(193 days)
The Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RR). The Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.
The Rainbow SET® Rad 87 Pulse CO-Oximeter and accessories (Rad 87) include the MX board with Masimo Rainbow SET technology. The Rad 87 provides noninvasive monitoring of arterial oxygen saturation (%SpO₂), pulse rate, carboxyhemoglobin saturation (%SpCO), methemoglobin saturation (%SpMet), total hemoglobin concentration (g/dl SpHb), and/or respiratory rate (RR). Other information displayed by the Rad 87 includes: Low Signal IQ (Low SIQ), Perfusion Index (PI), Pleth Variability Index (PVI), Total Arterial Oxygen Content (SpOC), Respiratory Signal Quality (RSQ), alarm status, alarm silence, battery life, sensor status, and trends. The Rad 87 has output interfaces include: Nurse Call analog output, and RS-232 serial output. The Rad 87 in this filing are the Rad-87 in the K080238 filing, but with the addition of respiratory rate monitoring.
The Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter and Accessories are indicated for the continuous noninvasive monitoring of several physiological parameters. The acceptance criteria and device performance are outlined below, along with details of the supporting studies.
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature | Acceptance Criteria (Specifications) | Reported Device Performance (Accuracy) |
|---|---|---|
| SpO2 (Oxygen Saturation) | ||
| No Motion | Display Range: 0-100% | 60-80% ± 3% (adults/pediatrics/infants) |
| Motion | 70-100% ± 2% (adults/pediatrics/infants); ± 3% (neonates) | |
| Low Perfusion | 70-100% ± 2% (adults/pediatrics/infants/neonates) | |
| Pulse Rate | ||
| No Motion | Display Range: 25-240 bpm | 25-240 bpm ± 3 bpm (adults/pediatrics/infants/neonates) |
| Motion | 25-240 bpm ± 5 bpm (adults/pediatrics/infants/neonates) | |
| Low Perfusion | 25-240 bpm ± 3 bpm (adults/pediatrics/infants/neonates) | |
| SpCO (Carboxyhemoglobin Saturation) | Display Range: 0-99% | 1-40% ± 3% (adults/pediatrics/infants) |
| SpMet (Methemoglobin Saturation) | Display Range: 0-99.9% | 1-15% ± 1% (adults/pediatrics/infants/neonates) |
| SpHb (Total Hemoglobin) | Display Range: 0-25 g/dL | 8-17 g/dl ± 1 g/dl (arterial or venous, adults/pediatrics/infants). (Accuracy not validated with motion or low perfusion.) |
| RR (Respiratory Rate) | Display Range: 0-150 breaths per minute | 4-70 breaths per minute ± 1 breath per minute (adults > 30kg) |
2. Sample Size Used for the Test Set and Data Provenance:
The document provides specific details for different parameters:
- SpO2, SpCO, SpMet (Adults): "healthy adult volunteers" were tested.
- SpO2, SpMet (Neonates): 16 neonatal NICU patients (age 7-135 days, weighing 0.5-4.25 kg). 79 data samples were collected.
- SpO2 (No Motion): "healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies."
- SpO2 (Motion): "healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies while performing rubbing and tapping motions."
- SpO2 (Low Perfusion): Bench top testing using a Biotek Index 2 simulator and Masimo's simulator.
- Pulse Rate: Bench top testing using a Biotek Index 2 simulator.
- SpHb: "healthy adult male and female volunteers and on surgical patients with light to dark skin pigmentation."
Data Provenance:
The studies appear to be prospective human blood studies on healthy volunteers and surgical patients for SpO2, SpCO, SpMet, and SpHb. Neonatal data was also collected prospectively in a NICU setting. Benchtop testing was used for low perfusion SpO2 and Pulse Rate.
Country of Origin: The document does not explicitly state the country of origin for the human volunteer studies; however, the submission is from Masimo Corporation based in Irvine, CA, USA, and approved by the FDA in the USA, suggesting the studies were likely conducted in the US or under US regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document does not specify the number of experts used or their qualifications for establishing ground truth. The ground truth for the physiological parameters was established using:
- A laboratory CO-Oximeter for SpO2, SpCO, SpMet, and SpHb.
- An ECG monitor for SpO2 (no motion and motion studies).
- A Biotek Index 2 simulator and Masimo's simulator for low perfusion SpO2 and Pulse Rate.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method involving human experts for the test set. Ground truth was established by reference devices (laboratory CO-Oximeter, ECG monitor) or simulators.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned in the provided text. The device is a direct physiological measurement device, not an image interpretation or diagnostic aid that typically involves human readers. Therefore, the concept of human readers improving with AI vs without AI assistance does not directly apply here.
6. Standalone (Algorithm Only) Performance Study:
Yes, the accuracy statements are for the device's standalone performance (algorithm only without human-in-the-loop performance). The accuracies are reported as deviations from concurrently measured reference values (e.g., laboratory CO-Oximeter, ECG monitor, or simulators). For example:
- "SpO2, SpCO and SpMet accuracy was determined by testing on healthy adult volunteers... against a laboratory CO-Oximeter."
- "The Masimo sensors have been validated for no motion accuracy... against a laboratory CO-Oximeter and ECG monitor."
7. Type of Ground Truth Used:
The ground truth used for the accuracy studies consists of:
- Reference device measurements: A laboratory CO-Oximeter and an ECG monitor.
- Simulator data: Biotek Index 2 simulator and Masimo's simulator for specific conditions (low perfusion SpO2 and pulse rate).
8. Sample Size for the Training Set:
The document does not provide information regarding the sample size for any training sets. Given the nature of a pulse CO-Oximeter which uses established physiological principles and signal processing, it's possible that the "training" (development and refinement) of the algorithms was not conducted in the same manner as for AI/machine learning algorithms that typically require large, distinct training datasets. It likely involved extensive engineering, signal processing, and iterative testing rather than a formalized "training set" in the context of deep learning.
9. How the Ground Truth for the Training Set Was Established:
As no specific training set is described, there is no information on how ground truth for such a set would have been established. Any internal development and testing would have likely relied on similar reference methods as described for the performance studies.
§ 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).