(91 days)
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No
The description focuses on standard vital sign monitoring and alarm functions, with no mention of AI or ML technologies. The device is described as a modification and integration of existing, non-AI/ML monitoring systems.
No
The device is intended for monitoring vital signs and providing signals for synchronization for an MRI scanner, not for treating any medical condition.
No.
The device is described as a monitoring system for vital signs and heart rhythm, primarily for synchronization with an MRI scanner and alarming for out-of-range parameters. It does not indicate the diagnosis of diseases or conditions.
No
The device description explicitly lists multiple hardware components (MCB, MEB, MDCU) that are integrated into a patient gurney, indicating it is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "monitor the heart rhythm and other vital signs for a patient undergoing an MRI procedure and to provide signals for synchronization for the MRI scanner." This describes a device that monitors physiological parameters directly from the patient's body.
- Device Description: The description details monitoring of ECG, non-invasive blood pressure, SPO2, respiration, and temperature. These are all measurements taken in vivo (within the living body), not in vitro (outside the living body, typically on samples like blood or tissue).
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples (blood, urine, tissue, etc.) or the use of reagents, which are hallmarks of IVD devices.
Therefore, the Philips Medical Systems Integrated Patient Monitoring System (IPMS) is a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Philips Medical Systems Integrated Patient Monitoring System (IPMS) is intended to monitor the heart rhythm and other vital signs for a patient undergoing an MRI procedure and to provide signals for synchronization for the MRI scanner.
Product codes
MWI, DXN, DQA, BZQ, FFL
Device Description
The Philips Medical Systems Integrated Patient Monitoring System (IPMS) is a significant modification of the Invivo Research Omni-Trak™ 3150/3155 Series Patient Monitoring System. This device has been used with the Philips MRI System.
The Philips Medical Systems Integrated Patient Monitoring System is intended to monitor the heart rhythm and other vital signs for a patient undergoing an MRI procedure and to provide signals for synchronization for the MRI scanner. The IPMS works on DC (battery) power supplies and monitors non-invasive blood pressure, SPO2, respiration, and temperature. This information can be displayed either at the monitor or remotely.
The monitor sounds an alarm if any monitored parameter falls outside the range indicated by the alarm limits. The alarm limits is programmable either manually or programmatically based on the current value of the parameter(s).
This monitoring system is MRI-compatible. It utilizes technology from the Invivo Research Omni-Trak™ 3150/3155 Scries Patient Monitoring System and the Invivo Research Millennia Patient Monitor. The IPMS consists of three major component parts; the MCB (Patient Connector Box), MEB (Monitoring Electronics Box), and MDCU (Monitoring Display and Control Unit) which are integrated into the Phillips Physiotrak patient gurney.
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
Validation and Verification Testing confirmed that this device operates as designed and intended.
Performance requirements are listed for:
- Electrical and Mechanical Characteristics (Line Voltage, Power Sources Available, Power Consumption, Battery, Electrical Safety, Electromagnetic Compatibility)
- Performance Requirements (Heart Rate Monitor: Range/Resolution, Rate Accuracy, Defibrillator Protection; Non-Invasive Blood Pressure Monitoring: Auto Mode Set Intervals, Pop-Off Pressure Level, Cuff Inflation Time; Pulse Oximetry: Range, Accuracy, Averaging Period; Respiration Monitoring: Range, Resolution, Accuracy; Temperature: Range, Accuracy, Time Constant)
- MRI Compatibility (Maximum RF Emissions, MRI In Bore Materials Used)
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
OCT 1 5 2004
K041918
page 1 of 2
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
Device Name
Integrated Patient Monitor System
Common Name
Multiparameter Patient Monitor
| Classification Names | Codes | Reference |
|---|---|---|
| 1. Monitor, Physiological Patient | MWI | 870.2300 |
| 2. System, Measurement, Blood Pressure, Non Invasive | DXN | 870.1130 |
| 4. Oximeter | DQA | 870.2700 |
| 3. Monitor, Breathing Frequency | BZQ | 868.2375 |
| 5. Thermometer, Electronic, Clinical | FFL | 880.2910 |
Predicate Devices:
Invivo Research Omni-Trak™ 3150/3155 Series Patient Monitoring System.
510(k) Number: K002030
Device Classification Name: Monitor, Physiological Patient (w/o Arr. Detector or Alarms) Regulation Number: 870.2300, 74 MWI
| Invivo Research Millennia 3500 Series Monitor |
|---|
| 510(k) Number: K974581 |
| Device Classification Name: Monitor, Cardiac (incl. cardiotachometer & rate alarm) |
| Regulation Number: 870.2300, 74 DRT |
Device Description:
Device Describution:
The Philips Medical Systems Integrated Patient Monitoring System (IPMS) is a significant modification books book The Invivo Research Omni-Trak™ 3150/3155 Series Patient Monitoring System. This Mevice has been
of the Invivo Research Omni-Trak™ 3150/3155 Series Patient Monitoring System of the Invivo Rescaren Online France - 3150133131796 patient gurney used with the Philips MRI System.
The Philips Medical Systems Integrated Patient Monitoring System is intended to monitor the heart The I million and other vital signs for a patient undergoing an MRI procedure and to provide signals for rhythm and other vital signs for a patient andergoing an work on DC (battery) power supplies and monitors synchionization for the Mr. Sountion) blood pressure, SPO2, respiration and temperature. This information can be displayed either at the monitor or remotely.
The monitor sounds an alarm if any monitored parameter falls outside the range indicated by the The montor sounds an allanits. The alarm limits is programmable either manually or programmally based on the current value of the paraméter(s).
1
Image /page/1/Picture/0 description: The image shows handwritten text. The text at the top reads "K04/1918". Below that, the text reads "page 2 of 2". The handwriting appears to be cursive.
IPMS Summary o tiveness, page 2 of 2
This monitoring system is MRI-compatible. It utilizes technology from the Invivo Research Omni-Trak™ 3150/3155 Scries Patient Monitoring System and the Invivo Research Millennia Patient Monitor. The IPMS consists of three major component parts; the MCB (Patient Connector Box), MEB (Monitoring Electronics Box), and MDCU (Monitoring Display and Control Unit) which are intograted into the Phillips Physiotrak patient gurney
Intended Use
The Philips Medical Systems Integrated Patient Monitoring System (IPMS) is intended to monitor the heart rhythm and other vital signs for a patient undergoing an MRI procedure and to provide signals for synchronization for the MRI scanner.
Summary of Performance Testing:
Validation and Verification Testing confirmed that this device operates as designed and intended:
| Parameter | Specification |
|---|---|
| ELECTRICAL AND MECHANICAL CHARACTERISTICS | |
| Line Voltage | 115 VAC +/- 10%, 50/60 Hz |
| Power Sources Available | AC Power, or internal battery power with remote charger |
| Power Consumption | 8 hours with 4 batteries |
| Electrical Safety | Per EN 60601-1 |
| Electromagnetic Compatibility | Per EN 60601-1-2 |
| PERFORMANCE REQUIREMENTS | |
| Heart Rate Monitor | |
| Range/Resolution | 0 to 250 BPM / 1 BPM |
| Rate Accuracy | 0.5% of reading, +/- 1BPM |
| 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, 4 Hrs |
| Pop-Off Pressure Level | 270 +/- 14 mmHg |
| Cuff Inflation Time | 3 to 20 seconds |
| Pulse Oximetry | |
| Range | 0 to 100% saturation |
| Accuracy |