(137 days)
The EMU40 Headbox is an electroencephalograph that works in conjunction with XLTEK NeuroWorks software {FDA 510(k) #K980214}.
The EMU40 Headbox is used to acquire, digitize, store and transmit physiological signals (such as EEG, pulse and oximetry signals) for EEG studies in research and clinical environments.
The EMU40 Headbox requires competent user input, and its output must be reviewed and interpreted by trained medical professionals who will exercise professional judgment in using this information.
The EMU40 Headbox is an electroencephalograph that works in conjunction with XLTEK NeuroWorks software {FDA 510(k) #K980214}. The EMU40 Headbox is used to acquire, digitize, store and transmit physiological signals (such as EEG, pulse and oximetry signals) for EEG studies in research and clinical environments.
This document is a 510(k) clearance letter from the FDA for a medical device called the "XLTEK EMU40 EEG Headbox". It doesn't contain information about acceptance criteria or a study proving the device meets acceptance criteria, as it's primarily a regulatory approval document.
Here's why the requested information cannot be extracted from this document:
- Acceptance Criteria and Device Performance Table: The document states that the device is "substantially equivalent" to legally marketed predicate devices. This is a regulatory finding based on comparison to existing devices, rather than a detailed performance study with specific acceptance criteria.
- Sample Size and Data Provenance: This information would be found in a study report, which is not part of this 510(k) letter.
- Number and Qualifications of Experts: Again, this would be part of a study design and not typically included in a 510(k) clearance letter.
- Adjudication Method: Not applicable or present in this regulatory document.
- MRMC Comparative Effectiveness Study: The letter does not mention a comparative effectiveness study.
- Standalone Performance Study: The letter does not describe a standalone performance study.
- Type of Ground Truth: Not applicable or present.
- Training Set Sample Size: Not applicable as this is not a study report.
- Ground Truth for Training Set: Not applicable.
In summary, this document is a regulatory approval for market clearance, not a technical report detailing performance criteria or study results. Therefore, it does not contain the information required to answer your request.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 2006
Excel-Tech. Ltd c/o Ms. Nicole Landreville, Eng. RAC Director, Quality and Regulatory 258 Bristol Circle Oakville, Ontario Canada L6H 5S1
Re: K053386
Trade/Device Name: XLTEK EMU40 EEG Headbox Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWO Dated: March 21, 2006 Received: March 23, 2006
Dear Mr. 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 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 vour 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
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Page 2 - Ms. Nicole Landreville, Eng. RAC
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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. 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 Manufacturers, 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
elmdl
Mark N. Melkerson
Director
Division of General, Restorative
and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
510(k) Number (if known): KoS 3386
Device Name: XLTEK EMU40 EEG Headbox
Indications for Use:
The EMU40 Headbox is an electroencephalograph that works in conjunction with XLTEK NeuroWorks software {FDA 510(k) #K980214}.
The EMU40 Headbox is used to acquire, digitize, store and transmit physiological signals (such as EEG, pulse and oximetry signals) for EEG studies in research and clinical environments.
The EMU40 Headbox requires competent user input, and its output must be reviewed and interpreted by trained medical professionals who will exercise professional judgment in using this information.
Prescription Use × (Per 21 CFR 801.109)
OR
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)
QmDQ
(Division Sign Off)
Division of General, Restorative,
and Neurological Devices
510(k) N
(Optional Format 1-2-96)
§ 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).