← Product Code [OMB](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMB) · K171184 # Persyst Mobile App (K171184) _Persyst Development Corporation · OMB · Sep 21, 2017 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMB/K171184 ## Device Facts - **Applicant:** Persyst Development Corporation - **Product Code:** [OMB](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMB.md) - **Decision Date:** Sep 21, 2017 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.1400 - **Device Class:** Class 2 - **Review Panel:** Neurology - **Attributes:** Software as a Medical Device ## Indications for Use The Persyst Mobile App is a software application that can be executed on a mobile platform. It is capable of displaying the original EEG data, and quantitative analysis of EEG data generated by the Persyst EEG Review and Analysis Software. This Mobile App is intended to be used by qualified medical practitioners who will exercise professional judgement in using the information. This device does not provide any diagnostic conclusion about the patient's condition to the user. ## Device Story Persyst Mobile App is a mobile software application for viewing EEG data and quantitative analysis results previously generated by Persyst EEG Review and Analysis Software. Operated by qualified medical practitioners in clinical settings; provides remote access to EEG data. Device does not perform primary analysis or provide diagnostic conclusions; serves as a visualization tool for existing data. Healthcare providers use the app to review EEG waveforms and quantitative trends to support clinical decision-making. Benefits include increased accessibility to patient EEG data for timely review by clinicians. ## Clinical Evidence No clinical data provided. Substantial equivalence is based on bench testing and verification of software functionality to ensure accurate display of EEG data and quantitative analysis results on the mobile platform. ## Technological Characteristics Software-only device (SaMD) designed for mobile platforms. Functions as a viewer for EEG data and quantitative analysis generated by Persyst EEG Review and Analysis Software. Connectivity via mobile network/Wi-Fi to access data. No hardware components or physical materials involved. ## Regulatory 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. ## Predicate Devices - Persyst EEG Review and Analysis Software ([K142636](/device/K142636.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Public Health Service Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. 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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 21, 2017 Persyst Development Corporation Dari Darabbeigi Vice President of Quality and Regulatory Affairs 420 Stevens Avenue Suite 210 Solana Beach, California 92075 Re: K171184 Trade/Device Name: Persyst Mobile App Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMB, OLT, OMA Dated: August 18, 2017 Received: August 21, 2017 Dear 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR {1}------------------------------------------------ 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 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 (DICE) 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 (DICE) 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. ## Michael J. Hoffmann -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}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K171184 Device Name PERSYST MOBILE APP Indications for Use (Describe) 1. The Persyst Mobile App is a software application that can be executed on a mobile platform. It is capable of displaying the original EEG data, and quantitative analysis of EEG data generated by the Persyst EEG Review and Analysis Software. This Mobile App is intended to be used by qualified medical practitioners who will exercise professional judgement in using the information. 2. 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) | | |----------------------------------------------------------------------------------|----------------------------------------------------------------------| | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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