PERSYST PRISM

K974718 · Persyst Development Corp. · GWS · Mar 9, 1998 · Neurology

Device Facts

• Record ID: K974718
• Device Name: PERSYST PRISM
• Applicant: Persyst Development Corp.
• Product Code: GWS · Neurology
• Decision Date: Mar 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1420
• Device Class: Class 1
• Attributes: Software as a Medical Device

Intended Use

This product is intended for use by a trained EEG reader. This software is intended for use by a trained EEG technician or neurologist.

Device Story

Persyst Prism is a software-only device operating on a standard personal computer. It processes digitized EEG signal files, either locally or via a network. The device performs signal analysis and visualization, generating outputs including average power spectra, compressed spectral arrays, topographic spectrum maps, topographic voltage plots, and correlation/lag analysis. It is intended for use in clinical settings by trained EEG technicians or neurologists. The software does not control life-sustaining functions, drug administration, or energy delivery. Clinicians use the displayed EEG data and spectral visualizations to assist in the interpretation of neurological activity.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-only device; runs on standard personal computer hardware. Functions include digital signal processing for EEG visualization (power spectra, topographic mapping, correlation/lag). Does not utilize a normative database. Requires external EEG acquisition system for signal digitization. No specialized hardware or energy delivery components.

Indications for Use

Indicated for use by trained EEG technicians or neurologists for the display and analysis of digitized EEG signals.

Regulatory Classification

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.

Predicate Devices

• STELLATE RHYTHM (K974718)

Submission Summary (Full Text)

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# 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

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|------------------------------------------|----|--------------------------|
| | | (Optional Format 1-2-96) |