The Maglife C is a multi-parameter patient monitor which is indicated for monitoring electrocardiogram (ECG), pulse oximetry (SpO2), pulse rate, partial carbon dioxide pressure at the end of expiration (EtCO2), nitrous oxide concentration (%N₂O), partial pressure of inspired carbon dioxide (min inspired CO2), respiratory rate (RR), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), concentration of gas inspired (isoflurane, halothane, enflurane, desflurane, sevoflurane), and fraction of inspired oxygen (FiO2) and temperature tracking in the immediate vicinity of a Magnetic Resonance Imagers for the surveillance of patients undergoing MRI examinations.

Device Description

The Maglife C is a multi-parameter patient monitor which is indicated for monitoring electrocardiogram (ECG), pulse oximetry (SpO2), pulse rate, partial carbon dioxide pressure at the end of expiration (EtCO-), nitrous oxide concentration (%N2O), partial pressure of inspired carbon dioxide (min inspired CO2), respiratory rate (RR), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), concentration of gas inspired and expired (isoflurane, halothane, enflurane, desflurane, sevoflurane), and fraction of inspired oxygen (FiO2) and temperature tracking.

The monitor consists of line-powered console (with optional back-up battery) which is placed outside the magnet boren, and appropriate electrodes, transducers, cables and tubes to allow the patient to be monitored during the examination. The console enclosure is a Faraday cage for the protection of sensitive electronic circuits.

AI/ML Overview

The provided text describes the 510(k) summary for the MAGLIFE C/MAGLIFE C Plus patient monitor. It focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. Here's a breakdown of the requested information:

Acceptance Criteria and Reported Device Performance

The device is evaluated based on its ability to function without degradation in performance within an MRI environment and to not interfere with the MRI unit. The reported performance suggests it meets these criteria.

Acceptance Criteria	Reported Device Performance
1. Maximum magnetic field strength the device can withstand without degradation of performance.	Tests were conducted "to determine the maximum field strength that Maglife C can withstand without degradation of performance." (Specific measurement of maximum field strength is not provided, only that it was tested and met the criteria).
2. Sufficiency of non-ferrous material to prevent movement due to magnetic attraction.	Tests were conducted "to verify that the amount of ferrous material in the Maglife C is sufficiently small so that movement of the unit due to magnetic attraction is not possible." (No specific measurement of ferrous material or force is provided, only that it met the criteria).
3. Effect on the homogeneity of the magnetic field inside the magnet bore without causing visible differences in images. (Tested with a 1.5 Tesla MR unit).	"These tests, using a 1.5 Tesla MR unit, showed that the Maglife could be placed as close as 60 cm from the front of the opening from the magnet without causing any visible difference in the images."

Since this is a 510(k) submission for a patient monitor and the studies are non-clinical tests, much of the requested information regarding clinical studies, ground truth, and expert evaluation is not applicable or explicitly stated in this document.

Here's an attempt to answer the remaining questions based on the provided text, indicating "Not Applicable" or "Not Stated" where the information is missing:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: Not applicable as these were non-clinical engineering and bench tests, not patient data tests. The "sample" would be the device itself.
Data Provenance: Not applicable. The tests were presumably conducted internally by SCHILLER MEDICAL or a contracted testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Number of Experts: Not applicable. Ground truth for these non-clinical tests would have been established by engineering standards and direct physical measurements/observations by testing personnel, not medical experts.
Qualifications of Experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. This refers to expert review of clinical cases. For non-clinical tests, compliance is typically determined by meeting predefined technical specifications or standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, an MRMC study was not done. This type of study involves human readers interpreting cases, often with AI assistance, which is not relevant for a patient monitor's non-clinical validation.
Effect Size: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: While the "device" itself functions standalone in terms of its monitoring capabilities, the testing described is primarily about its physical and electromagnetic compatibility within an MRI environment, not an AI algorithm's standalone diagnostic performance. No "algorithm only" performance study in the context of AI is described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: For the non-clinical tests described, the "ground truth" was established by engineering standards, physical laws, and direct measurement (e.g., whether the device moved, whether images showed visible differences, ability to function at a certain field strength). This is not equivalent to clinical ground truth derived from pathology or expert consensus.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device is a patient monitor, and there is no mention of an AI/machine learning component that would require a "training set" in the context of the 510(k) summary provided.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable, as there is no mention of a training set.

