The Neuro Omega System with the incorporated 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 Neuro Omega System with the incorporated 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 a seizure disorder.

The Neuro Omega System with the incorporated installed HaGuide 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.

NeuroSmart System:

The NeuroSmart System with the incorporated HaGuide Software, is intended to be used in assisting neurosurgeons, in the operating room during functional neurosurgery, to record from and stimulate brain motor and to aid in the placement of depth electrodes

Device Description

The cleared devices under K220553, the HaGuide Software incorporated in Neuro Omega/NeuroSmart systems, is designed to detect the STN region, it detects the entrance and exit boundaries of STN regions. Furthermore, it presents real-time graphs of power spectrum density and the normalized root mean square (nRMS) of the region. The HaGuide Software consists of the following components:

Patient Dashboard: The Patient Dashboard is comprised of a list of patients/cases that the user added, providing a user-friendly way to manage the surgery cases.
Planning Setup: The Planning Setup is used by the user to setup the surgery planning.
Trajectory Setup: The Trajectory Setup is used by the user to setup trajectory.
MER/HaGuide: MER/HaGuide is comprised of:
- Real-time Microelectrode Recording (MER) signal processing, presented as o Normalized Root Mean Square (NRMS) and Power Spectrum Density (PSD) graphs, to assist the user to interpret the signals.
- MER notes taking adding notes and tags to specific site location to o document and annotate the signals.
- HaGuide Recommendation: Detection of the Subthalamic Nucleus (STN) o borders, including the Intra STN detection of Dorsolateral Oscillatory Region (DLOR) and Ventromedial Non-Oscillatory Region (VMNR) boundary.
Operation Room Report Upload – Cloud: The OR report uploading feature is used to export the case data and HaGuide graphs and HaGuide recommendation securely to the cloud.
Raw Data Upload – Cloud: The raw data uploading feature is used to upload the raw recording data files securely to the cloud for offline processing

The HaGuide Software can work in three setups:

1. The HaGuide Software can be installed on the Neuro Omega/NeuroSmart PC and used on the system.
1. The HaGuide Software can be installed on an external PC as a standalone software for the purpose of working in off-line mode with no connection to the system.

In all setups the safety and effectiveness of the Neuro Omega/NeuroSmart systems isn't compromised, as the HaGuide Software is a non-blocking software (it doesn't affect the system's functionality even in malfunction). The HaGuide Software can run on both modes without affecting the Neuro Omega/NeuroSmart systems safety and effectiveness, nor its functionality.

AI/ML Overview

The provided text describes the regulatory clearance for the Neuro Omega System and NeuroSmart System, which incorporate the HaGuide Software. It focuses heavily on the software as a standalone component and its integration with the existing systems.

Based on the provided text, the study proving the device meets acceptance criteria is primarily non-clinical performance testing of the HaGuide Software and its integration with the Neuro Omega/NeuroSmart systems, rather than a clinical study evaluating human-in-the-loop performance or diagnostic accuracy with ground truth from clinical data.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed	Acceptance Criteria	Reported Device Performance
Software / System Verification	The acceptance criteria were defined according to the use cases and regressions tests performed by the Neuro Omega / NeuroSmart systems, to ensure proper functionality: - HaGuide SW integration with Alpha Omega cloud is tested. - The verification tests cover the design inputs (SRS) as well as use cases and sanity tests.	All tests passed the acceptance criteria.
Penetration Testing	The identified risks are determined, then the scales are passed in accordance to NIST SP 800-30r1.	Overall cybersecurity risks related to Confidentiality, Integrity, and Availability have been evaluated. This includes risks related to software supply chain. Any risks introduced by risk controls were evaluated and mitigated to an acceptable level.
EMC Reports (IEC 60601-1-2)	The subject devices are safe and effective and meet the requirements of IEC 60601-1-2:2014, IEC 60601-1-2:014/AMD1:2020.	All tests passed the acceptance criteria.
Safety Reports (IEC 60601-1)	Neuro Omega/NeuroSmart systems incorporated the HaGuide Software are safe and effective and meet the requirements of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020.	All tests passed the acceptance criteria.

Note: The provided document describes non-clinical performance tests focused on software verification, cybersecurity, electromagnetic compatibility (EMC), and electrical safety. It does not contain information about clinical performance such as diagnostic accuracy, sensitivity, or specificity in a medical context. The "HaGuide Recommendation" feature for STN border detection is mentioned, but no specific performance metrics or clinical study results for this feature are provided in the excerpt. The submission is framed as a 510(k) for a "new infrastructure and GUI" of the HaGuide software, maintaining the same purpose as the predicate, which implies a focus on demonstrating that the changes do not introduce new safety or effectiveness issues, rather than proving new clinical effectiveness.

