(116 days)
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Not Found
No
The provided text does not mention AI, ML, or related concepts like deep learning or neural networks. The description focuses on recording and stimulating bioelectric signals.
No
The stated intended uses are for assistance during functional neurosurgery, recording/stimulating brain and muscle activity for diagnosis/prognosis, and aiding electrode placement, not for treating a disease or condition.
Yes
The description states the device is intended "to aid the clinician in the diagnosis and prognosis of neuromuscular disease (EMG)."
No
The device description is not available, but the intended use explicitly mentions a "NeuroDrive unit" and the device's function involves recording and stimulating bioelectric signals, which strongly implies the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as assisting neurosurgeons during surgery, recording and stimulating brain and nerve activity, and aiding in electrode placement. It also mentions monitoring muscle and nerve signals for diagnosis and prognosis of neuromuscular disease (EMG) and recording brain electrical activity (EEG). These are all in vivo procedures, meaning they are performed on a living organism.
- 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. The Neuro Omega System does not appear to perform any such tests on bodily samples.
The device is used to directly interact with and measure electrical activity within the patient's body, which is characteristic of an in vivo medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Neuro Omega System, including the NeuroDrive unit, is intended to assist neurosurgeons in the operating room during functional neurosurgery and to record from and stimulate brain motor and sensory neurons and to aid in the placement of depth electrodes.
The Neuro Omega System is also intended to monitor, record and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical activity produced by nerves to aid the clinician in the diagnosis and prognosis of neuromuscular disease (EMG).The device may also be used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head (EEG).
Product codes
GZL, GWF, IKN, GWQ
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
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Anatomical Site
brain motor and sensory neurons (EEG), muscles, peripheral nerves (EMG)
Indicated Patient Age Range
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Intended User / Care Setting
medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional. The device may also be placed in the intensive care unit or operating room for continuous recording.
Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 882.1330 Depth electrode.
(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human services.
April 5,2013
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Alpha Omega Engineering Ltd. c/o Ilan Sharon P.O. Box 4414 (A109) Caesarea. 30889 Israel
Re: K123796
Trade/Device Name: Neuro Omega System Regulation Number: 21 CFR 882.1330 Regulation Name: Depth electrode Regulatory Class: Class II Product Code: GZL, GWF, IKN, GWQ Dated: March 10, 2013 · Received: March 15, 2013
Dear Mr. Sharon:
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.
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
1
Page 2 - Mr. Ilan Sharon
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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address: http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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,
JoyceM.D.Whang
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K123796
Device Name: Neuro Omega System
Indications For Use:
The Neuro Omega System, including the NeuroDrive unit, is intended to assist neurosurgeons in the operating room during functional neurosurgery and to record from and stimulate brain motor and sensory neurons and to aid in the placement of depth electrodes.
The Neuro Omega System is also intended to monitor, record and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical activity produced by nerves to aid the clinician in the diagnosis and prognosis of neuromuscular disease (EMG).The device may also be used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head (EEG).
The device is intended for use by medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional. The device may also be placed in the intensive care unit or operating room for continuous recording.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)