(90 days)
The 96 Channel EEG Headbox is intended to be used as an electroencephalograph: to acquire, store, and archive electroencephalographic signals with additional capabilities to record other physiological signals such as pulse oximetry.
The 96 Channel EEG Headbox is a digital electroencephalograph that can also record pulse oximetry signals.
The provided text focuses on the 510(k) summary and FDA clearance letter for a "96 Channel EEG Headbox." It describes the device, its intended use, and substantial equivalence to predicate devices. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. This type of information is typically found in engineering test reports, clinical study summaries, or validation reports, which are not included in the provided text.
Therefore, I cannot provide the requested information based solely on the input given.
To answer your request, I would need a document that describes the design verification and validation testing performed for the 96 Channel EEG Headbox, including:
- Specific performance metrics tested (e.g., signal-to-noise ratio, frequency response, common mode rejection ratio for EEG; perhaps accuracy for pulse oximetry if that was a critical performance characteristic).
- The acceptance criteria for each of these metrics.
- The results of the tests showing that the device met these criteria.
- Details on any clinical studies or usability testing, if performed, including sample size, data provenance, ground truth, and expert involvement.
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Image /page/0/Picture/0 description: This image contains text that appears to be from a document. The text includes the date "AUG 1 3 2002" and "APRIL 29, 2002", as well as a reference number "K 021599". The text also mentions "96 Channel EEG Headbox, PAGE 9 of 26" and "510(K) NOTIFICATION OF A NEW DEVICE", along with the brand name "XLTEK".
Section E -- 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: | Jennifer NgRegulatory Affairs |
|---|---|
| Address: | Excel Tech, Ltd.2568 Bristol CircleOakville, OntarioCanada, L6H 5S1 |
| Telephone: | (905) 829-5300 x244 |
| Fax: | (905) 829-5304 |
| E-mail: | jng@xltck.com |
| Common Names: | 96 Channel EEG Headbox |
| Classification Name: | Electroencephalograph |
| Description: | The 96 Channel EEG Headbox is a digitalelectroencephalograph that can also record pulseoximetry signals. |
| Intended Use: | The 96 Channel EEG Headbox is intended to beused as an electroencephalograph: to acquire,store, and archive electroencephalographicsignals with additional capabilities to recordother physiological signals such as pulseoximetry. |
| Predicate Devices: | Excel tech, Ltd. Neuro Works 128 Channel EEG510(k)# K000919Masimo SET Radical Pulse Oximeter510(k)# K992340 |
| Substantial Equivalence: | The XLTEK 96 Channel EEG Headbox issubstantially equivalent in safety andeffectiveness to the Excel Tech, Ltd.NeuroWorks 128 Channel EEG and the MasimoSET Radical Pulse Oximeter. |
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Image /page/1/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem is a stylized depiction of an eagle with three legs.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. John Mumford President Excel Tech, Ltd. 2568 Bristol Circle Oakville, Ontario Canada. L6H 5S1
- 9 2012
Re: K021599
Trade/Device Name: 96 Channel EEG Headbox, Model EMU96 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWQ, DQA Dated (Date on orig SE Itr): April 29, 2002 Received (Date on orig SE ltr): May 15, 2002
Dear Mr. Mumford:
This letter corrects our substantially equivalent letter of August 13, 2002.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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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): medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Kesia Alexander
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Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat 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 "XLTEK" in a stylized font. Below the logo, the text "510(K) NOTIFICATION OF A NEW DE" is present. The text is in a smaller font size compared to the logo.
96 Channel EEG Headbox, PAGE 8 of 26 APRIL 29, 2002
Section D -- Statement of Indications for Use
Page 1 of 1
510(k) Number (if known):
K 021599
Device Name:
ﻨﻪ ﺗ
96 Channel EEG Headbox
Indications for Use:
The 96 Channel EEG Headbox is intended to be used as an electroencephalograph: to acquire, store, and archive electroencephalographic signals with additional capabilities to record other physiological signals such as pulse oximetry.
(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 Format 1-2-96)
(Division Sign-Off)
Division of General. storative
and Neurological Devices
§ 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).