(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 (<50 μA); Meets or exceeds ANSI standard: "Safe Current Limits for Electromedical Apparatus," (SCLE) Dec, 1978 item 2.1.1. | Same |
| Front End electronics | Integrated front end electronics | Plug-in MPM |
| Front Panel keys | 5 | Same |
| Quicknobe | Yes | Same |
| Main screen | Yes | Same |
| Escape | Yes | Same |
| Silence - Red | Yes | Same |
| Alarm Off - Red | No | Yes |
| Print - Green | Yes | Same |
| NIBP Start/Stop - Yellow | Yes | Same |
| Software/Display Functions | ||
| Main Menu, Vital Signs, Patient data, Setup, Utilities, System Setup | Fixed list, List of patient data, Setup menu, List of virtual keys, Password protected | Same |
| Display size | 15 inch | Same |
| Display | All waveforms and numeric vital sings | Same |
| Operating System | QNX4 | Same |
| GUI, Menus | Same, Full set | Same |
| LAN | Yes, Optional Wireless LAN | Same |
| Optional Hardware enable | Touch screen | Same |
| Change ECG Lead Selection | YES | Same |
| Display of Arrhythmia Information | YES | Same |
| Data Review: Trends - Graphic | YES | Same |
| Data Review: Chart - Tabular | YES | Same |
| User defined Configuration Setup/Default Settings | YES | Same |
| Accessories | Accessories | Same |
| Vital Signs Inputs | ||
| ECG (Leads, Freq Response, Input Impedance, CMR, Input Dynamic Range, Input offset, Gain, Noise, Pacemaker Pulse Rejection, Defibrillator Protection, Lead Fault Sense, QRS Detection, Synchronous Defibrillation Signal, Analog Output) | 3, 5 or 12 leads; 0.5 to 40 Hz (Monitor), 0.05 to 150 Hz (Diagnostic), 1 to 25 Hz (Exercise); Typical 20 MΩ; At least 100 dB; ±5mV p-p; ±300mV; Manual selection of 250-8000x; Less than 30 μV p-p; 2.0 mV to 700 mV pulses of 0.2 to 2.0 mSec; Up to 5 KV, < 3 sec recovery; On any ECG electrode; 0.25 to 5.0 mV, 70-120 msec width; Pulse Width: 100 ms, Amplitude: 5 Vdc; 1 Volt / mVolt | Same |
| Heart Rate (Range, Acc, Response Time) | 20 to 350 bpm; Within 2 bpm; Less than 7 sec | Same |
| Blood Pressure (Input Sensitivity, Transducer Excitation, Ranges, Max variation, Zero Accuracy, Zero Drift, Transducer Load Impedance, Linearity, CMR, Freq Response) | 5 μvolts/volt/mmHg; 5 Volt; -50 to +300 mmHg; ± 2 mmHg; ± 0.2 mmHg; Less than ± 0.2 mmHg in 24 hours; 300 – 600Ω; Better than 1%; 80 dB minimum; DC to 12 Hz (DC to 40 Hz optional) | Same |
| Cardiac Output | Yes | Yes |
| Temperature (Range, Accuracy) | 27 °C to 45°C; ± 0.2°C | Same |
| Respiration (Freq Response, Range, Excitation) | 0.13 to 2.5 Hz, 3 dB bandwidth; 8 to 150 bpm; 65 kHz | Same |
| Pulse Oximetry (SpO2) (Probe Type, Range, Pulse Rate Range, Rate Accuracy, SpO2 Accuracy) | Masimo™ or Nellcor; 0% to 100%; 20-250 bpm; ± 3 bpm; Determined by specific sensor: ±2 digits (70-100%), ±3 digits (50-70%), ±3 digits (70-95%) | Same |
| Non-Invasive Blood Pressure (Method, Initial Inflation, Pressure Accuracy) | Oscillometric; 150 mmHg (adult), 120 mmHg (pediatric); Overall ± 3 mmHg | Same |
| EEG (Features, Number of channels) | EEG + aEEG; 2 | Same |
| Protection | ||
| Defibrillator Pulse Protection | 5KV as per ANSI/AAMI EC13 (9), clause 3.2.2.2 and per IEC 60601-2-27 (12), clauses 17,101 and 102 | Same |
| Degree of protection against electrical shock | Type CF and BF (ECG, IBP, CO = CF; NIBP, SpO2 = BF) | Same |
| Electrosurgical Interference Suppression | Yes | Same |
| Displayed Waveforms | ||
| ECG, BP, Respiration, SpO2, EtCO2, EEG | Up to 12 lead; Up to 4, separate or superimposed; 1; 1; 1; 2 channels | Same |
| Displayed Numeric Parameters | ||
| Heart Rate, Respiration Rate, SpO2, BP (Systolic/Diastolic/Mean), Temperature, EtCO2, CerebraLogik interface, Alarm Indications | Yes; Yes; Yes; Yes; 2; Yes (optional); EEG & aEEG; Yes | Same, Plug-in Module (option for EtCO2) |
| Spirometry Module (compared to Envoy) | ||
| Module size | Height: 10.0cm, Width: 4.0 cm, Depth: 14.0 cm | Height: 9.5cm, Width: 4.0 cm, Depth: 11.5 cm |
| Display Function (Air Flow, Volume, Airway pressure, Flow-volume loop, Pressure-volume loop, Pressure-flow loop, Derived parameters) | All Yes | Same |
