Two manufacturers have asked the FDA to clarify the types of devices covered in the agency’s draft guidance on ultrasound surgical aspirator devices.
The draft, issued in November 2016, recommended that manufacturers of the devices, with an indication for use in general surgery, laparoscopy, or gynecologic surgery, should prominently include the following contraindication in their product labeling:
CONTRAINDICATION: This ultrasonic surgical aspirator device is not indicated for and should not be used for the removal of uterine fibroids.
The agency also recommended that manufacturers update other portions of their labeling to make it consistent with this contraindication. For example, a manufacturer may revise the list of procedures in the labeling for which the aspirator can be used ().
Integra LifeSciences Corporation said the final guidance should clarify that it applies to general and specific indications for use within general, laparoscopic, and gynecologic surgery. Integra also noted that the draft guidance asks manufacturers with existing 510(k) clearances for ultrasonic surgical aspirators to provide updated labeling to purchasers of devices that have already been distributed. Integra said the final guidance should confirm that the updated labeling would not be considered a correction or require a correction report. The company also sought a clarification that manufacturers may post updated labeling on the web and provide paper copies upon request.
In a separate comment, Medtronic said the final guidance should specify which of two types of ultrasonic surgical instruments it applies to and how to differentiate between them. The two types, aspirators and dissectors, can be differentiated through their indications for use, the company said. The indications for use of ultrasonic dissectors typically refer to soft tissue incisions, vessel coagulation or a similar technology. Dissectors are intended as adjuncts to or substitutes for other surgical instruments such as scalpels or electrosurgical instruments. — Jeff Kinney