FDA Classifies Three Devices as Class II
The FDA made determinations for three de novo requests for classification this week.
Micro Interventional Devices’ Permaseal, indicated for soft tissue approximation of cardiac apical tissue during transcatheter value replacement, will be deemed a Class II device, the FDA said, which is the classification the company had requested n June 25.
Class II devices require special controls to provide reasonable assurance of safety.
Sommetrics’ cNEP Airway Management System was also classified a Class II device, despite a de novo request for Class I.
The airway management system is a silicone rubber collar that is attached to the neck and provides negative suction through a regulated vacuum source to provide a patient airway during mild to moderate sedation.
Lastly, Jan Medical’s cranial motion measurement device Brain Pulse was also classified as Class II with special controls. The Brain Pulse detects and amplifies skull motion caused by pulsatile flow from the cardiac cycle.
FDA Grants Ninth EUA for Zika Dx
The FDA granted an Emergency Use Authorization for InBios’ International’s Zika diagnostic to confirm the presence of Zika virus antibodies.
The ZIKV Detect IgM Capture ELISA detects Zika virus IgM antibodies in human sera.
Confirmation of the presence of anti-Zika IgM antibodies or other flavivirus IgM antibodies requires additional testing. The EUA marks the ninth Zika diagnostic the FDA has granted an emergency use authorization.
Levita’s Magnetic Surgical System Cleared
Levita’s magnetic surgical system was granted FDA clearance and received its CE Mark. The system was initially indicated for gallbladder removal surgery, but it is also used to magnetically retract and maneuver the gallbladder, which reduces the number of incisions.
Masimo Gets CE Mark for RAS-45 Sensor
Masimo gets the CE Marking of RAS-45, which is a single-use adult and pediatric acoustic respiration sensor for rainbow Acoustic Monitoring of respiration rate.
The respiratory acoustic monitoring system is noninvasive and continuously measures respiration rate using an adhesive sensor with an integrated acoustic transducer, RAS-45, that is applied to the patient’s neck. The sensor is for patients who weigh more than 22 lbs.
FDA grants 510(k) to Conventus
Conventus Orthopaedics received a 510(k) clearance from the FDA to market its new Conventus Cage device for fractured ulnar bone repair.
The device system employs the shape memory properties of nitinol to expand within the bone which creates a structure that prevents a collapse of the fracture repair. This eliminates the use of plates and screws.
The device is used for the treatment of distal and proximal ulna fractures.