- FDA on Monday issued an updated guidance advising manufacturers on how to prepare 510(k) submissions for electrosurgical cutting and coagulation devices and accessories used in general surgery.
- The document was originally published in August 2016, following the release of a draft guidance in March 2014.
- The updated guidance provides more information clarifying the types of electrosurgical devices covered by FDA’s recommendations. It also goes into greater detail than the draft document on testing requirements for thermal effects on tissue.
Also known as radiofrequency devices, the instruments addressed in the guidance fall under the Class II moderate-risk category and are used to cut or remove tissue and control bleeding with high-frequency electrical current.
FDA expanded the description of the types of electrosurgical devices it is addressing in the guidance to add that the instruments may have multiple uses, as long as one of the indications includes tissue cutting or coagulation. The guidance applies to electrosurgical devices that have both open and minimally invasive uses and to devices that may include an arthroscopic indication.
As first indicated in the draft guidance, the updated document does not cover dental electrosurgical units, endoscopic electrosurgical units, radiofrequency lesion generators and probes, bipolar and unipolar endoscopic coagulator-cutters, radiofrequency electrosurgical cautery apparatus, and thermal cautery units.
In a section on system testing, FDA added several paragraphs on the types of tests needed to gauge thermal damage to tissue. To support a specific soft tissue indication, testing should be performed in tissues relevant to those uses, and both the target and surrounding tissues should be included.
For a general soft tissue indication, testing liver, kidney and muscle tissue to cover a range of densities was recommended, but the agency said other tissue types may be appropriate based on the treatment location.
Recommendations were given for testing tissue for thermal damage at different temperatures and times. The agency also said thermal damage should be assessed with histological stains.
In comments submitted in response to the 2014 draft guidance, AdvaMed asked FDA to remove a requirement to provide performance testing that would show a component would be safe and effective when used with other manufacturers’ devices. The industry group said a manufacturer could not control what the competition does and should not have to perform additional testing for multiple manufacturers’ devices. FDA, however, did not remove that testing requirement.
FDA did follow AdvaMed’s suggestion to characterize software used in the devices as a major, rather than moderate, concern. There are many potential flaws in software that could lead to serious injury, such as unintended activation that could cause tissue damage, incorrect delivery of energy that could result in an inadequate vessel seal, or failure to deliver a warning during an unsafe condition, the association said in suggesting the change.