(248 days)
M Series Patient Monitor is intended to be used for monitoring, displaying, storing and alarming of multiple physiological parameters including ECG, Heart Rate (HR). Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient.
The monitor is to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport or hospital ambulance.
Note: M7000 does not have functions of Invasive Blood Pressure and Carbon Dioxide.
The proposed devices, M Series Patient Monitors, M66, M69, M7000, M8000 and M9000, are modification devices to the existed devices, M Series Patient Monitors, M66, M69, M7000, M8000 and M9000 as cleared in K100046 at 04/08/2010.
The proposed devices and the existed devices share same intended use, design principle and technical specifications. The main modification of the proposed devices is adding a SpO2 module, which was designed and manufactured by Masimo Corporation and previously cleared by FDA in K053269 at 12/21/2005. It is an independent module installed within the patient monitor, without any other modifications, and shall be used with the specified accessories, which are listed in following table.
Here's an analysis of the provided text regarding the acceptance criteria and study for the M Series Patient Monitor (K131876).
Overview:
This 510(k) submission is for modifications to an existing M Series Patient Monitor (K100046). The primary modification is the inclusion of a Masimo SpO2 module, which itself was previously cleared by the FDA (K053269). Therefore, the provided information focuses on demonstrating that the integrated device meets safety and performance standards, particularly for the SpO2 function, and is substantially equivalent to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily compares the proposed device's performance characteristics to the predicate device (K100046) and the standalone Masimo SpO2 module (K053269) rather than explicitly stating "acceptance criteria" in a separate section with specific numerical targets. However, the implicit acceptance criterion is that the proposed device performs at least as well as or identically to the predicate devices for each physiological parameter.
Below are the performance characteristics presented as a comparison, where "Same" indicates the proposed device meets the predicate's specification, and the specific numbers represent the reported performance for the proposed device (which is equivalent to the predicate).
| Parameter | Acceptance Criteria (Predicate / Masimo SpO2 Module Specification) | Reported Device Performance (Proposed Device) |
|---|---|---|
| ECG | ||
| Lead Mode | 5-leads ECG input / 3-leads ECG input | Same |
| CMRR | MON ≥105dB / OPS ≥105dB | Same |
| Sweep speed | 12.5mm/s, 25mm/s, 50mm/s | Same |
| HR Range | 10~350 bpm | Same |
| HR Accuracy | ±1% or ±1 bpm, whichever is greater | Same |
| NIBP | ||
| Method | Oscillometric | Same |
| Measurement Unit | mmHg / kPa | Same |
| Measurement Range | Adult 10-270 mmHg, Pediatric 10-235 mmHg, Neonatal 10-135 mmHg | Same |
| Accuracy (Static) | ±2% or ±3 mmHg, whichever is greater | Same |
| Accuracy (Clinical) | ±5 mmHg average error, ≤ 8 mmHg standard deviation | Same |
| TEMP | ||
| Range | 0.0~50.0°C | Same |
| Accuracy | At 45.1°C | Same |
| RESP | ||
| Method | Impedance variation between RA-LL (R-F) | Same |
| Measurement Range | 0~150 rpm | Same |
| Accuracy | ±2 rpm | Same |
| BLT SpO2 Module | (This refers to the previous SpO2 module in K100046, not the new Masimo module) | |
| SpO2 Range | 0~100% | Same |
| SpO2 Accuracy | At 70 | Same |
| PR Range | 25~250 bpm | Same |
| PR Accuracy | ±1% or ±1 bpm, whichever is greater | Same |
| Masimo SpO2 Module (Proposed Device/K053269 Predicate) | ||
| SpO2 Range | 1~100% | 1~100% (Same as Masimo predicate K053269) |
| SpO2 Accuracy | At 70 | At 70 |
| PR Range | 25~240 bpm | 25~240 bpm (Same as Masimo predicate K053269) |
| PR Accuracy | ±3 bpm (non-motion conditions); ±5 bpm (motion conditions) | ±3 bpm (non-motion conditions); ±5 bpm (motion conditions) (Same as Masimo predicate K053269) |
| PI Range | 0.02 ~ 20.0% | 0.02 ~ 20.0% (Same as Masimo predicate K053269) |
| IBP (Inapplicable to M7000) | ||
| Measurement Range | -50 ~ +300 mmHg | Same |
| Sensitivity | 5uV/V/mmHg, 2% | Same |
| Accuracy | ±4mmHg or 4%, whichever is greater | Same |
| EtCO2 (Inapplicable to M7000) | (This refers to the previous EtCO2 module in K100046, which is still used) | |
| Method | Infrared Absorption | Same |
| Mode | Main Stream / Side Stream | Same |
| Measurement Range | 0 | Same |
| Accuracy | 0 | Same |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the clinical or non-clinical test set. It mentions that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."
