The Neuro Omega system with the incorporated Navigation Tool software (the improved 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 with the incorporated Navigation Tool 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 a seizure disorder.

The Neuro Omega with the incorporated installed Navigation tool software, is intended for intraoperative use by medical personnel. Within hospitals, laboratories, clinics, or nursing home settings or outside of a medical facility under the direct supervision of a medical professional. The device may also be placed in the intensive care unit or operating room for continuous recording.

The NeuroSmart System with the incorporated Navigation Tool software, is intended to be used in assisting neurosurgeons, in the operating room during functional neurosurgery, to record from and stimulate brain motor and sensory neurons and to aid in the placement of depth electrodes.

Device Description

The Neuro Omega system is designed for different neurosurgery and neurophysiologic clinical applications including recording from and stimulating 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 stimulating peripheral nerves to aid in the diagnosis 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 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 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 the treatment of patients with a seizure disorder.

The subject device, the Neuro Omega incorporated the installed Navigation Tool software (the improved HaGuide software) is a real-time software incorporated in electrophysiological recording and stimulating systems (like: Neuro Omega and NeuroSmart systems).

The tool is designed to detect the STN region (improved HaGuide Tool as was cleared under K171581 for Neuro Omega & K172042 for NeuroSmart), it detects the entrance and exit boundaries of STN regions. The tool gives the user a stimulation location recommendation. Furthermore, the tool presents real-time graphs of power spectrum density and RMS of STN region.

The Navigation Tool can aid in the placement of a compatible DBS Lead when the lead is connected to the cleared Alpha Omega Disposable Sterile LeadConfirm (K191739) and to the Neuro Omega System. This feature allows the user to record through the implanted lead and based on the recordings show simple spectral measures (PSD) within the frequency bands of interest. Based on the recordings from the lead, and the NeuroProbe MicroElectrode recordings, this feature shows the correlation in frequency band between both these recordings.

When the subject device, the Neuro Omega incorporated the installed Navigation tool is connected to the internet, the relevant intraoperative data collected during DBS surgery can be uploaded to Alpha Omega's cloud by the physician for Neurologist use. This information will assist the Neurologist in programming of the Implantable Pulse Generator (IPG).

Alpha Omega's NeuroSmart system physiological navigation system is accurate, aiding the neurosurgeons during functional neurosurgery for placing Deep Brain Stimulation (DBS) electrodes.

The NeuroSmart system can record signals from the brain cells or stimulate the brain target zone during the operation procedure.

The subject device, the NeuroSmart incorporated the installed Navigation Tool software improved HaGuide software) is a real-time software incorporated in (the electrophysiological recording and stimulating systems (like: Neuro Omega and Neuro Smart systems).

The tool is designed to detect the STN, it detects the entrance and exit boundaries of STN regions. The tool gives the user a stimulation location recommendation. Furthermore, the tool presents real-time graphs of power spectrum density and RMS of each region.

Based on the recordings from the lead and the NeuroProbe MicroElectrode recordings, this feature shows the correlation in frequency band between both these recordings.

When the subject device, the NeuroSmart incorporated the installed Navigation tool is connected to the internet, the relevant intraoperative data collected during DBS surgery can be uploaded to Alpha Omega's cloud by the physician for Neurologist use. This information will assist the Neurologist in programming the Implantable Pulse Generator (IPG).

The Navigation Tool SW can work in two modes:

1. The Navigation Tool can be installed on the Neuro Omega/ NeuroSmart Systems.
1. The Navigation Tool can work as a standalone software, for that purpose it can be installed on external PC to work in off-line mode.

In both modes the safety and effectiveness of the Neuro Omega and NeuroSmart systems are not compromised, as the Navigation Tool software is a non-blocking software (it doesn't affect the system's functionality even in malfunction). The Navigation Tool software can run in both modes without affecting the Neuro Omega system safety and effectiveness, nor its functionality.

The main use of the Navigation tool SW when it runs as a standalone software, is for visual purpose only, meaning to receive data from the systems and present it in graphs. No changes are made to the retrieved data. Furthermore, the data will be used for verification only for the neurologist prior to fine-tuning the IPG work mode by using the IPG interface (not Alpha Omega's device).

