(87 days)
The Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial oxygen hemoglobin (SpO2), pulse rate, and total hemoglobin concentration (SpHb). The Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories are indicated for use, by trained personnel, with adult and pediatric individuals during both no motion and motion conditions and for individuals who are well or poorly perfused and in clinical and non-clinical settings (e.g., hospital-type facilities, home, clinics, physician offices, blood donation facilities, and ambulatory surgery centers).
The Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories in this filing are the same as the Rainbow SET® RadCheck Pulse CO-Oximeter and Accessories in K082052. The reason for this filing is to clarify the intended use and the labeling of the device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are presented as "Specifications" in the document. The reported device performance is presented as "Accuracy" values.
| Feature | Acceptance Criteria (Specification) | Reported Device Performance (Accuracy) |
|---|---|---|
| SpO2, No Motion Conditions | N/A (implied by accuracy ranges) | Adults, Pediatrics: 60-80% ± 3%; 70-100% ± 2% |
| SpO2, Motion Conditions | N/A (implied by accuracy ranges) | Adults, Pediatrics: 70-100% ± 3% |
| SpO2, Low Perfusion | N/A (implied by accuracy ranges) | Adults, Pediatrics: 70-100% ± 2% |
| Pulse Rate, No Motion | N/A (implied by accuracy ranges) | Adults, Pediatrics: 25-240 ± 3 bpm |
| Pulse Rate, Motion | N/A (implied by accuracy ranges) | Adults, Pediatrics: 25-240 ± 5 bpm |
| Pulse Rate, Low Perfusion | N/A (implied by accuracy ranges) | Adults, Pediatrics: 25-240 ± 3 bpm |
| SpHb, No Motion Conditions | N/A (implied by accuracy range) | Adults, Pediatrics: 8-17 g/dl ± 1 g/dl (Arterial or Venous) |
Additional Specifications/Features (not directly accuracy-related):
- Display Ranges: Saturation (SpO2): 0-100%; Pulse Rate: 25-240 bpm; Total Hemoglobin (SpHb): 0-25 g/dl; Total Oxygen Concentration (SpOC): 0-35 ml/dl; Perfusion Index: 0.02-20%
- Resolution: SpO2: 1%; Pulse Rate: 1 bpm; SpHb: 0.1 g/dl
- Operating Temperature: 41°F to +104°F (5°C to +40°C)
- Storage Temperature: -40°F to +158°F (-40°C to +70°C)
- Relative Humidity: 5% to 95% noncondensing
- Operating Altitude: 500 mbar to 1,060 mbar pressure; -1,000 ft to 18,000 ft
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample size for each test. However, it indicates:
- SpO2 Accuracy (No Motion): "healthy adult volunteers" (Footnote 1)
- SpO2 Accuracy (No Motion, Inducible Hypoxia): "healthy adult male and female volunteers with light to dark skin pigmentation" (Footnote 2)
- SpO2 Accuracy (Motion, Inducible Hypoxia): "healthy adult male and female volunteers with light to dark skin pigmentation" (Footnote 3)
- SpHb Accuracy: "(arterial/venous) blood from healthy adult male and female volunteers and on surgical patients with light to dark skin pigmentation" (Footnote 6)
The data provenance is prospective human blood studies for SpO2 and SpHb measurements, conducted on healthy adult volunteers and surgical patients. Additional testing for low perfusion and pulse rate accuracy was done via benchtop testing using simulators. The country of origin is not specified but implied to be the US given the FDA submission.
3. Number of Experts and Qualifications for Ground Truth
No external experts were used to establish the ground truth for the SpO2, Pulse Rate, or SpHb measurements. The ground truth was established by laboratory instruments, as detailed below.
4. Adjudication Method for the Test Set
No adjudication method is mentioned, as the tests primarily involved comparison against laboratory reference instruments, not expert interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The device is an oximeter, not an AI for image interpretation or diagnosis requiring human-in-the-loop comparison.
6. Standalone Performance
Yes, the accuracy specifications provided are for the standalone (algorithm only) performance of the device. The listed accuracies (e.g., ± 2%, ± 3%, ± 1 g/dl) refer to the device's ability to measure physiological parameters against a reference standard.
7. Type of Ground Truth Used
The ground truth for the various measurements was established using objective, established clinical and laboratory methods:
- SpO2 Accuracy (No motion, induced hypoxia, SpHb): A laboratory CO-Oximeter was used as the reference standard.
- SpO2 Accuracy (Motion): A laboratory CO-Oximeter and ECG monitor were used as reference standards.
- Pulse Rate Accuracy: A Biotek Index 2 simulator was used as the reference standard.
- Low Perfusion SpO2 Accuracy: A Biotek Index 2 simulator and Masimo's simulator were used as reference standards.
8. Sample Size for the Training Set
The document does not specify a separate training set or its sample size. This type of device (oximeter) is generally validated through accuracy studies against a reference standard, rather than a machine learning training/test set paradigm. The "development" of the device would involve calibration and algorithm refinement, but the number of samples or data points used for these internal processes is not disclosed in this regulatory submission.
9. How the Ground Truth for the Training Set was Established
Since no distinct training set is described for a machine learning model, the method for establishing ground truth for a "training set" is not applicable in the context of this submission. The device's underlying technology (Masimo Rainbow SET) would have been developed and calibrated using similar physiological studies and laboratory reference instruments during its initial development.
§ 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).