MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M

K040915 · Invivo Research, Inc. · MWI · Sep 22, 2004 · Cardiovascular

Device Facts

• Record ID: K040915
• Device Name: MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M
• Applicant: Invivo Research, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Sep 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Invivo Research Inc. Magnitude™ 3150M MRI Monitor is a device comprised of two separate monitors: the 3150M Monitor, which operates as the base monitor, and the 3155 Monitor, which operates as a Remote Display monitor. The 3150 and 3155 Monitors communicate through a bi-directional radio-link which operates within the MRI area. Both monitors display the patient information, and must be used together for the system to operate. A warning message is displayed if the radio-link is broken. The Invivo Research Inc. Magnitude™ 3150M MRI Monitor is intended for general hospital or clinical use within a magnetic resonance imaging (MRI) area by medical professionals whenever it is required to monitor concentrations of anesthetic gases. The agents monitored include halothane, enflurane, isoflurane, sevoflurane and desflurane. Additionally, this monitor also monitors end-tidal carbon dioxide, nitrous oxide, oxygen gas concentrations, ECG, non-invasive blood pressure, invasive blood pressure and temperature. This device is available for sale only upon the order of a physician or other related licensed medical professional.

Device Story

Magnitude 3150M MRI Monitor comprises base unit and remote display (3155) communicating via bi-directional radio-link; used in MRI suites by medical professionals. Inputs include anesthetic gases, CO2, N2O, O2, ECG, blood pressure, and temperature. Temperature sensing uses fiber-optic cable with Fabry-Pérot interferometer; fiber-optic medium eliminates RF-induced heating. System displays real-time patient vitals; provides warning if radio-link fails. Enables safe, accurate patient monitoring during MRI procedures; prevents RF interference with sensors.

Clinical Evidence

Bench testing only. Device verified against specifications: temperature range 20-44°C, accuracy ±0.3°C, resolution ±0.1°C, steady-state time <150s. Conformance to national/international safety standards for electromagnetic compatibility and anesthetic agent monitoring confirmed. Cleaning durability tested (min 5 cycles).

Technological Characteristics

Fiber-optic temperature sensor; Fabry-Pérot interferometer sensing principle. Reusable fiber-optic surface sensor; disposable applicator. MRI-compatible fiber-optic cable (non-electrical). Bi-directional radio-link for remote display. Operating range 16-40°C; storage -20-50°C. Humidity 15-95% RH.

Indications for Use

Indicated for hospital/clinical use in MRI environments for monitoring anesthetic gases (halothane, enflurane, isoflurane, sevoflurane, desflurane), end-tidal CO2, N2O, O2, ECG, NIBP, IBP, and temperature. Applicable to patients ranging from neonates (5kg) to adults. Prescription use only.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

• Invivo Research Millennia Vital Sign Monitor (K974581)
• Luxtron 3100 Biomedical Flouroptic Thermometer (K923189)
• Schiller Medical Maglife C (K023195)

Submission Summary (Full Text)

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# SEP 2 2 2004

# 510(k) Summary of Safety and Effectiveness

#### Submitter Information:

Invivo Research Inc. 12601 Research Parkway Orlando, FL 32826 407-275-3220 Contact: Mr. Neil Battiste

#### Product Name:

| Proprietary: | Magnitude™ 3150M MRI Monitor |
|-----------------|-----------------------------------------------------------------------|
| Common: | Multparameter Patient Monitor |
| Classification: | Anesthetic Gas Analyzer, enflurane - (73 CBO/21CFR 868.1500 Class II) |
| | Anesthetic Gas Analyzer, halothane - (73 CBO/21CFR 868.1620 Class II) |
| | Oxygen Gas Analyzer - (73 CBO/21CFR 868.1720 Class II) |
| | Thermometer, Electronic, Clinical - (73 CBO/21CFR 880.2910 Class II) |

## Predicate Devices:

The predicate devices are the temperature option of the Invivo Research Millennia Vital Sign Monitor (reference 510(k) Number K974581), the Luxtron 3100 Biomedical Flouroptic Thermometer. (reference 510(k) Number K923189) and the Schiller Medical Maglife C (reference 510(k) Number K023195). This predicate devices have the same performance specifications as the temperature option of the Magnitude™ 3150M MRI Monitor.

The temperature option of this device utilizes a Fabry-Pérot interferometer to determine accurate temperatures from 21℃ to 44℃.