The Navigation Tool provides an option to upload raw data and OR reports to the Alpha Omega server.

. The raw data include the MER .mpx files and the workspace files that were saved during the surgery by the Neuro Omega or NeuroSmart system (if enabled by the user).
The OR report includes all the HaGuide parameters, OR notes, stimulation . assessments, and lead recording.

The Alpha Omega server adheres to industry cybersecurity standards.

The Navigation Tool Software in both its modes, as a standalone software and a software installed on Neuro Omega/NeuroSmart systems, can upload data for storage via secured protocols (FTPS, HTTPS) to Alpha Omega server using the internet connectivity.

Neuro Omega/NeuroSmart software does not upload data to any web server. They are able to connect locally to the Navigation Tool, which is the only channel through which data can be uploaded to Alpha Omega server. The Navigation Tool cannot download or retrieve any data from Alpha Omega server.

AI/ML Overview

The provided text describes the regulatory clearance (K220553) for the "Neuro Omega System" and "NeuroSmart System," both incorporating the "Navigation Tool software." The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices (Neuro Omega system K171581 and NeuroSmart System K172042). The primary changes appear to be software updates (bug fixes and internet connectivity for the Navigation Tool) and the addition of the Navigation Tool software itself.

Here's an analysis of the acceptance criteria and supporting study information based on the provided text:

Key Takeaway: The document describes a substantial equivalence submission, which relies on non-clinical performance testing (software verification, cybersecurity, EMC) to ensure that the modifications do not raise new safety or effectiveness concerns compared to the predicate devices. It does not contain information about clinical studies (e.g., MRMC studies, human reader improvement with AI assistance, standalone performance on a clinical test set).

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided FDA document focuses on engineering and software verification tests rather than clinical performance metrics in terms of diagnostic accuracy or reader improvement. The "acceptance criteria" presented are primarily for technical functionality and regulatory compliance.

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Software/System Verification	Internet Connectivity works according to its intended use without interrupts to the Neuro Omega/NeuroSmart Software incorporated with Navigation Tool software.	All tests passed the acceptance criteria, determining the effectiveness of Neuro Omega/NeuroSmart System with Navigation Tool software.
	Functionality of the GUI of the Navigation Tool Software works according to its intended use.	All tests passed the acceptance criteria.
	Functionality of the NRMS and PSD Graphs of the Navigation Tool Software works according to its intended use.	All tests passed the acceptance criteria.
	Functionality of the HaGuide settings in the Navigation Tool Software works according to its intended use.	All tests passed the acceptance criteria.
	Recommendation window functionality verification of the improved HaGuide feature in the Navigation Tool Software.	All tests passed the acceptance criteria.
	Lead Correlation feature functionality in the Navigation Tool Software (Online Lead Correlation).	All tests regarding the Online Lead Correlation feature passed the acceptance criteria. (Note: Offline lead correlation analysis feature observed as a bug, but noted as not clinically used during surgeries).
	Functionality of the General settings in the Navigation Tool Software works according to its intended use.	All tests passed the acceptance criteria.
Coexistence Testing	The Neuro Omega and NeuroSmart successfully pass the coexistence testing to verify that other devices do not harm the uploading process. The Neuro Omega and NeuroSmart systems operate normally when the connection is down.	All tests passed the acceptance criteria.
Cybersecurity	All security check-ups meet/exceed the requirements for all well-known and established regulatory and compliance standards (based on NIST SP 800-115, OSSTMM, OWASP).	All tests passed the acceptance criteria.
Electromagnetic Compatibility	Neuro Omega PC supplier meets IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic Compatibility.	The Neuro Omega PC passed with no deviation.
	NeuroSmart PC is certified Federal Communications Commission (FCC) according to US CFR Title 47, FCC.	Certified Federal Communications Commission (FCC) NeuroSmart PC with no deviation.
	The Neuro Omega/NeuroSmart fulfill the requirements of IEC 60601-1-2:2014 (fourth edition) for electromagnetic compatibility.	All tests passed the acceptance criteria (Neuro Omega EMC Report E194610.00, Neuro Omega Medical IEC 60601-1-2 2014, NeuroSmart EMC Report E197560.00).

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of clinical data or patient cases. The tests described are non-clinical verification and validation activities conducted on the device hardware and software functionalities. Therefore, sample sizes for such tests would relate to the number of test cases executed rather than patient data. No information is provided regarding the country of origin or whether any data used for internal testing was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device submission focuses on substantial equivalence based on engineering and software performance tests, not on diagnostic accuracy requiring expert ground truth establishment from patient data.

4. Adjudication Method for the Test Set

Not applicable. As described above, the tests are primarily functional and regulatory compliance checks, not clinical studies requiring adjudication of results against a medical ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. The document makes no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The submission is for substantial equivalence of an updated neurophysiological recording and stimulation system with added software functionalities, not for an AI-assisted diagnostic tool designed to improve human reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The "Navigation Tool SW" can work in two modes:

Installed on the Neuro Omega/NeuroSmart Systems.
As a standalone software, installed on an external PC to work in off-line mode for visual purpose only (meaning to receive data from the systems and present it in graphs). No changes are made to the retrieved data. The data will be used for verification only for the neurologist prior to fine-tuning the IPG (Implantable Pulse Generator) work mode by using the IPG interface (not Alpha Omega's device).

While there is a "standalone" mode for the Navigation Tool, it is explicitly stated that its purpose is for "visual purpose only" and data presentation, not for making standalone diagnostic or treatment recommendations, nor does it perform "algorithm only" performance in a clinical diagnostic sense that would require a dedicated standalone performance study. The core function of the Neuro Omega and NeuroSmart systems remains recording and stimulation.

7. The Type of Ground Truth Used

For the non-clinical performance and regulatory compliance tests described, the "ground truth" implicitly refers to:

Pre-defined functional requirements and specifications (for software GUI, graph functionality, settings, etc.).
Industry standards (ISO 13485, ISO 14971, IEC 60601-1-2).
Regulatory guidelines (FDA Guidance for coexistence, NIST SP 800-115, OSSTMM, OWASP for cybersecurity, FCC regulations).

No clinical "ground truth" (e.g., expert consensus, pathology, outcomes data) is mentioned as being used for the evaluation presented in this document.

8. The Sample Size for the Training Set

Not applicable. The document does not describe the development or training of any machine learning or AI models. The Navigation Tool software provides functionalities like detecting STN regions and providing stimulation location recommendations, but the underlying methodology (e.g., rule-based, signal processing, or statistical) and any associated training data are not discussed. The submission focuses on verification of the software's functionality and safety, not on its learning capabilities or dataset-driven performance.

9. How the Ground Truth for the Training Set was Established

Not applicable, as no training set or machine learning/AI model training is described in the provided document.

Summary

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September 16, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Alpha Omega Engineering Ltd. Efrat Shamgar VP Quality & Regulatory Affairs Hamerkava St.6, Tsiporit Industrial Zone Nof HaGalil (Nazareth Illit), 1789062 Israel

Re: K220553

Trade/Device Name: Neuro Omega System, NeuroSmart System Regulation Number: 21 CFR 882.1330 Regulation Name: Depth Electrode Regulatory Class: Class II Product Code: GZL, GWF, IKN, GWQ, GYC Dated: August 12, 2022 Received: August 17, 2022

Dear Efrat Shamgar:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K220553

Device Name

Neuro Omega System and NeuroSmart System

Indications for Use (Describe)

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 a seizure disorder.

