(28 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description is limited to basic EEG functionality.
No
The device is an electroencephalograph used to acquire, store, and archive EEG signals. It is a diagnostic device, not a therapeutic one.
No
The device is used to acquire, store, and archive signals, but it does not state that it analyzes or interprets these signals for diagnostic purposes. Its intended use is described as an electroencephalograph, which is a recording device.
No
The device is described as a "digital electroencephalograph," which is a hardware device used to acquire EEG signals. While it likely includes software for signal processing and storage, the primary description points to a hardware component.
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, store, and archive electroencephalographic signals." This describes a device that measures electrical activity in the brain, which is a physiological signal from the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Lack of IVD Characteristics: The description does not mention analyzing samples from the body, detecting specific substances, or providing diagnostic information based on laboratory analysis.
The EMU128S is an electroencephalograph, which is a medical device used for measuring and recording electrical activity in the brain. This falls under the category of in vivo (within the living body) diagnostic or monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The EMU128S is intended to be used as an electroencephalograph: to acquire, store, and archive electroencephalographic signals.
Product codes (comma separated list FDA assigned to the subject device)
GWQ, GYC
Device Description
The EMU128S 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.
Excel Tech Ltd. - 128 Channel EEG Headbox
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 the date March 12, 2004, along with the company name XLLTEK. Below the company name, the text "SPECIAL 510(K) NOTIFICATION OF A NEW DEVICE" is written. The image also contains some text on the right side, but it is not fully legible.
K040360 Special 510(k) EMU128S March 8 2004 PAGE _________________________________________________________________________________________________________________________________________________________________________
Appendix C - 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 of Customer Satisfaction |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Excel Tech, Ltd.
2568 Bristol Circle
Oakville, Ontario
Canada, L6H 5S1 |
| Telephone: | (905) 829-5300 |
| Fax: | (905) 829-5304 |
| E-mail: | cmahon@xltek.com |
| Common Names: | EMU128S,
EMU128 Switch Matrix,
128 Channel EEG Headbox |
| Classification Name: | Electroencephalograph |
| Predicate Devices: | Excel Tech Ltd. - 128 Channel EEG Headbox |
| Description: | The EMU128S is a digital
electroencephalograph. |
| Substantial Equivalence: | The EMU128S is substantially equivalent in
safety and effectiveness to the XLTEK 128
Channel EEG Headbox. There is no change to
the acquisition, display, storage, or archiving of
the EEG data. The change is the addition of a
switch matrix. This switch matrix is an array of
relays used to facilitate external devices
attachments to the wires that contact the patient. |
| Indications for Use: | The EMU128S is intended to be used as an
electroencephalograph: to acquire, store, and
archive electroencephalographic signals. |
1
ここに
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Excel-Tech Ltd. c/o Mr. Cameron Mahon 2568 Bristol Circle Oakville, L6H5S1 Canada
Re: K040360
Trade/Device Name: EMU128S Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWQ, GYC Dated (Date on orig SE 1tr): January 30, 2004 Received (Date on orig SE ltr): February 13, 2004 APR
Dear Mr. Mahon:
This letter corrects our substantially equivalent letter of March 12, 2004.
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.
Image /page/1/Picture/11 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is facing to the right.
2
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 (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/CDRH/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
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
ir
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: EMU128S
Indications For Use:
The EMU128S is intended to be used as an electroencephalograph: to acquire, store, and archive electroencephalographic signals.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
K040360 510(k) Number_