FDA Classifies Brain Trauma Assays, Endoscopic Electrosurgical Clip Cutting Systems
Posted 13 June 2018 | By
In final orders issued Wednesday, the US Food and Drug Administration (FDA) classified brain trauma assessment tests and endoscopic electrosurgical clip cutting systems as class II devices.
Both device classifications were established via the De Novo pathway based on FDA’s review of 2016 and 2017 requests from Ovesco Endoscopy AG and Banyan Biomarkers, respectively. These in turn allow for a device sponsor of a brain trauma assay or an endoscopic electrosurgical clip cutting system to use the 510(k) pathway.
The devices must comply with the specified special controls in order to fall under the new classification as these measures are necessary to mitigate the potential risks to patient health and provide reasonable assurance of safety and effectiveness, according to FDA.
For brain trauma assessment tests, the special controls require developers to use at least one unmodified clinical specimen with the brain injury biomarker for performance testing as well as labeling statements indicating that the test is meant to be used in conjunction with other clinical information. The agency says the special controls are aimed at mitigating the risks of inaccurate test results.
On the endoscopic electrosurgical clip cutting system, FDA says the potential risks include unintended tissue damage and electrical shock. The agency says those risks should be mitigated by nonclinical performance data, usability and electrical safety testing, biocompatibility evaluation and sterilization validation, among other special controls described in the final order.
Earlier this week, the agency also finalized an order through the De Novo process for the classification of the in vivo cured intramedullary fixation rod
into class II.
Medical Devices; Immunology and Microbiology Devices; Classification of the Brain Trauma Assessment Test
Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Electrosurgical Clip Cutting System