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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)

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Image /page/4/Picture/1 description: The image contains the logo for Alpha Omega, a company that defines neuroscience technology. The logo features a stylized letter "A" in maroon and gray, with the company name written in a stylized font to the right. The text "K220553" is located to the left of 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. Registration: 9615126

Submission contact person:

Efrat Shamgar - VP, Quality & Regulatory Affairs Hamerkava St.6, Tsiporit Industrial Zone, P.O. Box 810, Nof HaGalil (Nazareth Illit) 1789062 Israel Tel: +972-4-6563-327 ext.143 Fax: +972-4-6574-075

Date Prepared: September 15, 2022

Device Classification

For Neuro Omega System:
Product Code:	GZL
Subsequent Product Code:	GWF, IKN, GWQ, GYC
CFR section:	21 CFR 882.1330
Subsequent CFR section:	21 CFR 882.1870, 1375, 1400, 1310
Regulation name:	Depth electrode
Subsequent regulation names:	Electroencephalograph, stimulator, electrical, evokedresponse, electromyography, diagnostic, cortical electrode
Trade Name:	Neuro Omega System
Common Name:	Intraoperative neurophysiological recordingand stimulating device
Classification:	Class II

For NeuroSmart System: Product Code: CFR section: Regulation name: Trade Name: Common Name:
Classification:

GZL 21 CFR 882.1330 Depth electrode NeuroSmart System Intraoperative neurophysiological recording and stimulating device Class II

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Image /page/5/Picture/1 description: The image shows the logo for Alpha Omega, a company that defines neuroscience technology. The logo features a stylized letter "A" in red and gray, with the words "ALPHA" and "omega" in red and gray respectively. The text "Defining Neuroscience Technology" is written in a smaller font below the logo. There is also the text "K220553" on the left side of the image.

1 Identification of Legally Marketed Predicate Devices

. Neuro Omega system (as cleared under K171581)
NeuroSmart System (as cleared under K172042) .

Device Description 2

2.1 Neuro Omega

The device is also designed for measuring bioelectric signals produced by muscles and stimulating peripheral nerves to aid in the diagnosis 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 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.

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Image /page/6/Picture/1 description: The image shows the logo for Alpha Omega, a company that defines neuroscience technology. The logo features a stylized letter "A" and the word "ALPHA" in a stylized font. The text "Defining Neuroscience Technology" is written below the logo. The code K220553 is written on the left side of the image.

2.2 NeuroSmart

Alpha Omega's NeuroSmart system physiological navigation system is accurate, aiding the neurosurgeons during functional neurosurgery for placing Deep Brain Stimulation (DBS) electrodes.

The NeuroSmart system can record signals from the brain cells or stimulate the brain target zone during the operation procedure.

Based on the recordings from the lead and the NeuroProbe MicroElectrode recordings, this feature shows the correlation in frequency band between both these recordings.

2.3 Navigation Tool

The Navigation Tool SW can work in two modes:

1. The Navigation Tool can be installed on the Neuro Omega/ NeuroSmart Systems.
1. The Navigation Tool can work as a standalone software, for that purpose it can be installed on external PC to work in off-line mode.

The main use of the Navigation tool SW when it runs as a standalone software, is for

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Image /page/7/Picture/1 description: The image shows the logo for Alpha Omega, a company that defines neuroscience technology. The logo features a stylized letter "A" with a red arch above a gray base. To the right of the "A" is the company name, "ALPHA omega", with the "ALPHA" in red and the "omega" in gray. Below the logo is the tagline "Defining Neuroscience Technology" in black. The text "K220553" is located to the left of the logo.

visual purpose only, meaning to receive data from the systems and present it in graphs. No changes are made to the retrieved data. Furthermore, the data will be used for verification only for the neurologist prior to fine-tuning the IPG work mode by using the IPG interface (not Alpha Omega's device).

The Navigation Tool provides an option to upload raw data and OR reports to the Alpha Omega server.

. The raw data include the MER .mpx files and the workspace files that were saved during the surgery by the Neuro Omega or NeuroSmart system (if enabled by the user).
The OR report includes all the HaGuide parameters, OR notes, stimulation . assessments, and lead recording.

The Alpha Omega server adheres to industry cybersecurity standards.

