(613 days)
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No
The document describes a vital signs monitor designed for the MRI environment and does not mention AI or ML capabilities.
No
The device is described as a "Vital Signs Monitor" and its primary function is to monitor vital signs during an MRI examination. It does not provide treatment or therapy.
Yes
The device is described as a "Vital Signs Monitor" that provides real-time display of waveforms, digital display of calculated parameters, and audible/visual alarm indicators for ECG, arterial blood oxygen saturation, pulse rate, CO2, respiration rate, and blood pressure. These are all parameters used to monitor a patient's physiological state and identify changes, which is a key aspect of diagnosis. The "Intended Use" also states that its indications for use are "identical to the indications for vital signs monitoring of patients not undergoing MRI examinations," implying its use in general patient assessment, which can be diagnostic.
No
The device description explicitly details multiple hardware components: a power supply, an operator console with display and keypad, and a connection box for patient connections. It also mentions nonmagnetic patient connections as accessories. This is not a software-only device.
Based on the provided information, the MAGLIFE® device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for "monitoring the vital signs of patients who are undergoing a Magnetic Resonance Imaging examination." This involves monitoring physiological parameters directly from the patient's body.
- Device Description: The device monitors vital signs like ECG, blood oxygen saturation, pulse rate, CO2, blood pressure, etc. These are all measurements taken in vivo (within the living body).
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body. IVDs are designed to perform tests on such specimens.
Therefore, the MAGLIFE® is a patient monitoring device used in vivo, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MAGLIFE® is a device for monitoring the vital signs of patients who are undergoing a Magnetic Resonance Imaging examination. This device is designed for this special environment where ordinary patient monitoring equipment cannot be used for the following reasons :
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- The magnetic and electric fields present in the vicinity of the MRI can interfere with the proper operation of ordinary monitors.
- ★ The presence of ferromagnetic materials in an ordinary monitor may influence the homogeneity of the magnetic field and thereby degrade the quality of the image acquired.
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- Some magnetic materials can become dangerous projectiles in the presence of large magnetic fields.
The indications for use are identical to the indications for vital signs monitoring of patients not undergoing MRI examinations.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The MAGLIFE® MRI-Compatible Vital Signs Monitor is a complete patient monitoring system designed to be installed inside the Faraday Cage. It monitors ECG, arterial blood oxygen saturation, pulse rate, expired end tidal CO2 (etCO2), N2O concentration (%N2O), minimum inspired CO2, respiration rate, noninvasive blood pressure, and invasive blood pressure.
The system consists of three enclosures ; a power supply which is permanently anchored to the floor, an operator console which includes a display and control keypad, and a connection box which is placed near the magnet opening and accepts the patient connections.
Output of information includes real-time display of waveforms, digital display of calculated parameters, and audible and visual alarm indicators.
Accessories include nonmagnetic patient connections for all parameters.
Safety of the operator and patient is ensured by compliance to IEC 601-1.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Tests:
MAGLIFE is certified (by GLEM Laboraty) about :
- Security of medical devices : NFC 74-010 (CEI 601-1) NFC 74-380.
- Performance of each module : NFC 74-381 NFC 74-382 NFC 74-388.
MAGLIFE obtained French approval by the French health ministery. MAGLIFE obtained GS Label from DEKRA in Germany (Stuttgart).
Clinical Tests:
More than 200 patients (80 % babies, 5 % adults under anaesthesia) were monitored over a two year period. About 25 % of the babies were premature with a weight less than 2 kg. The parameters used most were the SaO2 and the ECG. The optical SaO2 sensor is more sensitive to motion artifact than the electrical one especially in the case of babies.
For the ECG, in the majority of cases there are less than 10 % signal artifacts during the scan. Because of the lead used, the increased motion artifacts, and the extra deviation of the ST segment due to the BO, the ECG is useful mainly for monitoring rhythm. The signal depends on the electrode positioning, the coil, the MR-sequence, and the patient. In a few cases the ECG was not usable.
Conclusions:
The non-clinical testing showed that all parameters can be monitored in the MRI environment with no significant loss of accuracy.
The clinical studies showed that, with experience and operator training, the MAGLIFE® can monitor all desired parameters in most patients and does not produce any detectable image distortions or artifacts.
The combination ECG-SaO2-Capnography was useful essentially for premature babies. Invasive and noninvasive blood pressure are important in adults.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 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.
0
Image /page/0/Picture/1 description: The image shows the text "SEP 27 1996" in a slightly distorted and angled view. The letters "SEP" are larger and bolder than the rest of the text. The number "27" is positioned to the right of "SEP", and the year "1996" is located further to the right and slightly lower, appearing smaller due to perspective.
- Date this summary was prepared : 1.
December 18, 1995
Submitter's Name and Address 2.
O.D.A.M. 19, Avenue de la Gare B.P. 50 67162 Wissembourg Cedex FRANCE
Contact Person : Jean-Pierre MABIRE
| Telephone | : 33.88.63.36.00 |
|---|---|
| Telefax | : 33.88.54.36.32 |
3. Device Name
| Trade / Proprietary Name | : | MAGLIFE® |
|---|---|---|
| Common Name | : | MRI-Compatible Vital Signs Monitor |
| Classification Name | : | Patient Monitor |
・・
4. Predicate Device
The legally marketed device to which equivalence is being claimed :
- ォ OMNI TRAK 3100 MRI In vivo Research Inc 12601 Research Parkway ORLANDO FL 32826 USA
510(k) numbers : K864889 - K935020
5. Device Description
The MAGLIFE® MRI-Compatible Vital Signs Monitor is a complete patient monitoring system designed to be installed inside the Faraday Cage. It monitors ECG, arterial blood oxygen saturation, pulse rate, expired end tidal CO2 (etCO2), N2O concentration (%N2O), minimum inspired CO2, respiration rate, noninvasive blood pressure, and invasive blood pressure.
