(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) |
§ 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).