Summary

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K023195
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510(k) Summary for MAGLIFE C/MAGLIFE C Plus

1. Date this summary was prepared: February 5, 2003

2. Submitter's Name and Address

SCHILLER MEDICAL 4, rue Louis Pasteur ZAE Sud BP 90050 67162 WISSEMBOURG CEDEX FRANCE

3. Contact person

M. Court GOEHRY Regulatory Affairs & Vigilance Manager SCHILLER MEDICAL 4. rue Louis Pasteur Z.A.E Sud BP 90050 67162 WISSEMBOURG CEDEX France

Tel: + 33 3 88 63 36 00 Fax: + 33 3 88 94 12 82 E-mail: court.goehry@schiller.fr

4. Device Name

Maglife C/Maglife C Plus Trade/Proprietary Name:

MR Safe Patient Monitor Common Name:

Clasification Names: Patient physiological monitor

5. . Predicate Devices

The legally marketed devices to which equivalence is being claimed are:

MAGLIFE, marketed by O.D.A.M. (K950264) .
MRI-Compatible Model 9500 manufactured by Magnetic Resonance Corp. (K954120)
Omni Trak 3100 MRI manufactured by In Vivo Research (K864889) ●
. Model 3100 LUXTRON CK

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K023195
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6. Device Description

The Maglife C is a multi-parameter patient monitor which is indicated for monitoring electrocardiogram (ECG), pulse oximetry (SpO2), pulse rate, partial carbon dioxide pressure at the end of expiration (EtCO-), nitrous oxide concentration (%N2O), partial pressure of inspired carbon dioxide (min inspired CO2), respiratory rate (RR), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), concentration of gas inspired and expired (isoflurane, halothane, enflurane, desflurane, sevoflurane), and fraction of inspired oxygen (FiO2) and temperature tracking.

7. Intended Use

MAGLIFE C is intended for monitoring electrocardiogram (ECG), pulse oximetry (SpO2), pulse rate, partial carbon dioxide pressure at the end of expiration (EtCO2), nitrous oxide concentration (%N20), partial pressure of inspired carbon dioxide (min inspired CO2), respiratory rate (RR), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), concentration of gas inspired and expired (isoflurane, enflurane, desflurane, sevoflurane), and fraction of inspired oxygen (FiO2) and temperature tracking in the immediate vicinity of Magnetic Resonance Imagers for the surveillance of patients undergoing MRI examinations.

8. Comparison of Technological Characteristics

All four MRI compatible patient monitors employ established measurement methods combined with non-metallic sensors and fiber optic signal transmission to minimize the risk of burns and special shielding and filtering to minimize interference to and from the MRI unit.

9. Nonclinical Tests Used in Determination of Substancial Equivalence

The design of the Madife C has been thoroughly validated at the unit and system level. Non-clinical test were conducted to demonstrate compliance with the following standards:

IEC 601-1 ●
IEC 601-1-2 ●

Test were conducted in an MRI unit to determine the maximum field strength that Maglife C can withstand without degradation of performance and to verify that the amount of ferrous material in the Maglife C is sufficiently small so that movement of the unit due to magnetic attraction is not possible.

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Tests were conducted to assess the effect of the Maglife C on the Homogeneity of the magnetic field inside the magnet bore. These tests, using a 1.5 Tesla MR unit, showed that the Maglife could be placed as close as 60 cm from the front of the opening from the magnet without causing any visible difference in the images.

10. Conclusions From Nonclinical Testing

The testing of the Maglife C demonstrates that the performance is substantially equivalent to predicate devices cited above.

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Image /page/3/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, formed by a series of curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 3 2003

Schiller Medical SA c/o Mr. Court Goehry Regulatory Affairs Specialist 4, rue Louis Pasteur Z.A.E Sud BP 90050 67162 Wissembourg Cedex France

Re: K023195

Trade Name: Maglife C/Maglife C Plus Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm). Regulatory Class: Class II (two) Product Code: MWI Dated: May 2, 2003 Received: May 8, 2003

Dear Mr. Goehry:

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 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. Court Goehry

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) 594-4646. 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,

Bram 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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510(k) Number (if known): __________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K023195

Prescription Use	X	OR	Over-The-Counter Use
(Per 21 CFR 801.109)

I / I

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).