(357 days)
The Reprocessed Oxisensor II and OxiMax Sensors are intended for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. They are intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, intra-hospital transport, and home environments.
The Reprocessed Nellcor Oxisensor and OxiMax Sensors are designed for use with Nellcor and Nellcor-licensed pulse oximetry monitors that provide continuous noninvasive measurement of pulse rate and arterial oxygen saturation. The sensor contains three optical components: two light emitting diodes (LEDs) that serve as light sources and one photodiode that acts as a light detector. Both the LEDs and the photodiode are contained within a laminated envelope with an adhesive bandage for attachment to a patient. Attached to a laminated envelope is a sensor cable which terminates in a connector element that connects to the oximeter.
The sole difference between the OxiMax sensors and the Oxisensor II sensors is the OxiMax sensors each contain a memory chip carrying information about the sensor which the oximeter needs for correct operation, including in sensor data, Advanced Signal Evaluation, lot code and data set revision, and sensor model.
The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets those criteria for the Reprocessed Oxisensor II and OxiMax Sensors.
Instead, the document primarily focuses on the device description, indications for use, and a comparison of technological characteristics to predicate devices within the context of a 510(k) submission. The key assertion is that:
- "The Reprocessed Oxisensor II and OxiMax Sensors meet the same performance requirements as the predicate devices."
- "The technological characteristics of the Reprocessed Oxisensor II and OxiMax Sensors and the results of bench tests and laboratory tests do not raise new questions of safety or effectiveness when compared to the legally marketed predicate devices."
This indicates that the acceptance criteria for the reprocessed sensors were implicitly the same as those established for the original, legally marketed predicate devices. The "study" proving the device meets these criteria appears to be a series of "bench tests and laboratory tests" demonstrating technological equivalence and performance parity. However, the document does not provide specifics on:
- Quantitative acceptance criteria (e.g., specific accuracy ranges, precision values).
- Detailed results of the bench and laboratory tests.
- Sample sizes, data provenance, ground truth establishment, or expert involvement for any testing done.
- MRMC or standalone studies.
Without these details, it's impossible to populate the requested table and provide specific answers to the numbered questions. The current document focuses on regulatory approval based on substantial equivalence rather than a detailed performance study with explicit acceptance criteria and results.
§ 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).