MENNTOR X7

{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: - 1. Multi Parameter plug-in Module (MPM) - 2. Optional Wireless LAN - 3 Battery operated MPM - 4. Same user interface as VitaLogik and Envoy monitors - 5. Full compatibility with Ensemble Central station - 6. 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}------------------------------------------------ K141441 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: - 1. The Menntor X7 is a modular monitor while it's predicated device the VitaLogik 6000/6500 is a configured monitor - 2. 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 – 05/07/2010<br>K131789 – 12/27/2013 | | | Input Circuit Parameters | Configured | 2 Plug-in modules<br>Plug-in Multi Parameter<br>Module<br>(MPM) | | Chassis Leakage Current | All patient signal inputs fully<br>isolated (<50 μA)<br>Meets or exceeds ANSI<br>standard: "Safe Current Limits<br>for Electromedical Apparatus,"<br>(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 Hz<br>Diagnostic: 0.05 to 150 Hz,<br>Exercise : 1 to 25 Hz, -3 dB | Same | | Input Impedance: | Typical 20 MΩ<br>Minimum greater than:<br>5 MΩ differential, DC to 10<br>Hz; 2.5 MΩ differential 10 to<br>100 Hz 3 MΩ differential at 10<br>Hz | Same | | Common Mode Rejection: | At least 100 dB at 50/60 Hz<br>Without lead misbalance<br>86 db with lead misbalance<br>The common mode rejection<br>ratio is in accordance with<br>ANSI/AAMI EC11(9) Para.<br>3.2.11. | Same | | Input Dynamic Range: | ±5mV p-p at a rate up to<br>320mV/sec, as per<br>ANSI/AAMI EC13(8) Para.<br>3.2.9.1. | Same | | | VitaLogik 6000/6500 | Menntor X7 | | Input offset | $\pm$ 300mV, as per ANSI/AAMI<br>EC13 Para. 3.2.9.1. | Same | | Gain: | Manual selection of 250, 500,<br>1000, 2000, 4000 and 8000 x<br>ECG Signal impressed across<br>selected lead | Same | | Noise: | Less than 30 $\mu$ V p-p<br>referenced to input | Same | | Pacemaker Pulse Rejection: | Reject pulses from:<br>2.0 mV to 700 mV pulses of<br>0.2 to 2.0 mSec pulse widths<br>and $\ge$ 3.0mV for 0.1mSec<br>pulse width | Same | | Defibrillator Protection: | Up to 5 KV. Amplifier<br>Recovery time: < 3 seconds | Same | | Lead Fault Sense: | On any ECG electrode | Same | | QRS Detection: | 0.25 to 5.0 mV, 70-120 msec<br>width | Same | | Synchronous Defibrillation<br>Signal: | Pulse Width: 100 ms.<br>Amplitude: 5 Vdc amplitude<br>into 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 change<br>of 60 bpm from a base of 60<br>bpm | Same | | Blood Pressure | | | | Input Sensitivity: | 5 $\mu$ volts/volt/mmHg | Same | | Transducer Excitation: | 5 Volt | Same | | Ranges: | -50 to +300 mmHg. | Same | | Maximum variation during<br>zero: | $\pm$ 2 mmHg | Same | | | VitaLogik 6000/6500 | Menntor X7 | | | | | | Zero Accuracy: | $\pm$ 0.2 mmHg | Same | | Zero Drift: | Less than $\pm$ 0.2 mmHg in 24<br>hours | Same | | Transducer Load<br>Impedance: | 300 – 600Ω | Same | | Linearity: | Better than 1% of full scale | Same | | Common Mode Rejection: | 80 dB minimum (reference to<br>chassis 50/60Hz) | Same | | Frequency Response: | DC to 12 Hz<br>(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 dB<br>bandwidth | Same | | Range: | 8 to 150 bpm | Same | | Excitation: | 65 kHz | Same | | Pulse Oximetry (SpO2) | | | | Probe Type: | Masimo™ or Nellcor reusable<br>or disposable | Same | | Range: | 0% to 100%. | Same | | Pulse Rate Range: | 20-250 bpm, below 20 displays<br>zero | Same | | Rate Accuracy: | $\pm$ 3 bpm | Same | | | VitaLogik 6000/6500 | Menntor X7 | | SpO2 Accuracy: | Determined by specific sensor:<br>±2 digits between<br>70% and 100%<br>±3 digits between<br>50% and 70%.