Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014)
Neuralynx, Inc.The Atlas Stim Headbox by Neuralynx, Inc. is a medical device intended for cortical or intracranial stimulation during EEG examinations, such as stereo EEG (SEEG). It works as an accessory to the ATLAS Neurophysiology System, enabling controlled electrical stimulation of the brain using third-party electrodes and recording the brain's electrical responses. This device assists neurosurgeons and neurologists in mapping brain function, especially in complex cases requiring precise neural stimulation.
Intended Use
The ATLAS Stim Headbox is a low power, constant current or voltage mode, bi-phasic stimulator intended for cortical or intracranial stimulation during electroencephalography examinations (i.e. stereoEEG).
Technology
The device consists of an encased amplifier and embedded firmware that delivers electrical stimulation energy under the control of associated ATLAS Stim Headbox Software, connected via fiber optic ethernet interface. It allows multi-channel stimulation with enforced safety rules limiting total current and charge per pulse.
Performance
Performance testing included electrical safety, mechanical integrity, evoked response testing, electroencephalograph functionality tests, and software regression testing according to IEC standards. Tests demonstrated substantial equivalence to predicate devices in safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/14/2025
3 months - 2
FDA Approval
4/14/2025
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