March 4 2013, The FDA issued new guidance governing premarket notification submissions for pulse oximeters. The new guidelines apply to all 510(k) submissions for the non-invasive blood oxygen level and pulse rate measuring devices.
In the guidance, the FDA specified new rules for identifying, testing and assuring safety for the systems. The new document overrides the 1992 guidance on the same category. it will help device companies prepare their premarket notifications, or 510(k)s, for any pulse oximeter.
Scope
The scope of this document is limited to the Class II devices, Oximeter and Ear oximeter, classified under the following regulations:
21 CFR 870.2700 – Oximeter (product codes: DQA (Oximeter) and NLF (Oximeter, Reprocessed))
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.Contains Nonbinding Recommendations
This guidance does not address oximeters in product codes MUD (tissue saturation oximeter), NMD (reprocessed tissue saturation oximeter), or MMA (fetal pulse oximeter).
21 CFR 870.2710 –Ear Oximeter (product code: DPZ (Ear oximeter))
An ear oximeter is an extravascular device used to transmit light at a known wavelength(s) through blood in the ear. The amount of reflected or scattered light as indicated by this device is used to measure the blood oxygen saturation.