(41 days)
Not Found
Not Found
No
The provided 510(k) summary does not contain any keywords or descriptions related to AI, ML, image processing, training sets, test sets, or performance metrics typically associated with AI/ML devices.
No
The device is used for monitoring and assessment, not for treating a condition, disease, or injury.
Yes
The device is described as "assessing a patient's neurological status," which indicates it is used to identify or determine a patient's condition, a key function of a diagnostic device.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only or includes hardware components. Without this information, it's impossible to definitively classify the device.
Based on the provided information, the EP-16 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the EP-16 is for "neurological monitoring and assessment" in the operating room and critical care areas. This involves monitoring the patient's neurological status directly within the body or by measuring physiological signals from the body.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. The description of the EP-16's use does not involve the analysis of such specimens.
Therefore, the EP-16 falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EP-16 is intended for use in the operating room and critical care areas for neurological monitoring The LF-10 is thended for use in the operating room and EMG techniques to provide the and assessment. The instrument assess a patient's neurological status during surgery of long term monitoring in the ICU.
Product codes
GWF, GWQ, GWJ, GWE
Device Description
Not Found
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
operating room and critical care areas
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.
Not Found
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
Not Found
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized symbol resembling a bird or abstract human figure, with flowing lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. John R. Mumford President Excel Tech, Ltd. 2568 Bristol Circle Oakville, Ontario Canada L61-51S I
APR - 9 2012
Re: K992313
Trade/Device Name: XLTEK EP-16 Evoked Potential Headbox Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: II Product Code: GWF, GWQ, GWJ, GWE Dated (Date on orig SE ltr): June 30, 1999 Received (Date on orig SE ltr): July 9, 1999
Dear Mr. Mumford:
This letter corrects our substantially equivalent letter of August 19, 1999.
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour 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/Resourcesfor You/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
Enclosure
2
EXCEL TECH, LTD. 510(K) NOTIFICATION OF A NEW DEVICE : 2015) "XLTEK EP-16 Evoked Potential Device"
ATTACHMENT # 1
STATEMENT OF INDICATIONS FOR USE
Page 1 of 1
510(k) Number ( if known ) :
Device Name : XLTek EP-16 Evoked Potential Headbox Indications for Use :
The EP-16 is intended for use in the operating room and critical care areas for neurological monitoring The LF-10 is thended for use in the operating room and EMG techniques to provide the and assessment. The instrument assess a patient's neurological status during surgery of long term monitoring in the ICU.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Russell S. Vaysor Sr., J20
sion of General 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use _
(Optional Format 1-2-96)