K Number

Device Name

MAGLIFE C

Manufacturer

ODAM

Date Cleared

1998-01-13

(189 days)

Product Code

MHX

Regulation Number

870.1025

Intended Use

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 (%N Q), 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) in the immediate vicinity of a Magnetic Resonance Imagers for the surveillance of patients undergoing MRI examinations.

Device Description

MAGLIFE C is a multi-parameter patient monitor which has been designed for use in the immediate vicinity of a Magnetic Resonance Imagers for the surveillance of patients undergoing MRI examinations. The parameters that can be monitored are electrocardiogram (ECG), pulse oximetry (SpO2), pulse rate, partial carbon dioxide pressure at the end of expiration (EtCO2), nitrous oxide concentration (%N D), 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 (FiO). The monitor consists of a line-powered console (with optional back-up battery) which is placed outside the magnet bore, 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K950264, K954120, K864889

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard multi-parameter patient monitor for use in an MRI environment and does not mention any AI or ML capabilities.

Therapeutic

No.
The device is a multi-parameter patient monitor used for surveillance of patients, which means it measures and displays physiological parameters, but it does not treat or directly improve a medical condition.

Diagnostic

The device is a multi-parameter patient monitor used for surveillance during MRI examinations, which means it continuously measures and displays physiological parameters. It does not provide a diagnosis itself but rather aids in monitoring a patient's condition.

SaMD (Software as a Medical Device)

The device description explicitly states it consists of a line-powered console, electrodes, transducers, cables, and tubes, indicating it is a hardware device with associated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs analyze samples taken from the human body. The Maglife C is a patient monitor that directly measures physiological parameters on the patient (ECG, SpO2, blood pressure, respiratory gases, etc.). It does not analyze samples like blood, urine, or tissue in a laboratory setting.
The intended use is for patient monitoring during MRI. This is a direct patient care activity, not a diagnostic test performed on a sample outside the body.

The device description and intended use clearly indicate it's a patient monitoring system for real-time physiological data acquisition during MRI procedures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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 (%N,O), 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) in the immediate vicinity of Magnetic Resonance Imagers for the surveillance of patients undergoing MRI examinations.

Product codes (comma separated list FDA assigned to the subject device)

74 MHX

Device Description

The monitor consists of a line-powered console (with optional back-up battery) which is placed outside the magnet bore, 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical tests were conducted to demonstrate compliance with the following standards: Cardiac Monitors, Heart Rate Meters, and Alarms. . ANSI/AAMI EC13 - 1992; American National Standard for Pregelled ECG Disposable . Electrodes. ANSI/AAMI EC12 - 1991; Electronic or Automated Sphygmomanometers. . ANSI/AAMI SP10; . Nonautomated Sphygmomanometers. ANSI/AAMI SP9; . Blood Pressure Transducers. ANSI/AAMI BP22 - 1994; . American National Standard for Interchangeability for Resistive Bridge Type Blood Pressure Transducers. ANSI/AAMI BP23 - 1986; . Safe Current Limits for Electromedical Apparatus ANSI/AAMI ES21 1993; . IEC 601-1.

Tests 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.

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K950264, K954120, K864889

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
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.(b)
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.

Summary

K912335

JAN 1 3 1998

APPENDIX B

Revised 510(k) Summary

Additional Information - K972535 O.D.A.M. Maglife C

... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10/13/97

510(k) Summary for Maglife C

Date this summary was prepared: October 13, 1997 1.
Submitter's Name and Address 2.

O.D.A.M. 19, avenue de la gare 67162 Wissembourg cedex, France

Contact Person 3.
Mr. Court Goehry Groupe BRUKER O.D.A.M. 19, avenue de la gare 67162 Wissembourg cedex, France

Telephone 011 33 3 88 63 36 00 011 33 3 88 54 36 32 Telefax cg@bruker.fr E-mail

Device Name 4.
Maglife C Trade/Proprietary Name:

MR Safe Patient Monitor Common Name:

patient physiological monitor Classification Names:

、 ડ. 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) .
Device Description 6.

1. 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 (%N,O), 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) in the immediate vicinity of Magnetic Resonance Imagers for the surveillance of patients undergoing MRI examinations.

Comparison of Technological Characteristics 8.
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.
Nonclinical Tests Used in Determination of Substantial Equivalence 9.
The design of the Maglife C has been thoroughly validated at the unit and system level. Non-clinical tests were conducted to demonstrate compliance with the following standards:
Cardiac Monitors, Heart Rate Meters, and Alarms. . ANSI/AAMI EC13 - 1992
American National Standard for Pregelled ECG Disposable . Electrodes. ANSI/AAMI EC12 - 1991
Electronic or Automated Sphygmomanometers. . ANSI/AAMI SP10
. Nonautomated Sphygmomanometers. ANSI/AAMI SP9
. Blood Pressure Transducers. ANSI/AAMI BP22 - 1994
. American National Standard for Interchangeability for Resistive Bridge Type Blood Pressure Transducers. ANSI/AAMI BP23 - 1986
. Safe Current Limits for Electromedical Apparatus ANSI/AAMI ES21 1993
. IEC 601-1

Maglife C has been evaluated with respect to the recommendations for electrical testing included in the November 1993 Reviewer Guidance for Premarket Notification Submissions (Anesthesiology and Respiratory Devices Branch).

Conclusions From Nonclinical Testing 10.
The testing of the Maglife C demonstrates that the performance is substantially equivalent to predicate devices cited above.

Image /page/5/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 three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 1998

0.D.A.M. c/o Mr. James R. Veale Medical Device Consultants, Inc. 49 Plain Street 92760 North Attleboro, MA

Re: K972535 Maglife C Regulatory Class: II (two) Product Code: 74 MHX Dated: October 13, 1997 Received: October 15, 1997

Dear Mr. Veale:

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 additional controls. Existing major regulations affecting your device 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 requlation (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 requlatory 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 requlations.

Page 2 - Mr. James R. Veale

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 dev`ice 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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan, Ph.D.

Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

(972535 ... 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)

in. Png?

Division of Cardiovascular, Respiratory, and Neurological Device 510k) Nur

Prescription Use
(Per 21 CFR 801.109) ✓

Over-The-Counter Use