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510(k) Data Aggregation
(14 days)
VitaLogik 4000/4500 is intended for use as a multiparameter physiological patient monitoring system.
The VitaLogik 4000/4500 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 4000/4500 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 4000/4500 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 Intended Use of the Envoy monitor as indicated above is same as the Indications For Use.
The VitaLogik 4000/4500 is a configured multi-parameter physiological patient monitor, based on the hardware and software of the Mennen Medical VitaLogik 5000/5500 monitor, with integrated display screen. It is part of the Envoy/VitaLogik family and runs on same software versions.
In general, the VitaLogik 4000/4500 has the same functions, intended use and technology as the VitaLogik 5000/5550, the main different between the VitaLogik 4000/4500 and the VitaLogik 5000/5500 is the addition of battery power supply that gives the VitaLogik 4000/4500 same abilities as the VitaLogik 5000/5500 with the ability to use it as a transport monitor. To reduce the power consumption we have also replaced the hard disc memory with a Compact Flash memory.
The VitaLogik 4000/4500 uses identical display and patient data as do the VitaLogik 5000/5500 and Envoy monitors. The Ensemble central station and the Enguard remote monitor can both view the VitaLogik 4000/4500, VitaLogik 5000/ 5500 as well as the Envoy.
The VitaLogik 4000/4500 bedside patient monitor consists of a main processing unit, and an integrated color monitor with optional touch screen.
The front end electronic has same hardware and software as VitaLogik 5000/5500 . The input connectors are incorporated in the side panel of the monitor.
The VitaLogik 4000/4500 monitor presents vital signs in the same way and the same GUI (Craphic User Interface) as does the VitaLogic 5000/5500 monitor.
The VitaLogik 4000/4500 can acquire the following physiological signals of the patient:
- · ECG Waveform and measures Heart Rate, ST and Arrhythmia
- · Blood Pressures 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
- · NIBP Systolic, Diastolic and Mean pressure with measuring time stamp EtCO2 - EtCO2, inCO2 and Respiration Rate
The provided text is a Special 510(k) submission for the VitaLogik 4000/4500 patient monitor. Special 510(k)s are used for modifications to a legally marketed device that do not affect its intended use, fundamental scientific technology, safety and efficacy, and do not fall into categories inappropriate for a special 510(k) application.
This means the submission is primarily focused on demonstrating "substantial equivalence" to a predicate device (VitaLogik 5000/5500) rather than presenting a detailed de novo clinical study with specific acceptance criteria and performance metrics for an AI algorithm.
Therefore, many of the requested details, particularly those related to AI algorithm performance, ground truth, expert consensus, and sample sizes for training/test sets as would be found in an AI/ML device submission, are not applicable to this document.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, AUC) are provided in this document as it's a Special 510(k) for device modification, not a de novo clearance requiring clinical performance studies against specific endpoints. The device is deemed substantially equivalent to its predicate. The acceptance is based on the determination that the changes:
- Do not affect the intended use of the VitaLogik 5000/5500.
- Do not alter the fundamental scientific technology of the VitaLogik 5000/5500.
- Do not affect the safety and efficacy of the VitaLogik 5000/5500.
- Do not fall within the type of change inappropriate for a special 510(k) application.
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the submission is for a hardware and minor software modification to an existing patient monitor, not an AI/ML algorithm that would undergo testing with a clinical test set. The justification relies on the substantial equivalence to the predicate device, which would have undergone performance testing for its original clearance.
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)
This information is not applicable. Ground truth establishment by experts for a test set is relevant for AI/ML performance evaluation, which is not the focus of this Special 510(k).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in clinical studies to resolve discrepancies in expert ground truth labels for AI/ML validation, which is not present here.
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
This information is not applicable. MRMC studies are used to evaluate the impact of AI on human reader performance, which is not relevant for this device submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This submission is for a patient monitor, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable. Ground truth is not established in this Special 510(k) submission.
