(119 days)
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
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.
The provided document is a 510(k) premarket notification for a device modification, specifically the "VitaLogik" patient monitor, which is a modified version of the "Envoy" patient monitor. The document primarily focuses on demonstrating substantial equivalence to the predicate device rather than providing a detailed study report with specific acceptance criteria and performance data for the VitaLogik device itself.
Based on the information provided, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative format. Instead, it demonstrates that the VitaLogik device's performance characteristics are "Same" as the predicate Envoy device across a wide range of parameters. The acceptance criterion inherently is "performance is substantially equivalent to the predicate device."
Here's a table summarizing the reported device performance, noting that for almost all parameters, the VitaLogik is stated to be "Same" as the Envoy:
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance (VitaLogik) |
|---|---|---|
| ECG | Substantially equivalent to Envoy | Same as Envoy for: Input Circuit, Chassis Leakage Current, Degree of protection, Electrosurgical Interference Suppression, 3/5/6/12 Lead options, Input Impedance, Input Dynamic Range, Input offset, Noise, Defibrillator Protection, Gain, ECG Analog Output, Sampling Rate and Resolution, Frequency Response, QRS Detection Range, Heart Rate Counting Range/Accuracy, Heart Rate Alarm Settings, Leads analyzed, Common Mode Rejection, Lead Fault Detection, Pacemaker Detection and Rejection, Data Storage. |
| Respiration | Substantially equivalent to Envoy | Same as Envoy for: Lead Selection, Sensitivity Range, Impedance Range, Respiration Rate Counting Range, Respiration Frequency Response, Sampling rate, Respiration Alarm Settings, Data Storage. |
| Blood Pressure (IBP) | Substantially equivalent to Envoy | Same as Envoy for: LED for function, Transducer Excitation Voltage, Site Labels, Input Sensitivity, Dynamic Range, Zero Accuracy, Zero Drift, Blood Pressure Accuracy, Blood Pressure Linearity, Waveform Frequency Response, Sampling Rate, Fault Detection, Data Storage. |
| Cardiac Output & Temperature | Substantially equivalent to Envoy | Same as Envoy for: Adapter and Compatibility Cables, Temperature Range, Accuracy, Excitation, Frequency Response, Cardiac Output Determination Range, Injectate Volumes, Computation Constants, Displayed Data, Data Storage. |
| Non-Invasive Blood Pressure (NIBP) | Substantially equivalent to Envoy | Same as Envoy for: LED for function, Oscillometric Method, Displayed Parameters, Inflation Rate, Initial Inflation, Cycle Times, Measurement Ranges (Adult/Neonatal), Modes, Pressure Accuracy, Heart Rate, Data Storage. |
| Pulse Oximetry (SpO2) | Substantially equivalent to Envoy | Same as Envoy for: Masimo or Nelcor Technology, Saturation Range, SpO2 Accuracy, Pulse Rate Range, Saturation alarm limits. |
| End Tidal CO2 (EtCO2) | Substantially equivalent to Envoy | Same as Envoy for: LED for function, Microstream, Displayed Data, CO2 Display Range, Typical Accuracy (CO2), Typical Accuracy (Respiration Rate), Rise Time, Delay Time, CO2 Alarm Limits, Accuracy (for %/mmHg), Respiration Rate Alarm Limits, Sidestream Flow Rate, Start-up Time, Automatic Compensation, Ambient Temperature, Humidity, Barometric Pressure, Data Storage. |
| Universal Input | Substantially equivalent to Envoy | Same as Envoy for: Interface, Cable In/Out Detection, Electrical Isolation, Displays clinical and technical alarms. |
| Clinical Software Features | Substantially equivalent to Envoy | Same as Envoy for: Waveform Display, Numeric Display, Default Alarms, Data Display, User defined Configuration Setup, User defined Default Settings. |
| Electrical Specifications | Substantially equivalent to Envoy | Same as Envoy for: Main Processing Unit (AC Power Input, Maximum current, Dual fuse), AC Power Output for Local Display, Display Monitor. |
| Environmental Spec. | Substantially equivalent to Envoy | Same as Envoy for: Operating Conditions (Temperature, Humidity, Altitude, Vibration/Shock), Storage Conditions (Temperature, Humidity, Altitude). |
| Displayed Waveforms/Numeric Parameters | Substantially equivalent to Envoy | Many "Same" entries, e.g., ECG (Up to 12 lead), Respiration (1), SpO2 (1), EtCO2 (1). BP (VitaLogik has 2 separate or superimposed vs Envoy's up to 4). Numeric parameters like Heart Rate, Respiration Rate, SpO2, BP, Temperature. EtCO2 (optional for VitaLogik vs optional module for Envoy) |
| Alarm Indications | Substantially equivalent to Envoy | Same as Envoy |
| Display Functions | Substantially equivalent to Envoy | Same as Envoy for: Change ECG Lead Selection, Display of Arrhythmia Information, Data Review (Trends - Graphic/Chart - Tabular), User defined Configuration Setup, User defined Default Settings. |
