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, 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.

Device Description

ENVOY EtCO2 is a hospital based module, for monitoring EtCO2 physiological patient vital signs.

ENVOY vital signs EtCO2 module acquires vital signs data from the patient, and displays the patients waveform and alarms indication on the ENVOY display unit. This information is displayed simultaneously on the ENVOY Display Unit.

All processing and alarm determination for EtCO2 is made using Pryon technology based on currently marketed Pryon monitoring devices.

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.

Selection of the EtCO2 functions 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.

AI/ML Overview

The provided document is a 510(k) summary for the MENNEN MEDICAL LTD. ENVOY Patient Monitor with an EtCO2 module. It outlines the device's description, indications for use, and a summary of its validation, focusing on substantial equivalence to predicate devices rather than detailed acceptance criteria against specific performance metrics for the EtCO2 module itself. Therefore, much of the requested information about acceptance criteria and a specific study proving the device meets them directly is not present in the provided text.

Based on the information available:

Acceptance Criteria and Reported Device Performance

The document does not provide a table of quantitative acceptance criteria for the EtCO2 module's performance (e.g., accuracy, precision) or specific reported performance values against such criteria. Instead, it focuses on functional substantial equivalence to predicate devices and general safety and effectiveness based on design and software validation.

The "Displayed Parameter Message" and "Alarm Indication" table suggests functional equivalence for displaying and alarming on various EtCO2 related parameters between the ENVOY and the MERCURY, but these are not performance metrics.

Displayed Parameter Message	Alarm Indication	Mennen Medical ENVOY Patient Monitor	Mennen Medical MERCURY Patient Monitor
etCO2	Yes	Yes	Yes
Respiration Rate	Yes	Yes	Yes
inCO2	Yes	Yes	Yes
Apnea Information	Yes	Yes	Yes
EtCO2 Alarm Limits	Yes	Yes	Yes
Display Units	Yes	Yes	Yes
Display Labels	Yes	Yes	Yes
Sweep Speed	N/A	Yes	Yes
Grid	N/A	Yes	Yes

The document states that the ENVOY EtCO2 was "tested against Mennen Medical's Design Specifications," and "Simulated inputs were used to test the vital signs monitored by the ENVOY." It also mentions testing "against voluntary industrial standards where appropriate, and Mennen Medical design standards where appropriate, or where industrial standards did not exist." However, the specific quantitative acceptance criteria and the numerical results of these tests for EtCO2 performance are not provided.

Study Information

The document describes a validation study, but it lacks the detail typically found in a clinical or performance study report.

Sample size used for the test set and the data provenance:
- Test Set Size: Not explicitly stated. The validation used "simulated inputs" and "defined gas concentrations of CO2" for the EtCO2 module. This suggests a laboratory-based test with various CO2 concentrations rather than a patient-based test set, and therefore, typical "patient sample size" is not applicable in the usual sense.
- Data Provenance: The testing was done internally by Mennen Medical. The nature of "simulated inputs" and "defined gas concentrations of CO2" indicates lab data rather than retrospective or prospective patient data from a specific country.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for the "simulated conditions" was "defined gas concentrations of CO2," which would be established by the precise calibration of the gas mixing equipment, not by clinical experts.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no expert review or clinical adjudication is described for establishing ground truth in this type of simulation-based testing.
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: Not applicable. This device is a patient monitor, not an AI-assisted diagnostic tool requiring human reader interpretation, nor does it describe human-in-the-loop performance improvement.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the validation described appears to be a standalone performance assessment of the EtCO2 module against simulated inputs and design specifications. The focus is on the device's ability to accurately measure and display EtCO2 levels.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): "Defined gas concentrations of CO2" for software validation. This is a controlled, objective physical ground truth established by calibrated equipment.
The sample size for the training set: Not applicable. This document describes a traditional medical device validation using engineering and software testing, not a machine learning or AI algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable, as there is no training set for this device's validation as described.

Summary

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OCT 8 1099

	MENNEN MEDICAL LTD.Kiryat Weizmann Science ParkP.O.B. 102Rehovot 76100 IsraelTel: 972-8-938-3030Fax: 972-8-940-6519
Date:	30 August 1999
To:	Food and Drug AdministrationCenter for Devices and Radiological Health Document Control Center (HFZ-401)9200 Corporate BoulevardRockville MD 20850
Attn.:	Document Control Clerk
From:	Kenneth RaichmanDirector of Regulatory Affairs
Topic:	510(k) SummaryENVOY Patient Monitor - EtCO2 moduleSafety and Effectiveness
Product Name
Proprietary:	ENVOY EtCO2 Module
Common:	End-Tidal Physiological Patient Monitor
Establishment Registration Number and Address
Registration Number	9611022
	Mennen Medical LTD.Ken Raichman, Director of Regulatory AffairsKiryat Weizmann Science ParkRehovot 76100 IsraelTel: 972-8-938-3030
Classification (Section 513)
Classification:	Class III
Product Code	DSI III
Panel:	Anesthesiology and Respiratory/Cardiology
Performance Standards
None promulgated
Voluntary Standards	IEC 601-1, IEC 601-1-1, IEC 601-1-2, IEC 601-1-4, EN1441, AAMI/ANSI Standards
Predicate Devices
	MENNEN MEDICAL MERCURY (K940081)PRYON SC300 (CAP 400 AT - K935272)
Date Prepared:	30 October 1998
Date Revised:	29 August 1999

