(167 days)
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No
The document describes a vital signs monitor with a fiber-optic temperature sensor. There is no mention of AI or ML in the intended use, device description, or performance studies. The technology described is based on physical principles of temperature measurement and communication.
No
The device is described as a monitor intended for general hospital or clinical use to display patient information and concentrations of anesthetic gases, as well as vital signs like temperature, ECG, and blood pressure. It does not exert any therapeutic action on the patient.
Yes
The device "monitors concentrations of anesthetic gases," "end-tidal carbon dioxide, nitrous oxide, oxygen gas concentrations, ECG, non-invasive blood pressure, invasive blood pressure and temperature." This information is used for diagnostic purposes to assess a patient's physiological state.
No
The device description explicitly details hardware components like monitors, a fiber-optic cable, sensors, and a signal conditioner, indicating it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Invivo Research Inc. Magnitude™ 3150M MRI Monitor is a patient monitoring device that measures physiological parameters directly from the patient's body (in vivo). These parameters include anesthetic gas concentrations, end-tidal carbon dioxide, nitrous oxide, oxygen, ECG, blood pressure, and temperature.
- No Sample Analysis: The device does not analyze samples taken from the patient. It uses sensors applied to the patient to obtain real-time measurements.
Therefore, while it is a medical device used in a clinical setting, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CBO, MWI
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
patient's surface
Indicated Patient Age Range
Neonatal (5 kilograms) to Adult
Intended User / Care Setting
medical professionals; general hospital or clinical use within a magnetic resonance imaging (MRI) area
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)
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 | +/- 0.3°C |
| Resolution | +/- 0.1°C |
| Time to Steady State |
§ 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).
0
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.
1
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 |