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

Test Set Sample Size: Not explicitly stated as a "sample size" in the context of clinical data. The tests performed are engineering-focused:
- Software/System Verification: This involves internal regression tests and testing against "use cases and sanity tests." The number of test cases or specific data points tested is not enumerated.
- Penetration Testing: This involves analyzing and identifying risks, not a numerical "test set" of patient data.
- EMC/Safety Reports: These are engineering compliance tests performed on the physical devices.
Data Provenance: Not applicable in the context of clinical data for these non-clinical performance tests. The document does not describe the use of patient data for testing device performance related to medical diagnosis or treatment. The HaGuide Software's ability to "detect the STN region" and present "real-time graphs of power spectrum density and the normalized root mean square (nRMS)" suggests it processes physiological signals, but how these processed signals were specifically "tested" for accuracy against a clinical ground truth is not detailed in this section. The mention of "Raw Data Upload – Cloud" for "offline processing" suggests data collection, but not its use as a test set for a performance study.

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

Not applicable. The provided document describes non-clinical performance tests, not a clinical study involving human experts establishing ground truth for patient data.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document does not describe an MRMC study or any clinical comparative effectiveness study involving human readers with and without AI assistance. The focus is on the functional verification and safety of the software and system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The HaGuide Software is described as having a "standalone software" mode for "off-line processing" and for "visual purpose only, meaning receive data from the systems and present it in graphs." While it can run in standalone mode, the "performance" described in the acceptance criteria table is for functional verification, cybersecurity, and electrical safety, not for a standalone clinical performance evaluation of its algorithms (e.g., accuracy of STN detection). The document states, "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)." This suggests the software provides information to clinicians, but its algorithmic accuracy in providing medical insights is not the subject of the detailed performance tests presented.

7. The Type of Ground Truth Used

For the reported non-clinical performance tests:

Software/System Verification: Ground truth is established by the defined "design inputs (SRS) as well as use cases and sanity tests." This is based on functional and technical specifications, not clinical outcomes or expert consensus.
Penetration Testing: Ground truth is against cybersecurity best practices and standards (e.g., NIST SP 800-30r1).
EMC/Safety Reports: Ground truth is against established international standards (IEC 60601-1-2 and IEC 60601-1).

No clinical ground truth (e.g., pathology, surgical findings, long-term outcomes, or expert consensus on clinical images/signals) is mentioned as being used for the performance evaluation described.

8. The Sample Size for the Training Set

Not applicable. The document does not describe the use of machine learning or deep learning models that would require a "training set" for the HaGuide Software's core functionality. While the software "detects the STN region," it's not specified if this detection relies on a trained AI model or deterministic algorithms. The "new infrastructure and GUI" suggests software updates rather than new AI model development requiring a training set.

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

Not applicable, as no training set for an AI model is described.

Summary

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March 30, 2025

Image /page/0/Picture/1 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 and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The full name is "U.S. Food & Drug Administration".

Alpha Omega Engineering Ltd. Efrat Shamgar VP Quality & Regulatory Affairs Hamerkava St.6, Tsiporit Industrial Zone P.O. Box 810 Nof HaGalil (Nazareth Illit), 1789062 Israel

Re: K250601

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: February 27, 2025 Received: February 28, 2025

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory

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assistance/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,

Jay R. Gupta -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K250601

Device Name

Neuro Omega System; NeuroSmart System

Indications for Use (Describe)

Neuro Omega System:

The Neuro Omega System with the incorporated 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 a seizure disorder.

NeuroSmart System:

Type of Use (Select one or both, as applicable)

X 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/0 description: The image is a logo for Alpha Omega. The logo features the letters "Alpha" and "Omega" in a stylized font, with the "Alpha" in red and the "Omega" in gray. The logo also includes a tagline that reads "Defining Neuroscience Technology." The logo is likely used to represent a company or organization that is involved in neuroscience technology.

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

Device Classification

Common Name:

Classification:

For Neuro Omega:
Product Code:	GZL
Subsequent Product Code:	GWF, IKN, GWQ, GYC
CFR section:	21 CFR 882.1330
Regulation name:	Depth electrode
Trade Name:	Neuro Omega System
Common Name:	intraoperative neurophysiological Recordingand Stimulating device
Classification:	Class II
For NeuroSmart:
Product Code:	GZL
CFR section:	21 CFR 882.1330
Regulation name:	Depth electrode
Trade Name:	NeuroSmart System

NeuroSmart System intraoperative neurophysiological Recording and Stimulating device Class II

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Image /page/5/Picture/0 description: The image is a logo for Alpha Omega, a neuroscience technology company. The logo features a stylized letter "A" in red, with the word "ALPHA" in red and "omega" in gray. Below the logo is the tagline "Defining Neuroscience Technology" in black. The logo is clean and modern, and the colors are eye-catching.

