VITALOGIK MODEL 4000/4500

• K Number: K073140
• Device Name: VITALOGIK MODEL 4000/4500
• Manufacturer: MENNEN MEDICAL LTD.
• Date Cleared: 2007-11-21 ( 14 days)
• Product Code: DSI
• Regulation Number: 870.1025
• Type: Special
• Panel: CV
• Reference & Predicate Devices: K974510 , K983864 , K000563 , K001120 , K011784 , K022168 , K052288

Intended Use

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.

Device Description

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

AI/ML Overview

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.

Regulation Number and Section

§ 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.