(233 days)
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Unknown
The document mentions an "algorithm" for analyzing EEG signals but does not explicitly state whether this algorithm utilizes AI or ML techniques. The lack of information regarding training/test sets and performance metrics further suggests that it might not be an AI/ML-based device, but it's not definitively ruled out.
No.
The device is described as analyzing EEG signals and marking potential seizure events for review by clinical practitioners, and aids in analyzing EEG waveforms, but it does not provide any therapy or treatment.
No
The device description explicitly states, "IdentEvent does not provide any diagnostic conclusion about the patient's condition to the user." Its purpose is to mark events for review by qualified practitioners, not to provide a diagnosis itself.
Yes
The device description explicitly states "IdentEvent® is a software-only product". While it requires previously acquired EEG signals from a hardware device (EEG machine), the device itself is solely the software that processes these signals.
Based on the provided information, IdentEvent is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a patient's health.
- IdentEvent's Function: IdentEvent analyzes previously acquired EEG signals, which are electrical signals recorded from the scalp. These are not specimens derived from the body in the way that IVDs typically use.
- Intended Use: The intended use is to analyze and mark events in EEG traces for review by qualified practitioners, not to perform tests on biological samples.
Therefore, IdentEvent falls outside the scope of an In Vitro Diagnostic device. It is a software tool for analyzing physiological signals.
N/A
Intended Use / Indications for Use
IdentEvent® is a software-only product with an algorithm intended to analyze previously acquired, adult (≥18 years) scalp EEG signals and mark events that may correspond to electrographic seizures for the purpose of reviewing prolonged EEG traces. The marked events are reviewed, possibly deleted, and interpreted by qualified clinical practitioners who will exercise professional judgment in using the information.
IdentEvent also includes the display of the quantitative EEG parameters Amplitude Variation and Maximum Frequency, which are intended to help the user analyze the EEG waveform after it has been collected.
IdentEvent requires the use of EEGs recorded with at least a 16-channel scalp montage following the standard 10/20 electrode placement system. IdentEvent does not provide any diagnostic conclusion about the patient's condition to the user.
Product codes
OMB, OLT
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
scalp EEG signals
Anatomical Site
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Indicated Patient Age Range
adult (≥18 years)
Intended User / Care Setting
qualified clinical practitioners
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles. The symbol is composed of three distinct shapes, each resembling a human head in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 5, 2015
Optima Neuroscience, Inc. Ryan Kern CEO 11930 Research Circle Alachua, Florida 32615
Re: K150688
Trade/Device Name: IdentEvent 2.0A Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMB, OLT Dated: September 18, 2015 Received: September 24, 2015
Dear Ryan Kern:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150688
Device Name IdentEvent® 2.0A
Indications for Use (Describe)
IdentEvent® is a software-only product with an algorithm intended to analyze previously acquired, adult (≥18 years) scalp EEG signals and mark events that may correspond to electrographic seizures for the purpose of reviewing prolonged EEG traces. The marked events are reviewed, possibly deleted, and interpreted by qualified clinical practitioners who will exercise professional judgment in using the information.
IdentEvent also includes the display of the quantitative EEG parameters Amplitude Variation and Maximum Frequency, which are intended to help the user analyze the EEG waveform after it has been collected.
IdentEvent requires the use of EEGs recorded with at least a 16-channel scalp montage following the standard 10/20 electrode placement system. IdentEvent does not provide any diagnostic conclusion about the patient's condition to the user.
| Type of Use (Select one or both, as applicable) | |||
|---|---|---|---|
| -- | -- | -- | ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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