NEURO OMEGA SYSTEM

K123796 · Alpha Omega Engineering , Ltd. · GZL · Apr 5, 2013 · Neurology

Device Facts

• Record ID: K123796
• Device Name: NEURO OMEGA SYSTEM
• Applicant: Alpha Omega Engineering , Ltd.
• Product Code: GZL · Neurology
• Decision Date: Apr 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1330
• Device Class: Class 2

Intended 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.

Device Story

Neuro Omega System assists neurosurgeons during functional neurosurgery; records/stimulates brain motor and sensory neurons; aids depth electrode placement. System monitors, records, and displays bioelectric signals from muscles (EMG) and nerves; measures/records brain electrical activity (EEG). Used in OR, ICU, clinic, or lab by medical personnel. Device transforms electrical inputs from electrodes into visual displays for clinician review. Output aids diagnosis/prognosis of neuromuscular disease and surgical navigation. Benefits include precise electrode placement and real-time physiological monitoring during procedures.

Clinical Evidence

No clinical data provided; device cleared based on substantial equivalence to legally marketed predicate devices.

Technological Characteristics

System includes NeuroDrive unit for signal acquisition and stimulation. Supports EMG and EEG monitoring. Connectivity for continuous recording in clinical settings. Operates as a multi-modal neurophysiological recording and stimulation platform.

Indications for Use

Indicated for patients undergoing functional neurosurgery, requiring brain neuron recording/stimulation, depth electrode placement, or neuromuscular/neurological assessment. Used for EMG (muscle/nerve electrical activity) and EEG (brain electrical activity) monitoring, recording, and display. Intended for use by medical personnel in hospitals, clinics, labs, nursing homes, or under professional supervision.

Regulatory Classification

Identification

A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Joyce M. Whang |
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(Division Sign Off)

Division of Neurological and Physical Medicine

Devices (DNPMD)

| 510(k) Number | K123796 |
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