1 Identification of Legally Marketed Predicate Devices

. Neuro Omega/NeuroSmart systems incorporated with HaGuide Software (as cleared under K220553)

Device Description - HaGuide Software N

Patient Dashboard: The Patient Dashboard is comprised of a list of patients/cases that the user added, providing a user-friendly way to manage the surgery cases.
Planning Setup: The Planning Setup is used by the user to setup the surgery planning.
Trajectory Setup: The Trajectory Setup is used by the user to setup trajectory.
MER/HaGuide: MER/HaGuide is comprised of:
- Real-time Microelectrode Recording (MER) signal processing, presented as o Normalized Root Mean Square (NRMS) and Power Spectrum Density (PSD) graphs, to assist the user to interpret the signals.
- MER notes taking adding notes and tags to specific site location to o document and annotate the signals.
- HaGuide Recommendation: Detection of the Subthalamic Nucleus (STN) o borders, including the Intra STN detection of Dorsolateral Oscillatory Region (DLOR) and Ventromedial Non-Oscillatory Region (VMNR) boundary.
Operation Room Report Upload – Cloud: The OR report uploading feature is used to export the case data and HaGuide graphs and HaGuide recommendation securely to the cloud.
Raw Data Upload – Cloud: The raw data uploading feature is used to upload the raw recording data files securely to the cloud for offline processing

The HaGuide Software can work in three setups:

1. The HaGuide Software can be installed on the Neuro Omega/NeuroSmart PC and used on the system.
1. The HaGuide Software can be installed on an external PC as a standalone software for the purpose of working in off-line mode with no connection to the system.

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Image /page/6/Picture/0 description: The image shows the logo for Alpha Omega, a company that defines neuroscience technology. The logo features a stylized letter "A" in red, with a gray bridge-like structure underneath. To the right of the "A" is the word "omega" in gray, with the "o" slightly overlapping the "A". Below the logo is the tagline "Defining Neuroscience Technology" in a smaller font.

The main use of the HaGuide Software when it runs as a standalone software, is for visual purpose only, meaning 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). In addition, system status and alerts will be uploaded to the cloud to serve AO customer support by monitoring the system status and providing preventive alerts. It is important to note that during the surgery the alerts are gathered and they are uploaded to the cloud as a report after the surgery completion, therefore the case is not interrupted by any mean.

ന Intended Use of Device

This 510(K) submission is focused on the HaGuide Software as standalone software but since the HaGuide serves the Neuro Omega/NeuroSmart systems, the intended use is unified with Neuro Omega/ NeuroSmart intended use.

Neuro Omega 3.1

The Neuro Omega system with the incorporated 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 Neuro Omega System with the incorporated 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 a seizure disorder. The Neuro Omega with the incorporated installed HaGuide 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.

3.2 NeuroSmart

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Image /page/7/Picture/0 description: The image is a logo for Alpha Omega. The logo features the letters "Alpha" and "Omega" in a stylized font, with the "Alpha" in red and the "Omega" in gray. There is a red line above the letters. Below the letters is the phrase "Defining Neuroscience Technology".

4 Comparison to Predicate Device

The subject device, Neuro Omega/NeuroSmart systems incorporated with HaGuide Software, is substantially equivalent to the predicate device HaGuide Software incorporated within the Neuro Omega/NeuroSmart systems and as stand alone, as cleared under (K220553).

The intended use and indications of the proposed HaGuide Software serves the Neuro Omega/NeuroSmart Systems. Therefore, the intended use is unified with Neuro Omega/ NeuroSmart intended use and identical to the legally marketed Neuro Omega/NeuroSmart Systems (K220553).

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.

#	Comparisonparameter	Subject device:HaGuide Software	Predicate device:Neuro Omega/NeuroSmartincorporated with theHaGuide Software	SE comparison discussion
1	LegallydistributionclearanceNo.	Subject device	K220553
2	Owner	Alpha Omega EngineeringLtd.	Alpha Omega EngineeringLtd.
3	OperatingSystem	Windows 10,11 64bit	Same	SimilarityIdentical for the subjectdevice and the predicateDifferencesNone
4	Communicationprotocols	HTTPS and FTPS securedprotocols	Same	SimilarityIdentical for the subjectdevice and the predicateDifferencesNone
5	Softwareversion	HaGuide Software V6.0.0	HaGuide Software(previously namedNavigation Tool) V4.0.8	SimilarityThe purpose of thesoftware is Identical for

4.1 Technology Comparison – HaGuide Software:

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Image /page/8/Picture/0 description: The image is a logo for Alpha Omega. The logo features the letters "Alpha Omega" in a stylized font, with the "Alpha" in red and the "Omega" in gray. There is a tagline below the logo that reads "Defining Neuroscience Technology."

