Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes signal processing and analysis (detecting boundaries, calculating PSD and RMS, showing correlations) but does not mention the use of AI or ML algorithms for these tasks or for generating recommendations.

Therapeutic

Yes

The device is intended to assist neurosurgeons, record from and stimulate neurons, aid in electrode placement, monitor bioelectric signals, and provide stimulation for functional brain mapping during treatment of seizure disorders, all of which fall under therapeutic applications.

Diagnostic

Yes

The intended use explicitly states, "To monitor, record, and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor, record, and display the electrical activity produced by nerves to aid the clinician in the diagnosis and prognosis of neuromuscular disease (EMG)." The device also measures and records EEG and ECOG, which are diagnostic procedures.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the "Neuro Omega system with the incorporated Navigation Tool software (the improved HaGuide software), including the Drive Headstage unit" is the subject device. It also describes the Neuro Omega and NeuroSmart systems as electrophysiological recording and stimulating systems, which are hardware components. While the Navigation Tool software can function standalone, the overall device being cleared is a system that includes hardware.

IVD (In Vitro Diagnostic)

Based on the provided text, the Neuro Omega system with the incorporated Navigation Tool software is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly describes the device as being used in the operating room during functional neurosurgery, to record and stimulate brain neurons, aid in electrode placement, monitor and record bioelectric signals from muscles and nerves (EMG), measure and record brain electrical activity (EEG and ECOG), and provide stimulation for functional brain mapping. These are all procedures performed on the patient, not on samples taken from the patient.
Device Description: The description reinforces the intended use, detailing how the device interacts with the patient's body (recording from and stimulating brain cells, measuring muscle and nerve signals, etc.).
Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Neuro Omega system does not perform these functions. It directly interacts with the patient's physiological signals.

Therefore, the Neuro Omega system is a medical device used for physiological monitoring, recording, and stimulation during surgical and clinical procedures, but it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

GZL, GWF, IKN, GWQ, GYC

Device Description

Neuro Omega

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).

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.

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.

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 NeuroSmart System. This feature will allow 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 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).

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Brain, muscles, peripheral nerves

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Summary of non-clinical performance tests:

Test Performed: Software /System Verification

Test Method/Applicable Standards: Internet Connectivity checkup together with the Neuro Omega/ NeuroSmart
Acceptance Criteria: The internet connectivity works according to its intended use without any interrupts to the Neuro Omega/NeuroSmart Software incorporated with Navigation Tool software (improved HaGuide Software).
Results: All tests passed the acceptance criteria which determines the effectiveness of Neuro Omega / NeuroSmart System, with Navigation Tool software (improved HaGuide Software).

Test Performed: Navigation Tool Software GUI functionality

Test Method/Applicable Standards: The functionality of the GUI of the Navigation Tool Software works according to its intended use
Acceptance Criteria: All tests passed the acceptance criteria
Results: All tests passed the acceptance criteria which determines the effectiveness of Neuro Omega / NeuroSmart System, with Navigation Tool software (improved HaGuide Software).

Test Performed: NRMS and PSD Graphs functionality check-up of the Navigation Tool Software

Test Method/Applicable Standards: The functionality of the NRMS and PSD Graphs of the Navigation Tool Software works according to its intended use
Acceptance Criteria: All tests passed the acceptance criteria
Results: All tests passed the acceptance criteria which determines the effectiveness of Neuro Omega / NeuroSmart System, with Navigation Tool software (improved HaGuide Software).

Test Performed: Check the functionality of the HaGuide settings in the Navigation Tool Software

Test Method/Applicable Standards: The functionality of the HaGuide settings in the Navigation Tool Software works according to its intended use
Acceptance Criteria: All tests regarding the Online Lead Correlation feature passed the acceptance criteria
Results: All tests passed the acceptance criteria which determines the effectiveness of Neuro Omega / NeuroSmart System, with Navigation Tool software (improved HaGuide Software).

Test Performed: Recommendation window functionality verification of the improved HaGuide feature in the Navigation Tool Software

Acceptance Criteria: All tests passed the acceptance criteria
Results: All tests passed the acceptance criteria which determines the effectiveness of Neuro Omega / NeuroSmart System, with Navigation Tool software (improved HaGuide Software).

Test Performed: Lead Correlation feature functionality in the Navigation Tool Software

Acceptance Criteria: All tests regarding the Online Lead Correlation feature passed the acceptance criteria; Offline lead correlation analysis feature observed as a bug. But from clinical point of view this offline feature isn't used during surgeries, it is mostly used in offline analysis.
Results: All tests passed the acceptance criteria which determines the effectiveness of Neuro Omega / NeuroSmart System, with Navigation Tool software (improved HaGuide Software).

Test Performed: General settings functionality in the Navigation Tool Software

Test Method/Applicable Standards: The functionality of the General settings in the Navigation Tool Software works according to the its intended use
Acceptance Criteria: All tests passed the acceptance criteria
Results: All tests passed the acceptance criteria which determines the effectiveness of Neuro Omega / NeuroSmart System, with Navigation Tool software (improved HaGuide Software).

Test Performed: Coexistence Testing

Test Method/Applicable Standards: Coexistence testing according to “Radio Frequency Wireless Technology in Medical Devices Guidance” FDA Guidance issued August 2013
Acceptance Criteria: 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.
Results: All tests passed the acceptance criteria

Test Performed: Cybersecurity Penetration Testing

Test Method/Applicable Standards: 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.
Acceptance Criteria: All security check-ups meets/exceeds the requirements for all well-known and established regulatory and compliance standards
Results: All tests passed the acceptance criteria

Test Performed: PC Suppliers Reports for FCC and EMC

Test Method/Applicable Standards: 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
Acceptance Criteria: 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
Results: The Neuro Omega PC passed with no deviation

Test Performed: PC Suppliers Reports for FCC and EMC

Test Method/Applicable Standards: FCC Certificate according to the US Code of Federal Regulation (CFR) Title 47, FCC for NeuroSmart PC
Acceptance Criteria: Certified Federal Communications Commission (FCC) NeuroSmart PC
Results: Certified Federal Communications Commission (FCC) NeuroSmart PC with no deviation

Test Performed: EMC Reports based on IEC 60601-1-2

Test Method/Applicable Standards: IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic Compatibility
Acceptance Criteria: The Neuro Omega/NeuroSmart fulfill the requirements of IEC 60601-1-2:2014 (fourth edition)
Results: All tests passed the acceptance criteria

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K171581, K172042

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

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

1

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

2

Indications for Use

510(k) Number (if known) K220553

Device Name

Neuro Omega System and NeuroSmart System

Indications for Use (Describe)

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.

3

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.

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

Paperwork Reduction //
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."

4

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, evoked
response, electromyography, diagnostic, cortical electrode
Trade Name:	Neuro Omega System
Common Name:	Intraoperative neurophysiological recording
and 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

5

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