| Accessories | Substantially equivalent to Envoy | Same as Envoy accessories |
| GUI | Substantially equivalent to Envoy | Same as Envoy (Menu driven) |
| Front End electronics | Integrated front end electronics (vs Module rack for Envoy) | Integrated front end electronics |
| Front Panel keys | Reduced from 10 (Envoy) to 3 (VitaLogik) | 3 (Quicknobe, Main screen, Escape, Event, Silence, Alarm Off - all "Same" too, implying those keys are present on VitaLogik, total 6, but some like Vital Signs, Patient Data, Setup, Timer, Print, Record, Freeze are gone). The document clarifies that functions of omitted keys are accessed via menus or software Quickeys. |
| Main Menu items | Similar functionality to Envoy, with fixed vital signs list | Fixed list of vital signs (vs dynamic for Envoy), but individual parameters (ECG, Respiration, NIBP, Temperature, SpO2, BP, CO, EtCO2) are listed as "Yes" and "Same" respectively. Spirometry and EEG present on Envoy but "No" on VitaLogik. |
| Software Components | Substantially equivalent to Envoy | Same as Envoy for: Display, Operating System (QNX4), GUI, Menus. VitaLogik has a fixed vital signs list (vs dependent on available modules for Envoy). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in terms of patient data or clinical cases. The testing conducted was focused on proving that the device "meets all functional requirements and performance specifications" and complies with applicable industry and safety standards (IEC 60601 series). This suggests bench testing and possibly internal validation based on engineering specifications, rather than a clinical study with a patient data set.
Therefore, there is no stated sample size for a test set and no information on data provenance (country of origin, retrospective/prospective clinical data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since there is no mention of a clinical test set requiring expert interpretation or ground truth establishment from medical professionals, this information is not applicable and not provided in the document. The "ground truth" for the engineering and safety testing would be the established performance specifications and voluntary standards (e.g., IEC standards).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
As no clinical test set requiring human interpretation is described, adjudication methods are not applicable and not mentioned.
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
The VitaLogik is a physiological patient monitor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes "extensive safety and performance testing" of the VitaLogik device, indicating it was tested as a standalone system to ensure it met functional requirements and specifications. However, this is not an "algorithm-only" standalone performance in the context of an AI device. It refers to the device's performance as a complete monitoring system without necessarily involving human operators during the performance tests (though human interaction would be part of usability/safety). The performance data presented (e.g., accuracy of HR counting, BP, SpO2, EtCO2, etc.) are inherent to the device's measurement capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the testing appears to be the defined engineering performance specifications and the requirements of voluntary international standards (IEC 60601 series) mentioned in the document. These standards set benchmarks for safety, electrical characteristics, and performance accuracy for various physiological measurements. For example, for Heart Rate Accuracy, the ground truth would be a validated reference measurement against which the device's stated accuracy of "± 2 BPM" would be verified.
8. The sample size for the training set
The document describes a device modification, not a machine learning or AI algorithm where a "training set" would be typically used. The VitaLogik's software is stated to be "a brunch of the Envoy SW," meaning it's derived from the predicate device's existing software with modifications related to the hardware changes. Therefore, there is no concept of a "training set" in the context of this 510(k) submission.
9. How the ground truth for the training set was established
As there is no "training set" described for the VitaLogik in this context, this question is not applicable. The device relies on established physiological measurement principles and software developed to implement these principles, inherited from the predicate device.
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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,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
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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
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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.
