The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) issued two final orders Thursday, classifying an anesthesiology and an ENT device into class II.
The classifications complete the work on the de novo classification requests submitted to CDRH in early 2017. Vapotherm’s de novo request for the classification of the Precision Flow HVNI, which is designed to help patients breathe easily, was granted in April. The de novo request for the classification of MED-EL Elektromedizinische Geraete GmbH’s BONEBRIDGE device, which is touted
as “the world's first active bone conduction implant system,” was granted in July.
Based on CDRH’s review of the information submitted in the companies’ requests, the final orders named the generic type of devices the “high flow humidified oxygen delivery device” and the “active implantable bone conduction hearing system.” Both prescription devices are required to comply with the special controls in the final orders to become class II and provide reasonable assurance of safety and effectiveness while avoiding the automatic classification into class III.
With the final classifications, CDRH identified seven potential risks to patient health associated with the anesthesiology device type and eight with the ENT [ear, nose and throat] device.
Under each classification, five common risks were identified for both device types. These include adverse tissue reaction, interference with other devices, infection, software failure and device failure. Shared mitigation measures include biocompatibility evaluation, electromagnetic compatibility testing, labeling and software verification as well as non-clinical performance testing.
For the oxygen delivery device
, other risks include electrical shock injury from device failure and hypoxia or worsening hypercarbia due to improper device use. Safety testing, including electrical, thermal and mechanical, and labeling special controls are tied to each of these risks.
The remaining three risks agency staff identified for the bone conducting hearing implant
involve failure to confirm adequate bone thickness and consistency leading to dural erosion or compression, surgical complications, such as bleeding or implant migration, and implant failure due to fatigue, damage or loss of hermeticity. In addition to the labeling and nonclinical testing special controls for these risks, clinical performance testing should also be conducted on this type of device for risk-based mitigation purposes.
The classifications follow a larger trend at CDRH to reduce regulatory burden on industry and agency review staff partly by allowing for new class II devices to be evaluated via the 510(k) pathway, rather than the more data-intensive premarket application pathway. CDRH also finalized
classifications for six more device types earlier this month, including one class I device.