| Pulmonary mechanics parameters | Vt_e. PIP, PEEP, MAP, Plat, PF_i, PF_e, RR, Ve, I:E, COMP, RES, RSBI | Same |
| Clinical Alarms for derived parameters | Visual & Sound Alarms | Same |
| Data Storage (Trend, Chart, Waveforms) | Trend: Yes - up to 3 months; Chart: Yes- up to 3 months; Waveforms: Yes- up to 72 hours | Trend: Yes - up to 80 days; Chart: Yes - up to 80 days; Waveforms: Yes - 5 days |
| Degree of protection against electrical shock | Type BF applied part | Same |
| Sampling | 100 sps | Same |
| Airway Adapter spec (Flow Range, Accuracy, Dead Space, Connections, Length, Weight, Material) | 2 - 180 lpm; ± 5 % reading, or 0.5 lpm; 6.9 ml; 15 mm ID/22 mmOD patient end by 15 mm ID ventilator end (ISO 5356-1), Proprietary Smart connector, Tri-Tubing - triple 0.055" inch ID lumen; 2.5 inches (adapter) - 6 feet (tubing); 6.3 grams (minus tubing); Sensor - Polycarbonate (Makrolon), Tubing - Medical grade Polyvinyl Chloride | Same |
2. Sample sizes used for the test set and the data provenance
The document does not specify a "test set" in the context of labeled patient data for algorithm performance. Instead, it relies on:
- Performance tests using calibrated simulators: "Calibrated simulators were used to confirm the equivalence of each of the monitored Vital signs." (page 16) This means testing was done on the device's ability to accurately read and display signals generated by known, controlled inputs, mimicking physiological signals. The sample size for these simulated tests is not explicitly stated.
- System-level software validation: "At the system level, SW Validation of the performance of the Menntor X7 as compared to the VitaLogik 6000/6500 system was carried out in accordance with the test plan described in the Mennen Medical Validation Test Procedure for the Menntor X7." (page 16)
- Final performance tests: "Final testing for the Menntor X7 included performance tests designed to ensure that the device meets all functional requirements and performance specifications, in accordance with the requirements of the Final Test Procedure for the Menntor X7." (page 16)
- Electrical Safety and EMC Testing: Performed by an independent lab (page 16).
Since this is a 510(k) for a patient monitor and not a diagnostics AI/ML device, patient data provenance (country of origin, retrospective/prospective) and sample size for a "test set" as one might see in an AI/ML submission are not relevant or provided. The testing is primarily bench testing and software validation against established predicate performance.
3. 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 performance claims in this submission is the known output of calibrated simulators and the established performance specifications of the predicate devices, not expert human readers evaluating patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There's no human adjudication of "ground truth" labels/diagnoses as would be the case for an AI/ML diagnostic algorithm.
5. 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 physiological monitor, not an AI-assisted diagnostic tool. Its primary function is to acquire, process, display, and store vital signs. There is no "human reader" in the sense of interpreting complex medical images or data that the device then assists.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device's performance is inherently "standalone" in terms of its ability to acquire and process physiological signals from a patient. The "study" proving this is the direct comparison of its technical specifications and performance in bench testing against the predicate device's cleared specifications, as detailed in the comparison tables.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for verifying the Menntor X7's performance is established by:
- Calibrated Simulators: For vital signs acquisition and display (e.g., generating a known ECG waveform or blood pressure reading to ensure the device accurately measures and displays it).