8. The sample size for the training set
This information is not applicable. There is no mention of an AI/ML training set in this submission.
9. How the ground truth for the training set was established
This information is not applicable. There is no mention of an AI/ML training set or its ground truth establishment in this submission.
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(69 days)
ENVOY is intended for use as a multiparameter physiological patient monitoring system.
The ENVOY 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 ENVOY 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 ENVOY 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 Envoy is a multiparameter physiological patient monitor, capable of monitoring:
- · ECG/Heart Rate
- · invasive blood pressure
- · non-invasive blood pressure
- · respiration
- · pulse oximetry
- · two temperature channels
- · cardiac output
- · eTCO2
The Envoy bedside patient monitor consists of a main processing unit, a mountable color monitor, and a module rack housing the various Mennen Medical plug-in vital signs modules. The modules monitor the patient's vital signs. Up to six internal modules can be plugged into a module rack. The Envoy can accommodate two module racks. The vital sign data derived from the modules by the Envoy are presented on the monitor as waveform and numeric displays.
ENVOY vital signs modules acquire vital signs data from the patient, and display their waveforms and alarms indications on the ENVOY display unit. Vital signs and waveform information are displayed simultaneously on the ENVOY Display Unit. Up to 8 traces can be displayed at any one time.
The vital signs modules interface with readily available physiologic transducers through electrically isolated patient input connections. After amplification, the signals are digitized, analyzed and displayed. All processing and alarm determination for ECG, Respiration and Invasive Blood Pressure is made using proprietary algorithms and software based on previously marketed Mennen Medical monitoring devices tested against well known and accepted data bases that present representative examples of waveform artifact to be encountered in real case conditions. The SpO2, Non-Invasive Blood Pressure and EtCO2 Modules incorporate software and/or hardware technology developed by vendors whose products are marketed in the USA.
Information from each vital sign is presented in a separate portion of the display. Each vital sign is labeled for identification and numeric value. Displayed Vital sign information can include: Primary Vital Sign Name, Waveform, Vital Sign Numeric Value, Alarm Status Message.
Operation of the ENVOY is accomplished by interaction with front panel controls on the main processor unit. A quick-knob control allows direct interaction with displayed menus for direct parameter selection and setup. Where manual entry of alphanumeric information is required, a menu keyboard menu is display.
ENVOY is a reusable, software driven, patient monitor, intended for use as part of a physiological monitoring system in a hospital environment. As such it is not a life supporting, nor life sustaining device; nor is it implantable and therefore sterility is not a consideration.
ENVOY complies with IEC 601-1 Medical Electrical Equipment, IEC 601-2-2-27 Safety of Electrocardiographic monitoring, IEC 601-2-30 Requirements for Automatic Cycling Indirect Blood Pressure monitoring, AAMI/ANSI SP-10/A1 Electronic or Automated Sphygmomanometers, IEC 601-2-34 Requirements for Invasive Blood Pressure monitoring, AAMI/ANSI ES1 Safe Current Limits for Electromedical Apparatus, and AAMVANSI EC13, Cardiac Monitors, Heart Rate Meters and Alarms. ENVOY is not a kit, does not contain any drug or biological products and is not for prescription use.
The ECG/Resp. module is the source of all ECG data in the Envoy bedside monitor. ECG is measured using a multi-lead cable via electrodes attached to the patient's chest.
Monitoring the ECG produces a continuous waveform of cardiac electrical activity to enable an accurate assessment of a patient's current physiological condition. With the ECG module, you can use a 3, 5 6 or 10 lead electrode ECG cable set to display up to 12 selectable ECG leads in up to three channels.
The 12 Lead ECG/Resp. module is housed in the Envoy module rack, where it occupies a single slot. It includes ECG and respiration monitoring.
