ENGUARD REMOTE PATIENT MONITOR

• K Number: K020632
• Device Name: ENGUARD REMOTE PATIENT MONITOR
• Manufacturer: MENNEN MEDICAL LTD.
• Date Cleared: 2002-03-15 ( 16 days)
• Product Code: QYX , DSI , OYX
• Regulation Number: 870.1025
• Type: Special
• Panel: CV
• Reference & Predicate Devices: K001120
• Predicate For: N/A

Intended Use

Enguard is intended for use as a remote patient multiparameter monitoring system.

The Enguard 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 Enguard 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 Enguard 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 Enguard is a remote 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

AI/ML Overview

The provided document is a 510(k) premarket notification for the Mennen Medical Enguard Remote Patient Monitor. It is a reclassification and administrative change letter, and the original 510(k) response is dated March 15, 2002. The document does not contain a detailed study report with acceptance criteria and device performance results.

Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria and a study that proves the device meets those criteria. The document confirms that the device was found substantially equivalent to a predicate device (MENNEN MEDICAL ENVOY PATIENT MONITOR (K001120)), but it does not include the detailed performance data or study design that would typically be found in a clinical or performance validation report.

The information I can extract and provide based only on the provided text is limited to:

1. Trade/Device Names and Classification:

• Trade/Device Name: Enguard Remote Patient Monitor
• Regulation Number: 21 CFR 870.1025
• Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm)
• Regulatory Class: Class II (originally Class III, updated to Class II)
• Product Code: OYX, DSI

2. Intended Use/Indications for Use:

Enguard is intended for use as a remote multiparameter monitoring system. It can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure, and EtCO2. This allows monitoring of adult, pediatric, and neonatal patient conditions in various hospital areas. Functions include display of multiparameter waveforms, vital signs, alarm & status messages. It is intended for remote monitoring and recording patient information or any in-hospital application requiring remote patient monitoring.

Examples of Intended Clinical Applications:

• Critical Care Patients
• Cardiac Step-down/Telemetry Units
• Emergency Departments
• Intra-operative (Anesthesia) Monitoring
• Post Anesthesia Care

3. Predicate Device:

• MENNEN MEDICAL ENVOY PATIENT MONITOR (K001120)

4. Performance Standards (Voluntary):

• 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.

The following information cannot be provided from the given text:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts and their qualifications for ground truth.
• Adjudication method for the test set.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study (effect size).
• Results of a standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

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.