VITALOGIK

{0}------------------------------------------------ 052288 Image /page/0/Picture/2 description: The image shows the logo for "mennenmedical". The logo features a stylized lowercase "m" inside a circle, followed by the word "mennenmedical" in a sans-serif font. Below the word "mennenmedical" is the tagline "The Professional's Choice" in a smaller, italicized font. DEC 2 0 2005 Date: November 10, 2005 #### Topic: 510(k) Safety and Effectiveness Summary as per 21 CFR Section 807.92(c) #### Special 510(k): Device Modification - VitaLogik #### Establishment Name, Registration Number and Address: | Name: | Mennen Medical Ltd. | |----------------------|-----------------------------------------| | Registration Number: | 9611022 | | Operator Number: | 9011766 | | Address: | 4 Hayarden Street, Yavne, 81228, Israel | | Postal Address: | PO Box 102,<br>Rehovot, 76100, Israel | | Tel: | +972-8-9323333 | Fax: +972-8-9328510 Contact person: Micha Oestereich, 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: Micha Oestereich, Regulatory Affairs #### Product Name Proprietary: VitaLoqik Common: Physiological Patient Monitor Mennen Medical Part Number: 641-000-000 {1}------------------------------------------------ #### FDA Classification Classification Name: Classification Number: Classification: Product Code: Arrhythmia Detector and Alarm 21 CFR 870.1025 Class III 74 DSI #### Performance Standards: None promulgated #### Voluntary Standards: *IEC 60601-1: Medical Electrical Equipment Part:1 General Requirements for Safety File 4745C 1998:12 *IEC 60601-1-1 (2001) Medical Electrical Equipment Part 1-1: General Requirements for Safety Collateral Standard: Safety Requirements for Medical Electrical Systems *IEC 60601-1-2 (2001): Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests. #### *IEC 60602-2-27 (1994): Medical electrical equipment, Part 2. Requirements for safety of electrocardiograph monitoring equipment. #### *IEC 60601-2-30 (1995): Medical electrical equipment, Part 2 - requirements for safety of automatic cycling indirect blood pressure monitoring equipment #### *IEC 60601-2-34 (1994): Medical electrical equipment, Part 2 - Particular requirements for the safety of direct blood pressure monitoring equipment #### * IEC 60601-2-49 (2001): Particular Requirements for the safety of multifunction patient monitoring equipment #### * IEC 60601-1-8 (2003): General requirements for safety-collateral requirements, test & guidance for alarm system in medical electrical equipment & medical electrical systems {2}------------------------------------------------ #### Terminology: Envoy Patient Monitor = the predicate device. The Envoy was cleared for marketing by the FDA in the following 510(k) submittals: - K974510 14" April 1998 . - K983864 8" October 1999 . - K000563 17th May 2000 . - K001120 -- 8t" May2001 . - K011784 16th August 2001 ◆ - K022168 13 August 2002 . VitaLogik = Subject of this Special 510(k). The VitaLogik is a modified device to the Envoy Patient Monitor #### 1. Device Description: VitaLogik Monitor The VitaLogik is a configured multi-parameter physiological patient monitor, based on the hardware and software of the Mennen Medical Envoy monitor, without the module rack and modules. The front end electronic is composing the modules hardware and software into the chassis of the Bed Side Computer =BSC. The input connectors are incorporated in the front panel of the BSC It is offered in two basic options: Non-Invasive monitor and Full monitor. In the Non-Invasive version the vital signs are ECG, NIBP, SpO2 and Temperature. The Full monitor includes also two invasive Blood Pressures and Cardiac Output. Both have EtCO2 as an option. #### Functional Description of the VitaLogik The VitaLogik is a configured (no modules) monitor, based on the Envoy monitor, hardware and software, without the module rack and modules. It measures vital signs such as ECG/Heart rate, NIBP, SpO2, Temperature Cardiac output and EtCO2 as an option. It will be offered in two basic options: Non-Invasive monitor ECG/Heart rate, NIBP, SpO2. Temperature and Full monitor that includes also two invasive BP and Cardiac output. Both will have EtCO2 as an option. It will have one serial input for vendor devices. The VitaLogik