INTEGRATED PATIENT MONITORING SYSTEM
Device Facts
| Record ID | K041918 |
|---|---|
| Device Name | INTEGRATED PATIENT MONITORING SYSTEM |
| Applicant | Invivo Research, Inc. |
| Product Code | MWI · Cardiovascular |
| Decision Date | Oct 15, 2004 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2300 |
| Device Class | Class 2 |
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.
Device Story
Integrated Patient Monitoring System (IPMS) monitors vital signs during MRI procedures; provides synchronization signals for MRI scanners. Components: Patient Connector Box (MCB), Monitoring Electronics Box (MEB), Monitoring Display and Control Unit (MDCU); integrated into Philips Physiotrak patient gurney. Inputs: ECG, non-invasive blood pressure, SpO2, respiration, temperature. Operation: Battery or AC power; displays data locally or remotely; programmable alarm limits. MRI compatibility: Non-magnetic materials; RF noise suppression at Larmor frequencies. Used in clinical MRI environments by healthcare professionals. Output: Real-time vital sign monitoring and scanner synchronization; assists clinicians in patient management during imaging.
Clinical Evidence
Bench testing only. Validation and verification testing confirmed performance specifications for heart rate (0-250 BPM), NIBP, SpO2 (accuracy <3.0%), respiration (4-150 RPM), and temperature (0.3°C accuracy). MRI compatibility verified via RF emission testing (-100dB at Larmor frequencies) and use of non-magnetic materials.
Technological Characteristics
Non-magnetic materials; Lead-Acid Gel Cell batteries; AC/DC power; integrated into patient gurney. Sensing: ECG, NIBP, SpO2, respiration, temperature. Connectivity: Local display and remote monitoring. Electrical safety per EN 60601-1; EMC per EN 60601-1-2. Software: Programmable alarm limits.
Indications for Use
Indicated for patients undergoing MRI procedures requiring monitoring of heart rhythm, blood pressure, SpO2, respiration, and temperature, and requiring synchronization signals for the MRI scanner.
Regulatory Classification
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.
Predicate Devices
- Invivo Research Omni-Trak™ 3150/3155 Series Patient Monitoring System (K002030)
- Invivo Research Millennia 3500 Series Monitor (K974581)
Submission Summary (Full Text)
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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).
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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 | < 30 Volt-Amperes @ 120 VAC nominal (< 60 VA maximum during charging) |
| Battery | Lead-Acid Gel Cell (x4), Capacity > 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 | < 3.0% (60% to 100%) |
| Averaging Period | 3, 6, or 12 seconds |
| Respiration Monitoring | |
| Range | 4 to 150 RPM |
| Resolution | 1 RPM |
| Accuracy | 2% up to 60 RPM, 3.4% at 87 RPM, 5.6% at 142 RPM |
| Temperature | |
| Range | 20°C to 44°C |
| Accuracy | 0.3°C (32°C to 44°C) |
| Time Constant | 15 seconds |
| MRI COMPATIBILITY | |
| Maximum RF Emissions | Maximum -100dB RF noise at MRI Larmor Frequencies |
| MRI In Bore Materials Used | All materials are non- magnetic, and do not produce proton-signal emissions during MRI |
#### Conclusion
The Integrated Patient Monitoring System is safe, effective and substantially equivalent to the predicate ... t devices.
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 2004
Invivo Research, Inc. c/o Mr. Neil Battiste Director of Regulatory Affairs 12601 Research Parkway Orlando, FL 32826
Re: K041918
Trade Name: Integrated Patient Monitor System (IPMS) Regulation Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor Regulatory Class: Class II (two) Product Code: MWI Dated: September 16, 2004 Received: September 20, 2004
#### Dear Mr. Battiste:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because the device is substantially equivalent (for the indications felerenced above und nave acterimes ally marketed predicate devices marketed in interstate for use stated in the encrosaly to regists the enactment date of the Medical Device Amendments, or to Commerce provision to May 20, 1978, the excordance with the provisions of the Federal Food, DINA devices that have occh receasined in assere approval of a premarket approval application (PMA). alle Cosmetic Act (1101) that do not requent app to the general controls provisions of the Act. The r ou may, mercebre, market the act include requirements for annual registration, listing of general controls provisions practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is olasbirou (600 a00 ro) als. Existing major regulations affecting your device can may be subject to sach addrener sentlations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 – Mr. Neil Battiste
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuance of a backer complies with other requirements of the Act that TDA has made a decormmanon ana your stered by other Federal agencies. You must or any Federal statutes and regulations daminding, but not limited to: registration and issting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set as a CFK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic a forum in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product laulation control provisions (Section your device as described in your Section 510(k) I his letter will anow you to begin maneting your and equivalence of your device to a legally premarket nothleadon: The TDA miang of castification 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), please If you desire specific advice for your ac 1100 %. 4646. Also, please note the regulation entitled, Coniact the Ories of Come of Come the notification" (21CFR Part 807.97) you may obtain. IMISURahuing of Icrerchee to premaisonsibilities under the Act may be obtained from the Other general mionmation on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bhimma for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known):
K04/1918
Device Name: Integrated Patient Monitoring System
Indications For Use:
The Philips Medical Systems Integrated Patient Monitoring System The I mips Medical Bystems and other vital seen rhythm and other vital signs (ITMS) is intended to moments
for a patient undergoing an MRI procedure and to provide signals for synchronization for the MRI scanner.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR ..
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blummen
(Division Sign-Off)
(Division sign-Om)
Division of Cardiovascular Devices
510(k) Number K041918
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