PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE

K151929 · Persyst Development Corporation · OMB · Aug 12, 2015 · Neurology

Device Facts

• Record ID: K151929
• Device Name: PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE
• Applicant: Persyst Development Corporation
• Product Code: OMB · Neurology
• Decision Date: Aug 12, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

1. Persyst 13 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices using scalp electrodes and to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information. 2. The Seizure Detection component of Persyst 13 is intended to mark previously acquired sections of adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with a full scalp montage according to the standard 10/20 system. 3. The Spike Detection component of Persyst 13 is intended to mark previously acquired sections of the patient's EEG recordings that may correspond to spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. The Spike Detection component is intended to be used in patients at least one month old. Persyst 13 Spike Detection performance has not been assessed for intracranial recordings. 4. Persyst 13 includes the calculation and display of a set of quantitative measures intended to monitor and analyze the EEG waveform. These include FFT, Rhythmicity, Peak Envelope, Artifact Intensity, Amplitude, Relative Symmetry and Suppression Ratio. Automatic event marking is not applicable to the quantitative measures. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms. 5. The aEEG functionality included in Persyst 13 is intended to monitor the state of the brain. The automated event marking function of Persyst 13 is not applicable to aEEG. 6. Persyst 13 provides notifications for seizure detection, quantitative EEG that can be used when processing a record during acquisition. These include an on screen display and the optional sending of an email message. Delays of up to several minutes can occur between the beginning of a seizure and when the Persyst 13 notifications will be shown to a user. Persyst 13 notifications cannot be used as a substitute for real time monitoring EEG by a trained expert. 7. Persyst AR (Artifact Reduction) is intended to reduce EMG, eye movement, and electrode artifacts in a standard 10-20 EEG recording. AR does not remove the entire artifact signal, and is not effective for other types of artifacts. AR may modify portions of waveforms representing cerebral activity. Waveforms must still be read by a qualified medical practitioner trained in recognizing artifact, and any interpretation or diagnosis must be made with reference to the original waveforms. 8. This device does not provide any diagnostic conclusion about the patient's condition to the user.

Device Story

Persyst 13 is EEG review/analysis software; processes scalp EEG recordings; aids neurologists in assessment. Features: automated seizure detection (adults); spike detection (>=1 month); quantitative EEG measures (FFT, Rhythmicity, Peak Envelope, Artifact Intensity, Amplitude, Relative Symmetry, Suppression Ratio); aEEG brain state monitoring; Artifact Reduction (AR) for EMG/eye movement/electrode noise. Used by qualified medical practitioners in clinical settings. Inputs: previously acquired or real-time EEG data. Outputs: marked EEG traces, quantitative displays, and notifications (on-screen/email). Notifications are not for real-time monitoring by experts. AR modifies waveforms; original data must be reviewed. Device provides no diagnostic conclusions; requires professional judgment.

Clinical Evidence

No clinical data provided. The document focuses on the regulatory determination of substantial equivalence for software functionality.

Technological Characteristics

Software-based EEG review and analysis system. Operates on standard EEG inputs (10/20 scalp montage). Includes signal processing algorithms for quantitative measures (FFT, rhythmicity, etc.) and artifact reduction. Provides automated event marking and notifications. Designed for use by qualified medical practitioners.

Indications for Use

Indicated for review, monitoring, and analysis of EEG recordings in patients. Seizure detection for adults (>=18 years). Spike detection for patients >=1 month old. Not for intracranial recordings.

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

August 12, 2015

Persyst Development Corporation Dari Darabbeigi Vice President of Quality and Regulatory Affairs Persyst Development Headquarters 12625 High Bluff Drive Suite 213 San Diego, CA 92130

Re: K151929

Trade/Device Name: Persyst 13 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMB, OLT, OMA Dated: July 10, 2015 Received: July 14, 2015

Dear Ms. Dari Darabbeigi:

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

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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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 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) K151929

Device Name Persyst 13

## Indications for Use (Describe)

1. Persyst 13 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices using scalp electrodes and to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.

2. The Seizure Detection component of Persyst 13 is intended to mark previously acquired sections of adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with a full scalp montage according to the standard 10/20 system.

3. The Spike Detection component of Persyst 13 is intended to mark previously acquired sections of the patient's EEG recordings that may correspond to spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. The Spike Detection component is intended to be used in patients at least one month old. Persyst 13 Spike Detection performance has not been assessed for intracranial recordings.

4. Persyst 13 includes the calculation and display of a set of quantitative measures intended to monitor and analyze the EEG waveform. These include FFT, Rhythmicity, Peak Envelope, Artifact Intensity, Amplitude, Relative Symmetry and Suppression Ratio. Automatic event marking is not applicable to the quantitative measures. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms.

5. The aEEG functionality included in Persyst 13 is intended to monitor the state of the brain. The automated event marking function of Persyst 13 is not applicable to aEEG.

6. Persyst 13 provides notifications for seizure detection, quantitative EEG that can be used when processing a record during acquisition. These include an on screen display and the optional sending of an email message. Delays of up to several minutes can occur between the beginning of a seizure and when the Persyst 13 notifications will be shown to a user. Persyst 13 notifications cannot be used as a substitute for real time monitoring EEG by a trained expert.

7. Persyst AR (Artifact Reduction) is intended to reduce EMG, eye movement, and electrode artifacts in a standard 10-20 EEG recording. AR does not remove the entire artifact signal, and is not effective for other types of artifacts. AR may modify portions of waveforms representing cerebral activity. Waveforms must still be read by a qualified medical practitioner trained in recognizing artifact, and any interpretation or diagnosis must be made with reference to the original waveforms.

8. This device 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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