(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: |
§ 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).