(69 days)
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No
The document describes standard EEG/EP data acquisition and analysis software and hardware, with no mention of AI or ML algorithms for interpretation, diagnosis, or any other function. The focus is on data recording, display, and basic analysis features.
No
The device is intended for diagnosis and monitoring, and does not provide any therapy.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device "is intended to aid in the diagnosis and monitoring of potential disorders of the central and peripheral nervous system." This indicates its role in the diagnostic process.
No
The device description explicitly lists hardware components such as an EEG/ERP amplifier and power supply, in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "record and display EEG and EP (evoked potential) data in the clinic and hospital" and "aid in the diagnosis and monitoring of potential disorders of the central and peripheral nervous system." This describes a device that measures electrical activity from the body, not a device that examines specimens (like blood, urine, or tissue) in vitro (outside the body).
- Device Description: The components listed (amplifier, software, stimulation unit) are consistent with a system for measuring physiological signals directly from a patient.
- Input Imaging Modality: EEG and EP are measurements of electrical activity, not imaging modalities in the traditional sense of creating visual representations of internal structures or processes. While the device mentions DICOM import for medical images, this is likely for correlating the EEG/EP data with other imaging studies, not for the primary function of the device itself.
- Anatomical Site: The central and peripheral nervous system are parts of the body where the measurements are taken in vivo.
- Performance Studies: The performance studies focus on safety and effectiveness compared to predicate devices that are also systems for measuring physiological signals.
IVD devices are specifically designed to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device measures electrical activity directly from the patient's body, which falls under the category of a physiological monitoring or diagnostic device, not an IVD.
N/A
Intended Use / Indications for Use
Intended to record and display EEG and EP (evoked potential) data in the clinic and hospital. It is intended to aid in the diagnosis and monitoring of potential disorders of the central and peripheral nervous system.
Product codes
GWQ, GWE, GWJ
Device Description
Cognitrace provides a comprehensive EEG/ERP Data acquisition and analysis System. Cognitrace consists of the following components:
- 1 EEG/ERP amplifier
- Power supply for EEG/ERP amplifier
- eemagine EEG (K002631) software with Cognitrace extension modules
- Stimulation_unit
Cognitrace can perform complete sets of measurements for neurology and psychiatry:
- EEG: ■
- Visual Evoked Potential (VEP)
- Auditory Evoked Potential (AEP)
- P300 (Auditory oddball paradigm)
- Visual P300 (Visual oddball paradigm)
- CNV (Contingent Negative Variation)
- Option to add protocols using acoustic or visual stimulation. ■
The software components are:
- eemagine EEG, a novel, user-friendly and efficient software package for the . analysis of EEG data and
- eego, a novel, user-friendly EEG data acquisition system and allows you to record and review EEG, offering different amplifier configurations, eego is seemlessly integrated with the eemagine EEG software, which offers simplicity and efficiency in the analysis of EEG studies.
Mentions image processing
DICOM Import (medical Images)
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
central and peripheral nervous system
Indicated Patient Age Range
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Intended User / Care Setting
clinic and hospital
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices. The hardware components have been evaluated and found to comply with the same safety and EMC compatibility standards as the predicate.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
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051825 PAGE 1 OF 3
SEP 1 2005
EXHIBIT 2 510(k) Summary Cognitrace (Page 1 of 3) cemagine Medical Imaging Solutions GmbH Rudower Chausse 29 D-12489 Berlin, Germany Phone+ 49 (0)30 63926145 +49 (0) 30 63926146 Fax e-mail: info@eemagine.com May 31, 2005 Contact: Frank Zanow, General Manager
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- Identification of the Device: Proprietary-Trade Name: Cognitrace Classification Name/Product Codes: GWQ, GWE, and GWJ Common/Usual Name: Electroencephalograph with evoked response stimulation
- Equivalent legally marketed devices: This product is similar in function to the Nicolet 2. Bravo (K991054) and employs the software for which we obtained clearance in K002631.
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- Indications for Use (intended use) : Intended to record and display EEG and EP (evoked potential) data in the clinic and hospital. It is intended to aid in the diagnosis and monitoring of potential disorders of the central and peripheral nervous system.
-
- Description of the Device: Cognitrace provides a comprehensive EEG/ERP Data acquisition and analysis System. Cognitrace consists of the following components:
- 1 EEG/ERP amplifier
- Power supply for EEG/ERP amplifier 트
- eemagine EEG (K002631) software with Cognitrace extension modules 트
- Stimulation_unit
Cognitrace can perform complete sets of measurements for neurology and psychiatry:
- EEG: ■
- Visual Evoked Potential (VEP) 트
- Auditory Evoked Potential (AEP)
- P300 (Auditory oddball paradigm) 트
- Visual P300 (Visual oddball paradigm) 트
- 트 CNV (Contingent Negative Variation)
- Option to add protocols using acoustic or visual stimulation. ■
The software components are:
- eemagine EEG, a novel, user-friendly and efficient software package for the . analysis of EEG data and
- eego, a novel, user-friendly EEG data acquisition system and allows you to 트 record and review EEG, offering different amplifier configurations, eego is seemlessly integrated with the eemagine EEG software, which offers simplicity and efficiency in the analysis of EEG studies.
- Safety and Effectiveness, comparison to predicate device. The results of bench and user 5. testing indicates that the new device is as safe and effective as the predicate devices. The hardware components have been evaluated and found to comply with the same safety and EMC compatibility standards as the predicate.
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K051825 PAGE 2 OF 3
510(k) Summary Cognitrace (Page 2 of 3)
6. Substantial Equivalence Chart
| Feature | Nicolet Bravo Multi Modality
System (K991054) | Cognitrace |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INDICATIONS FOR
USE | Intended to record and display EEG, EP,
EMG and TCD data in the clinic and hospital
(including the hospital room, operating room,
emergency room, intensive care unit, neuro
intensive care unit, critical care unit, etc.), and
to import and display data from third-party
monitoring devices such as vital signs
monitors. It is intended to aid the diagnosis
and monitoring of potential disorders of the
central and peripheral nervous system and
muscles. | Intended to record and display EEG and EP (evoked
potential) data in the clinic and hospital. It is intended
to aid in the diagnosis and monitoring of potential
disorders of the central and peripheral nervous system. |
| Prescription Use | Yes | Yes |
| Testing Modes | EEG, EP, EMG | EEG, EP |
| Head Box | Uses a headbox.
Similar to Cognitrace but fewer channels (32)
available | EEG: Various headboxes available for up to 128 |
| Filters | Low filter: First order IIR digital filter
High filter: Second order IIR digital filter
Available sampling frequencies: