(191 days)
Not Found
No
The summary mentions digital signal processing (DSP) but does not mention AI, ML, or any related terms or concepts. The performance metrics are standard for vital sign monitoring and do not suggest AI/ML capabilities.
No
The device is described as a "monitoring system" intended to "monitor vital signs" and provide "signals for synchronization for the MRI scanner." This indicates that its primary function is to observe and collect data, not to directly treat or provide therapy to a patient.
No
The device is intended to monitor patient vital signs during MRI procedures. While monitoring involves collecting data, the described purpose is to assist clinicians in observing patient health, not to diagnose a disease or condition. The device provides measurements (e.g., heart rate, blood pressure, oxygen saturation) but does not interpret these measurements to arrive at a diagnosis.
No
The device description explicitly mentions "A combination of wireless communication, radio frequency (RF) shielding, digital signal processing (DSP), and adaptable mounting technologies" and "MRI In-Bore Materials Used: All materials are non- magnetic". This indicates the device includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for monitoring vital signs of patients undergoing MRI procedures. This involves monitoring physiological parameters directly from the patient's body.
- Device Description: The description reinforces the purpose of monitoring vital signs in the MRI environment.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on the analysis of such samples. IVDs are designed to be used in vitro (outside the body) to examine specimens.
The device is a patient monitoring system, which is a type of medical device used in vivo (within the body or on the body surface) to measure and display physiological parameters.
N/A
Intended Use / Indications for Use
The 3160 MRI Patient Monitoring System is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner.
The 3160 MRI Patient Monitoring System is intended for use by health care professionals.
Product codes (comma separated list FDA assigned to the subject device)
DRT, DXN, DQA, CCK, CBQ, CBS, CBR, CCL, MWI
Device Description
The 3160 MRI Patient Monitoring System is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. It is designed to assist clinicians in monitoring patient vital signs in the midst of the dynamic and evolving Magnetic Resonance environment. A combination of wireless communication, radio frequency (RF) shielding, digital signal processing (DSP), and adaptable mounting technologies address the challenges associated with patient monitoring in the MRI area. Built on Invivo's strong heritage in MRI patient vital signs monitoring, the 3160 orovides accurate, continuous, and reliable performance during all phase of MRI applications.
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
The 3160 MRI Patient Monitoring System is intended for use by health care professionals.
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)
The performance data included in this submission to compare equivalency of the Magnitude 3150/3155 and the Integrated Patient Monitor System 510(k) cleared devices to the modified 3160 MRI Compatible Patient Monitoring System met the performance requirements for accuracy and precision and indicates substantial equivalence to the predicate devices. Equivalent performance in meeting user requirements was also determined.
Validation and Verification Testing confirmed that this device operates as designed and intended:
Heart Rate Monitor
Range/Resolution: Adult: 30 to 249 BPM Neonate: 30 to 300 BPM / 1 BPM
Rate Accuracy: +/- 1% from 30 to 200 BPM, +/- 1.5% from 201 to 250 BPM, +/- 2% from 251 to 300 BPM (Neonate only)
Defibrillator Protection: Accepts and recovers from a defibrillator discharge up to 5 KV
Non-Invasive Blood Pressure Monitoring
Auto Mode Set Intervals: OFF, 1, 2, 2.5, 3, 5, 10, 15, 20, 30, 45 Min, or 1, 2 and 4 Hrs
Pop-Off Pressure Level: 285 +/- 14 mmHg
Cuff Inflation Time: 3 to 20 seconds
Pulse Oximetry
Range: 0 to 100% saturation
Accuracy:
§ 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
K050399 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
SUBMITTER INFORMATION
| A. | Company Name: | Invivo Research, Inc. |
|---|---|---|
| B. | Company Address: | 12601 Research Parkway |
| Orlando, FL 32826 | ||
| C. | Company Phone: | |
| Company Fax: | (407) 275-3220 | |
| (407) 249-2022 | ||
| D. | Contact Person: | Neil Battiste |
| Director of Regulatory Affairs (acting) | ||
| Invivo Research, Inc. | ||
| E. | Date Summary Prepared: | February 10, 2004 |
| DEVICE IDENTIFICATION | ||
| A. | Generic Device Name: | 3160 MRI Patient Monitor |
| B. | Trade/Proprietary Name: | 3160 Series MRI Compatible Patient |
| Monitoring System |
- Class II C. Classification: DRT, DXN, DQA, CCK, CBQ, CBS, Product Codes: D. CBR, CCL, MWI
DEVICE DESCRIPTION
The 3160 MRI Patient Monitoring System is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. It is designed to assist clinicians in monitoring patient vital signs in the midst of the dynamic and evolving Magnetic Resonance environment. A combination of wireless communication, radio frequency (RF) shielding, digital signal processing (DSP), and adaptable mounting technologies address the challenges associated with patient monitoring in the MRI area. Built on Invivo's strong heritage in MRI patient vital signs monitoring, the 3160 orovides accurate, continuous, and reliable performance during all phase of MRI applications.
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SUMMARY OF SAFETY AND EFFECTIVENESS Page 2/4
SUBSTANTIAL EQUIVALENCE
The Invivo Research System is of comparable type and is substantially
equivalent to the following predicate devices:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| Magnitude ™ | |||
| 3150/3155 MRI Patient | |||
| Monitoring System | Invivo Research, Inc. | K040915 | 09/22/04 |
| Integrated Patient | |||
| Monitoring System | Invivo Research, Inc. | K041918 | 10/15/04 |
INTENDED USE
The 3160 MRI Patient Monitoring System is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner.
The 3160 MRI Patient Monitoring System is intended for use by health care professionals.
COMPARISON TO PREDICATE DEVICE:
The MRI Compatible Patient Monitoring System and the predicate devices (Magnitude 3150/3155 and the Integrated Patient Monitoring System) are all portable monitors which are used to transmit vital sign information to a patient monitor during MRI procedures.
The systems differ in that the MRI Compatible Patient Monitor has been enhanced by providing wireless technology for the ECG leads and the pulse oximeter function, and by moving to a lithium battery for longer battery life.
Confidential
2
KO50394
SUMMARY OF SAFETY AND EFFECTIVENESS Page 3/4
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the 3160 MRI Compatible Patient Monitoring System and the predicate devices has been performed. The results of this comparison demonstrate that the 3160 MRI Compatible Patient Monitoring System is equivalent to the marketed predicate devices in technological characteristics.
ENVIRONMENTAL AND NON-CLINICAL TESTING:
Applicable environmental and non-clinical testing was performed per UL-2601-1 and IEC 60601-1-2 as well as other applicable standards and procedures. The 3160 MRI Compatible Monitoring System passed all tests.
PERFORMANCE DATA
The performance data included in this submission to compare equivalency of the Magnitude 3150/3155 and the Integrated Patient Monitor System 510(k) cleared devices to the modified 3160 MRI Compatible Patient Monitoring System met the performance requirements for accuracy and precision and indicates substantial equivalence to the predicate devices. Equivalent performance in meeting user requirements was also determined.
Summary of Performance Testing:
Validation and Verification Testing confirmed that this device operates as designed and intended:
| Parameter | Specification |
|---|---|
| ELECTRICAL AND MECHANICAL CHARACTERISTICS | |
| Operating Voltage | 90 to 264 VAC |
| Power Consumption | 30 Volt-Amperes with Charged batteries (48 VA maximum during charging) |
| Battery | Lithium Ion, Capacity > 8 hours |
| Electrical Safety | Per EN 60601-1 |
| Electromagnetic Compatibility | Per EN 60601-1-2 |
Confidential
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| PERFORMANCE REQUIREMENTS | ||
|---|---|---|
| Heart Rate Monitor | ||
| Range/Resolution | Adult: 30 to 249 BPM Neonate: 30 to 300 BPM / 1 BPM | |
| Rate Accuracy | $\pm$ 1% from 30 to 200 BPM | |
| $\pm$ 1.5% from 201 to 250 BPM | ||
| $\pm$ 2% from 251 to 300 BPM (Neonate only) | ||
| Defibrillator Protection | Accepts and recovers from a defibrillator discharge up to 5 KV | |
| Non-Invasive Blood Pressure Monitoring | ||
| Auto Mode Set Intervals | OFF, 1, 2, 2.5, 3, 5, 10, 15, 20, 30, 45 Min, or 1, 2 and 4 Hrs | |
| Pop-Off Pressure Level | 285 +/- 14 mmHg | |
| Cuff Inflation Time | 3 to 20 seconds | |
| Pulse Oximetry | ||
| Range | 0 to 100% saturation | |
| Accuracy |