Intended Use of Device 3

3.1 Neuro Omega

The Neuro Omega System with the incorporated Navigation Tool software (the improved 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 with the incorporated Navigation Tool 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 a seizure disorder. The Neuro Omega with the incorporated installed Navigation tool software, is intended for intraoperative use by medical personnel. Within hospitals, laboratories, clinics, or nursing home settings or outside of a medical facility under the direct supervision of a

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Image /page/8/Picture/1 description: The image shows the logo for Alpha Omega, a company that defines neuroscience technology. The logo features a stylized letter "A" and "O" in a burgundy color, with the rest of the company name in gray. The text "Defining Neuroscience Technology" is written in a smaller font below the logo. The image also contains the text "K220553" on the left side.

medical professional. The device may also be placed in the intensive care unit or operating room for continuous recording.

3.2 NeuroSmart

Comparison to Predicate Device 4

The subject devices, the Neuro Omega/NeuroSmart Systems incorporated the installed Navigation Tool software are substantially equivalent to the predicate devices as claimed in section 1.

The intended use and indications of the proposed Neuro Omega/NeuroSmart Systems are identical to the legally marketed Neuro Omega System (K171581) and to the legally marketed NeuroSmart System (K172042), respectively.

Based on the performance results provided in this submission and the analysis of similarities and differences presented in the Substantial Equivalence Discussion, Alpha Omega Technologies Ltd. believes that the proposed devices are substantially equivalent to the predicate devices without raising new safety and/or effectiveness issues.

Technology Comparison - Neuro Omega System: 4.1

Comparisonparameter	Subject device:Neuro Omega	Predicate device:Neuro Omega	Substantial Equivalencediscussion
LegallydistributionclearanceNo.	Subject device; K220553	K171581
Defining Neuroscience Technology
Comparisonparameter	Subject device:Neuro Omega	Predicate device:Neuro Omega	Substantial Equivalencediscussion
DeviceComponents	Main Unit including MobileRack, Power Supply,Isolation Transformer, PC,Monitor, keyboard, mouse,Speakers, I/O analog/ Digitalunit and Front-End unit.Headstage components:HeadBox, Connection Box.Drive Headstage System,Remote control handpiece,Headstage cables, and single-use electrodes cable.	Main Unit including MobileRack, Power Supply,Isolation Transformer, PC,Monitor, keyboard, mouse,Speakers, I/O analog/ Digitalunit and Front-End unit.Headstage components:HeadBox, Connection Box.Drive Headstage System,Remote control handpiece,Headstage cables, and single-use electrodes cable.	SimilarityIdentical for the subjectdevice and the predicateDifferencesNone
OperatingSystem	Windows 7, 10, 64bit	Same	SimilarityIdentical for the subjectdevice and the predicateDifferencesNone
Computer	Touch screen PC	Touch screen PC	SimilarityIdentical for the subjectdevice and the predicateDifferencesNone
TrolleyConnectors	4 USB ports	4 USB ports	SimilarityIdentical for the subjectdevice and the predicateDifferencesNone
Main Unitsystemconnectors	• Ethernet ports (1 GB)• 1 Remote port (USB)• 2 Audio out (3.5mm stereo)	Same	SimilarityIdentical for the subjectdevice and the predicateDifferencesNone
Communication	Ethernet protocol	Same	SimilarityIdentical for the subjectdevice and the predicateDifferencesNone
Peripherals	Wireless keyboard and mouse	Wireless keyboard and mouse	SimilarityIdentical for the subjectdevice and the predicate.DifferencesNone
Defining Neuroscience Technology
Comparisonparameter	Subject device:Neuro Omega	Predicate device:Neuro Omega	Substantial Equivalencediscussion
Number ofChannels	Up to 10 MER channels (5 Micro and 5 Macro) Up to 112 EEG/EMG/ECOG channels.	Same	SimilarityIdentical for the subject device and the predicateDifferencesNone
Softwareversion	Neuro Omega V1.6.2.1Navigation Tool V4.0.8	Neuro Omega V1.5.1.12	Similarities:Same software modules for supporting the Neuro Omega operation and applicationsDifferences: Bug fixesThe proposed Neuro Omega software supports the connectivity to the Internet Navigation Tool The differences were taken into consideration during the Risk management phase and all identified hazards were addressed to ensure that the Neuro Omega System remains safe and effective

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Image /page/9/Picture/2 description: The image shows the logo for Alpha Omega. The logo features the letters "Alpha" and "Omega" in a stylized font. The "Alpha" is in a dark red color, while the "Omega" is in gray. The logo also includes a red line that runs through the letters, creating a visual effect.

