(191 days)
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.
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.
Here's a summary of the acceptance criteria and study information for the K050399 device, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| ELECTRICAL AND MECHANICAL CHARACTERISTICS | ||
| Operating Voltage | 90 to 264 VAC | Passed all tests (implied by "met the performance requirements") |
| Power Consumption | 30 Volt-Amperes with Charged batteries (48 VA maximum during charging) | Passed all tests (implied by "met the performance requirements") |
| Battery Capacity | > 8 hours (Lithium Ion) | Passed all tests (implied by "met the performance requirements") |
| Electrical Safety | Per EN 60601-1 | Passed all tests (explicitly stated in "Summary of Performance Testing") |
| Electromagnetic Compatibility | Per EN 60601-1-2 | Passed all tests (explicitly stated in "Summary of Performance Testing") |
| Heart Rate Monitor | ||
| Range/Resolution (Adult) | 30 to 249 BPM / 1 BPM | Met performance requirements (accuracy and precision) |
| Range/Resolution (Neonate) | 30 to 300 BPM / 1 BPM | Met performance requirements (accuracy and precision) |
| Rate Accuracy (30-200 BPM) | ± 1% | Met performance requirements (accuracy and precision) |
| Rate Accuracy (201-250 BPM) | ± 1.5% | Met performance requirements (accuracy and precision) |
| Rate Accuracy (251-300 BPM) | ± 2% (Neonate only) | Met performance requirements (accuracy and precision) |
| Defibrillator Protection | Accepts and recovers from discharge up to 5 KV | Met performance requirements (accuracy and precision) |
| 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 | Met performance requirements (accuracy and precision) |
| Pop-Off Pressure Level | 285 +/- 14 mmHg | Met performance requirements (accuracy and precision) |
| Cuff Inflation Time | 3 to 20 seconds | Met performance requirements (accuracy and precision) |
| Pulse Oximetry | ||
| Range | 0 to 100% saturation | Met performance requirements (accuracy and precision) |
| Accuracy | < 3.0% (60% to 100%) | Met performance requirements (accuracy and precision) |
| Averaging Period | 3, 6, or 12 seconds | Met performance requirements (accuracy and precision) |
| Respiration Monitoring | ||
| Range | 4 to 150 RPM | Met performance requirements (accuracy and precision) |
| Resolution | 1 RPM | Met performance requirements (accuracy and precision) |
| Accuracy | +/- 5% or 2rpm (whichever is greater) | Met performance requirements (accuracy and precision) |
| Anesthetic Agents | ||
| Halothane Range | 0.15 to 6.0 Vol.% | Met performance requirements (accuracy and precision) |
| Halothane Accuracy | ± 0.15 Vol.% +15% relative | Met performance requirements (accuracy and precision) |
| Enflurane Range | 0.15 to 8.0 Vol % | Met performance requirements (accuracy and precision) |
| Enflurane Accuracy | (0.15-7 %) ± 0.15 Vol% + 15% relative | Met performance requirements (accuracy and precision) |
| Isoflurane Range | 0.15 to 6.0 Vol % | Met performance requirements (accuracy and precision) |
| Isoflurane Accuracy | ± 0.15 Vol.% +15% relative | Met performance requirements (accuracy and precision) |
| Sevoflurane Range | 0.15 to 9.0 Vol% | Met performance requirements (accuracy and precision) |
| Sevoflurane Accuracy | (0.15-8%) ± 0.15 Vol% + 15% relative | Met performance requirements (accuracy and precision) |
| Desflurane Range | 0.15 to 20 Vol% | Met performance requirements (accuracy and precision) |
| Desflurane Accuracy | ± 0.15 Vol.% +15% relative | Met performance requirements (accuracy and precision) |
| Carbon Dioxide Range | 0 to 10 Vol% | Met performance requirements (accuracy and precision) |
| Carbon Dioxide Accuracy | (measured with agent option) ± 4mmHG or 12%, whichever is greater | Met performance requirements (accuracy and precision) |
| Nitrous Oxide Range | 0 to 99 Vol % | Met performance requirements (accuracy and precision) |
| Nitrous Oxide Accuracy | (measured with agent option) ± 2% Vol + 8% relative | Met performance requirements (accuracy and precision) |
| MRI COMPATIBILITY | ||
| Maximum RF Emissions | Maximum -150dB RF noise at MRI Larmor Frequencies | Met performance requirements (accuracy and precision) |
| MRI In-Bore Materials | All materials are non-magnetic, and do not produce proton-signal emissions during MRI | Met performance requirements (accuracy and precision) |
Study Proving Device Meets Acceptance Criteria:
The document states that "Validation and Verification Testing confirmed that this device operates as designed and intended." It also mentions that "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."
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not specify the sample size used for the test set.
