VITALOGIK 6000/6500

K093766 · Mennen Medical , Ltd. · DSI · May 7, 2010 · Cardiovascular

Device Facts

• Record ID: K093766
• Device Name: VITALOGIK 6000/6500
• Applicant: Mennen Medical , Ltd.
• Product Code: DSI · Cardiovascular
• Decision Date: May 7, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended 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. 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 Story

Multiparameter physiological patient monitor; inputs include ECG, invasive/non-invasive blood pressure, temperature, pulse oximetry, respiration, and EtCO2 signals. Device processes these inputs to display real-time waveforms, vital signs, and status messages; provides alarm functionality for patient status changes. Used in hospital environments (ICU, telemetry, ED, OR, PACU) by clinicians. Output enables continuous patient surveillance, facilitating clinical decision-making regarding patient stability and intervention. Benefits include early detection of physiological abnormalities and centralized patient information management.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use as a physiological monitoring system.

Technological Characteristics

Multiparameter physiological monitor; supports ECG, IBP/NIBP, temperature, SpO2, respiration, and EtCO2 sensing. System includes display unit for waveforms and vital signs. Connectivity for in-hospital patient monitoring. Software-based alarm and status management.

Indications for Use

Indicated for adult, pediatric, and neonatal patients requiring physiological monitoring of ECG/heart rate, invasive/non-invasive blood pressure, temperature, pulse oximetry, respiration, and EtCO2 in hospital settings including critical care, telemetry, emergency, and anesthesia units.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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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

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## 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 [phone] or [phone] 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

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## 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.

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

*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)

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