IdentEvent

K150688 · Optima Neuroscience, Inc. · OMB · Nov 5, 2015 · Neurology

Device Facts

• Record ID: K150688
• Device Name: IdentEvent
• Applicant: Optima Neuroscience, Inc.
• Product Code: OMB · Neurology
• Decision Date: Nov 5, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

IdentEvent 2.0A is a software-only device for clinical review of prolonged EEG recordings. Input: previously acquired adult scalp EEG signals (minimum 16-channel, 10/20 system). Processing: algorithm identifies and marks potential electrographic seizures; calculates quantitative EEG parameters (Amplitude Variation, Maximum Frequency). Output: marked events and quantitative displays for clinician review. Usage: clinical setting; operated by qualified practitioners. The device assists in reviewing large datasets by highlighting potential events; clinicians interpret, verify, or delete marks to support clinical decision-making. Does not provide diagnostic conclusions.

Clinical Evidence

No clinical data provided. The device relies on bench testing and algorithmic performance validation for its intended use as a clinical decision support tool for EEG review.

Technological Characteristics

Software-only device; operates on previously acquired EEG data. Requires 16-channel scalp EEG input (10/20 system). Features automated event marking and quantitative EEG parameter calculation (Amplitude Variation, Maximum Frequency).

Indications for Use

Indicated for adult patients (≥18 years) undergoing review of prolonged scalp EEG traces to identify potential electrographic seizures. Requires EEG data recorded with at least 16-channel 10/20 electrode placement. Not for diagnostic use.

Regulatory Classification

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.

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## 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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