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U.S. Department of Health and Human Services

Product Classification

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Device stimulator, low electric field, tumor treatment
Definition Intended to treat tumors by application of low electic fields and indicated for treatment of recurrent glioblastoma multiforme (gbm) in patients who have received maximum standard therapy with continued disease progress, as defined by tumor growth or decline in neurological status.
Physical State The device consists of sets of contact electrodes that are applied to the patient's shaved head, a connecting cable and a belt mounted control box and signal generator. The sets are 3 electrodes each adn there can be 2 or 3 sets used at a time.
Technical Method This is a battery powered device. Electric fields that alter thier polarity at a frequency near 200kHz with an intensity near 0.7 V/cm are continuosly applied to the target tumor 24 hours a day for 6 months at a time. This electric field creates, during mitosis process, disruption of the microtubules due to the focussing effect of the narrow neck of the dividing cell.
Target Area The device is currently used only on the human head.
Review Panel Neurology
Product CodeNZK
Premarket Review Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible