Who is the manufacturer of Neuro Omega System?

Alpha Omega Engineering , Ltd. filed the 510(k) submission for Neuro Omega System (K171581).

What is the FDA product code for Neuro Omega System?

GZL. It is classified under 21 CFR 882.1330 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Neuro Omega System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Neuro Omega System?

Neuro Omega System (K123796); Nicolet Cortical Stimulator (K072964).

Who can help prepare an FDA 510(k) submission like Neuro Omega System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Neuro Omega System

K171581 · Alpha Omega Engineering , Ltd. · GZL · Dec 22, 2017 · Neurology

Device Facts

Record ID	K171581
Device Name	Neuro Omega System
Applicant	Alpha Omega Engineering , Ltd.
Product Code	GZL · Neurology
Decision Date	Dec 22, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1330
Device Class	Class 2
Attributes	Pediatric

Intended Use

The subject device, the Neuro Omega System incorporated the installed HaGuide software, including the Drive HeadStage 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 subject device, the Neuro Omega System incorporated the installed HaGuide software 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). To measure, record and display the electrical activity of the patient's brain obtained from two or more electrodes on the head (EEG). To measure, display and record the electrical activity of the patient's brain obtained from ECOG strip and grid electrodes. To provide stimulation via electrode pairs or a hand held bipolar probe for use in functional brain mapping procedures during treatment of patients with seizure disorder. The device is intended for intraoperative use by medical personnel. Within hospitals, 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 is an intraoperative neurophysiological recording and stimulation platform. Inputs include bioelectric signals from muscles (EMG), brain (EEG/ECoG), and peripheral nerves via electrodes. The system processes these signals to display real-time data and provide stimulation for functional brain mapping and target localization. The HaGuide software module identifies Subthalamic Nucleus (STN) boundaries (DLOR/VMNR) using power spectrum density and RMS analysis, providing stimulation location recommendations. Operated by neurosurgeons and medical personnel in ORs, ICUs, or clinics. Output assists clinicians in electrode placement and diagnosis of neuromuscular/seizure disorders. Benefits include improved accuracy in target localization for movement disorder surgeries.

Clinical Evidence

Retrospective, multi-center clinical validation study (n=81 patients, 105 surgeries, 213 electrodes) evaluated HaGuide software accuracy in mapping STN boundaries. Primary endpoint: percent agreement between software and expert neurosurgeon/electrophysiologist measurements. Results: 90.34% agreement (95% CI: 85.27-93.85%). Correlation coefficients for entry/exit depth were 0.9492 and 0.9317. Bland-Altman analysis showed mean differences of 0.18 mm and -0.15 mm. No adverse events reported.

Technological Characteristics

System comprises main unit (PC, monitor, I/O analog/digital unit), HeadStage (Head Box, connection box, Drive HeadStage), and accessories. Connectivity via Ethernet. Electrical safety per IEC 60601-1, 60601-2-10, 60601-2-26, 60601-2-40. Sterilization via steam (mechanical) and STERRAD (electrical). Software developed per ISO 62304. Class I electrical, Type BF protective.

Indications for Use

Indicated for adults and children requiring functional neurosurgery, neuromuscular disease diagnosis (EMG), EEG monitoring, ECoG recording, or functional brain mapping for seizure disorders. Used for recording/stimulating brain motor/sensory neurons, peripheral nerve stimulation, and depth electrode placement.

Regulatory Classification

Identification

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

Predicate Devices

Neuro Omega System (K123796)
Nicolet Cortical Stimulator (K072964)

Related Devices

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K172042 — NeuroNav System, NeuroSmart System · Alpha Omega Engineering , Ltd. · Feb 27, 2018
K183123 — microTargeting Guideline 4000 5.0 System · FHC, Inc. · Dec 20, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration" in a sans-serif font. The word "Administration" is on a separate line below "U.S. Food & Drug". December 22, 2017 Alpha Omega Engineering Ltd, Maysana Mousa QA/RA Manager Nazareth Industrial Park, Mount Precipice, St.2015 Nazareth, 1612102 IL ## Re: K171581 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, GYC Dated: November 13, 2017 Received: November 20, 2017 Dear Ms. Mousa: 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, William J. Heetderks -S 2017.12.22 14:03:23 -05'00' for Carlos L. Peña, PhD, MS 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) K171581 Device Name Neuro Omega System #### Indications for Use (Describe) The subject device, the Neuro Omega System incorporated the installed HaGuide software, including the Drive HeadStage 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 subject device, the Neuro Omega System incorporated the installed HaGuide software 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 of neuromuscular disease (EMG). -To measure, record and display the electrical activity of the patient's brain obtained from two or more electrodes on the head (EEG). -To measure, display and record the electrical activity of the patient's brain obtained from ECOG strip and grid electrodes. -To provide stimulation via electrode pairs or a hand held bipolar probe for use in functional brain mapping procedures during treatment of patients with seizure disorder. The device is intended for intraoperative use by medical personnel. Within hospitals, 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. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | |-----------------------------------------------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image is a logo for Alpha Omega. The logo features a stylized letter "A" in maroon, with a gray omega symbol underneath. The words "ALPHA" in maroon and "omega" in gray are to the right of the symbols. The tagline "Defining Neuroscience Technology" is in maroon below the logo. # 510(k) Summary This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.92 ## Submitter Information Alpha Omega Engineering Ltd. Mount Precipice 2015 P.O. Box 2268 Nazareth 1612102, Israel Tel:+972-4-6563-327 Fax:+972-4-6574-075 ### Submission contact person: Mrs. Maysana Mousa Tel:+972-4-6563-327 Fax:+972-4-6574-075 Mobile: +972-54-9043303 ### Device Classification | Proprietary Device Name: Common name: | Neuro Omega System Intraoperative neurophysiological recording and stimulating device | | | |----------------------------------------------------------------|---------------------------------------------------------------------------------------------|-----------------------|--------------------------------------| | Product Code: | GZL | | | | Subsequent Product Code: | GWF, IKN, GWQ, GYC | | | | Classification Name: | Depth Electrode | | | | Subsequent Classification names: | Electroencephalograph, electrical, electromyograph, electrode | evoked diagnostic, | stimulator, response, cortical | | Classification Regulation: Regulatory Class: | 21 CFR §882.1330 II | | | | Identification of Legally Marketed Predicate Devices | | | | | Neuro Omega System - For cortical recording and stimulation | | K123796 | | | Nicolet Cortical Stimulator - | | K072964 | | Page 1 of 18 {4}------------------------------------------------ ## 1. Device Description The Neuro Omega system is designed for different neurosurgery and neurophysiologic clinical applications including recording from and stimulate brain motor and sensory neurons to accurate navigation of electrodes for neurosurgery target localization in treatment of movement disorders by and to aid in the placement of depth electrodes. The device is also designed for measuring bioelectric signals produced by muscles and stimulate peripheral nerves to aid 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 subject device, the Neuro Omega System may also be used to measure, display and record the electrical activity of the patient's brain obtained from ECOG strip and grid electrodes. The subject device, the Neuro Omega System may also be used to provide stimulation via electrode pairs or a hand held bipolar probe for use in functional brain mapping procedures during treatment of patients with seizure disorder. The subject device, the Neuro Omega System incorporated the installed HaGuide software as a user option tool, which is a real-time software solution designed to accurately detects the Sub Thalamic Nucleus region, its entrance and exit boundaries as well gives the user a stimulation location recommendation. The HaGuide software robustly detects intra STN detection of Dorso lateral Oscillatory Region (DLOR) and Ventro Medical Non-Oscillatory Region (VMNR) boundary. The tool presents real time graphs of power spectrum density and RMS of each region. # 2. Intended Use of Device The subject device, the Neuro Omega System incorporated the installed HaGuide software, including the Drive HeadStage 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 subject device, the Neuro Omega System incorporated the installed HaGuide software 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). To measure, record and display the electrical activity of the patient's brain obtained from two or more electrodes on the head (EEG). To measure, display and record the electrical activity of the patient's brain obtained from ECOG strip and grid electrodes. To provide stimulation via electrode pairs or a hand held bipolar probe for use in functional brain mapping procedures during treatment of patients with seizure disorder. The device is intended for intraoperative use by medical personnel. Within hospitals, 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. {5}------------------------------------------------ ## 3. Safety & Effectiveness The Neuro Omega System has been compared to the New Omega System (K123796), in terms of intended use, indications for use, components, principles of operation, technological characteristics and safety features. | # | Compariso n parameter | Subject device: Neuro Omega | Primary Predicate device: Neuro Omega | Reference device for cortical recording and stimulation: Nicolet Cortical Stimulator | SE comparison discussion | |---|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | Legally distribution clearance No. | Subject device | K123796 | K072964 | | | 2 | Owner | Alpha Omega Engineering Ltd. | Alpha Omega Engineering Ltd. | Cardinal Health, Inc | | | 3 | Intended use and indications for use. | The subject device, the Neuro Omega System incorporated the installed HaGuide software, including the Drive HeadStage 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 subject device, the Neuro Omega System incorporated | 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 | The Cortical Stimulator is intended for use in functional brain mapping procedures during treatment of patients with seizure disorder, providing stimulation via electrode pairs or a hand held bipolar probe | Similarity The intended use and indications of the modified Neuro Omega is identical to the intended use and indications of the legally marketed Neuro Omega and the Nicolet Cortical Stimulator predicate Devices. Differences The intended use and indications of the modified | | # | Comparison parameter | Subject device: Neuro Omega | Primary Predicate device: Neuro Omega | Reference device for cortical recording and stimulation: Nicolet Cortical Stimulator | SE comparison discussion | | | | the installed HaGuide software 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). To measure, record and display the electrical activity of the patient's brain obtained from two or more electrodes on the head (EEG). To measure, display and record the electrical activity of the patient's brain obtained from ECOG strip and grid electrodes. To provide stimulation via electrode pairs or a hand held bipolar probe for use in functional brain mapping procedures during treatment of patients with seizure disorder. The device is intended for | 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. | | Neuro Omega combines the intended use and indications of the predicate and reference devices. | | # | Comparison parameter | Subject device: Neuro Omega | Primary Predicate device: Neuro Omega | Reference device for cortical recording and stimulation: Nicolet Cortical Stimulator | SE comparison discussion | | | | intraoperative use by medical personnel. Within hospitals, 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. The device is intended for intraoperative use by medical personnel. Within hospitals, 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. | | | | | 4 | Device code and regulation | Product Code: GZL Regulation #: 21CFR882.1330 Subsequent Product Code: GWF, IKN, GWQ, GYC Subsequent Regulation #: 21CFR882.1870, 21CFR | Product Code: GZL Regulation #: 21CFR882.1330 Subsequent Product Code: GWF, IKN, GWQ Subsequent Regulation #: 21CFR882.1870, 21CFR | Product Code: GYC Regulation #: 21CFR882.1310 | Similarity The device code and regulation number of the modified Neuro Omega are identical to the intended use and indications of the legally marketed Neuro | | # | Compariso n parameter | Subject device: Neuro Omega | Primary Predicate device: Neuro Omega | Reference device for cortical recording and stimulation: Nicolet Cortical Stimulator | SE comparison discussion | | | | 890.1375, 21CFR882.1400, 21CFR882.1310 | 890.1375, 21CFR882.1400 | | Omega and the Nicolet Cortical Stimulator Predicate Devices. Differences The device code and regulation number of the modified Neuro Omega combines the device code and regulation number of the predicate and reference devices. Additionally, the modified Neuro Omega does not include the ETN device code | ## • Intended Use Comparison {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ # • Performance Comparison | # | Comparison parameter | Proposed device: Neuro Omega | Primary Predicate device: Neuro Omega | Reference device: Nicolet Cortical Stimulator | SE comparison discussion | |-----|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | Legally distribution clearance No. | Subject device | K123796 | K072964 | | | 2 | Owner | Alpha Omega Engineering Ltd. | Alpha Omega Engineering Ltd. | Cardinal Health, Inc | | | 3 | Body Areas | Deep brain, cranial surface, intracranial cortex and body | Deep brain, cranial surface and body limbs | Intracranial brain cortex | Similarity Identical for Neuro Omega | | # | Comparison parameter | Proposed device: Neuro Omega | Primary Predicate device: Neuro Omega | Reference device: Nicolet Cortical Stimulator | SE comparison discussion | | | | limbs | | | modified and unmodified devices Differences In addition to deep brain, cranial surface and body limbs, the modified Neuro Omega may be used mapping the brain by stimulation of the cortical surface, which is equivalent to both predicate and reference devices. | | 4 | Target population | Adults and children | Adults and children | Adults and children | Similarity Identical. Differences None | | 5 | Users | Neurosurgeon, Neurosurgery staff and professional medical personnel. | Neurosurgeon, Neurosurgery staff and professional medical personnel. | Qualified medical personnel | Similarity Identical for Neuro Omega modified and unmodified devices Differences Subject device is equivalent to primary predicate device, Nicolet Cortical Stimulator can be used by qualified medical personnel | | 6 | Use | Within hospitals, laboratory, | Within hospitals, laboratory, | Within a hospital or | Similarity | | # | Comparison parameter | Proposed device: Neuro Omega | Primary Predicate device: Neuro Omega | Reference device: Nicolet Cortical Stimulator | SE comparison discussion | | | environment | 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 | 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 | clinical environment. | Identical. Differences Subject device is equivalent to primary predicate device, Nicolet Cortical Stimulator can be used within a hospital or clinical environment. | | 7 | Usability and Human Factors | ISO 62366, IEC 60601-1-6 and FDA draft guidance UCM259760 June 2011 | ISO 62366, IEC 60601-1-6 and FDA draft guidance UCM259760 June 2011 | Unknown | Similarity Identical for Neuro Omega modified and unmodified devices Differences None | | 8 | AC Power Supply | 100-120 V AC,220-240V AC 50/ 60 Hz | 100-120 V AC,220-240V AC 50/ 60 Hz | 100-120 V AC,220-240V AC 50/ 60 Hz | Similarity Identical. Differences None | | 9 | Software applications | GUI, Monitoring, display, Audio, signal processing, Recording, Stimulation control, identify number of channels connected. | GUI, Monitoring, display, Audio, signal processing, Recording, Stimulation control, identify number of channels connected. | GUI, display, signal processing and Stimulation control | Similarity Identical. Differences None | | 10. | Electrical Safety | IEC 60601-1 3rd ED + Risk analysis (ISO 14971) | IEC 60601-1 + Risk analysis (ISO 14971) | IEC 60601-1 | Similarity Tested for same or more resent safety standards Differences | | # | Comparison parameter | Proposed device: Neuro Omega | Primary Predicate device: Neuro Omega | Reference device: Nicolet Cortical Stimulator | SE comparison discussion | | 11 | Particular safety | IEC 60601-2-10, IEC 60601-2-26, IEC 60601-2-40 + Risk analysis (ISO 14971) | IEC 60601-2-10, IEC 60601-2-26, IEC 60601-2-40 + Risk analysis (ISO 14971) | IEC 60601-1, IEC 60601-2-26 | None Similarity Identical. Differences None | | 12 | Electromagnetic Compatibility | IEC 60601-1-2 + Risk analysis (ISO 14971) | IEC 60601-1-2 + Risk analysis (ISO 14971) | IEC 60601-1-2 | Similarity Identical. Differences None | | 13 | Sterility and Sterility standards | Sterility of the reusable components is performed by the hospital clinical staff and was validated to comply with the following standards: ISO 17665-1, ST81 and STERRAD | Sterility of the reusable components is performed by the hospital clinical staff and was validated to comply with the following standards: ISO 11135, ISO 10993-7, ST77, ST81, ST67 | Not relevant for the ECoG. | Similarity Identical for Neuro Omega modified and unmodified devices Differences For the modified Neuro Omega system only STERRAD sterilization is allowed for HeadStage electronic components, while in the legally cleared device ETO and STERRAD were allowed. | | 14 | Software development standard | ISO 62304 | ISO 62304 | Not relevant for the ECoG. | Similarity Identical for Neuro Omega modified and unmodified | | # | Comparison parameter | Proposed device: Neuro Omega | Primary Predicate device: Neuro Omega | Reference device: Nicolet Cortical Stimulator | SE comparison discussion | | | | | | | devices Differences None | | 15 | Electrical Class | I | I | Not relevant for the ECoG. | Similarity Identical for Neuro Omega modified and unmodified devices Differences None | | 16 | Protective Type | BF | BF | BF | Similarity Identical Differences None | | # | Compariso n parameter | Proposed device: Neuro Omega | Primary Predicate device: Neuro Omega | Reference device: Nicolet Cortical Stimulator | SE comparison discussion | | 1 | Legally distributio n clearance No. | Subject device | K123796 | K072964 | | | 2 | Owner | Alpha Omega Engineering Ltd. | Alpha Omega Engineering Ltd. | Cardinal Health, Inc | | | 3 | Device Components | Main Unit including: Mobile Rack, Power Supply, Isolation Transformer, PC, Monitor, keyboard, mouse, Speakers, I/O analog/ Digital unit and Front End unit. Head Stage components: Head Box, Connection Box. Drive HeadStage System, Remote control handpiece, Head stage cables, and single use electrodes cable. | Main Unit including: Mobile Trolley, Power Supply, Isolation Transformer, Panel PC, Monitor, keyboard, mouse, Speakers and Front End unit. Head Stage components: Head Box module, NeuroDrive System, Remote control handpiece, Head stage recording cable, Head stage cables and single use electrodes cable. | Hand-held unit including; display, power supply and control knob | Similarity Identical for Neuro Omega modified and unmodified devices Differences None | | 4 | Operating System | Windows 7, 64bit | Same | Not relevant for the ECoG HeadBox. | Similarity Identical for Neuro Omega modified and unmodified devices Differences None | | 5 | Computer | Touch screen PC | Industrial PC | Not relevant for the ECoG | Similarity | | # | Comparison parameter | Proposed device: Neuro Omega | Primary Predicate device: Neuro Omega | Reference device: Nicolet Cortical Stimulator | SE comparison discussion | | 6 | Trolley Connectors | 4 USB ports | 4 USB ports | Not relevant | Similarity Identical for Neuro Omega modified and unmodified devices Differences None | | 7 | Main Unit system connectors | •Ethernet ports •1 Remote port •2 Audio out | Same | Not relevant | Similarity Identical for Neuro Omega modified and unmodified devices Differences None | | 8 | Communicati on | Ethernet protocol | Same | Not relevant | Similarity Identical for Neuro Omega modified and unmodified devices Differences None | | # | Compariso n parameter | Proposed device: Neuro Omega | Primary Predicate device: Neuro Omega…