(96 days)
The IRadimed Corporation's 3880 MRI Patient Monitoring System is intended to monitor a single patient's vital signs for patients undergoing Magnetic Resonance Imaging (MRI) procedures.
The 3880 MRI Patient Monitoring System is intended for use by healthcare professionals.
The 3880 MRI Patient Monitoring System is intended for use in Adult and Pediatric, including Neonations, for monitoring of Electrocardiogram (ECG). Non-Invasive Blood Pressure (NIBP), and Temperature.
The 3880 MRI Patient Monitoring System is also intended for use in Adult and Pediatric. not including Neonatal populations, for monitoring of Pulse Oximetry (SpO2), Anesthetic Agents, Respiration, Capnography (CO2), and Oxygen (02).
The 3880 MRI Patient Monitoring System provides monitoring for three distinct patient types as defined below (Note: Pediatric group excludes Neonates):
| Patient Type | Age |
|---|---|
| 1 Adult | greater than 22 years |
| 2 Pediatric | (Includes: Infant, Child and Adolescent) |
| -Adolescent | aged 12 through 21 (up to but not including the 22nd birthday) |
| -Child | 2 years to less than 12 years |
| -Infant | 29 days to less than 2 years |
| 3 Neonate | from birth through the first 28 days of life |
The 3880 MRI Patient Monitoring System, also referred to as the 3880, is a multi-parameter vital signs monitor designed for use in the Magnetic Resonance (MR) environment by trained healthcare professionals. The 3880 processes and displays multiple parameters, waveforms, measurement numeric values and alarms. The device is powered by either AC line power or its internal battery. It is light weight making it a practical intra-department patient transportation monitor for use within the MRI suite. The device can be carried by its handle, mounted to a wheeled cart/stand, or patient bed. The 3880 provides monitoring for the following parameters:
- Electrocardiogram (ECG)
- Heart rate (HR- ECG, SpO2, and NIBP derived)
- Blood oxygen saturation/pulse oximetry (SpO2)
- Non-invasive blood pressure (NIBP)
- End-tidal and fractional inspired CO2 (EtCO2 and FiCO2)
- Anesthetic agents (AGENT) (requires 3886 Multi-Gas Unit)
- Desflurane (DES)
- Enflurane (ENF)
- Halothane (HAL)
- Isoflurane (ISO)
- Sevoflurane (SEV)
- Fractional inspired O2 (FiO2), and end-tidal and fractional inspired N2O (EtN2O and FiN2O) (requires 3886 Multi-Gas Unit)
- Temperature (TEMP)
- Respiration rate (CO2-derived)
The 3880 MRI Patient Monitoring System can be ordered with the following configurations:
Standard Configuration:
| 3880 MRI Patient Monitor | |||||
|---|---|---|---|---|---|
| Configuration | ECG | SpO2 | NIBP | CO2 | Temp |
| 3880 | X | X | X | X | X |
Optional Configuration (Requires 3880 and 3886):
| 3886 Multi-Gas Unit | |||
|---|---|---|---|
| Configuration | AGENTS | CO2 | O2 |
| 3886 | X | X | X |
The 3880 consists of the following key components:
- Patient monitor with buttons and touch screen display
- Wireless ECG POD, "ePOD"
- Wireless SpO2 POD, "oPOD"
- Battery for patient monitor
- Power supply and cables
- Operation Manual
Accessories to the 3880 are offered to accommodate various patient sizes. Key standard and optional accessories include:
- ECG cables and electrodes
- SpO2 sensors and grips
- NIBP cuffs and hoses
- Temperature sensor
- Cannulas
- Remote monitoring tablet (3885-T)
- Remote monitoring tablet docking base, including printer (3885-B)
- Multi-Gas Unit (3886)
- Mounting hardware and stand
The provided text is a 510(k) summary for the IRadimed Corporation's 3880 MRI Patient Monitoring System. It focuses on demonstrating substantial equivalence to a predicate device, the MIPM Tesla M3 MRI Patient Monitoring System (K142032). The device performance is primarily established through non-clinical testing and conformance to recognized consensus standards, with limited clinical data for a specific function.
Here's an analysis based on your requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" for overall device performance in the way one might expect for a diagnostic AI device (e.g., predefined sensitivity/specificity thresholds). Instead, the acceptance criteria are implicitly tied to conformance with various recognized consensus standards (largely related to safety, essential performance, and electromagnetic compatibility) and functional equivalence to the predicate device. For the NIBP function specifically, the acceptance criterion was meeting the requirements of ISO 81060-2.
