The US Food and Drug Administration (FDA) has released a new guidance document on using the 510(k) pathway to clear two types of pulse oximeters, small non-invasive sensors that are used to measure a patient's arterial blood oxygen saturation and pulse rate.
The devices commonly come in one of two forms: oximeters and ear oximeters, both of which are generally used on thinner parts of the body (ear, finger, foot, nose, etc) to allow for the passage of radiation or light through the body part. FDA's guidance, which finalizes a 2007 draft version of the same guidance, is intended to address the Class II (moderate-risk) version of both.
Sponsors should be prepared to make a comparison of their device relative to an FDA-approved predicate device, including an assessment of the device's intended patient population, intended application site, performance specifications, safety specifications, device features, design, device functions, accessories, and the geometry of the device.
The Linchpin of the 510(k): Performance
But most important to the success of a 510(k) application will be the extent to which the sponsor can show that the new device performs similarly relative to the predicate device, FDA said.
In order to show similarity, FDA advises sponsors to subject the device to the testing standard ISO 80601-2-61:2011, Medical Electrical Equipment-Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment. Other equivalent methods may be used to assess performance, FDA said, but these must be validated and justified.
Of particular concern to regulators will be the comparison between sensors. When testing, sponsors should be prepared to account for different application sites, design features, and the fit and function of the sensor. This accounting should come in the form of in vivo studies to determinate how accurate the device is relative to an already-approved or -cleared device.
However, "FDA will always consider alternatives to in vivo testing when the proposed alternatives are supported by an adequate scientific rationale," the agency wrote. "For example, when changes or modifications made do not affect the optical chain or signal processing path, then additional clinical studies may not be needed."
If a clinical study is needed, regulators said the majority of devices would be considered non-significant risk devices, and would therefore be able to submit an abbreviated application under 21 CFR 812.2(b).