(108 days)
OMB, OLT, OMA
Not Found
Unknown
The summary describes automated detection and analysis features (Seizure Detection, Spike Detection, Artifact Reduction) which could be implemented using AI/ML, but the document does not explicitly mention these technologies. Without a Device Description or specific mention of AI/ML terms, it's impossible to confirm.
No
The device is described as software for review, monitoring, and analysis of EEG recordings, and to aid in assessment. It specifically states that it "does not provide any diagnostic conclusion about the patient's condition" and is not a substitute for real-time monitoring by an expert, indicating it is an assistive tool for diagnosis/assessment, not a therapeutic intervention.
No
Explanation: Section 9 of the "Intended Use / Indications for Use" explicitly states, "This device does not provide any diagnostic conclusion about the patient's condition to the user."
Yes
The device is described as "EEG Review and Analysis Software" and its functions are entirely based on processing and analyzing existing EEG recordings. There is no mention of any hardware component being part of the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The intended use and device description clearly state that this software analyzes EEG recordings, which are electrical signals measured on the body's surface (scalp electrodes). It does not analyze biological samples like blood, urine, or tissue.
- The purpose is analysis of physiological signals, not analysis of biological samples. The software processes and analyzes the electrical activity of the brain as captured by the EEG device. This is distinct from analyzing the composition or characteristics of a biological sample.
Therefore, while this is a medical device used for diagnosis and assessment, it falls under the category of devices that analyze physiological signals rather than IVDs.
N/A
Intended Use / Indications for Use
-
Persyst 14 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. The device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
-
The Seizure Detection component of Persyst 14 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.
-
The Spike Detection component of Persyst 14 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 14 Spike Detection performance has not been assessed for intracranial recordings.
-
Persyst 14 includes the calculation and display of a set of qualitative measures intended to monitor and analyze the EEG waveform. These include FFT, Rhythmicty, 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.
-
Persyst 14 displays physiological signals, including the calculation and display of a heart rate measurement based on the ECG channel in the EEG recording, which are intended to aid in the analysis of an EEG. Heart rate measurement of Persyst 14 is not applicable to patients with pacemaker and/or active implantable devices.
-
The aEEG functionality included in Persyst 14 is intended to monitor the state of the brain. The automated event marking function of Persyst 14 is not applicable to aEEG.
-
Persyst 14 provides notifications for seizure detection, quantitative EEG and aEEG 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 14 notifications will be shown to a user. Persyst 14 notifications cannot be used as a substitute for real time monitoring EEG by a trained expert.
-
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.
-
This device does not provide any diagnostic conclusion about the patient's condition to the user.
Product codes
OMB, OLT, OMA
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
EEG
Anatomical Site
Brain
Indicated Patient Age Range
Adult (greater than or equal to 18 years) for Seizure Detection component.
Patients at least one month old for Spike Detection component.
Intended User / Care Setting
Qualified medical practitioners.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 29, 2018
Persyst Development Corporation Dari Darabbeigi Vice President of Quality and Regulatory Affairs 420 Stevens Avenue, Suite 210 Solana Beach, California 92075
Re: K182181
Trade/Device Name: Persyst 14 EEG Review and Analysis Software Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMB, OLT, OMA Dated: October 24, 2018 Received: October 31, 2018
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jay R. Gupta -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) K182181
Device Name Persyst 14 EEG Review and Analysis Software
Indications for Use (Describe)
-
Persyst 14 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. The device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
-
The Seizure Detection component of Persyst 14 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.
-
The Spike Detection component of Persyst 14 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 14 Spike Detection performance has not been assessed for intracranial recordings.
-
Persyst 14 includes the calculation and display of a set of qualitative measures intended to monitor and analyze the EEG waveform. These include FFT, Rhythmicty, 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.
-
Persyst 14 displays physiological signals, including the calculation and display of a heart rate measurement based on the ECG channel in the EEG recording, which are intended to aid in the analysis of an EEG. Heart rate measurement of Persyst 14 is not applicable to patients with pacemaker and/or active implantable devices.
-
The aEEG functionality included in Persyst 14 is intended to monitor the state of the brain. The automated event marking function of Persyst 14 is not applicable to aEEG.
-
Persyst 14 provides notifications for seizure detection, quantitative EEG and aEEG 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 14 notifications will be shown to a user. Persyst 14 notifications cannot be used as a substitute for real time monitoring EEG by a trained expert.
-
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.
-
This device does not provide any diagnostic conclusion about the patient's condition to the user.
3
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