#### Device Description:

The 3150M Fiber-Optic Temperature option enables the measurement of a patient's surface temperature both safely and accurately during all MRI procedures. This option utilizes a fiber-optic cable for interface between the temperature sensor at the patient application site and the measuring device. With this scheme, light channeled through a fiber-optic cable is the medium of temperature measurement rather than electrical conductor based components. The fiber-optic cable is impervious to the RF energy present during MRI procedures, thus eliminating the possibility of heating.

The Fiber-Optic Temperature option contains four items: 1) Re-usable fiber optic surface temperature sensor. 2) Disposable surface temperature sensor applicator for use on patients ranging from Neonatal (5 kilograms) to Adult. 3) Fiber optic connector on the outside of the 3150M. 4) Signal conditioner inside 3150M patient monitor.

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## Intended Uses:

The Invivo Research Inc. Magnitude™ 3150M MRI Monitor is a device comprised of two separate monitors: the 3150M Monitor, which operates as the base monitor, and the 3155 Monitor, which operates as a Remote Display monitor. The 3150 and 3155 Monitors communicate through a bi-directional radio-link which operates within the MRI area. Both monitors display the patient information, and must be used together for the system to operate. A warning message is displayed if the radio-link is broken.

The Invivo Research Inc. Magnitude™ 3150M MRI Monitor is intended for general hospital or clinical use within a magnetic resonance imaging (MRI) area by medical professionals whenever it is required to monitor concentrations of anesthetic gases. The agents monitored include halothane, enflurane, isoflurane, sevoflurane and desflurane. Additionally, this monitor also monitors end-tidal carbon dioxide, nitrous oxide, oxygen gas concentrations, ECG, non-invasive blood pressure, invasive blood pressure and temperature. This device is available for sale only upon the order of a physician or other related licensed medical professional.

# Summary of Performance Testing:

The Invivo Research Inc. Magnitude™ 3150M MRI Monitor conforms with national and available international product safety standards for electromagnetic compatibility, and anesthetic agent monitoring. This device was verified to function per the following specifications:

| PARAMETER | SPECIFICATION |
|-----------------------|-----------------------------------|
| Temperature Range | 20 to 44°C |
| Accuracy | $\pm$ 0.3°C |
| Resolution | $\pm$ 0.1°C |
| Time to Steady State | < 150 seconds |
| Output format | Selectable °C, °F |
| Storage Temperature | -20°C to 50°C |
| Operating Temperature | 16°C to 40°C |
| Relative Humidity | 15% to 95% RH non-condensing |
| Battery Condition | $\pm$ 0.3°C |
| Cleaning test | Minimum of 5 times with detergent |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized wing-like shapes above a wavy line.

SEP 2 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Invivo Research, Inc. c/o Mr Neil Battiste Director, Regulatory Affairs 12601 Research Parkway Orlando, FL 32826

Re: K040915

Trade Name: Magnitude™ 3150M MRI Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: II (two) Product Code: MWI Dated: August 27, 2004 Received: September 02, 2004

Dear Mr. Battiste:

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 for associated in to May 28, 1976, the enactment date of the Medical Device Amendments, or to eonimer to provision to 112) 2011-01-12 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 r ou may ontrols 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.

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Page 2 - Mr Neil Battiste

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

B/Zimmerman for
R. D. Zuckerman, M.D.

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): K040915

Device Name: Magnitude™ 3150M MRI Monitor

# Indications for Use:

The Invivo Research Inc. Magnitude™ 3150M MRI Monitor is a device comprised of two separate monitors: the 3150M Monitor, which operates as the base monitor, and the 3155 Monitor, which operates as a Remote Display monitor. The 3150 and 3155 Monitors communicate through a bidirectional radio-link which operates within the MRI area.. Both monitors display the patient information, and must be used together for the system to operate. A warning message is displayed if the radio-link is broken.

The Invivo Research Inc. Magnitude™ 3150M MRI Monitor is intended for general hospital or clinical use within a magnetic resonance imaging (MRI) area by medical professionals whenever it is required to monitor concentrations of anesthetic gases. The agents monitored include halothane, enflurane, isoflurane, sevoflurane and desflurane. Additionally, this monitor also monitors end-tidal carbon dioxide, nitrous oxide, oxygen gas concentrations, ECG, non-invasive blood pressure, invasive blood pressure and temperature. This device is available for sale only upon the order of a physician or other related licensed medical professional.

Over-The-Counter Use AND/OR Prescription Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Summa
(Division Sign Off)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number *K040915*