Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states that processing and alarm determination are made using "proprietary algorithms and software based on previously marketed Mennen Medical monitoring devices tested against well known and accepted data bases". There is no mention of AI or ML.

Therapeutic

No

The device is described as a "physiological patient monitor" intended for "monitoring vital signs." It processes and displays data, but does not provide therapy or treatment. The description explicitly states it is "not a life supporting, or life sustaining device."

Diagnostic

No.
The ENVOY Monitor is described as a physiological patient monitor intended for monitoring vital signs (ECG/Heart Rate, Invasive Blood Pressure, Respiration, Temperature, Noninvasive Blood Pressure, and Pulse Oximetry) of critically ill adult and pediatric patients. While it provides vital signs data, it does not explicitly state that it diagnoses conditions or diseases based on this data. It monitors and displays physiological information for healthcare providers to assess.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as a Main Processing Unit, Display Unit, Module Rack, and Vital Signs Plug-in Modules. While it mentions being "software driven," it is clearly a system that includes physical hardware for data acquisition, processing, and display.

IVD (In Vitro Diagnostic)

Based on the provided information, the ENVOY Monitor is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states that the device is for "monitoring vital signs of critically ill adult and pediatric patients in the hospital environment." This involves directly monitoring physiological parameters from the patient's body (ECG, blood pressure, respiration, temperature, pulse oximetry).
Device Description: The description details how the device acquires vital signs data from the patient using transducers and displays waveforms and numerical values. It processes signals from the patient's body.
Lack of In Vitro Activity: An IVD device is designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The ENVOY Monitor does not perform any analysis on such specimens. It directly measures physiological signals from the living patient.

Therefore, the ENVOY Monitor is a physiological patient monitor, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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, and Pulse Oximetry. 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.

Product codes (comma separated list FDA assigned to the subject device)

74 DSI

Device Description

ENVOY is hospital based, multiparameter patient monitor for monitoring physiological patient vital signs.

The ENVOY patient monitor system consists of the following components:

Main Processing Unit Display Unit Module Rack Vital Signs Plug-in Modules

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. SpO2 and Non-Invasive Blood Pressure Modules use sofware/hardware from vendors whose products already appearing on the USA market.

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, or life sustaining device; nor is it implantable and therefore sterility is not a consideration.

ENVOY complies with IEC 601-1 Medical Electrical Equipment, IEC 601-2-27 Safety of electrocardiographic monitoring, IEC 601-2-30 Requirements for automatic cycling indirect blood pressure monitoring, AAMI/ANSI SP-10 Electronic or Automated Sphygmomanometers, IEC 601-2-34 Requirements for invasive blood pressure monitoring, AAMI/ANSI ESI Safe Current Limits for Electromedical Apparatus, and AAMI/ANSI 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adult and pediatric patients

Intended User / Care Setting

qualified health care providers, in the hospital environment

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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. Simulated patient waveforms were generated using a DNI Navada Inc. 217A Patient simulator and Mennen Medical simulators.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Device validation studies were performed to verify that conditions detected by the "bedside device" were completely and accurately reported and displayed on the ENVOY. ENVOY was tested against Mennen Medical's Design Specifications, in accordance with the procedures identified in Part 7 Section 2, with results as presented in Part 7 Section 3. ECG/Heart Rate response was evaluated against the AAMI/ANSI Cardiac Monitors, Heart Rate Meters, and Alarms Standards. Testing of other Vital signs was performed against Mennen Medical's Design specifications. Measurements were within published specifications. Patient safety was confirmed by testing EN60601-1 and AAMI/ANSI Safe Current Limits for Electromedical Apparatus standard. ENVOY complies with IEC 601-1 requirements for flammability, mechanical abuse, temperature and humidity. Environmental testing was conducted pursuant to IEC-68-2-1 (Cold), IEC-68-2-2 (Dry Heat), IEC-68-2-3 and IEC-68-2-56 (Damp heat steady state), IEC-68-2-13 (Low air pressure), IEC-68-2-6 (Vibration - sinusoidal), IEC-68-2-36 (Random vibration wide band), IEC 68-2-27 (Shock) and MIL-STD-810E. EMC testing, pursuant to IEC 601-1-2. IEC 801-1/2/3/4 and 5. EN 55011 and CISPR 16 was conducted and compliance verified. Non-invasive blood pressure was evaluated for IEC601-2-30 Requirements for automatic cycling indirect blood pressure monitoring. The performance of the ENVOY was compared against another automated non-invasive blood pressure device (Mennen Medical HORIZON XL). The study followed the AAMI Electronic or Automate Sphygmomanometers Standard SP-10 (Refer to Part 8 for NIBP clinical trials and results). Clinical validation studies of the Pulse Oximetry Module are present in Part 8 of the submittal.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Measurements were within published specifications.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

MENNEN MEDICAL HORIZON XL (K911616), HEWLETT-PACKARD M1175/26A COMPONENT MONITORING SYSTME (K941811)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

K974510

ENNE

MEDICAL LTD.

APR 1 4 1998

(

MENNEN MEDICAL LTD. Kiryat Weizmann Science Park P.O.B. 102 Rehovot 76100 Israel Tel: 972-8-938-3030 Fax: 972-8-940-6519

30 October 1997 Date:
Food and Drug Administration To: Center for Devices and Radiological Health Document Control Center (HFZ-401) 1390 Piccard Drive Rockville MD 20850

Document Control Clerk Attn.:

Kenneth Raichman From: Director of Regulatory Affairs

510(k) Summary Topic: ENVOY Patient Monitor Safety and Effectiveness

Product Name

ENVOY Proprietary: Physiological Patient Monitor Common:

Establishment Registration Number and Address

9611022 Registration Number Mennen Medical LTD. Ken Raichman, Director of Regulatory Affairs Kiryat Weizmann Science Park Rehovot 76100 Israel Tel: 972-8-938-3030

Classification (Section 513)

Classification: Panel:

Class III Anesthesiology and Respiratory/Cardiology

Performance Standards

None promulgated

Voluntary Standards

AAMI/ANSI ES1 Safe Current Limits for Electromedical Devices AAMI/ANSI EC13, Cardiac Monitors, Heart Rate Meters and Alarms AAMI/ANSI SP-10, Electronic or Automated Sphygmomanometers IEC 601-1 Medical Electrical Equipment IEC 601-2-27 Safety of electrocardiographic monitoring IEC601-2-30 Requirements for automatic cycling indirect blood pressure monitoring IEC601-2-34 Requirements for Invasive Blood Pressure monitoring equipment

Predicate Devices

MENNEN MEDICAL HORIZON XL (K911616). HEWLETT-PACKARD M1175/26A COMPONENT MONITORING SYSTME (K941811).

Date Prepared: 30 October 1997

1

510(k) Summary, ENVOY Safety & Effectiveness