- Predicate Device Specifications: The established, legally marketed performance characteristics of the VitaLogik 6000/6500 and Envoy Spirometry module serve as the benchmark for equivalence.
- Industry and Safety Standards: Compliance with standards like IEC 60601 series, which specify performance and safety requirements for medical electrical equipment.
8. The sample size for the training set
Not applicable. This is a traditional medical device (patient monitor), not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML model. The "ground truth" for the device's design and verification is based on established engineering principles, physiological accuracy requirements for patient monitoring, and compliance with recognized medical device standards.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, composed of three curved lines that suggest a head, body, and legs. The figure is positioned within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 8, 2015
Mennen Medical Ltd. c/o Mr. Ifat Shwarts QA & RA Manager 4 Ha-yarden St. Yavne 8122804 P.O. Box 102 Rehovot 7610002 Yavne, 8122804 IL
Re: K141441
Trade/Device Name: Menntor X7 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: DSI Dated: November 6, 2014 Received: November 10, 2014
Dear Mr. Ifat Shwarts.
This letter corrects our substantially equivalent letter of January 9, 2015.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
{1}------------------------------------------------
Page 2 - Mr. Ifat Shwarts
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
university years,
forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: Menntor X7.
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.
| Prescription Use YES | AND/OR | Over-The-Counter Use NO |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
{3}------------------------------------------------
Traditional 510(k): Device Modification - Menntor X7
Image /page/3/Picture/2 description: The image shows the logo for Mennen Medical. The logo consists of a stylized letter "m" inside of a circle, with the words "mennen" in black and "medical" in light gray. The date "May 25, 2014" is printed below the logo.
Topic: 510K for Menntor X7 monitor
Establishment Name, Registration Number and Address:
| Name: |
|---|
| Registration Number: |
| Operator Number: |
| Address: |
| Postal Address: |
| Tel: |
| Fax: |
| Contact person: |
Mennen Medical Ltd. 9611022 9069173 4 Hayarden Street, Yavne, 81228, Israel PO Box 102, Rehovot, 76100, Israel +972-8-9323333 +972-8-9328510 Ifat Shwarts, Regulatory Affairs
To: Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville MD, 20850
Attn.: Document Control Clerk From: Ifat Shwarts, Regulatory Affairs
Attached please find a hard copy of our 510K submission. Additional electronic copy (which is an exact duplicate of the paper copy) of the submission is attached on CD
The following information is being submitted in conformance with 21 CFR 807.87:
| 1. | Classification Name | Detector and Alarm, Arrhythmia |
|---|---|---|
| 2. | Classification Number: | 21 CFR 870.1025 |
| 3. | Common/Usual Name | Physiological Patient Monitor |
| 4. | Trade/Proprietary Name | Menntor X7 |
| 5. | Part Number | 791-000-000 |
| 6. | Establishment Registration Number | 9611022 |
| 7. | FDA Classification | Class II |
| 8. | Product Code | DSI |
| 9. | Reviewing Panel | Cardiovascular |
| 10. | Performance Standards | Please see page 15, 16 |
| 11. | 510(k) Marketing clearance for VitaLogik 6000 | K093766 - May 7, 2010 |
{4}------------------------------------------------
Terminology
Menntor X7 = subject of this Traditional 510(k). The Menntor X7 is a modified device, of the VitaLogik 6000/6500 Patient Monitor and of the Envoy monitor Spirometry module
VitaLogik 6000/6500 Patient Monitor = the predicate device. The VitaLogik 6000/6500 was approved for marketing by the FDA in (K093766 dated 5.7.2010) and also with CerebraLogik in (K131789 dated 27.12.2013) Envoy monitor with Spirometry module = the predicated device The Envoy monitor was approved for marketing by FDA (K030722 dated 26.2.2004)
Definition of Product Family:
The Menntor X7 is a new member of the Envoy /VitaLogik family.
It uses the same GUI and data storage capabilities, as the other monitors
It can be viewed by the Ensemble central nurse station and by the Enguard remote monitor, as all other members of the family..
Data transfer and remote view is available between all members of the family.
The new Menntor X7 will measure, display and store the same vital signs as does the VitaLogik 6000/6500, plus Spirometry, same as on the Envoy monitor.