{
"1. A table of acceptance criteria and the reported device performance": {
"ECG/HEART RATE": {
"Monitored Leads": {
"Acceptance Criteria": "Same as predicate (3/5/6-leads)",
"Device Performance": "3/5/6/12 leads"
},
"Sampling Rate and Resolution": {
"Acceptance Criteria": "641 Hz sampling rate, 22 bit resolution",
"Device Performance": "The same"
},
"Frequency Response - analog output": {
"Acceptance Criteria": "Diagnostic: 0.05 to 150 Hz; Monitor: 0.5 to 40 Hz; Exercise: 1.0 to 25 Hz (According to ANSI/AAMI EC11 para.3.2.7.2)",
"Device Performance": "The same"
},
"Input Impedance": {
"Acceptance Criteria": "20M ohm typical; 5M ohm differential, dc to 10Hz; 2.5M ohm differential 10 to 100 Hz (as per ANSI/AAMI EC13 para.3.2.9.2)",
"Device Performance": "The same"
},
"Common Mode Rejection (CMR)": {
"Acceptance Criteria": "120 dB, minimum; Lead Fault Detection based on impedance",
"Device Performance": "The same"
},
"Baseline Recovery": {
"Acceptance Criteria": "within 3 sec, 1 sec after lead switch",
"Device Performance": "The same"
},
"Gain Levels": {
"Acceptance Criteria": "250 - 8000",
"Device Performance": "The same"
},
"Pacemaker Detection and Rejection": {
"Acceptance Criteria": "Amplitude: 2 mV to 700 mV; Width: 0.1 ms to 2.0 ms (as per ANSI/AAMI EC13 para.3.1.4); Pacemaker flag inserted into displayed waveform",
"Device Performance": "The same"
},
"Patient Isolation": {
"Acceptance Criteria": "Meets ANSI/AAMI ESI-1985 standard for Safe Current Limits for Electromedical Apparatus (5kV dc, 2.5kV AC)",
"Device Performance": "The same"
},
"Heart Rate (HR) Counting": {
"Acceptance Criteria": "20 to 300 BPM",
"Device Performance": "The same"
},
"HR Accuracy": {
"Acceptance Criteria": "± 2 BPM. Values below 20 are recorded as zero",
"Device Performance": "The same"
},
"QRS Detection Range": {
"Acceptance Criteria": "0.25 to 5.0 millivolt height; 70 to 120 milliseconds width",
"Device Performance": "The same"
},
"Leads analyzed for: Hear Rate and Arrhythmia Configuration": {
"Acceptance Criteria": "Top two displayed",
"Device Performance": "The same"
},
"HR Alarm Settings": {
"Acceptance Criteria": "20 (low) to 250 (high), non-overlapping",
"Device Performance": "The same"
},
"Lead Fault Sense": {
"Acceptance Criteria": "when ECG electrode is interrupted or becomes marginal",
"Device Performance": "The same"
},
"Defib. Pulse Protection": {
"Acceptance Criteria": "5KV (as per ANSI/AAMI EC13, clause 3.2.2.2 and per IEC 601-2-27, clause 17,101 and 102)",
"Device Performance": "The same"
},
"Degree of protection against electrical shock": {
"Acceptance Criteria": "Type CF",
"Device Performance": "The same"
},
"Electrosurgical Interference Suppression Provided": {
"Acceptance Criteria": "Yes",
"Device Performance": "The same"
},
"Dynamic Range": {
"Acceptance Criteria": "differential voltage of up to ± 5mv at a rate up to ±320 mV/sec (as per ANSI/AAMI EC13, para. 3.2.9.1)",
"Device Performance": "The same"
},
"Noise": {
"Acceptance Criteria": "3K ohm",
"Device Performance": "The same"
},
"Manual Threshold Mode": {
"Acceptance Criteria": "0.2 ohm/1000 ohm (0.02%) to 5 ohm/1000 ohm (0.5%) at 20 BPM",
"Device Performance": "0.2 ohm/1500 ohm (0.013%) to 5 ohm/1000 ohm (0.33%) at 20 BPM"
},
"Automatic Threshold": {
"Acceptance Criteria": "0.35 ohm/1000 ohm (0.035%) to 5 ohm/1000 ohm (0.5%) at 20 BPM",
"Device Performance": "The same"
},
"Alarm Settings": {
"Acceptance Criteria": "Low rate: 0 - 150 BPM; High rate: 8 - 150 BPM",
"Device Performance": "Low rate: 0 - 120 BPM; High rate: 8 - 120 BPM"
},
"Apnea Alarm Delay": {
"Acceptance Criteria": "10 - 90 sec, selectable (default 10 sec.)",
"Device Performance": "The same"
},
"Apnea Alarm Reset": {
