(221 days)
Menntor X7 is intended for use as a multi-parameter physiological patient monitoring system.
The Menntor X7, is a modular monitor with a Multi Parameter Module (MX57, MPM) that can monitor ECG/heart rate, invasive blood pressures , temperature, pulse oximetry, respiration, non-invasive blood pressure, and Cardiac Output
The Menntor X7 can also monitor EtCO2, Spirometry and EEG, and display aEEG.
The MPM (MX57) is equipped with a battery and can continue monitoring it's vital sign when out of the host Menntor X7
This effectively allows the Menntor X7 to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital.
Functions include display of multi-parameter waveforms, vital signs, alarm & status messages.
The Mennen Medical Menntor X7 is intended for sale as a system for monitoring and recording patient information on any in-hospital application requiring patient monitoring.
The following are examples of intended clinical applications:
- · Critical Care Patients
- · Cardiac Step-down Units
- · Emergency Departments
- · Intra-operative (Anesthesia) Monitoring
- · Post Anesthesia Care
*The Intended Use of the Menntor X7 as indicated above is same as the Indications For Use.
The Menntor X7 is a modular multi-parameter physiological patient monitor, based on the hardware and software of the Mennen Medical VitaLogik 6000/6500 and Envoy monitors, with integrated display screen. It is part of the Envoy/VitaLogik Monitor family and runs on same software versions.
In general, the Menntor X7 has the same functions, similar intended use and technology as the other members of the Mennen Medical monitor family.
The Menntor X7 uses identical display format and patient data as does the VitaLogik 6000/6500 monitor. The Ensemble central station and the Enguard remote monitor can both view the Menntor X7 as well as the other members of the family: VitaLogik 6000/6500, VitaLogik 4000/4500, VitaLogik 5000/ 5500 and Envoy.
The Menntor X7 bedside patient monitor consists of MX57 - Multi Parameter plug in Module, (MPM), two additional single parameters plug in modules, a main processing unit, and an integrated color monitor with optional touch screen. The front end electronics incorporated in the MPM has same hardware and software as VitaLogik 6000/6500 . The input connectors are incorporated in the side panel of the MPM.
The MPM (MX57) has an optional 5.7" display, that enables the MPM to continue monitoring when taken out of the Menntor X7 host.
The Menntor X7 monitor presents vital signs in the same way and the same GUI (Graphic User Interface) as does the VitaLogik 6000/6500 monitor.
The Menntor X7 can acquire the following physiological signals of the patient:
· ECG - Waveform. Arrhythmia and numeric values of Heart Rate, and ST
- · Blood Pressures Waveform and numeric values of, Diastole and Mean pressure
- · Temperature As a numeric value in Cº or Fº
- · SpO2 Photoplethysmographic waveform and numeric value of the oxygen saturation and pulse rate
- · NIBP Systolic, Diastolic and Mean pressure with measuring time stamp
- · EtCO2 EtCO2, inCO2 and Respiration Rate
- · Spirometry
- · EEG and aEEG.
The provided document is a 510(k) premarket notification for the Menntor X7 patient monitor. It focuses on demonstrating substantial equivalence to predicate devices (VitaLogik 6000/6500 and Envoy monitor with Spirometry module) rather than providing a detailed study proving the device meets specific acceptance criteria through clinical trials or standalone performance evaluation against a large, adjudicated dataset.
This type of submission relies heavily on comparisons of technical specifications and functional equivalence to existing cleared devices. Therefore, many of the requested details regarding acceptance criteria, study sample sizes, expert adjudication, and MRMC studies are not present as they are typically associated with de novo submissions or more complex, novel AI/ML device approvals.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the Menntor X7 are primarily based on demonstrating equivalence in performance specifications to the predicate devices. The document provides a detailed comparison table (pages 7-8) of various vital signs parameters, listing the specifications of the predicate device (VitaLogik 6000/6500) and stating "Same" for the Menntor X7 if the performance is identical. This "Same" implicitly serves as the acceptance criterion, meaning the Menntor X7 performs at least as well as the predicate for those parameters.
Since the document repeatedly states "Same" for the Menntor X7's performance compared to the predicate, we can construct a table reflecting this. The acceptance criteria are the predicate's performance specifications.
| Parameter | Acceptance Criteria (VitaLogik 6000/6500 Performance) | Reported Device Performance (Menntor X7) |
|---|---|---|
| Hardware Parameters | ||
| Input Circuit Parameters | Configured | 2 Plug-in modules, Plug-in Multi Parameter Module (MPM) |
| Chassis Leakage Current | All patient signal inputs fully isolated ( |
§ 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.