(357 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 Neonatal populations, for monitoring of Electrocardiogram (ECG), Pulse Oximetry (SpO2), Non-Invasive Blood Pressure (NIBP), Temperature, Anesthetic Agents, Respiration, Capnography (CO2), and Oxygen (O2).
The 3880 MRI Patient Monitoring System, also referred to as the 3880, cleared October 25th, 2017, 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 attached to a 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 (AGENTS) (requires 3886 Multi-Gas Unit) ●
- Desflurane (DES) O
- Enflurane (ENF) O
- Halothane (HAL) O
- Isoflurane (ISO) O
- Sevoflurane (SEV) O
- 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 provided text describes a 510(k) premarket notification for the Iradimed Corporation's 3880 MRI Patient Monitoring System. The purpose of this submission is to expand the indications for use to include neonatal populations for Pulse Oximetry (SpO2), Capnography (CO2), and Anesthetic Agents (AGENTS). The manufacturer claims substantial equivalence to previously cleared devices.
Based on the provided text, the device itself is a patient monitoring system, and the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the non-clinical and potentially clinical testing performed to demonstrate substantial equivalence for the expanded indications.
Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by conformance to FDA-recognized consensus standards for medical electrical equipment. The "reported device performance" is indicated by a "Pass" for each standard.
| Acceptance Criteria (FDA Recognized Consensus Standard) | Standard ID | Reported Device Performance |
|---|---|---|
| Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance | 60601-1 | Pass |
| Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility – Requirements and Tests | 60601-1-2 | Pass |
| Medical Electrical Equipment - Part 1-8: General Requirements For Basic Safety And Essential Performance - Collateral Standard: General Requirements, Tests And Guidance For Alarm Systems In Medical Electrical Equipment And Medical Electrical Systems | 60601-1-8 | Pass |
| Medical Electrical Equipment - Part 2-27: Particular Requirements For The Basic Safety And Essential Performance Of Electrocardiographic Monitoring Equipment | 60601-2-27 | Pass |
| Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers | 80601-2-30 | Pass |
| Medical Electrical Equipment - Part 2-55: Particular Requirements For The Basic Safety And Essential Performance Of Respiratory Gas Monitors | 80601-2-55* | Pass |
| Medical Electrical Equipment - Part 2-56: Particular Requirements For Basic Safety And Essential Performance Of Clinical Thermometers For Body Temperature Measurement | 80601-2-56 | Pass |
| Medical Electrical Equipment - Part 2-61: Particular Requirements For Basic Safety And Essential Performance Of Pulse Oximeter Equipment | 80601-2-61* | Pass** |
| Medical Devices – Application Of Risk Management To Medical Devices | 14971 | Pass |
| Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process | 10993-1 | Pass |
| Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity | 10993-5 | Pass |
| Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization | 10993-10 | Pass |
| Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Device in MR Environment | F2052-15 | Pass |
| Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment | F2503-13 | Pass |
| Standard Test Method For Measurement Of Magnetically Induced Torque On Medical Devices In The Magnetic Resonance Environment | F2213-11 | Pass |
| Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications | 62133 | Pass |
Notes from the document:
- *All FDA Recognized Consensus Standards test reports listed above were provided and reviewed with the primary predicate device, which was cleared to market under K172200. The test reports provided in this submission, identified with asterisks in the table above, have been supplied in Section 18 to support substantial equivalence with the parameter specific predicates for the SpO2 and CO2/AGENTS parameters.
- ** Additional bench testing comparing performance of the Masimo SET Rad 8 was conducted to demonstrate equivalence of the subject device which integrates Masimo MS Series Module and sensor technology. The testing demonstrated equivalence of both systems when configured for use in neonates.
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "The proposed modifications to the 3880 MRI Patient Monitoring Systems labeling does not require non-clinical performance testing. The non-clinical performance testing provided in K172200 has not changed since the submission and is still applicable to the modified device."
- Sample Size for Test Set: Not directly specified in the provided text for the current submission (K180903). The reliance is on prior testing from K172200 and the specified predicate devices (K050399, K053269, K171121). For the SpO2 performance, "The SpO2 volunteer blood study testing results using ISO 80601-2-61:2011 were submitted with K172200." This suggests human subject data for SpO2 accuracy, but the sample size is not stated here. "Additional bench testing comparing performance of the Masimo SET Rad 8 was conducted" for neonatal SpO2, but again, the sample size (e.g., number of test points, subjects) is not provided.
- Data Provenance: The data is primarily from non-clinical performance testing (bench testing) and possibly a volunteer blood study. The origin (country, retrospective/prospective) of this data is not specified, but typically, premarket testing for FDA clearance is conducted under good laboratory practices (GLP) and may involve international standards but is intended for the US regulatory context. The nature of the submission (510(k) for an expanded indication) suggests this isn't a large-scale clinical trial with geographical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is typically relevant for studies involving subjective interpretations (e.g., image analysis for AI diagnostic devices). For a vital signs monitor, the "ground truth" would be established by validated reference measurement devices or controlled physiological conditions. The document does not describe the use of experts to establish ground truth in the way one would for diagnostic imaging.
4. Adjudication Method for the Test Set
Not applicable in the context of this submission. Adjudication methods (e.g., 2+1, 3+1) are common in studies where multiple human readers assess cases and their disagreements need to be resolved to establish a "ground truth" or reference standard. For a vital signs monitor, the performance is typically assessed against a known standard or reference measurement, not through human consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is primarily for diagnostic medical devices (e.g., AI for radiology) to compare the performance of human readers with and without AI assistance. This submission is for a vital sign monitoring system, and the equivalence is established through conformance to performance standards and comparison to predicate devices, not improvement in human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
The device is a patient monitoring system, which intrinsically involves a human-in-the-loop (healthcare professional) for operation and interpretation. The "performance" refers to its accuracy and reliability in measuring physiological parameters, which is assessed against objective standards, not as a standalone AI algorithm independent of human use. The performance data is essentially "standalone" in the sense that the device's measurements are validated against reference measurements, assuming correct operation by a human, but it's not an AI algorithm in the typical sense of generating a diagnosis or recommendation.
7. The Type of Ground Truth Used
The ground truth for the performance testing is based on:
- Validated Reference Measurement Devices: For parameters like SpO2, NIBP, temperature, CO2, and anesthetic agents, the "ground truth" is typically obtained from highly accurate, calibrated reference instruments under controlled conditions (e.g., volunteer blood study for SpO2, calibrated pressure sources for NIBP, known gas concentrations for CO2/agents).
- Consensus Standards: Conformance to recognized international and national standards (e.g., ISO 80601 series) dictates the methods for validation and the acceptable ranges of error, effectively serving as the definition of acceptable "ground truth" performance.
8. The Sample Size for the Training Set
The provided document does not mention "training sets" in the context of machine learning or AI algorithms. This device is a physiological monitor, not an AI/ML-based diagnostic or prognostic tool. Therefore, there is no "training set" in the sense of data used to train an algorithm. The development of such devices relies on engineering design, validation against physical and physiological models, and adherence to established measurement principles, not data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of an AI/ML training set, this question is not applicable.
§ 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).