TPLC - Total Product Life Cycle

• Device: automatic event detection software for full-montage electroencephalograph
• Definition: Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user
• Product Code: OMB
• Regulation Number: 882.1400
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AUSTRIAN INSTITUTE OF TECHNOLOGY GMBH
	SUBSTANTIALLY EQUIVALENT	1
CERIBELL, INC.
	SUBSTANTIALLY EQUIVALENT	2
EPITEL, INC.
	SUBSTANTIALLY EQUIVALENT	1
HOLBERG EEG AS
	SUBSTANTIALLY EQUIVALENT	1
LVIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)
	SUBSTANTIALLY EQUIVALENT	1
PERSYST DEVELOPMENT CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2022	1	1
2023	3	3
2024	10	10

Device Problems	MDRs with this Device Problem	Events in those MDRs
Crack	8	8
Unintended Movement	6	6
Break	2	2
Sparking	2	2
Communication or Transmission Problem	1	1
Material Twisted/Bent	1	1
Power Problem	1	1
Physical Resistance/Sticking	1	1
Device Fell	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	12	12
Cardiac Arrest	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Natus Neurology DBA Excel Tech., Ltd. (XLTEK)	II	Feb-22-2022