(318 days)
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Not Found
No
The description focuses on user annotation and visualization, with no mention of automated analysis, AI, or ML terms.
No
The software is used for visualization and reporting of brain activity, aiding in diagnosis, but it does not directly treat or prevent a disease or condition.
Yes
The device is described as "visualization and reporting of the electrical activity of the brain," which directly supports making a diagnosis.
Yes
The description explicitly states "The GridView software" and describes its function as visualization and reporting based on user annotation of images. There is no mention of any hardware component being part of the device itself. While it uses input from MRI and intracerebral electrodes, these are external to the GridView software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- 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.
- Device Function: The GridView software visualizes and reports on the electrical activity of the brain using images (MRI) and superimposed electrode images. It involves user annotation of these images.
- Lack of Biological Sample Analysis: The description does not mention the analysis of any biological samples from the patient. The input is imaging data (MRI) and electrical activity data from electrodes.
Therefore, the GridView software falls under the category of medical devices that process and visualize imaging and electrical data, rather than performing in vitro diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The GridView software is indicated for use by qualified and trained medical personnel for the visualization and reporting of the electrical activity of the brain in adult patients with intracerebral electrodes. This reporting is obtained by user annotation of images of the patient's brain (MRI) on which images of the electrodes are superimposed.
Product codes
OLX, LLZ
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
MRI
Anatomical Site
brain
Indicated Patient Age Range
adult patients
Intended User / Care Setting
qualified and trained medical personnel
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
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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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Excel-Tech, Ltd. c/o Ms. Goldy Singh Director of Quality and Regulatory 2568 Bristol Circle Oakville, Ontario Canada L6H 5S1
Re: K100126
Trade/Device Name: Stellate Gridview Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLX and LLZ Dated: October 29, 2010 Received: November 1, 2010
Dear Ms. Singh:
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.
DEC - 3 2010
1
Page 2 - Ms. Goldy Singh
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,
Ruk. Atteun, m for
Melvin R. Felder, M.D.
Malvina B. Eydelman, M.I Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE STATEMENT
.. . .
DEC - 3 2010
K100126 ______________________________________________________________________________________________________________________________________________________________________ 510(k) Number:
Device Name: Gridview Software
The GridView software is indicated for use by qualified and trained medical personnel for the visualization and reporting of the electrical activity of the brain in adult patients with intracerebral electrodes. This reporting is obtained by user annotation of images of the patient's brain (MRI) on which images of the electrodes are superimposed.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ V (Per 21 CFR 801.109)
OR.
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
KRISTEN BOWSHER
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________