<br>±3 digits between<br>70% and 95%. | Same | | Non-Invasive Blood<br>Pressure | | | | Method: | Oscillometric | Same | | Initial Inflation: | 150 mmHg (adult)<br>120 mmHg (pediatric). | Same | | Pressure Accuracy: | Overall ± 3 mmHg, full scale. | Same | | EEG | | | | Features | EEG + aEEG | Same | | Number of channels | 2 | Same | | Protection | | | | Defibrillator Pulse<br>Protection | 5KV as per ANSI/AAMI EC13<br>(9), clause 3.2.2.2 and per<br>IEC 60601-2-27 (12),<br>clauses 17,101 and 102 | Same | | Degree of protection<br>against electrical shock | Type CF and BF.<br>ECG, IBP and CO = CF<br>NIBP and SpO2 = BF | Same | | Electrosurgical<br>Interference Suppression | Yes | Same | | Displayed Waveforms | | | | ECG | Up to 12 lead | Same | | BP | Up to 4, separate or<br>superimposed | Same | | Respiration | 1 | Same | | SpO2 | 1 | Same | | EtCO2 | 1 | Same | | EEG | 2 channels | Same | | Displayed Numeric<br>Parameters | | | | Heart Rate | Yes | Same | | Respiration Rate | Yes | Same | | SpO2 | Yes | Same | | BP - Systolic, Diastolic,<br>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 Lead<br>Selection | YES | Same | | Display of Arrhythmia<br>Information | YES | Same | | Data Review: Trends -<br>Graphic | YES | Same | | Data Review: Chart -<br>Tabular | YES | Same | | User defined Configuration<br>Setup | YES | Same | | User defined Default<br>Settings | 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. - 6. Spirometry Module | | Envoy<br>Spirometry module | Menntor X7 – Spirometry<br>plug-in module | |--|----------------------------|-------------------------------------------| |--|----------------------------|-------------------------------------------| {13}------------------------------------------------ | Spirometry module P/N | 551-137-000 | 751-137-000 | |-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------| | 510K number | K030722 02/26/2004 | | | Module size: | Height: 10.0cm<br>Width: 4.0 cm<br>Depth: 14.0 cm | Height: 9.5cm<br>Width: 4.0 cm<br>Depth: 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,<br>PF_i, PF_e, RR, Ve, I:E,<br>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 | | | Envoy<br>Spirometry module | Menntor X7 - Spirometry<br>plug-in module | | Connections: | Airway - 15 mm ID/22 mmOD<br>patient end by 15 mm ID<br>ventilator end (ISO 5356-1)<br>Proprietary Smart connector.<br>Tri-Tubing - triple 0.055" inch<br>ID lumen | Same | | Length: | 2.5 inches (adapter) - 6 feet<br>(tubing) | Same | | Weight: | 6.3 grams (minus tubing) | Same | | Material: | Sensor - Polycarbonate<br>(Makrolon).<br>Tubing - Medical grade<br>Polyvinyl 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,<br>2 (4 optional) Invasive pressures | Same | | LAN | Yes<br>Optional 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: - 1. The Menntor X7 is a modular monitor, while the VitaLogik 6000/6500 is a configured monitor {16}------------------------------------------------ - 2. EtCO2 on Menntor X7 is on a plug-in module as opposed to built-in on VitaLogik 6000/6500 - 3. 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: 1. 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. 2. The acquisition and display of the Spirometry data and waveforms by the Menntor X7 remain the same for the predicate device Envoy Spirometry module. 3. The menu of the Menntor X7 is identical in response to the relevant menu items on the predicate device VitaLogik 6000/6500. 4. 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. 5. 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 ## 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.