protection	5KV as per ANSI/AAMI EC13 (9),clause 3.2.2.2 and per IEC 601-2-27(12), clause 17,101 and 102	the same
Degree of protectionagainst electrical shock	Type CF	the same
MonitoredParametersECG/HEART RATE	ENVOY3/5/6 Lead ECG/Resp. module	ENVOY12 Lead ECG/Resp. module
ElectrosurgicalInterferenceSuppression Provided	Yes	the same

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

K011784

Food and Drug Administration

ENVOY ENVOY Monitored 12 Lead ECG/Resp. module 3/5/6 Lead ECG/Resp. module Parameters ECG/HEART RATE the same differential voltage of up to ± 5mv at Dynamic Range a rate up to ±320 mV/sec as per ANSI/AAMI EC13(9), para. 3.2.9.1 <30 microVp-p ANSI/AAMI EC13(9) the same Noise para.3.2.9.3

ENVOY Patient Monitor - Device Modification: Special 510 (k) for 12 Lead ECG/Resp. module

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Image /page/6/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically "KO11784". The characters are written in a clear, sans-serif font, and they appear to be handwritten. The image is a close-up shot, focusing solely on the characters without any background elements.

Food and Drug Administration

ENVOY Patient Monitor – Device Modification: Special 510 (k) for 12 Lead ECG/Resp. module

MonitoredParametersRESPIRATION	ENVOY3/5/6 Lead ECG/Resp. module	ENVOY12 Lead ECG/Resp. module
Part/Option Number	551-104-000	C51-112-000
Lead Selection	RA-LA (transthorac) or RA-LL(transabdominal)	the same
Frequency Response	0.13 to 2.5 Hz (-3 dB)	the same
Impedance Range	100 to 3000 ohm @ 100 kHz	100 to 1500 ohm @ 65 kHz -No Substantial Difference
Respiration SensitivityRange	0.2 ohm to 5.0 ohm	the same
Respiration RateCounting Range	8 to 150 BPM	8 to 120 BPM -No Substantial Difference
Overload RecoveryTime	typically 1 sec,max 10 sec	the same
Lead Fault Sense	>3K ohm	the same
Manual threshold mode	0.2 ohm/1000 ohm (0.02%) to 5ohm/1000 ohm (0.5%) at 20 BPM	0.2 ohm/1500 ohm (0.013%) to 5ohm/1000 ohm (0.33%) at 20 BPM
Automatic Threshold	0.35 ohm/1000 ohm (0.035%) to 5ohm/1000 ohm (0.5%) at 20 BPM	the same
Alarm Settings	Low rate: 0 - 150 BPMHigh: rate: 8 - 150 BPM	Low rate: 0 - 120 BPMHigh: rate: 8 - 120 BPM -No Substantial Difference
Apnea Alarm Delay	10 - 90 sec, selectable(default 10 sec.)	10 - 90 sec, selectable(default 10 sec.) -the same
Apnea Alarm Reset	Automatic as defined by Systemadministrator (default 3 breaths)	the same

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

Food and Drug Administration

ENVOY Patient Monitor – Device Modification: Special 510 (k) for 12 Lead ECG/Resp. module

DisplayedParameters	ENVOY3/5/6 Lead ECG/Resp. module	ENVOY12 Lead ECG/Resp. module
ECG	Yes	Yes
Heart Rate	Yes	Yes
Respiration	Yes	Yes

Alarm Indications:	ENVOY3/5/6 Lead ECG/Resp. module	ENVOY12 Lead ECG/Resp. module
ECG	Visual & Sound	Visual & Sound
Heart Rate	Visual & Sound	Visual & Sound
Respiration	Visual & Sound	Visual & Sound

DisplayFunctions	ENVOY3/5/6 Lead ECG/Resp. module	ENVOY12 Lead ECG/Resp. module
Change ECG LeadSelection	YES	YES
Display of ArrhythmiaInformation	YES	YES
Data Review: Trends	YES	YES
Data Review: Tabular	YES	YES
User definedConfiguration Setup	YES	YES
User defined DefaultSettings	YES	YES

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

K011784

Food and Drug Administration

17 July, 2001

ENVOY Patient Monitor -- Device Modification: Special 510 (k) for 12 Lead ECG/Resp. module

Conclusion of comparison of Technological characteristics:

We consider the 12 Lead ECG/Resp. module to be substantially equivalent to the 3/5/6 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 *do not raise any new issues of safety and effectiveness

Testing

The 12 Lead ECG/Resp. module of the Envoy patient monitor 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. The 12 Lead ECG/Resp. module of the Envoy patient monitor has also been clinically tested and evaluated in a local hospital.

Signature:

A. Kassel

Asher Kassel Director of Regulatory Affairs MENNEN MEDICAL LTD.

972-8-9383011 Tel: 972-8-9406519, or Fax: E-mail: asher@mmi.co.il

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

Image /page/9/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 6 2001

Mr. Asher Kassel Mennen Medical Ltd. Kiryat Weizmann Science Park P.O.B. 102 Rehovot 76100 ISRAEL

Re: K011784

Trade Name: Envoy Patient Monitor, 12 Lead ECG/Resp. Module Regulatory Number: 21 CFR 870.1025 Regulatory Class: III (three) Product Code: 74 DSI Dated: July 17, 2001 Received: July 19, 2001

Dear Mr. Kassel:

We have reviewed your Section 510(k) notification of intent to market the device referenced we nave 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 stated in the onerosare, to regarry ent date of the Medical Device Amendments, or to devices that provision in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (100). Tot may) attresses, sontols provisions of the Act include requirements for annual provisions of the Frea - 11tes, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remarket rippt of ally wills) will be code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspottonist the GMP regulation may result in regulatory action. In addition, FDA may publish

{10}------------------------------------------------

Page 2 - Mr. Asher Kassel

further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 yours,

James E. Dillard III

Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{11}------------------------------------------------

Food and Drug Administration

K011784

7 June, 2001

ENVOY Patient Monitor – Device Modification: Special 510 (k) for 12 Lead ECG/Resp. module

INDICATIONS FOR USE

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 The ENVOT our monitor oximetry, respiration, non-invasive blood pressure and temporature offectively 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

Dale Till
Division of Cardiovascular & Respiratory Devices
510(k) Number K011784

Prescription Use - $\checkmark$

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.