VITALOGIK 6000/6500 by MENNEN MEDICAL LTD.

The VitaLogik 6000/6500 can monitor ECG/heart rate, invasive blood pressures , temperature channels, pulse oximetry, respiration, non-invasive blood pressure and EtCO2.

This effectively allows the VitaLogik 6000/6500 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 6000/6500 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

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information needed to construct the table of acceptance criteria and the comprehensive study description you requested. The document is a 510(k) clearance letter for a patient monitor (VitaLogik 6000/6500), which declares its substantial equivalence to predicate devices and lists its intended uses.

It does not include:

Specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds).
Details of a performance study (like test set size, data provenance, expert qualifications, adjudication methods, MRMC study results, or standalone algorithm performance).
Information about the training set size or how its ground truth was established.

Therefore, I cannot fulfill your request based on the provided input.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of the human form, with three figures connected in a flowing design.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Mennen Medical Ltd. c/o Ifat Oren Shwarts 4 Ha-Yarden St. P.O Box 102 Yavne, Rehovot Israel 76100

MAY - 7 2010

Re: K093766

Trade/Device Name: VitaLogik 6000/6500 Physiological Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class II (two) Product Code: DSI Dated: April 8, 2010 Received: April 12, 2010

Dear Mr. Shwarts:

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 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.

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

{1}------------------------------------------------

Page 2 - Mr. Shwarts

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known): <

2963766

Device Name: VitaLogik 6000/6500

Indications For Use:

VitaLogik 6000/6500 is intended for use as a multiparameter physiological patient monitoring system.

The VitaLogik 6000/6500 can monitor ECG/heart rate, invasive blood pressures , temperature channels, pulse oximetry, respiration, non-invasive blood pressure and EtCO2.

The Mennen Medical VitaLogik 6000/6500 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 6000/6500 monitor as indicated above is the same as the Indications for Use.

AND/OR

Prescription Use YES (Part 21 CFR 801 Subpart D) 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		Page 1 of 1
510(k) Number

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.