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510(k) Data Aggregation
(89 days)
The Rainbow Adhesive Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), and/or total hemoglobin (SpHb). The Rainbow Adhesive Sensors 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 hospitals, hospital-type facilities, mobile, and home environments.
The Rainbow Adhesive Sensors are fully compatible disposable sensor for use with Masimo Rainbow SET and Masimo Rainbow SET compatible pulse CO-Oximeter monitors. They represent a design change to the Masimo Rainbow DCI and Direct Connect (Reusable) Sensors in the K080238 filing and the Rainbow Adhesive CO-Oximetry Sensors in the K071024 filing.
The Rainbow Adhesive Sensors in this filing have the same intended use/indications for use and performance specifications as the Rainbow Reusable Sensors in the K080238 filing. However, The Rainbow Adhesive Sensors in this filing are similar in construction to the Rainbow Adhesive CO-Oximetry Sensors in the K071024 filing. The main difference is that the sensors in the K071024 filing have 8wavelengths and the sensors in this filing have 12-wavelengths.
Similar to the 8-wavelength sensors in this filing include the emitter and detector assemblies connecting to the flex circuit, and an adhesive bandage to allow the sensor to be attached to the patient's finger, hand, foot or toe. Sensor sizing for use with adult, pediatric, infant, and neonatal patients are the same for the sensors in the K071024 and for the sensors in this filing. The patient-contact materials in the Rainbow Adhesive Sensors in this filing are the same that is used in the K071024 filing. Also similar to the sensors in the K071024 filing, the Rainbow Adhesive Sensors in this filing are supplied non-sterile for single patient use.
Here's a breakdown of the acceptance criteria and the study details for the Rainbow Adhesive Pulse CO-Oximeter Sensors (K081659):
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance | Patient Population |
|---|---|---|---|
| SpO2 Accuracy (no motion/motion) |
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(105 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 (measured by an SpO2 sensor), carboxyhemoglobin saturation (measured by an SpCO/SpMet sensor), and/or methemoglobin saturation (measured by an SpCO/SpMet sensor). The Masimo 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 hospitals, hospital-type facilities, mobile, and home environments.
The Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter (Rad 87) with Rainbow technology is noninvasive monitoring of arterial oxygen saturation (%SpO₂), pulse rate, carboxyhemoglobin saturation (%SpCO), and/or methemoglobin saturation (%SpMet). The Rad 87 features an LED display that continuously displays numeric values for %SpO₂ and pulse rate. Other information displayed by the Rad 87 include: %SpCO and/or %SpMet, Low Signal IQ (Low SIQ), Perfusion Index (PI), Pleth Variability Index (PVI), alarm status, alarm silence, battery life, sensor status, trends, and pleth waveform. The Rad 87 has output interfaces including Nurse Call analog output, RS-232 serial output, and optional wireless connection to Patient SafetyNet.
Here's an analysis of the acceptance criteria and study information for the Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter, based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Range/Accuracy) | Reported Device Performance (Range/Accuracy) |
|---|---|---|
| oxygen Saturation (%SpO2) | ||
| No Motion Conditions | ||
| Adults, Peds, Infants, Neonates | 60% - 80% ± 3% | 60% - 80% ± 3% |
| Adults, Peds, Infants, Neonates | 70% - 100% ± 2% | 70% - 100% ± 2% |
| Adults, Peds, Infants, Neonates | 0% - 69% unspecified | 0% - 69% unspecified |
| Motion Conditions | ||
| Adults, Peds, Infants, Neonates | 70% - 100% ± 3% | 70% - 100% ± 3% |
| Low Perfusion Conditions | ||
| Adults, Peds, Infants, Neonates | 70% - 100% ± 2% | 70% - 100% ± 2% |
| Adults, Peds, Infants, Neonates | 0% - 69% unspecified | 0% - 69% unspecified |
| Carboxyhemoglobin Saturation (%SpCO) | 0% - 40% ± 3% | 0% - 40% ± 3% |
| Methemoglobin Saturation (%SpMet) | 0% - 15% ± 1% | 0% - 15% ± 1% |
| Pulse Rate (bpm) | ||
| No Motion Conditions | 25 - 240 ± 3 bpm | 25 - 240 ± 3 bpm |
| Motion Conditions | 25 - 240 ± 5 bpm | 25 - 240 ± 5 bpm |
| Low Perfusion Conditions | 25 - 240 ± 3 bpm | 25 - 240 ± 3 bpm |
Note: The "Reported Device Performance" column directly reflects the "Accuracy" section provided in the specifications. The document states that the performance meets or exceeds the requirements of ISO 9919, but it doesn't provide a separate set of performance data that is distinct from the stated accuracy specifications. Therefore, the "Reported Device Performance" is assumed to be the stated accuracy.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document simply states "healthy adult volunteer subjects" for the clinical studies. It does not specify the exact number of subjects used in the clinical test set.
- Data Provenance: The data is from prospective clinical studies conducted on "healthy adult volunteer subjects." The country of origin is not specified in the provided document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable in this context. The ground truth was established using a laboratory instrument, not human experts.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
Not applicable. The ground truth for the clinical test set was established by a laboratory CO-oximeter, not through human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The studies described are focused on the device's accuracy against a laboratory reference standard. Human reader performance, with or without AI assistance, is not mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
Yes, a standalone study was done. The clinical studies directly assess the performance accuracy of the Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter (algorithm/device only) against a lab reference. The "Method of Operation" section describes the device continuously displaying values for the practitioner's aid, which implies standalone operation in deriving these values.
7. The Type of Ground Truth Used
The ground truth used for the clinical tests was laboratory analysis of arterial blood samples obtained from subjects. Specifically, "the arterial hemoglobin oxygen determined from arterial blood samples with a laboratory CO-oximeter."
8. The Sample Size for the Training Set
The document does not specify a separate "training set" or its sample size. The description focuses on clinical studies performed to validate the device's accuracy. It's possible that internal calibration and development involved training data, but this information is not provided in the 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
Since a dedicated "training set" with ground truth establishment is not described, this information is not available in the document. The principles of operation mention "multi-wavelength calibration equations," suggesting that the device was empirically calibrated for SpO2 and likely for SpCO/SpMet. However, details on the data used for establishing this calibration (which could be considered analogous to a training set) are not provided.
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