uses identical display and patient data as does the Envoy. The Ensemble central station and the Enquard remote monitor can both view the VitaLogik as well as the Envoy. The VitaLogik has serial input for interface with other vendor devices in the same way that does the UIM module of the Envoy. {3}------------------------------------------------ # Non Invasive VitaLogik version: Vital signs parameters - Diagnostic 7 or 12 Lead ECG . - Non-invasive Blood Pressure . - Pulse Oximetry (SpO2) . - Temperature . - EtCO2 (optional) . ## Full VitaLogik version: Vital signs parameters - Diagnostic 7 or 12 Lead ECG . - Non-invasive Blood Pressure . - Pulse Oximetry (SpO2) . - Temperature ● - 2 Invasive Blood Pressure channels . - Cardiac Output . - EtCO2 (optional) . #### VitaLogik Options: - Non Invasive monitor . - Full monitor ● - EtCO2 . #### Main components of the VitaLogik: The VitaLogik system consists of: #### (A) a Bed side computer and - (B) a Display - (A) The Bed side computer acquires, processes, and converts vital signs from the patient into waveforms and digital signals. The VitaLogik can acquire the following physiological signals of the patient: - · ECG Waveform and measures Heart Rate, ST and Arrhythmia - · Blood Pressure Waveform and measures Systole, 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 {4}------------------------------------------------ - · NIBP Systolic, Diastolic and Mean pressure with measuring time stamp - · EtCO2 EtCO2, inCO2 and Respiration Rate - (B) The Display is used to display the measurement and waveforms, and alarms. It does not have any control function. #### INDICATIONS FOR USE VitaLogik is intended for use as a multiparameter physiological patient monitoring system. The VitaLogik can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood two temporature onances, palows the VitaLogik to monitor a wide-range prodult, 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 VitaLogik is intended for sale as a system for monitoring and r no monthen information or any in-hospital application requiring 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 {5}------------------------------------------------ # 2. Substantial Equivalence: VitaLogik versus Envoy # Comparison: Envoy with VitaLogik The following tables summarize and compare data on the Envoy (predicate device i The following tables Summanize and Sexpecial 510(K) submittal, the VitaLogik. | | Envoy | VitaLogik | |----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | Part/Option Number | 550-010-017 | 641-000-000 | | Input Circuit<br>Parameters | | | | Chassis Leakage<br>Current | All patient signal inputs fully<br>isolated (<50 μΑ)<br>Meets or exceeds ANSI<br>standard: "Safe Current<br>Limits for Electromedical<br>Aparatus," (SCLE) Dec,<br>1978 item 2.1.1. | Same | | Degree of protection<br>against electrical<br>shock | Type CF and BF.<br>ECG, IBP and CO = CF<br>NIBP and SpO2 = BF | Same | | Electrosurgical<br>Interference<br>Suppression | Yes | Same | | ECG | 3/5/6/12 Lead | Same | | Input Impedance: | Typical 20 ΜΩ<br>Minimum greater than:<br>5 MΩ differential, DC to 10<br>Hz; 2.5 MΩ differential 10<br>to 100 Hz 3 ΜΩ differential<br>at 10 Hz | 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 | | | Envoy | VitaLogik | | | | | | Input offset | $\pm$ 300mV, as per<br>ANSI/AAMI<br>EC13 Para. 3.2.9.1. | Same | | Noise: | Less than 30 μ V p-p<br>referenced to input | Same | | Defibrillator<br>Protection: | Up to 5 KV. Amplifier<br>Recovery time: < 3 seconds | Same | | Gain: | Manual selection of 1/4, 1/2,<br>1, 2, 4, 8 mV/cm | Same | | ECG Analog Output: | 1 Volt / mVolt | Same | | Sampling Rate and | Sampling rate: 640Hz | Same | | Resolution | Resolution:<br>22 bit | Same | | Frequency Response | Diagnostic : 0.05 to150 Hz | Same | | | Monitoring: 0.5 to 40 Hz | | | | Exercise: 1.0 to 25 Hz | | | | ST: 0.05 to 40 Hz | | | QRS Detection Range | Height: 0.25 to 5.0 millivolt | Same | | | Width: 70 to 120 mSec | | | Heart Rate Counting | Range: 20 to 300 BPM | Same | | | Accuracy: ± 2 BPM | | | | Note: Values below 20 are<br>forced to zero. | | | Heart Rate Alarm<br>Settings | High and low rate: 20 - 250<br>BPM non-overlapping | Same | | Leads analyzed for Heart<br>Rate and Arrhythmia<br>Configuration | Top two displayed | Same | | | Envoy | VitaLogik | | ECG Leads: | | Same | | 3 Lead cable | -- I or II or III | | | 5 Lead cable | -- I, II, III, aVR, aVL, aVF, V | | | 6 Lead cable | -- I, II, III, aVR, aVL, aVF, Va, Vb | | | 12 Lead module | -- I, II, III, aVR, aVL, aVF, V1-V6 | | | Common Mode Rejection | 120 dB, minimum | Same | | Lead Fault Detection | Based on impedance | Same | | Pacemaker Detection and Rejection | Amplitude: 2 mV to 700 mV<br>Width: 0.1 ms to 2.0 ms<br>Pacemaker flag inserted into displayed waveform | Same | | Data Storage : | Beat notification RR Interval Heart Rate ST values Arrhythmia Alarms Parameter settings Cycle time and measurement time markers All measurements for 36 hrs S/D/M and pulse rate values Alarm event markers | Same | | Respiration | | | | Lead Selection | RA-LA or RA-LL | Same | | Respiration Sensitivity Range | 0.2 ohm to 5.0 ohm | Same | | | Envoy | VitaLogik | | Impedance Range | 100 to 3,000 ohm @ 65 kHz | Same | | Respiration Rate<br>Counting Range | 8 to 150 BPM | Same | | Respiration Frequency<br>Response | 0.13 to 2.5 Hz (-3 dB) | Same | | Sampling rate: | 38 Hz | Same | | Respiration Alarm<br>Settings | Low rate: 0 - 150 BPM<br>High rate: 8 - 150 BPM<br>Apnea: User configurable<br>Cardiac coincidence alarm | Same | | Data Storage : | Respiration rate Respiration rate Alarms Apnea alarms Waveform labels and annotations Instantaneous resp. rate Alarm event markers | Same | | BP | LED for function indication | Same | | Transducer Excitation<br>Voltage | +5 VDC<br>Separate excitation driver for<br>each channel | Same | | Site Labels: | BPX, ART, PAP, CVP, RAP,<br>LAP, ICP | Same | | Input Sensitivity | 5 microVolt/Volt/mmHg | Same | | Dynamic Range | -- Pressure range:<br>-50 to +300 mmHg<br>-- Zero range:<br>±200 mmHg<br>-- Total dynamic range:<br>-200 to +450 mmHg | Same | | | Envoy | VitaLogik | | Zero Accuracy | ±0.2 mmHg | Same | | Zero Drift | Less than ±0.2 mmHg in 24<br>hours, at constant temperature) | Same | | Blood Pressure Accuracy | ±2 mmHg or ±2%, whichever<br>is greater, exclusive of<br>transducer | Same | | Blood Pressure Linearity | within 1% across entire range | Same | | Waveform Frequency<br>Response | 0 - 15 Hz | Same | | Sampling Rate | 320 Hz | Same | | Fault Detection | • Shorted transducer<br>• Transducer in/out<br>• Cable out | Same | | Data Storage | Systolic, Diastolic and Mean<br>Alarms | Same | | Cardiac Output and<br>Temperature | | | | Adapter and<br>Compatibility Cables | -- COSetª Interface cable<br>-- Ice Bath Cardiac Output<br>interface cable<br>-- Dual temperature interface<br>cable (ysi-400) | Same | | Temperature Range | Blood temperature:<br>27°C to 45°C (80.6° to 113° F)<br>Injectate temperature:<br>0°C to 25°C (32° to 77° F)<br>Body temperature:<br>0°C to 43°C (32° to 109.4°F) | Same | | | Envoy | VitaLogik | | Accuracy | Blood temperature:<br>$±0.1°C$ (32.18°F)<br>Injectate temperature:<br>$±0.1°C$ (32.18°F) | Same | | Excitation | 10μA, maximum | Same | | Frequency Response | 0 to 15 Hz | Same | | Cardiac Output<br>Determination Range | 0 to 20 liters per minute | Same | | Injectate Volumes | 1, 3, 5, and 10cc | Same | | Computation Constants | Table built as new values are<br>used | Same | | Displayed Data | Cardiac Output Cardiac Index Stroke Volume Stroke Volume Index Blood Temperature Injectate Temperature Trial Number | Same | | Data Storage :<br>- In Cardiac Output<br>mode | Cardiac Output Hemodynamic Calculation results Measuring time | Same | | Data Storage<br>- In Two Temp mode: | Temperatures Delta-Temp Temperature Alarms | Same | | Non-Invasive Blood<br>Pressure | LED for function indication<br>Oscillometric Method | Same | | Displayed Parameters | Systolic, Diastolic, Mean<br>pressure values<br>Time of last measurement,<br>measurement Interval, | Same | | | Envoy | VitaLogik | | Inflation Rate | Within 5 sec. | Same | | Initial Inflation: | 150 mmHg (adult)<br>120 mmHg (pediatric). | Same | | Cycle Times | Deflation time (typical):<br>30 sec.