- The document does not provide information regarding the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- The document does not mention using experts to establish ground truth for a test set. This appears to be a performance validation based on technical specifications rather than diagnostic interpretation.
4. Adjudication Method for the Test Set:
- An adjudication method is not applicable as the testing described focuses on technical performance parameters and not on diagnostic interpretation requiring and comparing human expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- A MRMC comparative effectiveness study was not done. The submission focuses on validating technical performance against established specifications and demonstrating substantial equivalence to predicate devices, not on comparing reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- A standalone study was done, in the sense that the device's performance characteristics (e.g., heart rate accuracy, NIBP accuracy, pulse oximetry accuracy) were tested and validated independently of a human operator's diagnostic interpretation. The data presented covers the intrinsic performance of the device's monitoring functions.
7. Type of Ground Truth Used:
- The ground truth used was based on established engineering and medical device performance specifications and standards. For vital signs measurements (e.g., heart rate, SpO2, NIBP), this would typically involve comparison against highly accurate reference instruments or simulated physiological signals that meet the specified accuracy requirements. For electrical safety, EMC, and MRI compatibility, the ground truth refers to conformance with standards like UL-2601-1 and IEC 60601-1-2.
8. Sample Size for the Training Set:
- The document does not mention a training set. This device is a patient monitoring system, which typically relies on algorithms and hardware designed to measure physiological parameters based on known physical principles, rather than a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- As there is no mention of a training set, this information is not applicable and not provided in the document.
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K050399 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
SUBMITTER INFORMATION
| A. | Company Name: | Invivo Research, Inc. |
|---|---|---|
| B. | Company Address: | 12601 Research ParkwayOrlando, FL 32826 |
| C. | Company Phone:Company Fax: | (407) 275-3220(407) 249-2022 |
| D. | Contact Person: | Neil BattisteDirector 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 PatientMonitoring 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 PatientMonitoring System | Invivo Research, Inc. | K040915 | 09/22/04 |
| Integrated PatientMonitoring 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
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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 | < 3.0% (60% to 100%) | |
| Averaging Period | 3, 6, or 12 seconds | |
| Respiration Monitoring | ||
| Range | 4 to 150 RPM | |
| Resolution | 1 RPM | |
| Accuracy | +/- 5% or 2rpm (whichever is greater) | |
| Anesthetic Agents | ||
| Halothane | Range: 0.15 to 6.0 Vol.% | Accuracy: $\pm$ 0.15 Vol.% +15% relative |
| Enflurane | Range: 0.15 to 8.0 Vol % | Accuracy: (0.15-7 %) $\pm$ 0.15 Vol% + 15% relative |
| Isoflurane | Range: 0.15 to 6.0 Vol % | Accuracy: $\pm$ 0.15 Vol.% +15% relative |
| Sevoflurane | Range: 0.15 to 9.0 Vol% | Accuracy: (0.15-8%) $\pm$ 0.15 Vol% + 15% relative |
| Desflurane | Range: 0.15 to 20 Vol% | Accuracy: $\pm$ 0.15 Vol.% +15% relative |
| Carbon Dioxide | Range: 0 to 10 Vol% | Accuracy: (measured with agent option) $\pm$ 4mmHG or 12%, whichever is greater |
| Nitrous Oxide | Range: 0 to 99 Vol % | Accuracy: (measured with agent option) $\pm$ 2% Vol + 8% relative |
| MRI COMPATIBILITY | ||
| Maximum RF Emissions | Maximum -150dB 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 test results demonstrate the 3160 MRI Compatible Patient Monitoring System is substantially equivalent to the Magnitude 3150/3155 Series Patient Monitoring System and the Integrated Patient Monitoring System devices.
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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.
AUG 2 6 2005
Food and Drug Administration
Public Health Service
9200 Corporate Boulevard Rockville MD 20850
Invivo Resarch, Inc. c/o Eduardo Rey Regulatory Compliance Engineer 12601 Research Parkway Orlando FL 32826
Re: K050399
Trade/Device Name: Patient Monitor System, Model 3160 Regulation Number: 21 CFR 870. Regulation Name: Regulatory Class: Class II Product Code: MWI Dated: August 22, 2005 Received: August 23, 2005
Dear Mr. Rey:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 -- Mr. Eduardo Rey
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality Bystellin (Sections 531-542 of the Act); 21 CFR 1000-1050. product faction of to begin marketing your device as described in your Section 510(k) I mis lotter will and w yourse of substantial equivalence of your device to a legally premance hother hother results in a classification 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 active of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international 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,
Vitimotov
Brand 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): _K050399
Device Name: 3160 MRI Patient Monitoring System
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.
V Prescription Use (Part 21 CFR 801 Subpart D)
Canada Canada Canada Callery Comments Comments Comments of Commendential Andress
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bremmer
iolvistøn Sign-Off) Division of Cardiovascular Devices 510((k) Number_
Page of of
§ 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).