#	Comparisonparameter	Subject device:HaGuide Software	Predicate device:Neuro Omega/NeuroSmartincorporated with theHaGuide Software	SE comparison discussion
				the subject device andthe predicateDifferencesnew infrastructure andGUI but the purpose stillthe same, also risks andsecurity aspects, weretaken into considerationduring the Riskmanagement phase, andcovered all the Hazards.

Summary of non-clinical performance tests: 5

TestPerformed	Test Method/ApplicableStandards	Acceptance Criteria	UnexpectedResults/Significant	Results
Software/SystemVerification	This verification performedon the HaGuide Software, and checked that thedesign output meets the SW design input.This Verification wasconducted similar to thereports that werepresented in previoussubmission under K220553.The verification was madeaccording to:• ISO 13485:2016Medical devices –Qualitymanagementsystems –Requirements forregulatory purposes• ISO 14971: 2019Medical devices -	The acceptance criteriawere defined according tothe use cases andregressions testsperformed by the Neuroomega / NeuroSmartsystems, to ensure properfunctionality:HaGuide SW integrationwith Alpha Omega cloud istested.The verification tests coverthe design inputs (SRS) aswell as use cases and sanitytests.	--	All tests passedthe acceptancecriteria
TestPerformed	TestStandards	Method/Applicable	Acceptance Criteria	UnexpectedResults/Significant	Results
	Application of riskmanagement tomedical devices• IEC62304:2006/A12015Medical devicesoftware - Softwarelife cycle processes
PenetrationTesting	The cybersecurity riskmanagement activities for theNeuro Omega/ NeuroSmartSystems and HaGuideSoftware, was conducted incompliance with AAMI TIR57and NIST SP 800-30. Theexecution of this assessmentresulted in a risk analysis, riskevaluation, risk acceptability,and security controlimplementation/traceability,and a summary ofcybersecurity-relatedlabelling.		The identified risks aredetermined, than the scalesare passed in accordance toNIST SP 800-30r1.	--	Overallcybersecurityrisks related toConfidentiality,Integrity, andAvailability havebeen evaluated.This includesrisks related tosoftware supplychain.Any risksintroduced byrisk controlswere evaluatedand mitigated toan acceptablelevel
EMCReportsbased on IEC60601-1-2	Alpha Omega conducted EMCtests for the Neuro Omega andNeuroSmart incorporated theHaGuide Software accordingto IEC 60601-1-2 Medicalelectrical equipment Part 1-2:General requirements for		the subject devices are safeand effective and meet therequirements of IEC 60601-1-2:2014, IEC 60601-1-2:014/AMD1:2020	--	All tests passedthe acceptancecriteria
TestPerformed	Test Method/ApplicableStandards	Acceptance Criteria	UnexpectedResults/Significant	Results
	basic safety and essentialperformance CollateralStandard: ElectromagneticCompatibility and checkedthat the design output meetsthe standard requirements
SafetyReportsbased on IEC60601-1	Alpha Omega conductedSafety tests for the NeuroOmega and NeuroSmartincorporated the HaGuideSoftware according to IEC60601-1 Medical electricalequipment Part 1: Generalrequirements for basic safetyand essential performanceand checked that the designoutput meets the standardrequirements	Neuro Omega/NeuroSmartsystems incorporated theHaGuide Software are safeand effective and meet therequirements of IEC 60601-IEC 60601-1:2005, IEC60601-1:2005/AMD1:2012,IEC 60601-1:2005/AMD2:2020	--	All tests passedthe acceptancecriteria

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Image /page/9/Picture/0 description: The image shows the logo for Alpha Omega. The logo features a stylized letter "A" with a curved line above it, and the words "ALPHA" and "omega" written in a stylized font. The text "Defining Neuroscience Technology" is written below the logo.

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Image /page/10/Picture/0 description: The image is a logo for Alpha Omega, a company that defines neuroscience technology. The logo features a stylized letter "A" in red, with a gray bridge-like structure underneath. The words "ALPHA" and "omega" are written in a stylized font, with the "ALPHA" in red and the "omega" in gray. Underneath the logo, the words "Defining Neuroscience Technology" are written in a smaller font.

Conclusions б

Based on the above, it is Alpha Omega's opinion that the proposed modified HaGuide Software incorporated within Neuro Omega/ NeuroSmart systems has been compared to the predicates (Neuro Omega/NeuroSmart incorporated with HaGuide Software) in terms of intended use, indications for use, components, principles of operation, technological characteristics, and safety features.

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).