(14 days)
No
The summary describes a standard multiparameter physiological patient monitor and does not mention any AI or ML capabilities. The functions listed are typical for such devices (displaying waveforms, vital signs, alarms).
No
This device is described as a "patient monitoring system" intended for "monitoring and recording patient information," indicating it provides diagnostic information, not therapy.
No
The device is described as a "multiparameter physiological patient monitoring system" intended for "monitoring and recording patient information." While it acquires physiological signals (e.g., ECG, blood pressure), its stated purpose is monitoring and displaying these parameters, not to diagnose a condition or disease.
No
The device description explicitly states it is a "configured multi-parameter physiological patient monitor, based on the hardware and software" and includes components like a "main processing unit, and an integrated color monitor with optional touch screen." It also mentions "front end electronic" and "input connectors," indicating significant hardware components beyond just software.
Based on the provided information, the VitaLogik 4000/4500 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a "multiparameter physiological patient monitoring system." It monitors physiological signals directly from the patient's body (ECG, blood pressure, temperature, SpO2, respiration, NIBP, EtCO2).
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, disease, or congenital abnormality. The VitaLogik 4000/4500 does not analyze such specimens.
- Device Description: The description focuses on the hardware and software for acquiring and displaying physiological signals from the patient.
- Lack of IVD-related information: There is no mention of analyzing samples, reagents, or laboratory procedures, which are characteristic of IVD devices.
Therefore, the VitaLogik 4000/4500 falls under the category of a patient monitoring system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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
Product codes (comma separated list FDA assigned to the subject device)
DSI
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
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 patient conditions
Intended User / Care Setting
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
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
K974510, K983864, K000563, K001120, K011784, K022168
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).
Not Found
§ 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
Food and Drug Administration Special 510(k) for VitaLogik 4000/4500
Image /page/0/Picture/2 description: The image shows the logo for Mennen Medical. The logo consists of a stylized letter "m" inside of a circle on the left, followed by the word "mennen" in a sans-serif font. Below "mennen" is the word "medical" in a lighter, dotted font. The logo is simple and modern.
NOV 2 1 2007
Topic: SPECIAL 510K: for change of VitaLogik 5000/5500 monitor
510(k) Number: K073140 Establishment Name, Registration Number and Address:
| Name: | Mennen Medical Ltd. |
|---|---|
| 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: | Ifat Oren, Regulatory Affairs |
The following information is being submitted in conformance with 21 CFR 807.87:
- l. Classification Name
-
- Classification Number:
-
- Common/Usual Name
-
- Trade/Proprietary Name
-
- FDA Classification
-
- Product Code
-
- Reviewing Panel
-
- 510(k) Marketing clearance for VitaLogik
Detector And Alarm, Arrhythmia · 21 CFR 870.1025 Physiological Patient Monitor VitaLogik 4000/4500 Class III DSI Cardiovascular K052288 - December 20, 2005
Terminology
VitaLogik 4000/4500 = subject of this Special 510(k). The VitaLogik 4000/4500 is a modified device, of the VitaLogik 5000/5500 Patient Monitor
VitaLogik 5000/5500 Patient Monitor = the predicate device. The VitaLogik 5000/5500 was approved for marketing by the FDA (K052288 - 20 Dec. 2005)
Envoy Patient monitor = First device in the family. The Envoy was approved for marketing by the FDA
- K974510 14th April 1998 .
- . K983864 - 8th October 1999
- K000563 17th May 2000 .
- K001120 8" May2001 .
- K011784 16th August 2001 .
- K022168 1st August 2002 .
The difference between the members of the monitor family is in their packaging. The Envoy is a three unit monitor, the VitaLogik 5000/5500 has two units - Bed Side Computer and a stand alone display. The VitaLogik 4000/4500 is a one piece monitor with inbuilt display.
1
Subject of this special 510(k) = VitaLogik 4000/4500
Definition of Product Family: The VitaLogik 4000/4500 is a new member of the Envoy / As the other monitors it uses the same GUI and data storage capabilities. VitaLogik family. It can be viewed by the same Ensemble central nurse station and by the Enguard remote monitor. Data transfer and remote view is available between all members of the family.
The new VitaLogik 4000/4500 will measure, display and store the same vital signs as does the VitaLogik 5000/5500
It is offered in two basic options: VitaLogik 4000 -- Non-Invasive monitor (the vital signs are ECG. NIBP. SpO2 and Temperature ) and VitaLogik 4500 Full monitor (includes also two invasive Blood Pressures and Cardiac Output). Both have EtCO2 as an option.
