OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM

K971840 · Invivo Research, Inc. · MHX · Mar 4, 1998 · Cardiovascular

Device Facts

• Record ID: K971840
• Device Name: OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM
• Applicant: Invivo Research, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Mar 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended Use

This device is intended for use as a patient vital signs monitor during magnetic resonance imaging (MRI) scans. It is intended to be used by or on the order of a physician or similarly qualified health care professional. This device is intended for use in the hospital environment (MRI, Radiology Clinic, or similar settings). This device is not intended for home use.

Device Story

Omni-Trak 3150 Series Patient Monitor provides vital sign monitoring for patients undergoing MRI procedures. Device inputs include physiological signals: ECG, pulse oximetry, blood pressure (invasive/non-invasive), end-tidal CO2/N2O, and respiration effort. System processes these signals to display real-time patient data for clinical staff. Used in hospital MRI suites or radiology clinics; operated by physicians or qualified healthcare professionals. Output allows clinicians to track patient stability during imaging, facilitating immediate intervention if physiological parameters deviate from safe ranges. Benefits include continuous patient safety monitoring within the high-magnetic field environment of an MRI scanner.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Patient monitor designed for MRI compatibility. Monitors ECG, heart rate, SpO2, NIBP, IBP, EtCO2/N2O, and respiration. Form factor is a clinical monitor unit. Connectivity and specific materials not detailed in provided text.

Indications for Use

Indicated for monitoring vital signs in patients undergoing MRI scans in hospital or clinical settings. Parameters include ECG, heart rate, pulse oximetry, non-invasive blood pressure, invasive blood pressure, end-tidal carbon dioxide/nitrous oxide, and respiration effort. Not for home use.

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 9200 Corporate Boulevard Rockville MD 20850

MAR - 4 1998

Mr. Francis X. Casey Invivo Research, Inc. 12601 Research Parkway Orlando, FL 32826

K971840 Re: Omni-Trak™ 3150 Series Patient Monitor Regulatory Class: II (two) Product Code: 74 MHX Dated: February 16, 1998 February 17, 1998 Received:

Dear Mr. Casey

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such Existing major regulations affecting your device additional controls. can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the-Quality System Regulation (QS) for Medical Devices: ..... General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Francis X. Casey

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## ATTACHMENT 1

## INDICATIONS FOR USE

This device is intended for use as a patient vital signs monitor during magnetic resonance imaging (MRI) scans. It is intended to be used by or on the order of a physician or similarly qualified health care professional. This device is intended for use in the hospital environment (MRI, Radiology Clinic, or similar settings). This device is not intended for home use.

This device includes the capability for monitoring the following patient parameters:

- ECG .
Heart Rate .

Pulse Oximetry .

Non-Invasive Blood Pressure ●

. Invasive Blood Pressure

End-Tidal Carbon Dioxide / Nitrous Oxide .

Respiration effort .

. Rra

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K971840