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 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.

AI/ML Overview

The provided text describes the Invivo Research Inc. Magnitude™ 3150M MRI Monitor, which monitors various parameters, including temperature. The focus of the performance testing summary in the document is on the specifications for the temperature option of the device.

Here's the breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document includes a table of specifications that serve as acceptance criteria for the temperature monitoring function of the device. The reported device performance is stated as conforming to these specifications.

Parameter	Acceptance Criteria (Specification)	Reported Device Performance
Temperature Range	20 to 44°C	Conforms to specification
Accuracy	± 0.3°C	Conforms to specification
Resolution	± 0.1°C	Conforms to specification
Time to Steady State	< 150 seconds	Conforms to specification
Output format	Selectable °C, °F	Conforms to specification

Note: The "Storage Temperature," "Operating Temperature," "Relative Humidity," "Battery Condition," and "Cleaning test" listed in the document are environmental, operational, or durability specifications rather than direct performance metrics of temperature measurement. However, for "Battery Condition," it specifies "± 0.3°C," implying that battery condition does not negatively impact temperature accuracy beyond this tolerance. For clarity, only direct temperature performance criteria are included in the table above.

2. Sample Size Used for the Test Set and Data Provenance

The document states, "This device was verified to function per the following specifications." However, it does not provide details on the sample size for the test set used to verify these specifications for the temperature option.

It also does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts or any ground truth establishment method involving experts for validating the temperature performance. The specifications are objective measurements (e.g., accuracy, resolution) that would typically be validated against a calibrated reference standard, not expert consensus.

4. Adjudication Method for the Test Set

Given that the performance criteria are objective technical specifications (accuracy, resolution, time to steady state), an adjudication method like 2+1 or 3+1 is not applicable and therefore not mentioned. The device's measurements would be compared against a known standard.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study is typically performed for AI-assisted diagnostic tools where human interpretation of medical images or data is involved. The Invivo Research Inc. Magnitude™ 3150M MRI Monitor is a patient monitoring device that provides direct measurements. Therefore, an MRMC comparative effectiveness study was not performed or described in the provided text, as it's not relevant to this type of device.

6. Standalone Performance Study (Algorithm Only)

The device is a hardware monitoring system that incorporates a fiber-optic temperature option. The performance specifications refer to the direct output of the device itself. Therefore, the "Summary of Performance Testing" implicitly describes the standalone performance of the device's temperature monitoring capability, as it's an algorithm/hardware-only measurement without a "human-in-the-loop" component for interpretation of the raw temperature data.

7. Type of Ground Truth Used

For the temperature monitoring function, the ground truth would typically be established by comparison to a highly accurate and calibrated reference thermometer or temperature standard. The document doesn't explicitly state "ground truth" but implies that the device's measurements were verified against what are considered established standards for temperature measurement to ensure it meets the listed accuracy and resolution specifications.

8. Sample Size for the Training Set

The document describes performance testing for a finished device, not the development of a machine learning algorithm that requires a training set. Therefore, a "training set" in the context of AI/ML is not applicable and no sample size is provided.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for an AI/ML algorithm involved, the establishment of ground truth for a training set is not applicable. The device's performance is verified against established metrology standards.

Summary

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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:

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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.

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 (301) 594-4648. 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 (301) 443-6597 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.

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

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
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.(b)
Classification. Class II (performance standards).