Justification for Special 510(k) Submittal:
Based on the FDA Guidance Doc. (March 20, 1998) "The New 510(k) Paradigm" The evaluation of Regulatory Affairs (RA) of Mennen Medical Ltd. is that the changes made to the VitaLogik 5000/5500 to enable it to function as a single unit physiological patient monitor with an inbuilt display:
(i) do not affect the intended use of the VitaLogik 5000/5500
- (ii) do not alter the fundamental scientific technology of the VitaLogik 5000/5500
- (iii) do not affect the safety and efficacy of the VitaLogik 5000/5500
(iv) do not fall within the type of change that is inappropriate for a special 510(k) application.
Indication For Use
Device Name: VitaLogik 4000/4500
VitaLogik 4000/4500 is intended for use as a multiparameter physiological patient monitoring svstem.
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 VitaLogik 4000/4500 monitor as indicated above is the same as the Indications For Use.
2
Device Description: VitaLogik 4000/4500
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
Comparison: VitaLogik 4000/4500 with VitaLogik 5000/5500 Substantial Equivalence:
VitaLogik 5000/5500 Photo
VitaLogik 4000/4500 Photos
Image /page/2/Picture/18 description: The image shows a close-up of a digital display screen. The screen displays several numerical values, including 60, 132/77, 95, 32/20, and 25.3. At the bottom of the screen, the time 00:19:39 is displayed.
Image /page/2/Picture/19 description: The image shows a screen displaying various numerical values. The numbers 60 and 95 are prominently displayed, along with the fraction 132/77. Additionally, the number 25.3 is visible, as well as the fraction 32/20. The time 00:19:39 is also displayed on the screen.
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3
The major differences between the VitaLogik 4000/4500 and the VitaLogik 5000/5500 are:
-
- The VitaLogik 4000/4500 works also on battery
-
- The VitaLogik 4000/4500 has integrated display and is thus a one piece monitor, as compared to VitaLogik 5000/5500 that has a stand alone display
-
- The input connectors of the VitaLogik 4000/4500 are on the side of the monitor, as compared to connectors on the front for the predicated device VitaLogik 5000/5500
-
- The VitaLogik 4000/4500 user a Compact Flash memory instead of a hard disc in VitaLogik 5000/5500
The following table compares the major software element and/or changes done in the VitaLogik 4000/4500 vs. the VitaLogik 5000/5500:
| SW Component | VitaLogik 5000/5500 | VitaLogik 4000/4500 |
|---|---|---|
| Display | All waveforms and numeric vital signs | Same |
| Operating System | QNX4 | Same |
| GUI | Same | Same |
| Menus | Full set | Same |
| Vital signs | Depend on model: | Same |
| 5000 - Non invasive | ||
| 5500 - Invasive |
We consider the VitaLogik 4000/4500 to be substantially equivalent to the VitaLogik 5000/5500 monitor and we submit that any differences between the two systems
- fall within the scope of a Special 510(k) Device Modification and t
- do not raise any new issues of safety and effectiveness .
Confidentiality
Mennen Medical Ltd. considers its intent to market the VitaLogik 4000/4500 System to be confidential commercial information. The Company has not disclosed its intent to market this device to anyone except its employees, others with a financial interest in the Company, its advertising and its consultants. The Company, therefore, requests the FDA not disclose the existence of this application until such time as final action on the submission is taken.
In addition, some of the material in this application may be trade secret or confidential or financial information within the meaning of 21 CFR § 20.61 and therefore not disclosable under the Freedom of Information Act, even after the existence of the application becomes public. We ask that FDA consult with the Company as provided in 21 CFR § 20.45 before making any part of this submission publicly available.
Signature:
Hat Oren
Ifat Oren QA & Regulatory Affairs MENNEN MEDICAL LTD. +972-8-9323333 ext. 213 Fax: +972-8-9328510 Tel: E-mail: Ifat@mmi.co.il
4
Image /page/4/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 1 2007
Mennen Medical LTD c/o Mr. Ifat Oren 4 Hayarden St., Yvane P.O. Box 102 Rehovot ISRAEL 76100
Re: K073140
VitaLogik Model 4000/4500 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrythmia Detector and Alarm Regulatory Class: Class II (two) Product Code: DSI Dated: November 1, 2007 Received: November 7, 2007
Dear Mr. Oren:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
5
Page 2 - Mr. Ifat Oren
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mooaney
Zuckermar Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):
Device Name: VitaLogik 4000/4500
Indications For 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.
Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (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)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K073146 |
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