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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
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- · 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
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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 CircuitParameters | ||
| Chassis LeakageCurrent | All patient signal inputs fullyisolated (<50 μΑ)Meets or exceeds ANSIstandard: "Safe CurrentLimits for ElectromedicalAparatus," (SCLE) Dec,1978 item 2.1.1. | Same |
| Degree of protectionagainst electricalshock | Type CF and BF.ECG, IBP and CO = CFNIBP and SpO2 = BF | Same |
| ElectrosurgicalInterferenceSuppression | Yes | Same |
| ECG | 3/5/6/12 Lead | Same |
| Input Impedance: | Typical 20 ΜΩMinimum greater than:5 MΩ differential, DC to 10Hz; 2.5 MΩ differential 10to 100 Hz 3 ΜΩ differentialat 10 Hz | Same |
| Input Dynamic Range: | ±5mV p-p at a rate up to320mV/sec, as perANSI/AAMI EC13 (8) Para.3.2.9.1. | Same |
| Envoy | VitaLogik | |
| Input offset | $\pm$ 300mV, as perANSI/AAMIEC13 Para. 3.2.9.1. | Same |
| Noise: | Less than 30 μ V p-preferenced to input | Same |
| DefibrillatorProtection: | Up to 5 KV. AmplifierRecovery time: < 3 seconds | Same |
| Gain: | Manual selection of 1/4, 1/2,1, 2, 4, 8 mV/cm | Same |
| ECG Analog Output: | 1 Volt / mVolt | Same |
| Sampling Rate and | Sampling rate: 640Hz | Same |
| Resolution | Resolution: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 areforced to zero. | ||
| Heart Rate AlarmSettings | High and low rate: 20 - 250BPM non-overlapping | Same |
| Leads analyzed for HeartRate and ArrhythmiaConfiguration | 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 mVWidth: 0.1 ms to 2.0 msPacemaker 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 RateCounting Range | 8 to 150 BPM | Same |
| Respiration FrequencyResponse | 0.13 to 2.5 Hz (-3 dB) | Same |
| Sampling rate: | 38 Hz | Same |
| Respiration AlarmSettings | Low rate: 0 - 150 BPMHigh rate: 8 - 150 BPMApnea: User configurableCardiac 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 ExcitationVoltage | +5 VDCSeparate excitation driver foreach channel | Same |
| Site Labels: | BPX, ART, PAP, CVP, RAP,LAP, ICP | Same |
| Input Sensitivity | 5 microVolt/Volt/mmHg | Same |
| Dynamic Range | -- Pressure range:-50 to +300 mmHg-- Zero range:±200 mmHg-- Total dynamic range:-200 to +450 mmHg | Same |
| Envoy | VitaLogik | |
| Zero Accuracy | ±0.2 mmHg | Same |
| Zero Drift | Less than ±0.2 mmHg in 24hours, at constant temperature) | Same |
| Blood Pressure Accuracy | ±2 mmHg or ±2%, whicheveris greater, exclusive oftransducer | Same |
| Blood Pressure Linearity | within 1% across entire range | Same |
| Waveform FrequencyResponse | 0 - 15 Hz | Same |
| Sampling Rate | 320 Hz | Same |
| Fault Detection | • Shorted transducer• Transducer in/out• Cable out | Same |
| Data Storage | Systolic, Diastolic and MeanAlarms | Same |
| Cardiac Output andTemperature | ||
| Adapter andCompatibility Cables | -- COSetª Interface cable-- Ice Bath Cardiac Outputinterface cable-- Dual temperature interfacecable (ysi-400) | Same |
| Temperature Range | Blood temperature:27°C to 45°C (80.6° to 113° F)Injectate temperature:0°C to 25°C (32° to 77° F)Body temperature:0°C to 43°C (32° to 109.4°F) | Same |
| Envoy | VitaLogik | |
| Accuracy | Blood temperature:$±0.1°C$ (32.18°F)Injectate temperature:$±0.1°C$ (32.18°F) | Same |
| Excitation | 10μA, maximum | Same |
| Frequency Response | 0 to 15 Hz | Same |
| Cardiac OutputDetermination Range | 0 to 20 liters per minute | Same |
| Injectate Volumes | 1, 3, 5, and 10cc | Same |
| Computation Constants | Table built as new values areused | Same |
| Displayed Data | Cardiac Output Cardiac Index Stroke Volume Stroke Volume Index Blood Temperature Injectate Temperature Trial Number | Same |
| Data Storage :- In Cardiac Outputmode | Cardiac Output Hemodynamic Calculation results Measuring time | Same |
| Data Storage- In Two Temp mode: | Temperatures Delta-Temp Temperature Alarms | Same |
| Non-Invasive BloodPressure | LED for function indicationOscillometric Method | Same |
| Displayed Parameters | Systolic, Diastolic, Meanpressure valuesTime of last measurement,measurement Interval, | Same |
| Envoy | VitaLogik | |
| Inflation Rate | Within 5 sec. | Same |
| Initial Inflation: | 150 mmHg (adult)120 mmHg (pediatric). | Same |
| Cycle Times | Deflation time (typical):30 sec.BP time-out: 60 - 180 sec | Same |
