(18 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description is not available to provide further clues.
No
The device is intended to acquire, display, store, and archive electroencephalographic signals, which is a diagnostic function, not a therapeutic one. It records brain activity but does not administer any treatment.
Yes
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components for acquiring and processing the electroencephalographic signals.
Based on the provided information, the XLTEK TREX 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 involves measuring electrical activity from the brain, which is a physiological process within the body.
- 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. The XLTEK TREX does not operate on such samples.
- Input Modality: The input is electroencephalographic signals, which are directly measured from the patient's scalp.
Therefore, the XLTEK TREX is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The XLTEK TREX is intended to be used as an electroencephalograph: to acquire, display, store and archive electroencephalographic signals.
Product codes
GWQ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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)
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§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human profiles or a triple-stranded helix, possibly representing health, people, and services.
AUG 2 7 2004
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Nicole Landreville Regulatory Affairs Senior Manager Excel Tech Ltd. 2568 Bristol Circle Oakville, Ontario L6H 5S1 Canada
Re: K042150
Trade/Device Name: XLTEK Trex Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWQ Dated: August 3, 2004 Received: August 9, 2004
Dear Ms. Landreville:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for assession to May 28, 1976, the enactment date of the Medical Device Amendments, or 10 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 he 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.
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Page 2 - Ms. Nicole Landreville
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with and w yourse of substantial equivalence of your device to a legally premaired 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), please If you desire specific at novellance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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,
Muriam C. Provost
+6 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
2
STATEMENT OF INDICATIONS FOR USE
1 042150 510(k) Number (if known):
Device Name: XLTEK Trex
Indications for Use:
The XLTEK TREX is intended to be used as an electroencephalograph: to acquire, display, store and archive electroencephalographic signals.
Prescription Use X (Per 21 CFR 801.109) OR
ﺮ ﺍﻟﻤﺮﻛﺰ ﺍﻟﻤﺘﺮﺍﺗﻴﺠﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
iriam C. Provost
(Division Sign-Off Division of General, Restorative, and Neurological Devices
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(Optional Format 1-2-96)
510(k) Number_________________________________________________________________________________________________________________________________________________________________