(119 days)
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No
The summary describes a standard multiparameter physiological patient monitor and does not mention any AI or ML capabilities.
No.
The device is described as a "patient monitoring system" and its functions are related to "monitoring and recording patient information" and displaying "multiparameter waveforms, vital signs, alarm & status messages." It does not mention any therapeutic capabilities or interventions.
No
The device is described as a "patient monitoring system" and a "patient monitor" intended for "monitoring and recording patient information". Its functions include displaying waveforms, vital signs, and alarm messages. While monitoring provides data that can be used for diagnosis, the device itself is not stated to perform diagnostic a s s e s sments or interpretations of the data to arrive at a diagnosis. It collects and displays physiological parameters, leaving the diagnostic interpretation to the clinician.
No
The device description explicitly states it is "based on the hardware and software" of a previous monitor and includes "front end electronic" and "input connectors incorporated in the front panel," indicating it is a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that VitaLogik is a "multiparameter physiological patient monitoring system." It monitors physiological parameters directly from the patient (ECG, blood pressure, temperature, pulse oximetry, respiration, EtCO2).
- Device Description: The description reinforces that it's a patient monitor, measuring vital signs directly from the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on samples taken from the body, not to directly monitor physiological signals within the body.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
74 DSI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric and neonatal
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K974510, K983864, K000563, K001120, K011784, K022168
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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, |
| 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 | ||
| Parameters | ||
| Chassis Leakage | ||
| Current | All patient signal inputs fully | |
| isolated ( |