Sponsors of 510(k)s for electrosurgical devices and bipolar electrosurgical vessel sealers meant for general surgery can skip studies on FDA-approved components, the FDA says.
In a pair of final guidance documents released Friday, the FDA is now advising sponsors to rely on an original 510(k) as a reference, allowing sponsors to avoid additional trials for the component or accessory. This, however, does not exempt sponsors from having to demonstrate compatibility between components or accessories and the proposed device.
The final guidance documents contain minimal revisions from their draft versions, both of which were released in March 2014.
An exemption for additional trials applies to system testing for vessel sealers, the FDA says. When the 510(k) falls within a family of closely related devices — with identical jaw geometry, surface characteristics, materials, clamping force, output power and generator control algorithm — it’s unnecessary to repeat system tests, according to the final guidance.
Otherwise, the FDA still recommends system tests to demonstrate bipolar electrosurgical vessel sealer performance for new sealing systems or those modified to an extent that there might be a substantial effect. For instance, if the jaw surface characteristic or clamping force is modified, the agency expects system tests.
The final guidance documents bring to the fore labeling expectations that had previously been placed in the margins. The documents remind sponsors that although labeling is not a requirement for clearance, any product labels must comply with the requirements laid out in 21 C.F.R. §801.
Recommendations Virtually Unchanged
The labeling recommendations for the vessel sealers and electrosurgical devices remain virtually unchanged. The FDA suggested a new warning statement for electrosurgical devices, recommending sponsors with reusable instruments include a statement “that visual inspection alone may not be sufficient to ensure that the insulation is intact.”
Descriptions of device designs should include exploded view or assembly view, or else connection diagrams, the final document states. The draft version of the guidance documents had recommended sponsors submit either block diagrams or connection diagrams.
In the final document, the agency defines term certain terms as well, such as force to jaw failure, as it discusses performance data for the devices. The guidance documents define force to jaw failure “as the force required to cause the actuating component to no longer be able to grasp or close on the target tissue.”
Test recommendations provide further detail for sponsors in the final versions, however, the crux of the agency’s advice is consistent with those made in the draft version. For example, as it relates to vessel sealers, the FDA expands on its prior recommendations for system tests on thermal spread on vessels.
Two-dimensional histological assessments are “minimally acceptable measurements,” the agency says in one of the final documents. Three-dimensional histological assessments, on the other hand, are recommended as they are needed to quantify thermal spread in seals. In particular, the agency says the three-dimensional histological assessments should apply to seals that generate special growth characteristics, such as asymmetrical growth.
As in the draft version, the final document recommends that sponsors conduct basic electrical, thermal and electromagnetic performance testing to check for electrical safety and electromagnetic compatibility.