DREAM CATCHER

K972122 · Rest Technologies, Inc. · GXY · Aug 29, 1997 · Neurology

Device Facts

• Record ID: K972122
• Device Name: DREAM CATCHER
• Applicant: Rest Technologies, Inc.
• Product Code: GXY · Neurology
• Decision Date: Aug 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Intended Use

The Dream Catcher is a headpiece with adjustable mounts for attaching surface electrodes with lead wires, intended for use during various types of EEG testing in which only a subset of the full 10/20 electrode sites are required. This cap is NOT intended for use in which a full set of the 10/20 electrode positions need to be monitored, or in which precise localization of the EEG activity is of vital importance such as localization of a seizure focus. The Dream Catcher holds electrodes at the C3, Cz, C4, O1, OZ, O2, A1 and A2 positions.

Device Story

Dream Catcher is an EEG headpiece featuring adjustable mounts for surface electrodes; designed for clinical EEG testing requiring limited electrode coverage. Device holds electrodes at specific 10/20 system positions: C3, Cz, C4, O1, OZ, O2, A1, and A2. Operated by clinicians in a clinical setting to secure electrodes during EEG monitoring. Does not support full 10/20 array monitoring or high-precision localization tasks like seizure focus identification. Provides mechanical support for electrode placement to facilitate signal acquisition.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Headpiece with adjustable mechanical mounts for surface EEG electrodes. Designed for specific 10/20 system positions (C3, Cz, C4, O1, OZ, O2, A1, A2). Passive mechanical device; no energy source, software, or electronic components.

Indications for Use

Indicated for patients undergoing EEG testing requiring a subset of 10/20 electrode sites. Not indicated for full 10/20 monitoring or clinical scenarios requiring precise localization of EEG activity, such as seizure focus localization.

Regulatory Classification

Identification

A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

:

Mr. Ronald Luich, P.E. Rest Technologies, Inc. 827 20th Street-Santa Monica, CA 90403

AUG 29 1997

K972122 Re: Trade Name: DREAM CATCHER Regulatory Class: II Product Code: 84 GXY Dated: May 31, 1997 Received: June 5, 1997

Dear Mr. Luich:

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 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 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 requlation may result in regulatory action. רו I 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. Ronald Luich, P.E.

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 requlation (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 requlation 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,

I porced ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Thomas J. Cadlahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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| 510(k) Number (if known): | K972122 |
|---------------------------|---------------|
| Device Name: | DREAM CATCHER |

## Indications For Use:

The Dream Catcher is a headpiece with adjustable mounts for attaching surface The Draam Cations. To a neateried for use during various types of EEG testing electrodes with read whos, intertisin only a subset of the full 10/20 electrode sites are required. This cap is NQT intended for use in which a full set of the 10/20 electrode positions need to be monitored, or in which precise localization of the EEG activity is of vital importance such as localization of a seizure focus. The Dream Catcher holds electrodes at the C3, Cz, C4, O1, OZ, O2, A1 and A2 positions.

## 8/25/97 Re2

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

## Over-The-Counter Use

(Optional Formal 1-2-96)

Thomas f. Callahon

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number.