PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE

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Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 ### May 19, 2014 Persyst Development Corporation Mr. Dari Darabbeigi Vice President of Quality / Regulatory 12625 High Bluff Drive, Suite 213 San Diego, California 92130 Re: K133793 Trade/Device Name: Persyst 12 EEG Review and Analysis Software Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMB, OLT, OMA Dated: April 15, 2014 Received: April 18, 2014 Dear Mr. 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 or any I with all the Act's requirements, including, but not limited to: registration and listing (21 {1}------------------------------------------------ Page 2 - Mr. Dari Darabbeigi CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Felipe Aguel -S for 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}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 510(k) Number (if known) K133973 #### Device Name Persyst 12 EEG Review and Analysis Software #### Indications for Use (Describe) I. Persyst 12 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 and Seizure Probability component of Persyst 12 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 tecordings should be obtained with a full scalp montage according to the standard 10/20 system. 3. The Spike Detection component of Persyst 12 is intended to mark previously acquired sections of the patient's EEG recordings that may correspond to spikes, in order to assist qualified cinical practitioners in the assessment of EEG traces. The Spike Detection component is intended to be used in patients at least one month old. Persyst 12 Spike Detection performance has not been assessed for intracranial recordings. 4. Persyst 12 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, Amplinde, Relative Symmetry and Suppression Ratio. Automatic event marking is not applicative measures. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms. 5. The aEEG functionality included in the Persyst 12 is intended to monitor the brain. The automated event marking function of Persyst 12 in not applicable to aEEG. 6. Persyst 12 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 12 notifications will be shown to a user. Persyst 12 notifications cannot be used as a substitute for real time monitoring of the underlying 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 entifact signal, and is not effective for other types of artifacts. AR may modify portions of waveloms 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) | | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| | <table style="border:none;"><tr><td><b> <span style="font-size:10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </b></td><td><b> <span style="font-size:10pt;">□ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </b></td></tr></table> | <b> <span style="font-size:10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </b> | <b> <span style="font-size:10pt;">□ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </b> | | <b> <span style="font-size:10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </b> | <b> <span style="font-size:10pt;">□ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </b> | | # PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ## FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) # ം Date: 2014.05.19 Date: {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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