1. Device Description: Menntor X7
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
{5}------------------------------------------------
- · 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.
Functional Description of the Menntor X7
The Menntor X7 is a modular monitor, based on the Envoy monitor for Spirometry and on VitaLogik 6000/6500 monitor for all other vital signs. It differs in hardware but uses the same software versions for display and data storage, It uses the Multi Parameter Module (MPM) to measures vital signs such as ECG/Heart rate, NIBP, SpO2, Temperature, Invasive pressures, Cardiac output. It uses plug in modules to measure EtCO2 and Spirometry.
The Menntor X7 uses identical display format and patient data as do the VitaLogik 6000/6500 monitor. The Ensemble central station and the Enguard remote monitor can both view the Menntor X7, VitaLogik 6000/6500, VitaLogik 4000/4500, VitaLogik 5000/ 5500 as well as the Envoy.
The Menntor X7 has two serial inputs for interface with other vendor devices in the same way as the serial input on VitaLogik 6000/6500.
Menntor X7: Vital signs parameters
- Diagnostic 7 or 12 Lead ECG ●
- Non-invasive Blood Pressure .
- Pulse Oximetry (SpO2) ●
- Temperature ●
- 2 (optional 4) Invasive Blood Pressure channels ●
- . Cardiac Output
- EtCO2 (Module)
- Spirometry (Module) ●
- CerebraLogik EEG & aEEG ●
Main components of the Menntor X7:
The Menntor X7 system consists of:
(A) Menntor X7 host monitor with integrated Display
Acquires, processes, and converts vital signs from the patient into waveforms and digital signals, and stores vital signs waveforms and the numeric parameters
(B) The Multi-Parameter Module. (MPM)
The Menntor X7 uses a plug in MPM to acquire the following physiological
{6}------------------------------------------------
signals of the patient:
- · ECG Waveform , Arrhythmia and numeric values of Heart Rate, and ST
- · Blood Pressures Waveform and numeric values Systole. Diastole and Mean pressure
- · SpO2 Photoplethysmographic waveform and numeric value of the oxygen saturation and pulse rate
- · NIBP Systolic, Diastolic and Mean pressure with measuring time
- · Temperature As a numeric value in Cº or Fº
It uses also two plug-in modules to measure:
- · EtCO2 EtCO2, inCO2 and Respiration Rate
- · Spirometry Flow, Volume and Airway pressure waveforms, and numeric parameters of the pulmonary mechanics
Reasons for developing the Menntor X7 :
The Menntor X7 was developed for those users that wish to have a modular patient monitor with in-built display. It uses the capabilities of the other members of Mennen Medical monitor family, and same menus and display options.
The main advantages of the Menntor X7 are:
-
- Multi Parameter plug-in Module (MPM)
-
- Optional Wireless LAN
- 3 Battery operated MPM
-
- Same user interface as VitaLogik and Envoy monitors
-
- Full compatibility with Ensemble Central station
-
- Full compatibility with Enguard remote monitor
Substantiel Equivalence of Menntor X7 to VitaLogik 6000/6500 and to Envoy Spirometry module
Comparison: Menntor X7 with VitaLogik 6000/6500
VitaLogik 6000/6500 - side view and front view
Image /page/6/Picture/22 description: The image shows the back panel of a device, possibly a television or monitor, featuring various input and output ports. There are several circular ports, likely for connecting cables, arranged in a grid-like pattern. The ports are labeled "LINK 1" and "LINK 2", suggesting they are used for connecting multiple devices or components. Additionally, there are a few smaller buttons or switches, along with ventilation slats on the side of the device.
Image /page/6/Picture/23 description: The image shows a medical monitor displaying various vital signs and readings. The monitor displays a heart rate of 60, blood pressure readings of 36/41 and 40/5, and other values such as 6.0/7.9, 5.8, 68/74, and 5.8. The time displayed on the monitor is 11:49. The monitor also shows waveforms and other graphical representations of the patient's condition.
4 of 16
{7}------------------------------------------------
Image /page/7/Picture/1 description: The image shows two pieces of medical equipment. The equipment on the right is a monitor displaying a variety of vital signs, including a heart rate of 60, blood pressure of 119/80-92, and other metrics such as 24/9-13 and 40/5. The monitor also displays a waveform and a timer showing 00:05:13. The equipment on the left appears to be a medical device with various ports and controls.
Menntor X7 - Side View and front view
The major differences between the Menntor X7 and the VitaLogik 6000/6500 are:
-
- The Menntor X7 is a modular monitor while it's predicated device the VitaLogik 6000/6500 is a configured monitor
-
- Menntor X7 has a Spirometry module based on the Envoy monitor as it's predicated device
12. Device comparison: Menntor X7 versus VitaLogik 6000/6500
Menntor X7 with VitaLogik 6000/6500 Comparison:
The following table summarize and compare data of the VitaLogik 6000/6500, Predicated device, to the subject of this submission, the Menntor X7.
| VitaLogik 6000/6500 | Menntor X7 | |
|---|---|---|
| Part/Option Number | 781-100-000 | 791-000-000 |
| 510 K | K093766 – 05/07/2010K131789 – 12/27/2013 | |
| Input Circuit Parameters | Configured | 2 Plug-in modulesPlug-in Multi ParameterModule(MPM) |
| Chassis Leakage Current | All patient signal inputs fullyisolated (<50 μA)Meets or exceeds ANSIstandard: "Safe Current Limitsfor Electromedical Apparatus,"(SCLE) Dec, 1978 item 2.1.1. | Same |
| Hardware comparison | ||
| VitaLogik 6000/6500 | Menntor X7 | |
| Front End electronics | Integrated front end electronics | Plug-in MPM |
| Front Panel keys | 5 | Same |
| Quicknobe | Yes | Same |
| Main screen | Yes | Same |
| Escape | Yes | Same |
| Silence - Red | Yes | Same |
| Alarm Off - Red | No | Yes |
| Print - Green | Yes | Same |
| NIBP Start/Stop - Yellow | Yes | Same |
| Main Menu | ||
| Vital Signs | Fixed list of vital signs | Same |
| Patient data | List of patient data | Same |
| Setup | Setup menu | Same |
| Utilities | List of virtual keys | Same |
| System Setup | Password protected | Same |
| Vital signs Inputs | ||
| ECG | 3, 5 or 12 leads | Same |
| Frequency Response | Monitor Mode: 0.5 to 40 HzDiagnostic: 0.05 to 150 Hz,Exercise : 1 to 25 Hz, -3 dB | Same |
| Input Impedance: | Typical 20 MΩMinimum greater than:5 MΩ differential, DC to 10Hz; 2.5 MΩ differential 10 to100 Hz 3 MΩ differential at 10Hz | Same |
| Common Mode Rejection: | At least 100 dB at 50/60 HzWithout lead misbalance86 db with lead misbalanceThe common mode rejectionratio is in accordance withANSI/AAMI EC11(9) Para.3.2.11. | Same |
| Input Dynamic Range: | ±5mV p-p at a rate up to320mV/sec, as perANSI/AAMI EC13(8) Para.3.2.9.1. | Same |
| VitaLogik 6000/6500 | Menntor X7 | |
| Input offset | $\pm$ 300mV, as per ANSI/AAMIEC13 Para. 3.2.9.1. | Same |
| Gain: | Manual selection of 250, 500,1000, 2000, 4000 and 8000 xECG Signal impressed acrossselected lead | Same |
| Noise: | Less than 30 $\mu$ V p-preferenced to input | Same |
| Pacemaker Pulse Rejection: | Reject pulses from:2.0 mV to 700 mV pulses of0.2 to 2.0 mSec pulse widthsand $\ge$ 3.0mV for 0.1mSecpulse width | Same |
| Defibrillator Protection: | Up to 5 KV. AmplifierRecovery time: < 3 seconds | Same |
| Lead Fault Sense: | On any ECG electrode | Same |
| QRS Detection: | 0.25 to 5.0 mV, 70-120 msecwidth | Same |
| Synchronous DefibrillationSignal: | Pulse Width: 100 ms.Amplitude: 5 Vdc amplitudeinto 500Ω, short-circuit proof | Same |
| ECG Analog Output: | 1 Volt / mVolt | Same |
| Heart Rate | ||
| Range: | 20 to 350 bpm | Same |
| Accuracy: | Within 2 bpm | Same |
| Response Time: | Less than 7 sec for step changeof 60 bpm from a base of 60bpm | Same |
| Blood Pressure | ||
| Input Sensitivity: | 5 $\mu$ volts/volt/mmHg | Same |
