The US Food and Drug Administration (FDA) on Friday finalized two guidances intended to help makers of electrosurgical devices file 510(k) submissions to the agency.
The guidances, Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery and Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery were first introduced in draft form in March 2014.
Electrosurgical devices, also referred to as radiofrequency (RF) devices, are used in surgery to cut or remove tissue, or cauterize blood vessels to control bleeding via an electrical current. Bipolar vessel sealers are also used to control bleeding, but rely on an electrical current passing between two electrodes.
In June, FDA cleared the first electrosurgical vessel sealer for a pediatric use. Its developer, JustRight Surgical's says its 3mm vessel sealer is five to nine times smaller than other vessel sealers and uses significantly less energy, making it safe for use in smaller patients.
Specifically, the guidances cover Class II medical devices that would fall under FDA classification for electrosurgical cutting and coagulation devices and accessories, and does not cover other electrosurgical devices, such as those for dental or endoscopic use.
In both guidances, FDA lays out specific recommendations for the information that must be included for the device description and the data necessary to demonstrate substantial equivalence with devices already on the market.
The guidances also make specific recommendations for biocompatibility, sterility, reprocessessing, pyrogenicity, performance data, as well as electrical safety and electromagnetic compatibility for the devices.
Additionally, the guidances each contain a list of more than a dozen warnings FDA expects the devices to be labeled with, unless sponsors can justify omitting specific warnings. In its comments on the draft guidance, medical device maker Cook took issue with FDA's placement of four of the warnings, saying they more closely resemble contraindications or operating instructions and should be placed elsewhere on the label. However, FDA appears to have not taken their argument, as all four are retained in the final guidance.
FDA's final guidance for general electrosurgical devices contains a notable difference in its approach to software, in line with a recommendation made the Advanced Medical Technology Association's comments on the draft guidance.
In the draft version, FDA said it "generally considers the software for electrosurgical devices generators that are intended for general surgery indications to present a 'moderate' level of concern," and said sponsors should provide justification for any software they believe presents a greater level of concern in their submissions.
However, in the final version, FDA says it considers the software for such devices to present a "major" concern, and puts the onus on sponsors to prove that their software presents a lower level of concern.
Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery
Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery