FDA Finalizes Guidances For 510(k) Submissions For Electrosurgical Devices

By Jof Enriquez,
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The U.S. Food and Drug Administration (FDA) has released two final guidance documents to assist sponsors in their premarket notification [510(k)] submissions for Class II electrosurgical devices [also called radiofrequency (RF) devices or high-frequency (HF) devices] indicated specifically for general tissue cutting and/or coagulation.

Both guidances recommend that manufacturers include appropriate information on device description, including regulation number, indications for use, device design and components, and a side-by-side, tabular format comparison of those components of the device and a legally marketed predicate device to show substantial equivalence.

FDA recommends that sponsors perform nonclinical tests for each major component, including electrosurgical unit (ESU) testing, mechanical testing, neutral electrode thermal performance, contact impedance, adhesion testing, and accessories testing.

Examples of system testing demonstrating all components working together are likewise provided.

The final guidance, Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery, recommends testing thermal effects on a range of tissue densities, testing temperature sensing/monitoring features, Contact Quality Monitoring (CQM) and/or continuity monitoring capabilities, and active capacitive coupling resistance testing.

The supplemental final guidance, Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery, recommends demonstrating bipolar electrosurgical vessel sealer performance through burst pressure data and measurements on the spread of thermal damage along vessels. If the 510(k) is for a new vessel sealing system, or for modifications that can reasonably be expected to modify the tissue effect of the system, then chronic animal studies are warranted, says FDA.

Recommendations on software, biocompatibility, sterility, reprocessing, pyrogenicity, shelf life, and electrical safety and electromagnetic compatibility are detailed in the first guidance, but also apply to bipolar electrosurgical vessel sealers. Both guidances itemize labeling requirements for electrosurgical devices, including clear statements of indications for use, cautions, operating information, and specific warnings with sample language, as well as labels for the device, its components, and packaging.

According to RAPS, consistent with comments by the Advanced Medical Technology Association (AdvaMed), FDA writes in the final guidances that it considers the software for electrosurgical devices to present a "major" concern, and puts the onus on sponsors to prove that their software presents a lower level of concern. In contrast, FDA had written in the draft version that software presents a "moderate" level of concern, and recommends for sponsors to prove that software presents a greater level of concern.