| Transducer Excitation: | 5 Volt | Same |
| Ranges: | -50 to +300 mmHg. | Same |
| Maximum variation duringzero: | $\pm$ 2 mmHg | Same |
| VitaLogik 6000/6500 | Menntor X7 | |
| Zero Accuracy: | $\pm$ 0.2 mmHg | Same |
| Zero Drift: | Less than $\pm$ 0.2 mmHg in 24hours | Same |
| Transducer LoadImpedance: | 300 – 600Ω | Same |
| Linearity: | Better than 1% of full scale | Same |
| Common Mode Rejection: | 80 dB minimum (reference tochassis 50/60Hz) | Same |
| Frequency Response: | DC to 12 Hz(DC to 40 Hz optional) | Same |
| Cardiac Output | Yes | Yes |
| Temperature | ||
| Range: | 27 °C to 45°C | Same |
| Accuracy: | $\pm$ 0.2°C | Same |
| Respiration | ||
| Frequency Response: | 0.13 to 2.5 Hz., 3 dBbandwidth | Same |
| Range: | 8 to 150 bpm | Same |
| Excitation: | 65 kHz | Same |
| Pulse Oximetry (SpO2) | ||
| Probe Type: | Masimo™ or Nellcor reusableor disposable | Same |
| Range: | 0% to 100%. | Same |
| Pulse Rate Range: | 20-250 bpm, below 20 displayszero | Same |
| Rate Accuracy: | $\pm$ 3 bpm | Same |
| VitaLogik 6000/6500 | Menntor X7 | |
| SpO2 Accuracy: | Determined by specific sensor:±2 digits between70% and 100%±3 digits between50% and 70%.±3 digits between70% and 95%. | Same |
| Non-Invasive BloodPressure | ||
| Method: | Oscillometric | Same |
| Initial Inflation: | 150 mmHg (adult)120 mmHg (pediatric). | Same |
| Pressure Accuracy: | Overall ± 3 mmHg, full scale. | Same |
| EEG | ||
| Features | EEG + aEEG | Same |
| Number of channels | 2 | Same |
| Protection | ||
| Defibrillator PulseProtection | 5KV as per ANSI/AAMI EC13(9), clause 3.2.2.2 and perIEC 60601-2-27 (12),clauses 17,101 and 102 | Same |
| Degree of protectionagainst electrical shock | Type CF and BF.ECG, IBP and CO = CFNIBP and SpO2 = BF | Same |
| ElectrosurgicalInterference Suppression | Yes | Same |
| Displayed Waveforms | ||
| ECG | Up to 12 lead | Same |
| BP | Up to 4, separate orsuperimposed | Same |
| Respiration | 1 | Same |
| SpO2 | 1 | Same |
| EtCO2 | 1 | Same |
| EEG | 2 channels | Same |
| Displayed NumericParameters | ||
| Heart Rate | Yes | Same |
| Respiration Rate | Yes | Same |
| SpO2 | Yes | Same |
| BP - Systolic, Diastolic,Mean | Yes | Same |
| Temperature | 2 | Same |
| EtCO2 | Yes (optional) | Plug in Module (option) |
| CerebraLogik interface | EEG & aEEG | Same |
| Alarm Indications | Yes | Same |
| Display Functions | VitaLogik 6000/6500 | Menntor X7 |
| Change ECG LeadSelection | YES | Same |
| Display of ArrhythmiaInformation | YES | Same |
| Data Review: Trends -Graphic | YES | Same |
| Data Review: Chart -Tabular | YES | Same |
| User defined ConfigurationSetup | YES | Same |
| User defined DefaultSettings | YES | Same |
| Accessories | Accessories | Same |
{8}------------------------------------------------
.
{9}------------------------------------------------
.
{10}------------------------------------------------
・
{11}------------------------------------------------
:
{12}------------------------------------------------
Conclusion of comparison of technological characteristics:
We consider the Menntor X7 when used with the MPM inserted in the host Menntor X7 to be substantially equivalent to the VitaLogik 6000/6500 monitor and we submit that the differences between the two monitors do not raise any new issues of safety and effectiveness.
