(154 days)
The MRC Reprocessed Pulse Oximeter sensors are used as a noninvasive method to provide continuous SpO2 monitoring and pulse rate monitoring. These devices are intended for prescription use.
The Midwestern Reprocessing Center reprocessed pulse oximeter sensors are non-invasive sensors used to provide continuous SpO2 monitoring and pulse rate. The sensors contain a dual wavelength light emitting diode (LED), and an optical photodiode sensor which are housed in a pad which attaches to the patient using adhesive material. The LED emits red and infrared light in alternate pulses, governed by the Oximeter instrument. The photodiode sensor responds to the light and generates a current that is interpreted by the Oximeter instrument. The Oximeter instrument interprets the different amounts of each light type (red and infrared) from the output of the photodiode and interprets the information and displays a reading. The sensor operates without any type of tissue penetration, electrical contact, or heat transfer to the patient. The sensors use optical means to determine the light absorption of functional arterial hemoglobin. The sensor is indicated for use as a non-invasive method to provide continuous SpO2 monitoring and pulse rate.
{
"acceptance_criteria_and_performance_table": null,
"study_summary": {
"sample_size_test_set": null,
"data_provenance": null,
"number_of_experts_ground_truth_test_set": null,
"qualifications_experts_ground_truth_test_set": null,
"adjudication_method_test_set": null,
"mrmc_comparative_effectiveness_study": false,
"effect_size_human_readers_mrmc": null,
"standalone_performance_study": true,
"type_of_ground_truth": "clinical testing and non-clinical functional testing (such as performance/functional testing, cleaning validation, and biocompatibility testing)",
"sample_size_training_set": null,
"ground_truth_establishment_training_set": null
},
"additional_notes": "The provided text indicates that 'Clinical Testing demonstrated that the reprocessed devices used with its compatible pulse oximeter perform as intended and are safe and effective' and 'Based on the assessment of clinical testing, non-clinical functional testing, cleaning validation, and biocompatibility testing performed, Midwestern Reprocessing Center concludes that the Midwestern Reprocessing Center reprocessed pulse Oximeter sensors are substantially equivalent to their predicate devices'. However, no specific acceptance criteria or quantitative performance metrics are provided to be presented in a table. The document focuses on demonstrating substantial equivalence through various tests rather than specific performance against numerical acceptance criteria. Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text."
}
§ 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).