<br>BP time-out: 60 - 180 sec | Same | | Measurement Ranges,<br>Adult (in mmHg) | Systolic: 25 to 255<br>Diastolic: 10 to 220<br>Mean: 18 to 235 | Same | | Measurement Ranges,<br>Neonatal (in mmHg) | Systolic: 20 to 135<br>Diastolic: 5 to 110<br>Mean: 10-125 | Same | | Modes: | Auto, Manual, STAT | Same | | Pressure (Transducer)<br>Accuracy | ±3 mmHg or ±2%,<br>whichever is greater | Same | | Heart Rate | 40 to 140 BPM | Same | | Data Storage : | • measurement time markers<br>• S/D/M<br>• Alarm event markers | Same | | Pulse Oximetry (Sp02) | Masimo or Nelcor Technology | Same | | Saturation Range | 1% to 100% Sp02 | Same | | Sp02 Accuracy | % SpO2 ± 1 standard deviation | Same | | Pulse Rate Range | 20 to 250 BPM ±3 BPM | Same | | Saturation alarm limits: | 50% to 100% | Same | | | Envoy | VitaLogik | | | | | | End Tidal CO2 | LED for function indication | Same | | Microstream | Air outlet | | | | | | | Displayed Data | Waveform labels and<br>annotations | Same | | | EtCO2, inCO2 and respiration<br>rate values | | | CO2 Display Range: | 0-100 mmHg | Same | | Typical Accuracy: CO2 | $\pm$ 2 mmHg for CO2 | Same | | | range of 0-38 mmHg | | | | $\pm$ 5% for CO2 | | | | range of 39-99 mmHg + 0.08%<br>for every 1 mmHg above 38<br>mmHg | | | Typical Accuracy: | 0 -- 70 bpm +/- 1 bpm | Same | | Respiration Rate | 71 – 120 bpm +/- 2 bpm | | | | 121 – 150 bpm +/- 3 bpm | | | Rise Time | 190 msec (10% - 90%) | Same | | Delay Time | 2.7 Sec (10% - 90%) typical | Same | | CO2 Alarm Limits: | 0 to 100 mmHg/ | Same | | | 0 to 10% | | | | 0-15 kPA | | | Accuracy: | for % measurement: 0.1% | Same | | | for mmHg measurement: 1mm | | | Respiration Rate Alarm | Neonatal: 0 to 150 BMP | Same | | Limits: | Adult: 0-50 BPM | | | Sidestream Flow Rate: | 50 ml/min. nominal | Same | | Start-up Time: | 30 sec. typical | Same | | Automatic<br>Compensation: | At least once per hour | Same | | Ambient Temperature: | 0-65° C Sidestream | Same | | | Envoy | VitaLogik | | | | | | Humidity: | 10-95% RH, non-condensing | Same | | Barometric Pressure: | 430-795 Hg (-1250 to 15,000 ft.) | Same | | Data Storage : | EtCO2, inCO2 and Respiration Rate values Alarms Apnea Alarm | Same | | Universal Input | Interface to other vendor device protocols in RS232. | Same | | Number of inputs | One on Uniport module<br>Three on Multiport | One only | | Cable In/Out Detection | Yes | Yes | | Provides electrical<br>isolation between the<br>monitor and external<br>device/s | Yes | Yes | | Displays clinical and<br>technical alarms from<br>external device/s | Yes | Yes | | Clinical Software Features | | | | Waveform Display | 175 mm horizontal area 7 sec. @ 25mm/sec Up to 8 traces Overlapping traces Expanded display | Same | | Numeric Display | 85 mm horizontal area 25mm Heart Rate 20mm Sp02 "Big Numbers" | Same | | | Envoy | VitaLogik | | Default Alarms | User defined Fixed or calculated values | Same | | Data Display | Tabular charts Graphic trends | Same | | Electrical Specifications | | | | Main Processing Unit | AC Power Input<br>90-132/180-264 VAC, single phase, at 47-63 Hz.<br>Maximum current:<br>Dual fuse: each 3.15A, 250V. Slow Blow | Same | | AC Power Output for<br>Local Display | 90-132/180-264 VAC at 47-63 Hz, single phase.<br>Comes through the MPU power switch.<br>Maximum Output power:<br>130W | Same | | Display Monitor | 15", 17", 20" and flat screen (15", 18") are available.<br>Complies with Part 15 of the FCC Rules | Same | | Environmental Spec. | | | | | Envoy | VitaLogik | | Operating Conditions | Temperature: +5°C to +40°C<br>Humidity: 10 to 95 percent, non-condensing<br>Altitude: -350 to 3050 meters<br>( -1300 to 10,000 feet)<br>Vibration/Shock: per<br>Mennen Medical:<br>Design for Regulatory | Same | | Storage Conditions | Temperature:-15 °C to +60 °C<br>Humidity: 10 to 95 percent, non-condensing<br>Altitude: -350 to 5000 meters<br>( -1300 to 17,000 feet) | Same | Page 6 of 24 {6}------------------------------------------------ : ・ {7}------------------------------------------------ ·· {8}------------------------------------------------ {9}------------------------------------------------ : {10}------------------------------------------------ Food and Drug Administration I Ood and Drefecation – Envoy Patient Monitor: Special 510(k) for VitaLogik {11}------------------------------------------------ T {12}------------------------------------------------ : {13}------------------------------------------------ Food and Drug Administration Pood and Drug Promination – Envoy Patient Monitor: Device Modification – Envoy Patient Monitor: Special 510(k) for VitaLogik {14}------------------------------------------------ . {15}------------------------------------------------ Food and Drug Administration Fold and Drug AtdininGrany Patient Monitor: Special 510(k) for VitaLogik . . | | Envoy | VitaLogik | |--------------------------------------------|---------------------------------------------------------|-------------------------------------| | Displayed Waveforms | | | | ECG | Up to 12 lead | Same | | BP | Up to 4, separate or<br>superimposed | 2 separate or<br>superimposed | | Respiration | 1 | Same | | SpO2 | 1 | Same | | EtCO2 | 1 | Same | | Displayed Numeric<br>Parameters | | | | Heart Rate | Yes | Same | | Respiration Rate | Yes | Same | | SpO2 | Yes | Same | | | Envoy | VitaLogik | | Displayed Waveforms | | | | ECG | Up to 12 lead | Same | | BP | Up to 4, separate or<br>superimposed | 2 separate or<br>superimposed | | Respiration | 1 | Same | | SpO2 | 1 | Same | | EtCO2 | 1 | same | | Displayed Numeric<br>Parameters | | | | BP - Systolic, Diastolic,<br>Mean | Yes | Same | | Temperature | 2 | Same | | EtCO2 | Yes (optional module) | Optional | | Alarm Indications | Yes | Same | | Display Functions | Envoy | VitaLogik | | 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<br>Configuration Setup | YES | Same | | User defined Default<br>Settings | YES | Same | | Accessories | Envoy accessories | Same | | GUI | Menu driven | same | | Item | Envoy | VitaLogik | | Front End<br>electronics | Module rack | Integrated front end<br>electronics | | Front Panel<br>keys | 10 | 3 | | Quicknobe | Yes | Same | | Main screen | Yes | Same | | Escape | Yes | Same | | Vital Signs - Orange | Yes | No | | Patient data - Orange | Yes | No | | Setup - Orange | Yes | No | | Timer - Yellow | Yes | No | | Print - Green | Yes | No | | Record -<br>Green | Yes | No | | Event -<br>Green | Yes | Yes | | Freeze -<br>Green | Yes | No | | Silence - Red | Yes | Yes | | Alarm Off -<br>Red | Yes | Yes | | Menu item | Envoy | VitaLogik | | Vital Signs | Dynamic list of vital<br>signs per available<br>modules | Fixed list of<br>vital signs | | ECG | Yes | Yes | | Respiration | Yes | Yes | | NIBP | Yes | Yes | | Temperature | Yes | Yes | | SpO2 | Yes | Yes | | BP | Yes | Yes | | CO | Yes | Yes | | EtCO2 | Optional | Optional | | Spirometry | Yes | No | | EEG | Yes | No | | Patient data | Same | Same | | Setup | Same | Same | | Setup --<br>Software<br>version | Shows software<br>version and module<br>rack, setting. | Show only<br>software<br>version | | Setup -<br>Parallel port | Yes | No | | System Setup | Same | Same | | System<br>Setup-<br>Parallel port<br>setup | Yes | No | : {16}------------------------------------------------ : Food and Drug Administration Device Modification – Envoy Patient Monitor: Special 510(k) for VitaLogik : . {17}------------------------------------------------ ### Comparison ______________________________________________________________________________________________________________________________________________________________________________ #### Hardware comparison {18}------------------------------------------------ #### Main Menu items comparison ______________________________________________________________________________________________________________________________________________________________________________ {19}------------------------------------------------ #### 3. Similarities and Differences in Design: #### VitaLogik versus Envoy ______________________________________________________________________________________________________________________________________________________________________________ The following technological and other characteristics/features apply to both the VitaLogik and the Envoy. - 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 . - Invasive BP input circuit . - Non Invasive BP measurement . - SpO2 measurement . - Selectable filters for ECG . - Analog output for ECG and BP . - Display of vital signs and physiological waveforms . - Same GUI and same menus . - Monitoring at central nurse station . The major differences between the VitaLogik and the Envoy are - The VitaLogik does not have a module rack 0 - The VitaLogik is a configured monitor