-
- Spirometry Module
| EnvoySpirometry module | Menntor X7 – Spirometryplug-in module | |
|---|---|---|
| -- | ---------------------------- | ------------------------------------------- |
{13}------------------------------------------------
| Spirometry module P/N | 551-137-000 | 751-137-000 |
|---|---|---|
| 510K number | K030722 02/26/2004 | |
| Module size: | Height: 10.0cmWidth: 4.0 cmDepth: 14.0 cm | Height: 9.5cmWidth: 4.0 cmDepth: 11.5 cm |
| Display Function | ||
| Air Flow waveform | Same | |
| Volume waveform | Same | |
| Airway pressure waveform | Same | |
| Flow-volume loop | Same | |
| Pressure-volume loop | Same | |
| Pressure-flow loop | Same | |
| Derived parameters | Same | |
| Pulmonary mechanics parameters | Vt_e. PIP, PEEP, MAP, Plat,PF_i, PF_e, RR, Ve, I:E,COMP, RES, RSBI | Same |
| Clinical Alarms for derived parameters | Visual & Sound Alarms | Same |
| Data Storage | ||
| Trend of derived parameters | Yes - up to 3 months | Yes - up to 80 days |
| Chart of derived parameters | Yes- up to 3 months | Yes - up to 80 days |
| Waveforms of Flow, Volume and Pressure | Yes- up to 72 hours | Yes - 5 days |
| Specifications | ||
| Degree of protection against electrical shock | Type BF applied part | Same |
| Sampling | 100 sps | Same |
| Airway Adapter specification | ||
| Flow Range: | 2 - 180 lpm (33 - 3000 ml/s) | Same |
| Accuracy: | $\pm$ 5 % reading, or 0.5 lpm | Same |
| Dead Space: | 6.9 ml | Same |
| EnvoySpirometry module | Menntor X7 - Spirometryplug-in module | |
| Connections: | Airway - 15 mm ID/22 mmODpatient end by 15 mm IDventilator end (ISO 5356-1)Proprietary Smart connector.Tri-Tubing - triple 0.055" inchID lumen | Same |
| Length: | 2.5 inches (adapter) - 6 feet(tubing) | Same |
| Weight: | 6.3 grams (minus tubing) | Same |
| Material: | Sensor - Polycarbonate(Makrolon).Tubing - Medical gradePolyvinyl Chloride | Same |
·
{14}------------------------------------------------
Conclusion of comparison of Spirometry technological characteristics:
We consider the Menntor X7 Spirometry module to be substantially equivalent to the Envoy Spirometry module and we submit that the differences between the two monitors do not raise any new issues of safety and effectiveness.
{15}------------------------------------------------
The following table compares the major software element and/or changes done in the Menntor X7 vs. the VitaLogik 6000/6500, predicate device ( K131789 dated 27.12.2013) and also in (K093766 dated 7.2.2014)
| SW Component | VitaLogik 6000/6500 | Menntor X7 |
|---|---|---|
| Display size | 15 inch | Same |
| Display | All waveforms and numeric vital sings | Same |
| Operating System | QNX4 | Same |
| GUI | Same | Same |
| Menus | Full set | Same |
| Vital signs 6000 | Non invasive | Same |
| Vital signs 6500 | Cardiac Output,2 (4 optional) Invasive pressures | Same |
| LAN | YesOptional Wireless LAN | Same |
| Optional Hardware enable | Touch screen | Same |
We consider the Menntor X7 to be substantially equivalent to the Vital ogik 6000/6500 monitor and we submit that any differences between the two systems
· do not raise any new issues of safety and effectiveness
7. Similarities and Differences in Design:
Menntor X7 versus VitaLogik 6000/6500
The following technological and other characteristics/features apply to both the Menntor X7 and the VitaLogik.
- . Intended for use in hospitals
- Do not change the functionality of the monitor .
- Isolated inputs for vital signs sensors ●
- . ECG amplifier front end with defibrillator protection
- Selectable filters for ECG
- Invasive BPs input circuit
- Non Invasive BP measurement ●
- Sp02 measurement
- Analog output for ECG and BP ●
- Display of vital signs and physiological waveforms .