| Measurement Ranges,Adult (in mmHg) | Systolic: 25 to 255Diastolic: 10 to 220Mean: 18 to 235 | Same |
| Measurement Ranges,Neonatal (in mmHg) | Systolic: 20 to 135Diastolic: 5 to 110Mean: 10-125 | Same |
| Modes: | Auto, Manual, STAT | Same |
| Pressure (Transducer)Accuracy | ±3 mmHg or ±2%,whichever is greater | Same |
| Heart Rate | 40 to 140 BPM | Same |
| Data Storage : | • measurement time markers• S/D/M• 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 andannotations | Same |
| EtCO2, inCO2 and respirationrate 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%for every 1 mmHg above 38mmHg | ||
| 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 |
| AutomaticCompensation: | 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 moduleThree on Multiport | One only |
| Cable In/Out Detection | Yes | Yes |
| Provides electricalisolation between themonitor and externaldevice/s | Yes | Yes |
| Displays clinical andtechnical alarms fromexternal 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 Input90-132/180-264 VAC, single phase, at 47-63 Hz.Maximum current:Dual fuse: each 3.15A, 250V. Slow Blow | Same |
| AC Power Output forLocal Display | 90-132/180-264 VAC at 47-63 Hz, single phase.Comes through the MPU power switch.Maximum Output power:130W | Same |
| Display Monitor | 15", 17", 20" and flat screen (15", 18") are available.Complies with Part 15 of the FCC Rules | Same |
| Environmental Spec. | ||
| Envoy | VitaLogik | |
| Operating Conditions | Temperature: +5°C to +40°CHumidity: 10 to 95 percent, non-condensingAltitude: -350 to 3050 meters( -1300 to 10,000 feet)Vibration/Shock: perMennen Medical:Design for Regulatory | Same |
| Storage Conditions | Temperature:-15 °C to +60 °CHumidity: 10 to 95 percent, non-condensingAltitude: -350 to 5000 meters( -1300 to 17,000 feet) | Same |
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Food and Drug Administration I Ood and Drefecation – Envoy Patient Monitor: Special 510(k) for VitaLogik
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Food and Drug Administration Pood and Drug Promination – Envoy Patient Monitor:
Device Modification – Envoy Patient Monitor:
Special 510(k) for VitaLogik
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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 orsuperimposed | 2 separate orsuperimposed |
| Respiration | 1 | Same |
| SpO2 | 1 | Same |
| EtCO2 | 1 | Same |
| Displayed NumericParameters | ||
| 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 orsuperimposed | 2 separate orsuperimposed |
| Respiration | 1 | Same |
| SpO2 | 1 | Same |
| EtCO2 | 1 | same |
| Displayed NumericParameters | ||
| BP - Systolic, Diastolic,Mean | Yes | Same |
| Temperature | 2 | Same |
| EtCO2 | Yes (optional module) | Optional |
| Alarm Indications | Yes | Same |
| Display Functions | Envoy | VitaLogik |
| Change ECG LeadSelection | YES | Same |
| Display of ArrhythmiaInformation | YES | Same |
| Data Review: Trends -Graphic | YES | Same |
| Data Review: Chart -Tabular | YES | Same |
| User definedConfiguration Setup | YES | Same |
| User defined DefaultSettings | YES | Same |
| Accessories | Envoy accessories | Same |
| GUI | Menu driven | same |
| Item | Envoy | VitaLogik |
| Front Endelectronics | Module rack | Integrated front endelectronics |
| Front Panelkeys | 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 -Green | Yes | No |
| Event -Green | Yes | Yes |
| Freeze -Green | Yes | No |
| Silence - Red | Yes | Yes |
| Alarm Off -Red | Yes | Yes |
| Menu item | Envoy | VitaLogik |
| Vital Signs | Dynamic list of vitalsigns per availablemodules | Fixed list ofvital 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 --Softwareversion | Shows softwareversion and modulerack, setting. | Show onlysoftwareversion |
| Setup -Parallel port | Yes | No |
| System Setup | Same | Same |
| SystemSetup-Parallel portsetup | 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 andnumeric vital sings | Same |
| Operating System | QNX4 | Same |
| GUI | Same | Same |
| Menus | Full set | Same |
| Vital signs | Depend on availablemodules | 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
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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________________________________________________________________________________________________________________________________________________________________
§ 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.