(88 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on identifying events for user review, not autonomous decision-making or learning.
No.
The software identifies spike and seizure events for review and interpretation by a user but does not control the delivery of energy, administration of drugs, or life-sustaining functions, and no therapeutic claims are made.
No
The document explicitly states, "No diagnostic or effectiveness claims are made." While it identifies spike and seizure events for review by a user, it disclaims diagnostic capabilities.
Yes
The device description explicitly states "The Persyst Reveal is a software only product. It runs on a personal computer and requires no specialized hardware."
Based on the provided information, it is unlikely that this device is an IVD (In Vitro Diagnostic). Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves analyzing biological samples like blood, urine, tissue, etc.
- Device Description: The Persyst Reveal software analyzes digitized EEG input, which is a recording of electrical activity in the brain. This is a physiological signal, not a biological specimen derived from the body in the way an IVD typically uses.
- Intended Use: The software identifies spike and seizure events for review and interpretation by a trained professional. While this information is used in a diagnostic context, the software itself is processing a physiological signal, not performing an in vitro test on a biological sample.
- Lack of Biological Sample Analysis: There is no mention of the software analyzing blood, urine, tissue, or any other biological specimen.
In summary, the Persyst Reveal software processes a physiological signal (EEG) rather than performing an in vitro test on a biological sample. This aligns it more with devices that analyze physiological data for diagnostic support rather than with the typical definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This software is intended for use by a trained EEG technician or neurologist.
Product codes
GWS
Device Description
The Persyst Reveal is a software only product. It runs on a personal computer and requires no specialized hardware. It identifies spike and seizure events are then reviewed, possibly deleted, and interpreted by the user. The digitized EEG input is read from a file on the personal computer (or available across the network).
Neither the computer nor the software control the delivery of energy, the administration of parenteral drugs, or another form of life sustaining function to the patient.
No diagnostic or effectiveness claims are made.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained EEG technician or neurologist.
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)
Stellate Sensa
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
Section 2 - Summary of Safety and Effectiveness
Stellate Sensa
The Stellate Sensa (predicate device) is a software only product. It runs on a personal computer and identifies spike and seizure events. These events are then reviewed, possibly deleted, and interpreted by the user.
Neither the computer nor the software control the delivery of energy, the administration of parenteral drugs, or another form of life sustaining function to the patient.
No diagnostic or effectiveness claims are made.
Persyt Reveal
The Persyst Reveal is a software only product. It runs on a personal computer and requires no specialized hardware. It identifies spike and seizure events are then reviewed, possibly deleted, and interpreted by the user. The digitized EEG input is read from a file on the personal computer (or available across the network).
Neither the computer nor the software control the delivery of energy, the administration of parenteral drugs, or another form of life sustaining function to the patient.
No diagnostic or effectiveness claims are made.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/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. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, composed of three curved lines.
AUG - 3 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Scott B. Wilson President Persyst Development Corporation 316 Skyline Drive Prescott, Arizona 86303
Re: K011397
Trade/Device Name: Persyst Reveal Regulation Number: 882.1420 Regulatory Class: Class I Product Code: GWS Dated: May 2, 2001 Received: May 7, 2001
Dear Mr. Wilson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Scott B. Wilson
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
L. Mark A. Wilkinson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
011397
Device Name: Persyt Reveal (previously Persyst SpikeDetector)
Indications for Use:
This software is intended for use by a trained EEG technician or neurologist.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
Mark M Millener
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number
(Optional Format 3-10-98)