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510(k) Data Aggregation
(74 days)
The Rainbow Adhesive Sensors and Rainbow Pediatric Reusable Sensors are indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin (SpCO), and/or methemoglobin (SpMet) saturation. 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 hospital-type facilities, mobile, and home environments. The Rainbow Pediatic Reusable Sensors are indicated for use with pediatic 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 compatible pulse CO-Oximeter monitors. They represent a design change to the Masimo Rainbow DCI-DC CO-Oximetry Sensors.
The Rainbow Adhesive Sensors are similar in construction to the predicate devices except that the Rainbow Adhesive Sensors are disposable sensors that are flex circuit and cable based while the Rainbow DCI-DC CO-Oximetry Sensors are cable based. The emitter and detector assemblies are connected to the flex circuit. The sensors have an adhesive bandage to allow the sensor to be attached to the patient's finger, hand, foot or toe. The same emitters (with 8 wavelengths) are used in Rainbow Adhesive Sensors. Two sizes of Rainbow Adhesive Sensors are available for use with adult, pediatric, infant and neonatal patients. The two sensors are essentially identical except for the emitter and detector spacing and size and orientation of the patient contacting materials in the Rainbow Adhesive Sensors are the same that is used in Masimo's LNCS and LNOP single use sensor lines. The Rainbow Adhesive Sensors are supplied non-sterile for single patient use.
The Rainbow Pediatric Reusable Sensor are fully compatible sensors 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-DC CO-Oximetry Sensors.
The Rainbow Pediatric Reusable Sensor is exactly the same as the predicate sensor (Rainbow DCI-DC sensor) except that the pads in the sensor are smaller to accommodate the digits of pediatric patients. The patient contacting materials in the Rainbow Pediatric Reusable Sensor is exactly the same as the predicate sensor (Rainbow DCI-DC sensor). The Rainbow Pediatric Reusable Sensors are supplied non-sterile.
The information provided in the 510(k) summary is for new Masimo Rainbow Adhesive CO-Oximetry Sensors and Rainbow Pediatric Reusable Sensors, which are intended to be compatible with Masimo Rainbow SET pulse CO-Oximeter monitors. The summary describes performance testing for these new sensors, primarily focusing on SpO2, SpCO, and SpMet accuracy.
Here's an analysis of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy (for both Rainbow Adhesive and Pediatric Reusable Sensors) | The implicit acceptance criterion is that the accuracy of the new sensors should be equivalent to or better than the predicate devices and meet established standards for pulse oximetry. The provided performance values suggest the goal was to achieve accuracy within clinical ranges previously accepted for Masimo's technology. | Adults, Pediatrics, Infants: < 2% SpO2 Arms in the range of 70%-100% SaO2. < 3% SpO2 Arms in the range of 60%-80% SaO2 and 60%-70% SaO2. Neonates: < 3% SpO2 Arms in the range of 70%-100% SaO2. (Note: The text states "less than 3% AgMs for neonates" which is likely a typo and should be SpO2 Arms given the context. Also, the lower range for neonates for SpO2 is not explicitly stated if different from adults/pediatrics/infants) |
| SpCO Accuracy (for Rainbow Adhesive Sensors) | The implicit acceptance criterion is that the accuracy of the new sensors should be equivalent to or better than the predicate devices and comparable to Masimo's existing Rainbow SET technology for CO-Oximetry. | < 3.5% SpCO Arms in the range of 1%-40% SaCO. |
| SpCO Accuracy (for Rainbow Pediatric Reusable Sensors) | Similar to Rainbow Adhesive Sensors. | < 3% SpCO Arms in the range of 1%-40% SaCO. |
| SpMet Accuracy (for Rainbow Adhesive Sensors) | The implicit acceptance criterion is that the accuracy of the new sensors should be equivalent to or better than the predicate devices and comparable to Masimo's existing Rainbow SET technology for CO-Oximetry. | < 1% SpMet Arms in the range of 1%-15% SaMet. |
| SpMet Accuracy (for Rainbow Pediatric Reusable Sensors) | Similar to Rainbow Adhesive Sensors. | < 1% SpMet Arms in the range of 1%-15% SaMet. |
Study Proving Acceptance Criteria:
Clinical studies were performed to demonstrate the accuracy of the Masimo Rainbow SET technology with the new Rainbow Adhesive Sensors and Rainbow Pediatric Reusable Sensors.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The specific number of subjects (test set sample size) is not explicitly stated in the provided text. It mentions "healthy adult volunteer subjects" for the SpO2 testing and "human blood studies on healthy adult volunteers" for SpCO/SpMet. The number of patients in each category (adult, pediatric, infant, neonatal) is not detailed.
- Data Provenance:
- Country of Origin: Not explicitly stated, but clinical studies were performed on "healthy adult volunteer subjects," implying human data, likely prospective as participants were "subjected to a progressive induced hypoxia."
- Retrospective/Prospective: The SpO2 accuracy studies involved "progressive induced hypoxia," which is a prospective experimental design in a controlled environment. The SpCO and SpMet studies were "human blood studies," also suggesting a controlled, prospective setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: This information is not provided.
- Qualifications of Experts: This information is not provided. The ground truth for SpO2, SpCO, and SpMet was established using a "CO-Oximeter" (a laboratory device), not by expert human readers.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable or not specified. Ground truth was established by a laboratory CO-Oximeter, not through human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done as this device (oximeter sensor) does not involve human interpretation of images or other data for diagnosis. The performance is assessed against a laboratory gold standard.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, the performance testing described is inherently a standalone assessment of the device (sensor + CO-Oximeter algorithm). The accuracy of the sensors is measured directly against a reference laboratory instrument (CO-Oximeter) without human intervention in interpreting the sensor's output for the purpose of the study.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for SpO2, SpCO, and SpMet was established by an (ex-vivo) laboratory CO-Oximeter analysis of arterial blood samples.
- For SpO2: "measuring the arterial hemoglobin saturation value with the instruments against the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter."
- For SpCO and SpMet: "validated in human blood studies on healthy adult volunteers against a laboratory CO-Oximeter".
8. The Sample Size for the Training Set
- Training Set Sample Size: The document does not provide any information regarding a training set. This is typical for medical device submissions focusing on clinical validation of hardware (sensors) and associated algorithms where the algorithms might have been developed using internal, proprietary datasets, and only the final validation against a reference standard is presented.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Since no training set information is provided, how its ground truth was established is also not available from this document.
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