K Number
K972122
Device Name
DREAM CATCHER
Date Cleared
1997-08-29

(85 days)

Product Code
Regulation Number
882.1320
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 Description
The Dream Catcher is a headpiece with adjustable mounts for attaching surface electrodes with lead wires.
More Information

Not Found

Not Found

No
The summary describes a passive headpiece for holding electrodes and does not mention any computational or analytical functions, let alone AI/ML.

No
The device is described as a headpiece for attaching electrodes for EEG testing, which is a diagnostic procedure, not a therapeutic intervention.

No
The device is a headpiece designed to hold electrodes for EEG testing. It facilitates the testing procedure but does not itself analyze or interpret data to diagnose a condition.

No

The device description explicitly states it is a "headpiece with adjustable mounts for attaching surface electrodes with lead wires," indicating it is a physical hardware component, not software only.

Based on the provided information, the Dream Catcher 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.
  • Dream Catcher's Function: The Dream Catcher is a headpiece designed to hold surface electrodes for EEG testing. EEG (Electroencephalography) is a non-invasive method that measures electrical activity in the brain from the surface of the scalp. It does not involve testing samples taken from the body.
  • Intended Use: The intended use clearly states it's for use during EEG testing, which is a physiological measurement technique, not an in vitro diagnostic test.

Therefore, the Dream Catcher falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The Dream Catcher is a headpiece with adjustable mounts for attaching surface electrodes with lead wires. It is 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 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.

Product codes

84 GXY

Device Description

The Dream Catcher is a headpiece with adjustable mounts for attaching surface electrodes with lead wires.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Head

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 882.1320 Cutaneous electrode.

(a)
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.(b)
Classification. Class II (performance standards).

0

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.

1

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 (301) 594-4639. 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 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 (800) 638-2041 or (301) 443-6597, 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

2

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.