The US Food and Drug Administration (FDA) has released two new draft guidance documents intended to clarify the premarket notification requirements for electrosurgical devices.

Background

Premarket notification-also known as the 510(k) pathway-represents a faster and less expensive path to market than the premarket approval process, which requires the submission of full clinical data illustrating the safety and efficacy of a device. By contrast, premarket notifications are cleared for marketing based on FDA's finding that a device is "substantially equivalent" to an already-approved predicate device. This requires minimal, if any, human testing.

Electrosurgical devices-sometimes referred to as radiofrequency (RF) or high frequency (HF) devices-generally have two primary uses: to cut and remove tissue, or to control bleeding by sealing (e.g. cauterizing) a wound. They do this through the use of a high-frequency electrical current.

A variant of electrosurgical devices, known as biopolar vessel sealers, differ slightly in that they work to seal blood and lymphatic vessels through the use of electrical current passed between two electrodes.

Guidance Documents

FDA's two draft guidance documents, Premarket Notification Submissions for Electrosurgical Devices for General Surgery (FR) and Premarket Notification Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery (FR), provide an overview of the recommended contents for 510(k) submissions.

Among the guidance document's more interesting additions comes in Section V, "Software." In it, regulators recommend that device manufacturers consider the cybersecurity of electrosurgical devices, as well as the potential for malfunctioning software to affect the performance of the device.

"FDA generally considers the software for electrosurgical device generators that are intended for general surgery indications to present a 'moderate' level of concern," FDA wrote. "However, new or unusual indications, applications, or technological characteristics may result in a higher level of concern.  If you believe that the software in your device presents either a 'minor' or a 'major' level of concern as defined in the software guidance, you should provide a scientific justification that supports your rationale of the level of concern based on the possible consequences of software failure."

Other requirements discussed in the guidances include biocompatibility, sterility, reprocessing, pyrogenicity, performance data, safety, clinical testing and labeling.

Comments on the guidance documents are due 90 days after their publication in the Federal Register.

 

Premarket Notification Submissions for Electrosurgical Devices for General Surgery (FR)

Premarket Notification Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery (FR)