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Image /page/10/Picture/1 description: The image shows the logo for Alpha Omega. The logo features a stylized letter "A" with a curved top and a gray base. To the right of the "A" is the word "omega" in gray, with a stylized line above it that connects to the word "ALPHA" in red. The logo is simple and modern, with a clear emphasis on the company's name.

Technology Comparison – NeuroSmart System:

Comparisonparameter	Subjectdevice:NeuroSmart	Predicatedevice:NeuroSmart	Substantial Equivalencediscussion
LegallydistributionclearanceNo.	Subject device; K220553	K172042

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Image /page/11/Picture/2 description: The image shows the logo for Alpha Omega. The logo features a stylized letter "A" in red with a gray base, followed by the word "omega" in gray. A red line extends from the top of the "A" and curves over the word "omega", adding a dynamic element to the design.

Comparisonparameter	Subjectdevice:NeuroSmart	Predicatedevice:NeuroSmart	Substantial Equivalencediscussion
DeviceComponents	Main Unit including MobileRack, Power Supply, IsolationTransformer, Laptop PC(including Keyboard andScreen), mouse, Speakers andpatient isolated unit (PatientBox).	Main Unit including MobileRack, Power Supply, IsolationTransformer, Laptop PC(including Keyboard andScreen), mouse, Speakers andpatient isolated unit (PatientBox).	SimilarityIdentical for the subjectdevice and the predicate.DifferencesNone
	Patient area components:Remote control hand-piece andsignal cable	Patient area components:Remote control hand-piece andsignal cable
	Headstage components: Driveunit, Headstage recording, andstimulation cable	Headstage components: Driveunit, Headstage recording, andstimulation cable
Softwareversion	NeuroSmart V.1.0.10Navigation Tool V4.0.8	NeuroSmart V-1.0.0	Similarities:Same software modulesfor supporting theNeuroSmart operation andapplicationsDifferences:• The proposedNeuroSmart softwaresupports the connectivityto the Internet• Navigation ToolThe differences were takeninto consideration duringthe Risk management phaseand all identified hazardswere addressed to ensurethat the NeuroSmart Systemremains safe and effective