with a fixed set of parameters 0 - The VitaLogik front panel is different from the Envoy ্ত - The VitaLogik has only 5 hardware keys as compared to 12 on the o Envoy panel The VitaLogik monitor provides access to the functions of the Hardware keys, which were omitted, via the menus. On the original Envoy monitor the Hardware keys were used as a shortcut to the same menu items, thus functionality is not reduced. If one or more of the missing hardware keys in the VitaLogik are frequently used in a given setup the missing hardware key can be replaced by software Quickeys available on both the Envoy and it's modified version VitaLogik. For example on the Envoy there is a hardware key to 'Patient Data'. On the VitaLogik the 'Patient Data' can be reached via the Main menu, or a software Quicknob can be create as a shortcut to 'Patient Data'. We submit that the change from Module rack monitor to configured monitor with the same menue and display does not amount to a change in the "fundamental scientific technology" of the Envoy and does not disqualify the VitaLogik from being the subject of a Special 510(k). The example brought down in 21 CFR 862.9 of a change in the "fundamental {20}------------------------------------------------ Food and Drug Administration Device Modification - Envoy Patient Monitor: Special 510(k) for VitaLogik scientific technology" ("a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade"), involves a radical change in the method and type of treatment given to the patient. The VitaLogik SW is a brunch of the Envoy SW that takes into account the replacement of the module rack and modules into a configured monitor The following table compares the major software element and/or changes done in the VitaLogik vs. the Envoy: | SW Component | Envoy | VitaLogik | |------------------|------------------------------------------|-----------| | Display | All waveforms and<br>numeric vital sings | Same | | Operating System | QNX4 | Same | | GUI | Same | Same | | Menus | Full set | Same | | Vital signs | Depend on available<br>modules | Fixed | #### Conclusion of comparison of technological characteristics: We consider the VitaLogik monitor to be substantially equivalent to the Envoy monitor and we submit that any differences between the two systems - fall within the scope of a Special 510(k) Device Modification and . - do not raise any new issues of safety and effectiveness . #### Testing The VitaLogik has been subject to extensive safety and performance testing. Final testing for the system included various performance tests designed to ensure that the device meets all functional requirements and performance specifications. Safety testing and EMC testing were performed by an independent testing laboratory to ensure that the device complies with applicable industry and safety standards. #### Indications for Use {21}------------------------------------------------ Food and Drug Administration Device Modification – Envoy Patient Monitor: 11 - 11 - 11 Special 510(k) for VitaLogik The Indications for Use of the VitaLogik remains basically the same at those set out for the Envoy (predicate device), K001120. See page 16 below for the Indications for Use. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {22}------------------------------------------------ #### INDICATIONS FOR USE VitaLogik is intended for use as a multiparameter physiological patient monitoring system. The VitaLogik 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 VitaLogik 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 VitaLogik is intended for sale as a system for monitoring and recording patient information or any in-hospital application requiring 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 {23}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Image /page/23/Picture/2 description: The image shows the seal of the Department of Health and Human Services, USA. The seal features a stylized eagle with its wings spread, surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement. The eagle is depicted in a simple, line-art style, and the text is in a sans-serif font. The overall design is clean and professional, reflecting the department's role in public health and welfare. DEC 2 0 