(27 days)
Not Found
No
The summary describes a standard digital electroencephalograph and does not mention any AI or ML capabilities.
No
The device is described as an electroencephalograph that acquires, displays, stores, and archives electroencephalographic signals, which are diagnostic functions, not therapeutic.
Yes
The device is described as an electroencephalograph that acquires, displays, stores, and archives electroencephalographic signals. While it doesn't explicitly state "diagnosis," these functions are fundamental to the diagnostic process in neurology, as EEG signals are analyzed by clinicians to diagnose neurological conditions. The predicate device is also an EEG, which is a common diagnostic tool.
No
The device description explicitly states it is a "digital electroencephalograph," which is a hardware device used to acquire EEG signals. The summary does not mention it being software that processes data from a separate hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "acquire, display, store, and archive electroencephalographic signals." This describes a device that measures electrical activity in the brain, which is a physiological signal from the body.
- Device Description: It is described as a "digital electroencephalograph," which aligns with measuring electrical brain activity.
- Lack of IVD Characteristics: There is no mention of analyzing samples taken from the body (like blood, urine, tissue, etc.) to provide information about a physiological state, disease, or condition. IVDs work in vitro (outside the body) on these samples.
Therefore, the 80 Channel EEG is a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 80 Channel EEG is intended to be used as an electroencephalograph: to acquire, display, store, and archive electroencephalographic signals.
Product codes (comma separated list FDA assigned to the subject device)
GWQ
Device Description
The 80 Channel EEG is a digital electroencephalograph
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
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1400 Electroencephalograph.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: This image shows a document with the XLTEK logo and the text "SPECIAL 510(K) DEVICE MODIFICATION". The document also includes the text "SPECIAL 510(K) 80 CHANNEL EEG", "DECEMBER 14, 2001", and "PAGE 49 of 51". There is also a handwritten number at the top right that reads "K014147".
Section F -- 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR § 807.92.
| Name: | Cameron Mahon
Vice President, Customer Satisfaction | JAN 1 4 2002 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Address: | XLTEK
2568 Bristol Circle
Oakville, Ontario
Canada, L6H 5S1 | |
| Telephone: | (905) 829-5300 | |
| Fax: | (905) 829-5304 | |
| E-mail: | research@xltek.com | |
| Common Names: | 80 Channel EEG | |
| Classification Name: | Electroencephalograph | |
| Predicate Devices: | 24 Channel Ambulatory EEG [FDA 510(k) K982479] | |
| Description: | The 80 Channel EEG is a digital electroencephalograph | |
| Substantial Equivalence: | The 80 Channel EEG is substantially equivalent to the 24 Channel
Ambulatory EEG [FDA 510(k) K982479] | |
| Indications for Use: | The 80 Channel EEG is intended to be used as an
electroencephalograph: to acquire, display, store, and archive
electroencephalographic signals. | |
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 2002
XLTEK Sonja Markez Regulatory Affairs 2568 Bristol Circle Oakville, Ontario Canada L6H 5S1
Re: K014147
Trade Name: 80 Channel EEG Regulation Number: 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWQ Dated: December 14, 2001 Received: December 18, 2001
Dear Ms. Markez:
We have reviewed your Section 510(k) premarket 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Sonja Markez
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis iction with and w you to ough anding of substantial equivalence of your device to a legally premation hoticated on " 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 11 you dostro specific and 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 OF 1 F ar 4659. Additionally, for questions on the promotion and advertising of Compination at (301) 594-4639 Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oince general miorination on Joseph international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark McMillan
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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Image /page/3/Picture/0 description: The image shows the logo for XILTEK, followed by the words SPECIAL 510(K). Below the logo, the words SPECIAL 510(K) DEVICE MODIFICATION are printed. The image also contains the words 80 CHANNEL EE and DECEMBER 14, 20.
80 CHANNEL EEG DECEMBER 14, 2001 PAGE 50 of 51
Section G – INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
80 Channel EEG
Indications for Use:
The 80 Channel EEG is intended to be used as an electroencephalograph: to acquire, display, store, and archive electroencephalographic signals.
(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)
Over-The Counter Use
Mark n millenor
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number .
OR