5 Summary of non-clinical performance tests:

Test Performed	Test Method/ApplicableStandards	Acceptance Criteria	Results
Software /SystemVerification	Internet Connectivity checkuptogether with the NeuroOmega/ NeuroSmart	The internetconnectivity worksaccording to its	All tests passed theacceptance criteria whichdetermines the
Test Performed	Test Method/ApplicableStandards	Acceptance Criteria	Results
*All verification wasmade according to:• ISO13485:2016Medicaldevices-Qualitymanagementsystems -Requirementsfor regulatorypurposes• ISO 14971:2019Medicaldevices -Application ofriskmanagement tomedical devices	intended use withoutany interrupts to theNeuro Omega/NeuroSmart Softwareincorporated withNavigation Toolsoftware (improvedHaGuide Software).	effectiveness of NeuroOmega / NeuroSmartSystem, with NavigationTool software (improvedHaGuide Software).
Navigation Tool Software GUIfunctionality	The functionality ofthe GUI of theNavigation ToolSoftware worksaccording to itsintended use	All tests passed theacceptance criteria
NRMS and PSD Graphsfunctionality check-up of theNavigation Tool Software	The functionality ofthe NRMS and PSDGraphs of theNavigation ToolSoftware worksaccording to itsintended use	All tests passed theacceptance criteria
Check the functionality of theHaGuide settings in theNavigation Tool Software	The functionality ofthe HaGuide settingsin the Navigation ToolSoftware worksaccording to itsintended use	All tests regarding theOnline Lead Correlationfeature passed theacceptance criteria
Recommendation windowfunctionality verification of theimproved HaGuide feature inthe Navigation Tool Software		All tests passed theacceptance criteria
Lead Correlation featurefunctionality in the NavigationTool Software		All tests regarding theOnline Lead Correlationfeature passed theacceptance criteria;Offline lead correlationanalysis feature observedas a bug. But from clinicalpoint of view this offlinefeature isn't used duringsurgeries, it is mostly usedin offline analysis.
General settings functionalityin the Navigation ToolSoftware	The functionality ofthe General settings inthe Navigation ToolSoftware worksaccording to theits intended use	All tests passed theacceptance criteria
Test Performed	Test Method/Applicable Standards	Acceptance Criteria	Results
Coexistence Testing	Coexistence testing according to “Radio Frequency Wireless Technology in Medical Devices Guidance” FDA Guidance issued August 2013	The Neuro Omega and NeuroSmart successfully pass the coexistence testing to verify that other devices do not harm the uploading process. The Neuro Omega and NeuroSmart systems operate as normally when the connection is down.	All tests passed the acceptance criteria
CybersecurityPenetration Testing	Cybersecurity testing – following “Gray box” approach.The tests were performed based on the industry penetration testing approach derived from the National Institute of Standards and Technology (NIST) Special Publication (SP) (“NIST SP 800-115”) – “Technical Guide to information Security Testing and Assessment”, the Open Source Security Testing Methodology Manual (“OSSTMM”) – authored by the institute for Security and Open Methodologies “ISECON”) and the Open Web Application Security Project (“OWASP”) testing methodologies.	All security check-ups meets/exceeds the requirements for all well-known and established regulatory and compliance standards	All tests passed the acceptance criteria
PC Suppliers Reportsfor FCC and EMC	IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic Compatibility and checked that the design output meets the standard requirements, for Neuro Omega supplied PC	The Neuro Omega PC supplier meets IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic Compatibility	The Neuro Omega PC passed with no deviation
Test Performed	Test Method/ApplicableStandards	Acceptance Criteria	Results
	FCC Certificate according tothe US Code of FederalRegulation (CFR) Title 47,FCC for NeuroSmart PC	Certified FederalCommunicationsCommission (FCC)NeuroSmart PC	Certified FederalCommunicationsCommission (FCC)NeuroSmart PC with nodeviation
EMC Reports basedon IEC 60601-1-2	IEC 60601-1-2 Medicalelectrical equipment Part 1-2:General requirements for basicsafety and essentialperformance CollateralStandard: ElectromagneticCompatibility	The Neuro Omega/NeuroSmart fulfill therequirements of IEC60601-1-2:2014(fourth edition)	All tests passed theacceptance criteriaReports:• Neuro Omega EMCReport E194610.00• Neuro OmegaMedical IEC 60601-1-22014• NeuroSmart EMCReport E197560.00

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Image /page/12/Picture/2 description: The image shows the logo for Alpha Omega, a neuroscience technology company. The logo features a stylized letter "A" in red, with a gray omega symbol underneath. The company name "Alpha Omega" is written in a combination of red and gray next to the logo. The tagline "Defining Neuroscience Technology" is written in smaller font below the logo.

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Image /page/13/Picture/2 description: The image shows the logo for Alpha Omega. The logo features a stylized letter "A" in gray with a red arch above it, followed by the word "omega" in gray. Above the word "omega" is the rest of the word "ALPHA" in red. Below the logo is the text "Refining Neuroscience Technology."

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Image /page/14/Picture/1 description: The image shows the text "K220553" on the left side. To the right of the text is a logo for Alpha Omega. The logo consists of a stylized letter "A" inside a circle above a stylized omega symbol, and the words "ALPHA omega" in a stylized font.

6 Conclusions

Based on the results of the testing above, the modified Neuro Omega/ NeuroSmart Systems are substantially equivalent to the legally cleared predicate devices referred to in section 4 of this document.

Regulation Number and Section

§ 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).