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510(k) Data Aggregation
(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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