"Acceptance Criteria": "Automatic as defined by System administrator (default 3 breaths)",
"Device Performance": "The same"
}
},
"DISPLAYED PARAMETERS": {
"ECG": {
"Acceptance Criteria": "Yes",
"Device Performance": "Yes"
},
"Heart Rate": {
"Acceptance Criteria": "Yes",
"Device Performance": "Yes"
},
"Respiration": {
"Acceptance Criteria": "Yes",
"Device Performance": "Yes"
}
},
"ALARM INDICATIONS": {
"ECG": {
"Acceptance Criteria": "Visual & Sound",
"Device Performance": "Visual & Sound"
},
"Heart Rate": {
"Acceptance Criteria": "Visual & Sound",
"Device Performance": "Visual & Sound"
},
"Respiration": {
"Acceptance Criteria": "Visual & Sound",
"Device Performance": "Visual & Sound"
}
},
"DISPLAY FUNCTIONS": {
"Change ECG Lead Selection": {
"Acceptance Criteria": "YES",
"Device Performance": "YES"
},
"Display of Arrhythmia Information": {
"Acceptance Criteria": "YES",
"Device Performance": "YES"
},
"Data Review: Trends": {
"Acceptance Criteria": "YES",
"Device Performance": "YES"
},
"Data Review: Tabular": {
"Acceptance Criteria": "YES",
"Device Performance": "YES"
},
"User Defined Configuration Setup": {
"Acceptance Criteria": "YES",
"Device Performance": "YES"
},
"User Defined Default Settings": {
"Acceptance Criteria": "YES",
"Device Performance": "YES"
}
}
},
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The document states that the 12 Lead ECG/Resp. module 'has also been clinically tested and evaluated in a local hospital.' However, it does not specify the sample size of the test set nor the specific country of origin, or if it was retrospective or prospective.",
"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)": "This information is not provided in the document.",
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "This information is not provided in the document.",
"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": "No MRMC comparative effectiveness study is mentioned. This device is a patient monitor, not an AI-assisted diagnostic tool for human readers.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "The device's proprietary algorithms for ECG, Respiration, and Invasive Blood Pressure are stated to be 'based on previously marketed Mennen Medical monitoring devices tested against well known and accepted data bases that present representative examples of waveform artifact to be encountered in real case conditions.' This suggests standalone testing of the algorithms was performed, but specific details of this testing are not provided for the modified device.",
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "For the algorithms, 'well known and accepted data bases that present representative examples of waveform artifact to be encountered in real case conditions' were used. This implies a ground truth based on established clinical examples and likely expert-validated data, though the exact method is not detailed.",
"8. The sample size for the training set": "The document does not explicitly mention a training set, but refers to algorithms being 'based on previously marketed Mennen Medical monitoring devices tested against well known and accepted data bases'. The sample size of these databases is not specified.",
"9. How the ground truth for the training set was established": "The ground truth for the underlying algorithms was established using 'well known and accepted data bases that present representative examples of waveform artifact to be encountered in real case conditions.' The specific methodology for establishing this ground truth (e.g., expert consensus, independent validation) is not detailed for the original databases."
}
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