Here's a summary derived from the "SUMMARY OF NON-CLINICAL PERFORMANCE DATA" and "SUMMARY OF CLINICAL PERFORMANCE DATA" sections within the provided text:
| Performance Metric/Standard | Acceptance Criteria (Implicit from Compliance) | Reported Device Performance |
|---|---|---|
| Overall Device | Performance, functionality, usability, and reliability characteristics established through verification, validation, and testing activities, adhering to specifications cleared for the predicate device and the 3880 MRI Patient Monitoring System, and requirements from FDA Recognized Consensus Standards. | "Verification, validation, and testing activities establish the performance, functionality, usability and reliability characteristics of the device with respect to the predicate. Testing involved system level tests, biocompatibility, performance, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and the specifications of the 3880 MRI Patient Monitoring System as well as the requirements from FDA Recognized Consensus Standards... Results of the non-clinical testing demonstrate that the device operates as intended within its performance specifications and is substantially equivalent to the predicate device." |
| Safety and Essential Performance | Compliance with IEC 60601-1 (General Requirements for Basic Safety and Essential Performance) | Pass |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (EMC Requirements) | Pass |
| Alarm Systems | Compliance with IEC 60601-1-8 (Alarm Systems) | Pass |
| ECG Monitoring | Compliance with IEC 60601-2-27 (Electrocardiographic Monitoring Equipment) | Pass |
| Non-Invasive Blood Pressure (NIBP) | Compliance with ISO 81060-2 (Clinical Validation Of Automated Measurement Type) and operating as intended within performance specifications. | "Non-invasive Blood Pressure (NIBP) clinical performance data provided in Section 20 demonstrates that the device meets the requirements of ISO 81060-2 (2013) 'Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type', operates as intended within the performance specifications and is safe and effective for clinical use." |
| Respiratory Gas Monitors | Compliance with IEC 80601-2-55 (Respiratory Gas Monitors) | Pass |
| Clinical Thermometers | Compliance with IEC 80601-2-56 (Clinical Thermometers for Body Temperature Measurement) | Pass |
| Pulse Oximeters | Compliance with IEC 80601-2-61 (Pulse Oximeter Equipment) | Pass |
| Risk Management | Compliance with ISO 14971 (Application of Risk Management to Medical Devices) | Pass |
| Biocompatibility | Compliance with ISO 10993-1, 10993-5, 10993-10 (Biological Evaluation of Medical Devices) | Pass |
| MRI Environment Testing | Compliance with ASTM F2052-15 (Magnetically Induced Displacement Force), ASTM F2503-13 (Marking Medical Devices), ASTM F2213-11 (Magnetically Induced Torque) | Pass |
| Batteries | Compliance with IEC 62133 (Secondary Cells and Batteries) | Pass |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "clinical performance data provided in Section 20" for NIBP. However, Section 20 is not included in the provided text. Therefore, details regarding the sample size, data provenance (country of origin, retrospective/prospective nature) for the NIBP clinical test set are not available in this document.
For the non-clinical performance data, the "test set" would refer to the physical devices and simulated conditions used for testing against the consensus standards. No sample sizes are specified for these tests. Their provenance is implied to be IRadimed Corporation's testing facilities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable in the context of this 510(k) submission. The 3880 MRI Patient Monitoring System is a vital signs monitor, not a diagnostic imaging AI device. Its performance is evaluated against physiological measurement accuracy standards and safety/performance standards, not against expert consensus on images. For the NIBP clinical data, the "ground truth" would be established by a reference NIBP measurement method, not human experts evaluating images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for this device type and evaluation. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human readers of diagnostic images where consensus among experts is needed to establish ground truth for ambiguous cases. This device measures physiological parameters.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The 3880 MRI Patient Monitoring System is a vital signs monitor and does not involve AI assistance for human readers of diagnostic images. Therefore, an MRMC comparative effectiveness study is not relevant to its regulatory submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone vital signs monitor. Its performance in measuring vital signs (ECG, NIBP, SpO2, Temperature, CO2, Anesthetic Agents, O2) is assessed as an algorithm/device-only performance in relation to established physiological measurement standards. The non-clinical testing referenced demonstrates this standalone performance. The NIBP clinical study also evaluates the device's standalone accuracy against a reference.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance testing (conformance to IEC/ISO standards), the "ground truth" is effectively the defined specifications and measurement accuracy requirements within those standards. These are objective, measurable criteria.
For the NIBP clinical validation, the ground truth would be established by a reference method for blood pressure measurement, as per ISO 81060-2. This standard specifies how clinical validation should be performed and what constitutes an accurate reference measurement.
8. The sample size for the training set
This information is not applicable. The 3880 MRI Patient Monitoring System is a traditional medical device (vital signs monitor) and not an AI/Machine Learning device that undergoes a "training" phase with a dataset in the conventional sense. Its design and performance are based on engineering principles and compliance with established standards, not on learning from a large dataset.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 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).