(82 days)
STELLATE RHYTHM
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard EEG signal processing and display.
No
The device is a software product that displays digitized EEG signals and related data for interpretation by a trained professional. It does not control energy delivery, administer drugs, or perform life-sustaining functions, nor does it directly treat or mitigate a disease or condition.
Yes
The device displays digitized EEG signals and is used by trained EEG readers or neurologists to interpret these signals, which are used for diagnosis.
Yes
The device description explicitly states "The Persyst Prism is a software only product. It runs on a personal computer and requires no specialized hardware." This directly indicates it is a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states that the device "displays digitized EEG signals, power spectra, topographic maps, etc." and reads "digitized EEG input is read from a file". EEG (Electroencephalography) measures electrical activity in the brain using electrodes placed on the scalp. This is a measurement of a physiological signal from the body, not an analysis of a sample taken from the body.
- Lack of sample analysis: There is no mention of analyzing biological samples like blood, urine, or tissue.
Therefore, the Persyst Prism software, as described, falls under the category of a medical device that processes and displays physiological signals, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This software is intended for use by a trained EEG technician or neurologist.
Product codes
GMS
Device Description
The Persyst Prism is a software only product. It runs on a personal computer and requires no specialized hardware. It displays digitized EEG signals, power spectra, topographic maps, etc. These functions are all controlled and interpreted by 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.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
STELLATE RHYTHM Classification: 21 CFR 882.1420
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1420 Electroencephalogram (EEG) signal spectrum analyzer.
(a)
Identification. An electroencephalogram (EEG) signal spectrum analyzer is a device used to display the frequency content or power spectral density of the electroencephalogram (EEG) signal.(b)
Classification. Class I (general controls).
0
Section 2 - Summary of Safety and Effectiveness
MAR - 9 1998
Submitter
Persyst Development Corporation 316 Skyline Drive Prescott, AZ 86303 520/708-0705 Contact: Scott Wilson Submitted: December 12, 1997
Device
PERSYST PRISM Classification: 21 CFR 882.1420
Predicate Device
STELLATE RHYTHM Classification: 21 CFR 882.1420
Description
The Persyst Prism is a software only product. It runs on a personal computer and requires no specialized hardware. It displays digitized EEG signals, power spectra, topographic maps, etc. These functions are all controlled and interpreted by 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.
Intended Use
This product is intended for use by a trained EEG reader.
Comparison Summary of Technological Characteristics
Both Prism and Rhythm support the following digital EEG plots: average power spectrum, compressed spectral arrays, topographic spectrum, topographic voltage plots, and correlation and lag. Neither product utilizes a normative database. Rhythm is capable of digitizing an analog signal while Prism requires that the signal be digitized by a separate EEG acquisition system. Both are software only products.
5974718
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three flowing ribbons extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 9 1998
Mr. Scott B. Wilson · President Persyst Development Corporation 316 Skyline Drive 86303 Prescott, Arizona
Re: K974718 PERSYST PRISM Trade Name: Regulatory Class: I Product Code: GMS December 12, 1997 Dated: Received: December 17, 1997
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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.
2
Page 2 - Mr. 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) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K974718
Device Name: PERSYST PRISM
Indications For Use:
: 1
This software is intended for use by a trained EEG technician or neurologist.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K974718 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| (Optional Format 1-2-96) |