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510(k) Summary, ENVOY EtCO2 Safety & Effectiveness

Device Description

ENVOY EtCO2 is a hospital based module, for monitoring EtCO2 physiological patient vital signs.

All processing and alarm determination for EtCO2 is made using Pryon technology based on currently marketed Pryon monitoring devices.

Indications for Use:

Mennen Medical is extending the current Indications for Use statement for the Envoy to include EtCO2 monitoring.

Substantial Equivalency Information:

Mennen Medical submits that the ENVOY EtCO2 is substantially equivalent to the EtCO2 of the MENNEN MEDICAL MERCURY (K940081) and the Pryon CAP 400 AT - K935272. The following tables summarize data on the Mennen Medical ENVOY employing the Pryon Duet board, and the Mennen Medical MERCURY.

DisplayedParameter Message	Alarm Indication	Mennen MedicalENVOYPatient Monitor	Mennen MedicalMERCURYPatient Monitor
etCO2	Yes	Yes	Yes
Respiration Rate	Yes	Yes	Yes
inCO2	Yes	Yes	Yes
Apnea Information	Yes	Yes	Yes
EtCO2 Alarm Limits	Yes	Yes	Yes
Display Units	Yes	Yes	Yes
Display Labels	Yes	Yes	Yes
Sweep Speed	N/A	Yes	Yes
Grid	N/A	Yes	Yes

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Marketing History

EtCO2 has a well known marketing history.

Summary of Validation

Device validation studies were performed to verify that conditions detected by the "bedside device" were completely and accurately reported and displayed on the ENVOY.

Validation:

ENVOY EtCO2 was tested against Mennen Medical's Design Specifications, in accordance with the procedures identified in Part 3, with results as presented in Part 5.

Simulated inputs were used to test the vital signs monitored by the ENVOY. The objective of this study was to compare the performance of the ENVOY against voluntary industrial standards where appropriate, and Mennen Medical design standards where appropriate, or where industrial standards did not exist.

Software validation was tested against Mennen Medical's test plan protocol as presented in Part 5. Simulated conditions were evaluated against defined gas concentrations of CO2.

Conclusions Drawn from Validation Studies:

The results of the validation studies indicate that ENVOY EtCO2 is safe, effective and poses no new risks when compared against the Mennen Medical Design Standards, and equipment already in clinical use.

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Software Validation

Software validation verified the functionality of the Mennen Medical ENVOY EtCO2 from a "black box" approach. Validation was performed by a persons other than those involved in the design of the system. This independent audit confirmed that the system software met the specified requirements.

Software Validation Plan:

The software validation plan tested the following areas:

Verified that the system performed according to specified requirements.

Verified the system by exercising user input and assuring correct output.

Checked for hidden functionality.

Verified that the system recovers from errors.

The SOFTWARE VALIDATION PLAN was reviewed and approved by Mennen Medical's Engineering and Quality Assurance Departments, insuring that the tests were both valid and thorough.

The SOFTWARE VALIDATION PLAN was executed and the results were analyzed by the Quality Assurance and Engineering Departments. The results met expectations and the software was approved for release, pending clearance of the 510(k) process.

MENNEN MEDICAL LTD.

Kenneth Raichman, Director of Regulatory Affairs

Enclosures.

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Image /page/4/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle's head and neck, depicted with three parallel lines forming the shape.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 8 1999

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

Re: . K983864 ETCO2 Module of Envoy Patient Monitor Regulatory Class: II (two) Product Code: 73 CCK and 74 MHX Dated: August 16, 1999 Received: Auqust 18, 1999

Dear Mr. Kassel:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 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 affecting your device can be found in the 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 requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish 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.

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Page 2 - Mr. Asher Kassel

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 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,

Thomas J. Callahan

Thomas J. C allahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known)

983864

Device Name

ENVOY PATIENT MONITOR

Indications for Use:

MRI Compatibility Statement:

The ENVOY is not compatible for use in MRI magnetic field.

(DO NOT WRITE BELOW THIS LINE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
or
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Form 1-2-96)

(Division Sign-Off)
Division of Cardiovascular, Respi
and Neurological Devices

510(k) Number K983864

Regulation Number and Section

§ 868.1400 Carbon dioxide gas analyzer.

(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).