PERSYST REVEAL

K011397 · Persyst Development Corp. · OMB · Aug 3, 2001 · Neurology

Device Facts

• Record ID: K011397
• Device Name: PERSYST REVEAL
• Applicant: Persyst Development Corp.
• Product Code: OMB · Neurology
• Decision Date: Aug 3, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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

Device Story

Persyst Reveal is software-only device running on personal computers; processes digitized EEG input files from local or network storage. Device identifies potential spike and seizure events for user review; user may delete or interpret findings. Does not control energy delivery, drug administration, or life-sustaining functions. Operated by EEG technicians or neurologists in clinical settings. Output presented to clinician to facilitate review and interpretation of EEG data; intended to assist in clinical workflow rather than provide automated diagnostic or effectiveness claims.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-only device; runs on standard personal computers. No specialized hardware required. Connectivity via local file access or network. No energy source or physical materials involved.

Indications for Use

Indicated for use by trained EEG technicians or neurologists to assist in the review of EEG data for the identification of spike and seizure events.

Regulatory Classification

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

• Stellate Sensa

Submission Summary (Full Text)

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## 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.

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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.

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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 [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" (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 [phone] or [phone] 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

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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.

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# 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)