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mennen Medical, Ltd c/o Ms. Micha Oestereich QA & Regulatory Affairs Manager P.O. Box 102 Rehovot, 76100 ISRAEL Re: K052288 Trade Name: VitaLogik Regulation Number: 21 CFR 870.1025 Regulation Name: 21 CFR 076.1025 Regulation Name: Arrhythmia Detector and Alarm (including ST-segment measurement and alarm) Regulatory Class: Class III (three) Product Code: DSI Dated: November 16, 2005 Received: November 22, 2005 Dear Ms. Oestereich: We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 910(x) premained is substantially equivalent (for the indications and cates and have determined the device is substantially interests to intere for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally mances province Amendments, or to commerce prior to May 28, 1776, the chance with the provisions of the Federal Food. Drug. devices that have been reclassified in accordance with the provision (PMA) devices that have been itClassified in accordance was in a premarket approval applications (PMA). and Cosmetic Act (Act) that do not require approval of a premarket approvali and Cosmetic Act (Act) that to hot require approval controls provisions of the Act. The You may, therefore, market the device, subject to the general controls, succision, l You may, therefore, market me device, baction of the one of the supportunities with and general Controls provisions of the rise labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into Existing major regulations affecting your device can be may be subject to such additional comboler a fittle 21, Parts 800 to 898. In addition, FDA may be found in the Ood of reasts concerning your device in the Federal Register. {24}------------------------------------------------ Page 2 - Ms. Micha Oestereich Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuation of a bacevice complies with other requirements of the Act that FDA has made a decemination that your as roos be for Federal agencies. You must or any Federal statutes and regulations administer or of limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 800); good mart 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declois Decembed in your device as described in your Section 510(k) I his letter will anow you to begin mankeling your antial equivalence of your device to a legally premarket notification. THC PDA midning of bassification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your do not our starties note the regulation entitled, Contact the Office of Comphance at (210) 216 - 16 - 16 - 16 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 Misoranung by icierchee to promance to promance the Act from the Division of Small other general information on your responsibilities at its toll-free number (800) 638-2041 or Manufacturers, International and Consultation of the world be responsible industry/support/index.html. Sincerely yours, Bhimmena for ). Zuckerman, M.D. Dire ctor Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {25}------------------------------------------------ # Indications for Use 510(k) Number (if known):_K052288 Device Name:__VitaLogik Indications For Use: thons For Use: VitaLogik is intended for use as a multiparameter physiological patient monitoring system. of The VitaLogik can monitor ECG/heart rate, two invasive blood pressure channels, 1 he VilaLogik Can monitor LOGHourrato, respiration, non-invasive blood two temperature channels, pulse oximetry, respiration, city to manitar a wide two temperature chamels, pulse oximotly, roophalade-ik to monitor a wide-range of the pressure and EIGUZ. This encentery anows the This So 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 VitaLogik is intended for sale as a system for monitoring nation i he Mennen Medical vitaEogik is intended for sails application requiring 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 Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) . AND/OR Over-The-Counter Use_ (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) Bhimman Division sign-on (Division sign-o Division of Cardiovascular Devices 510(k) Number kn51288 Page 1 of __ 1________________________________________________________________________________________________________________________________________________________________