(192 days)
Radius VSM:
The Radius VSM and accessories are intended to be used as both a wearable multi-parameter patient monitor and an accessory to a multi-parameter patient monitor that is intended for multi-parameter physiological patient monitoring in hospital and healthcare facilities.
The Radius VSM and accessories are indicated for the monitoring of hemodynamic (including ECG, arrhythmia detection, non-invasive blood pressure, SpO2, Pulse Rate, PVi, heart rate, and temperature), and respiratory (e.g., impedance, acoustic, and pleth-based respiration rate) physiological parameters along with the orientation and activity of adults.
The Radius VSM and accessories are indicated for the non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) of well or poorly perfused adults during both no motion and motion conditions.
The Radius VSM and accessories are indicated for continuous monitoring of skin temperature of adults.
The Radius VSM and accessories are indicated for monitoring of the orientation and activity of patients including those susceptible to pressure ulcers.
The Radius VSM and accessories are indicated for the continuous non-invasive monitoring of PVI as a measure of relative variability of the photoplethysmograph (pleth) of adults during no motion conditions. PVi may be used as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure and device related factors. PV i measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient's condition and should not be based solely on PVi.
Devices with Masimo technology are only indicated for use with Masimo accessories.
Radius VSM Accessories:
Radius VSM ECG Electrodes are disposable, single-patient ECG electrodes intended to acquire ECG signals from the surface of the body. They are indicated for use on adults for up to 3 days of skin surface contact.
Radius VSM Blood Pressure Cuffs are accessories intended to be use with a noninvasive blood pressure measurement system to measure blood pressure. They are indicated for use on adults during no motion conditions.
The Radius VSM and Accessories is a wearable, multi-modular patient monitoring platform that allows for the ability to scale and tailor the use of monitoring technologies based upon the hospital's and clinician's assessment of what technologies are appropriate. The purpose of this submission is the premarket notification for the introduction of Masimo Radius VSM and Accessories, including its use with the previously cleared Root (K191882) and Masimo Patient SafetyNet (K071047).
The Radius VSM and Accessories system comprises of the Radius VSM Wearable Monitor, Radius VSM ECG Module and Electrodes, and the Radius VSM NiBP Module and Cuff.
The provided text describes the acceptance criteria and study results for the Masimo Radius VSM and Accessories device, focusing specifically on the Non-invasive Blood Pressure (NiBP) feature.
1. Acceptance Criteria and Reported Device Performance (NiBP Feature):
The clinical performance analysis for the NiBP feature supported by the Masimo Radius VSM device had the following acceptance criteria and reported values:
| Parameter | Acceptance Criteria | Reported Device Performance | Pass/Fail |
|---|---|---|---|
| Mean value of the differences ( $\bar{x}_n$ ) | $ \bar{x}_n \le 5$ mmHg | Systolic: -1.23 mmHg | Pass |
| Diastolic: -2.67 mmHg | Pass | ||
| Standard deviation of differences ( $s_n$ ) | $s_n \le 8$ mmHg | Systolic: 7.32 mmHg | Pass |
| Diastolic: 7.13 mmHg | Pass | ||
| Standard deviation of differences per subject (sm) | Systolic: ≤ 6.82 mmHg | Systolic: 6.17 mmHg | Pass |
| Diastolic: ≤ 6.39 mmHg | Diastolic: 6.26 mmHg | Pass |
The device met all specified acceptance criteria for the NiBP feature.
2. Sample Size and Data Provenance for the Test Set:
- Sample Size:
- NiBP Feature: 89 subjects.
- ECG Waveform Comparison: 31 subjects.
- Patient Posture, Position, and Activity: 20 subjects.
- Aggregate Respiration Rate (First Study): 48 subjects.
- Aggregate Respiration Rate (Second Study): The number of healthy volunteer subjects is not explicitly stated, but it's implied to be a separate group for validation of integration.
- Data Provenance: The document does not explicitly state the country of origin. The studies are described as "clinical studies," implying prospective data collection for the purpose of validating the device. The term "healthy volunteer subjects" used in the fifth study further suggests prospective, controlled data collection.
3. Number of Experts and Qualifications for Ground Truth:
The document does not specify the number or qualifications of experts used to establish ground truth for any of the studies mentioned.
4. Adjudication Method for the Test Set:
The document does not describe any specific adjudication method for the test set data.
5. MRMC Comparative Effectiveness Study:
No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human readers improving with AI assistance is made in the provided text. The studies focus on device performance against reference measurements or previously cleared monitors/algorithms, not on human-AI collaboration.
6. Standalone Performance (Algorithm Only):
- For the NiBP feature, the study was conducted to validate the clinical performance of the Radius VSM's NiBP feature against reference blood pressure measurements, implying standalone performance of the algorithm integrated into the device.
- For the ECG waveform comparison, the device's ECG output was compared to an existing FDA-cleared ECG monitor, indicating standalone performance of the device's ECG functionality.
- For the patient posture, position, and activity feature, the testing supported the "correct integration of the algorithm that was previously cleared," suggesting a focus on the device's implementation of an existing standalone algorithm.
- For the Aggregate Respiration Rate, the algorithm's performance was evaluated against manually annotated capnography data, indicating standalone algorithm performance.
7. Type of Ground Truth Used:
- NiBP: Clinical performance was validated through comparison against "reference blood pressure measurements."
- ECG: Comparison against an "FDA cleared ECG monitor."
- Patient Posture, Position, and Activity: Based on the "correct integration of the algorithm that was previously cleared." The original ground truth for this algorithm (K191882) is not detailed here, but the study validates its implementation in the new device.
- Aggregate Respiration Rate: "Reference respiration rate derived from manual annotated capnography data."
8. Sample Size for the Training Set:
The document does not provide information on the sample size used for training sets for any of the algorithms or features. The studies described are validation (test set) studies.
9. How Ground Truth for the Training Set was Established:
As no information regarding training sets is provided, there is no detail on how their ground truth was established. The document focuses on the validation of integrated features, some of which (like PVi, RRa, and position monitoring) leverage previously cleared Masimo technologies, implying that their development and training (if applicable) occurred prior to this submission.
§ 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.