For the Masimo SpO2 module, the text states its accuracy has been "verified comply with the declaration of specification" and refers to its prior clearance (K053269). This suggests that the clinical data supporting the SpO2 performance would have been part of the K053269 submission, not newly generated for K131876. Therefore, the provenance of that data would be from the original Masimo clearance study. The K131876 submission itself primarily relies on equivalence to the previously cleared Masimo module and adherence to standards.
No details are provided regarding the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the given text. For a device like a patient monitor, ground truth for physiological parameters is typically established through recognized calibrated reference devices or invasive measurements, rather than expert consensus on interpretation. For SpO2, this would involve co-oximetry and controlled hypoxia studies. Since this submission relies on equivalence to a previously cleared module, the details of how ground truth was established would reside in the original Masimo K053269 submission.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of a patient monitor measuring physiological parameters, "adjudication" in the sense of multiple experts reviewing an output is less applicable than direct comparison against a known reference standard (gold standard).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed, nor is it applicable to this type of device. MRMC studies are typically used for diagnostic devices where human interpretation (readers) of images or data is a critical component, and the AI's role is to assist or replace that interpretation. This patient monitor provides direct physiological measurements.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The entire device (including the Masimo SpO2 module) functions as a standalone measurement device. Its performance, as specified in the tables (e.g., SpO2 accuracy, PR accuracy), is its standalone algorithm-only performance. The "human-in-the-loop" aspect is the clinician interpreting and acting upon the displayed physiological data, but the measurement itself is autonomous. The verification of compliance with specifications effectively serves as the standalone performance study.
7. Type of Ground Truth Used
For patient monitors measuring vital signs, the ground truth is typically established using:
- Calibrated Reference Devices: For parameters like NIBP, temperature, and respiration, highly accurate, independently calibrated devices serve as the reference.
- Invasive Measurements (Gold Standard): For SpO2, the gold standard for accuracy verification involves controlled desaturation studies where arterial blood samples are taken and analyzed by a co-oximeter. This likely formed the basis for the Masimo SpO2 module's original clearance (K053269).
- Physiological Stimuli: For ECG, a calibrated ECG simulator is used.
The document implicitly refers to these types of ground truth by mentioning compliance with standards like ISO 9919:2005 for pulse oximeters, which mandates specific testing methodologies against reference standards.
8. Sample Size for the Training Set
The document does not report a sample size for a training set. This is because the device is a measurement instrument incorporating a previously cleared, established Masimo SpO2 module. While the Masimo module itself would have been developed using some form of training data (e.g., spectral data to train its algorithms to differentiate oxygenated from deoxygenated blood and motion artifacts), this detail is not provided in a 510(k) summary for a subsequent device integrating it. The focus of this K131876 submission is on integrating the module and ensuring overall device safety and performance according to relevant standards.
9. How the Ground Truth for the Training Set Was Established
As no training set is discussed or implied for the M Series Patient Monitor itself in this submission, this information is not provided. The embedded Masimo SpO2 module's original development would have involved establishing ground truth for its algorithms, likely through clinical trials with subjects experiencing varying levels of oxygen saturation, with reference measurements from co-oximeters.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.