The system consists of three enclosures ; a power supply which is permanently anchored to the floor, an operator console which includes a display and control keypad, and a connection box which is placed near the magnet opening and accepts the patient connections.
Output of information includes real-time display of waveforms, digital display of calculated parameters, and audible and visual alarm indicators.
のあるのではないと思いませんではないでする
Accessories include nonmagnetic patient connections for all parameters.
Safety of the operator and patient is ensured by compliance to IEC 601-1.
1
6. Intended Use
The MAGLIFE® is a device for monitoring the vital signs of patients who are undergoing a Magnetic Resonance Imaging examination. This device is designed for this special environment where ordinary patient monitoring equipment cannot be used for the following reasons :
-
- The magnetic and electric fields present in the vicinity of the MRI can interfere with the proper operation of ordinary monitors.
- ★ The presence of ferromagnetic materials in an ordinary monitor may influence the homogeneity of the magnetic field and thereby degrade the quality of the image acquired.
-
- Some magnetic materials can become dangerous projectiles in the presence of large magnetic fields.
The indications for use are identical to the indications for vital signs monitoring of patients not undergoing MRI examinations.
7. Comparison of Technological Characteristics
Both the OMNI TRAK 3100 MRI and the MAGLIFE® are multi-parameter vital signs monitors that can be installed inside the Faraday cag for monitoring patient undergoing MRI examinations. Both designs use well accepted measurement techniques that have been modified to optimize performance in the magnetic and electric fields found in the vicinity of the MRI and to prevent interference with the quality of the images. Both monitor ECG, arterial blood oxygen saturation, pulse rate, expired end tidal CO2 (etCO2), N20 concentration (%N20), minimum inspired CO2, respiration rate, non-invasive blood pressure.
The two systems differ in the following respects :
- Only the MAGLIFE® offers Invasive Blood pressure. -
- Only the MAGLIFE® offers a pulse oximetry sensor for use on the ear. -
- MAGLIFE® is intended to be permanently installed in a fixed location within the Faraday ုး cage, while the OMNI TRAK 3100 MRI is a portable outside outside of the shielding room. .
8. Nonclinical Tests Used in Determination of Substantial Equivalence
MAGLIFE is certified (by GLEM Laboraty) about :
്ഥാന്ത്രി വിശ്വീപരിക്കുന്നത് കോട്ടിക്കുന്നു. അവലംബം കാലക്കുന്ന കാലക്കുന്നു. കാലാക്കുന്നും കാലാക്കുന്നു. കാലക്കുന്നും കാലക്കുന്നു. കാലക്കുന്നു കാലക്കുന്നു. കാലക്കുന്നു കാലക്ക
- Security of medical devices : NFC 74-010 (CEI 601-1) NFC 74-380 ।
- Performance of each module : NFC 74-381 NFC 74-382 NFC 74-388 ।
MAGLIFE obtained French approval by the French health ministery. MAGLIFE obtained GS Label from DEKRA in Germany (Stuttgart)
2
Clinical Tests Used in Determination of Substantial Equivalence ഗ്
More than 200 patients (80 % babies, 5 % adults under anaesthesia) were monitored over a two year period. About 25 % of the babies were premature with a weight less than 2 kg. The parameters used most were the SaO2 and the ECG. The optical SaO2 sensor is more sensitive to motion artifact than the electrical one especially in the case of babies.
For the ECG, in the majority of cases there are less than 10 % signal artifacts during the scan. Because of the lead used, the increased motion artifacts, and the extra deviation of the ST segment due to the BO, the ECG is useful mainly for monitoring rhythm. The signal depends on the electrode positioning, the coil, the MR-sequence, and the patient. In a few cases the ECG was not usable.
10. Conclusions from Nonclinical and Clinical Testing
:
A Children Comments of Children Children
The non-clinical testing showed that all parameters can be monitored in the MRI environment with no significant loss of accuracy.
The clinical studies showed that, with experience and operator training, the MAGLIFE® can monitor all desired parameters in most patients and does not produce any detectable image distortions or artifacts.
The combination ECG-SaO2-Capnography was useful essentially for premature babies. Invasive and noninvasive blood pressure are important in adults.
11. Other Information Deemed Necessary by FDA
ಿನ ನಿಗ್ರಿ ಸಾಮಿರಿಕೆಯ ಕ್ರಮ ಸಾಹಿತ್ಯ ಸಂಸ್ಕಾರ ವಿರುದು ಮಾಡಿ ಮಾಡಿಸುವ ಒಂದು ಪ್ರಾಮದಲ್ಲಿ ಸ
The 510(k) Summary is used by FDA when a member of the public requests information about your 510(k). FDA will send out a copy of only the summary to anyone who requests information. it should be brief, but should mention all the points listed above.
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- The summary includes only information that is also covered in the body of the 510(k).
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★ The summary does not contain any puffery or unsubstantiated claims.
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な The summary does not contain any raw data, i.e., contains only summary data.
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★ The summary does not contain any trade secret or confidential commercial information.
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★ The summary does not contain any patient identification information.