(81 days)
The Masimo Rainbow SET RadCheck Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial hemoglobin (SpO2), pulse rate, and total hemoglobin (SpHb). The Masimo Rainbow SET RadCheck Pulse CO-Oximeter and Accessories are indicated for use, by trained personnel, with adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused in clinical and non-clinical settings.
The Masimo Rainbow SET® RadCheck Pulse CO-Oximeter and Accessories (RadCheck) have modified intended use/indications for use in comparison to the Rad 57t Pulse CO-Oximeters and Accessories (Rad 57t) in the K080238 filing. The main difference is that the RadCheck in this filing is for spot checking, whereas the Rad 57t in K0808238 is for continuous monitoring. The keypad membrane and the software of the RadCheck also differ from the Rad 57t.
The RadCheck in this filing is similar in construction to the Rad 57t in the K0808238 filing, including the 12-wavelength technology for the measurement of total hemoglobin. The performance of the Radcheck is similar to the Rad 57t. Similar to the Rad 57t, the RadCheck provides noninvasive monitoring of arterial oxygen saturation (%SpO2), pulse rate, and total hemoglobin concentration (g/d) SpHb). Other information displayed by the RadCheck include: Low Signal IQ (Low SIQ), Perfusion Index (PI), Total Arterial Oxygen Content (SpOC), battery life, and sensor status.
Here's a breakdown of the acceptance criteria and study information for the Masimo Rainbow SET RadCheck Pulse CO-Oximeter and Accessories, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Parameter/Condition | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy (No Motion) | Adults, Pediatrics: 60% - 80% ± 3% | Not explicitly stated as a separate "reported performance" against this specific criterion, but the overall SpO2 accuracy studies (details below) support these ranges. |
| Adults, Pediatrics: 70% - 100% ± 2% | Not explicitly stated as a separate "reported performance" against this specific criterion, but the overall SpO2 accuracy studies (details below) support these ranges. | |
| Adults, Pediatrics: 0% - 69% unspecified | ||
| SpO2 Accuracy (Motion) | Adults, Pediatrics: 70% - 100% ± 3% | Not explicitly stated as a separate "reported performance" against this specific criterion, but the overall SpO2 accuracy studies (details below) support these ranges. |
| Adults, Pediatrics: 0% - 69% unspecified | ||
| SpO2 Accuracy (Low Perfusion) | Adults, Pediatrics: 70% - 100% ± 2% | Not explicitly stated as a separate "reported performance" against this specific criterion, but the overall SpO2 accuracy studies (details below) support these ranges. |
| Adults, Pediatrics: 0% - 69% unspecified | ||
| Pulse Rate Accuracy (No Motion) | Adults, Pediatrics: 25 - 240 bpm ± 3 bpm | Not explicitly stated as a separate "reported performance" against this specific criterion, but the overall Pulse Rate accuracy studies (details below) support these ranges. |
| Pulse Rate Accuracy (Motion) | Adults, Pediatrics: 25 - 240 bpm ± 5 bpm | Not explicitly stated as a separate "reported performance" against this specific criterion, but the overall Pulse Rate accuracy studies (details below) support these ranges. |
| Pulse Rate Accuracy (Low Perfusion) | Adults, Pediatrics: 25 - 240 bpm ± 3 bpm | Not explicitly stated as a separate "reported performance" against this specific criterion, but the overall Pulse Rate accuracy studies (details below) support these ranges. |
| SpHb Accuracy (No Motion) | Adults, Pediatrics: 8 - 17 g/dl ± 1 g/dl | Masimo Rainbow SET RadCheck meets this specification with an accuracy of ±1 g/dl for SpHb values between 8-17 g/dl. |
Note: The document explicitly states "The RadCheck performance is equivalent to those of the Rad 57t," implying that these specifications are met by the RadCheck device as well. The accuracy values provided are stated as "specifications" for the device, and the "Studies" section confirms its validation against these.
Study Information Proving Device Meets Acceptance Criteria
The document uses several "human blood studies" and "bench-top testing" to validate the accuracy claims.
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Sample Size Used for the Test Set and Data Provenance:
- SpO2 Accuracy (No Motion): "healthy adult volunteers" (specific number not provided). Data provenance: Human blood studies.
- SpO2 Accuracy (No Motion) (extended 70-100% range): "healthy adult male and female volunteers with light to dark skin pigmentation" (specific number not provided). Data provenance: Induced hypoxia studies, human blood studies.
- SpO2 Accuracy (Motion): "healthy adult male and female volunteers with light to dark skin pigmentation" (specific number not provided). Data provenance: Induced hypoxia studies, human blood studies.
- SpO2 Accuracy (Low Perfusion): Not human subjects. Bench-top testing.
- Pulse Rate Accuracy (No Motion): Not explicitly detailed for no motion specifically, but the general pulse rate accuracy was evaluated via bench-top testing.
- Pulse Rate Accuracy (Motion): Not explicitly detailed for motion specifically, but the general pulse rate accuracy was evaluated via bench-top testing.
- Pulse Rate Accuracy (Low Perfusion): Not human subjects. Bench-top testing.
- SpHb Accuracy (No Motion): "healthy adult male and female volunteers and on surgical patients with light to dark skin pigmentation" (specific number not provided). Data provenance: Human subjects.
- For all human studies: The country of origin for the data is not specified in the provided text. The studies appear to be prospective as they involve induced hypoxia or direct measurement against a laboratory method.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable in the context of this device. The ground truth relies on laboratory instruments (CO-Oximeter, ECG monitor) and simulators, not human expert consensus for interpreting device output.
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Adjudication Method:
- Not applicable. Ground truth is established by quantitative measurements from reference devices.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is typically performed for diagnostic imaging or interpretation tasks where human readers make assessments. This device is a measurement device.
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Standalone (Algorithm only without human-in-the-loop performance) Study:
- Yes. The accuracy claims are for the device's measurements (SpO2, Pulse Rate, SpHb) directly against laboratory references or simulators, which represents the standalone performance of the algorithm and sensor.
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Type of Ground Truth Used:
- Laboratory CO-Oximeter: Used as the ground truth for SpO2 and SpHb measurements.
- ECG monitor: Used as the ground truth for pulse rate during human blood studies.
- Biotek Index 2 simulator and Masimo's simulator: Used as the ground truth for SpO2 (low perfusion) and Pulse Rate (bench-top testing).
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Sample Size for the Training Set:
- The document describes validation studies, not necessarily specific training sets for a machine learning model. The underlying "Rainbow SET technology, MX-1 Board/Circuitry" implies significant prior development and data but the size of a distinct "training set" is not provided here.
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How the Ground Truth for the Training Set Was Established:
- Not explicitly detailed for a "training set" in this document. During product development and prior iterations (e.g., for the predicate device Masimo Rainbow SET Rad 57t), ground truth would have been established using the same reference methods as the validation studies (laboratory CO-Oximeters, ECG monitors, and simulators).
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).