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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

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

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.

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