- . Same GUI and same menus
- . Monitors, Central Nurse Stations, Recorders and Printer on common LAN network
- . Monitoring at central nurse station
- Optional Wireless LAN
The major differences between the Menntor X7 and the VitaLogik 6000/6500 are:
-
- The Menntor X7 is a modular monitor, while the VitaLogik 6000/6500 is a configured monitor
{16}------------------------------------------------
-
- EtCO2 on Menntor X7 is on a plug-in module as opposed to built-in on VitaLogik 6000/6500
-
- Menntor X7 has a Spirometry module, that is not part of VitaLogik 6000/6500
8. Conclusion of comparison of technological characteristics:
We consider the VitaLogik 6000/6500 to be substantially equivalent to the VitaLogik 4000/4500 monitor and we submit that any differences between the two systems
- do not raise any new issues of safety and effectiveness ●
9. Verification, Validation and Testing
The Menntor X7 and it's MPM have been subject to extensive performance testing to ensure that:
- The acquisition and display of the patient data and waveforms by the Menntor X7 remain the same for the predicate device VitaLogik 6000/6500.
Calibrated simulators were used to confirm the equivalence of each of the monitored Vital signs.
-
The acquisition and display of the Spirometry data and waveforms by the Menntor X7 remain the same for the predicate device Envoy Spirometry module.
-
The menu of the Menntor X7 is identical in response to the relevant menu items on the predicate device VitaLogik 6000/6500.
-
At the system level, SW Validation of the performance of the Menntor X7 as compared to the VitaLogik 6000/6500 system was carried out in accordance with the test plan described in the Mennen Medical Validation Test Procedure for the Menntor X7.
-
The SW Test Description for the Menntor X7 was derived from the SW Test Description for the VitaLogik 6000/6500 .
Final testing for the Menntor X7 included performance tests designed to ensure that the device meets all functional requirements and performance specifications, in accordance with the requirements of the Final Test Procedure for the Menntor X7. 6. Electrical Safety testing and EMC testing were performed by an independent testing laboratory to ensure that the device complicable industry and safety standards.
10. Proposed Labeling
The system is called Menntor X7, and was assigned a P/N 791-000-000 The Multi Parameter Module is called MX57 and was assigned P/N 751-000-0XX
Page 1-1 of the Menntor X7 User Guide contains the following
Prescription Notice
CAUTION! Federal law restricts this device to sale by or on the order of qualified medical personnel only.
{17}------------------------------------------------
The following symbols appear on page 2-4 of the Menntor X7 User's Guide and on the front panel of the MPM. See the image of the front panel of the VitaLogik Menntor X7 on page 3-4 in the User manual.
Image /page/17/Figure/2 description: The image shows two medical device symbols and their corresponding text descriptions. The first symbol is a yellow triangle with an exclamation point inside, accompanied by the text "Attention - see Accompanying Instructions for Use". The second symbol depicts a person inside a square with horizontal lines on either side, and the text reads "Type BF Applied part (next to NIBP, SpO2, Temperature and EtCO2 connectors)".
Image /page/17/Picture/3 description: The image shows a black heart inside of a square. On either side of the square are two small, black, plus-sign-like shapes. The heart is centered in the square. The plus-sign shapes are aligned horizontally with the heart.
Type CF Applied Part -- Defibrillation Proof (next to ECG, IBP and CO connector)
Symbols and labeling on the front panel of the VitaLogik
11. Voluntary Standards
Appropriate voluntary standards for this device, to which conformance have been demonstrated:
-
- IEC 60601-1: (2005+A1:2012) Medical Electrical Equipment Part: 1 General Requirements for Safety
-
- IEC 60601-1-2 (2007+C11:2010): Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
- % IEC 60601-2-27 (2011): Medical electrical equipment, Part 2, Requirements for safety of electrocardiograph monitoring equipment.
-
- IEC 80601-2-30 (2009+A1:2013): (was tested on the VL 6000-predicate device. the module wasn't changed) Medical electrical equipment, Part 2 - requirements for safety of automatic cycling indirect blood pressure monitoring equipment
- & IEC 60601-2-34 (2011): (was tested on the VL 6000-predicate device. the
{18}------------------------------------------------
module wasn't changed)
Medical electrical equipment, Part 2 - Particular requirements for the safety of direct blood pressure monitoring equipment
-
- IEC 60601-2-49 (2011):
Particular Requirements for the safety of multifunction patient monitoring equipment
- IEC 60601-2-49 (2011):
や IEC 60601-1-8 (2012):
General requirements for safety-collateral requirements, test & guidance for alarm system in medical electrical equipment & medical electrical systems
12. Indications for Use
Device Name: Menntor X7
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 monitor as indicated above is the same as the Indications for Use.
§ 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.