(30 days)
Not Found
Yes
The device description explicitly mentions "HaGuide Recommendation: Detection of the Subthalamic Nucleus (STN) borders, including the Intra STN detection of Dorsolateral Oscillatory Region (DLOR) and Ventromedial Non-Oscillatory Region (VMNR) boundary." This type of automated detection and recommendation based on signal processing is indicative of AI/ML technology being used for analysis and interpretation of the MER signals.
Yes.
The device is intended to assist neurosurgeons, monitor/record bioelectric signals from muscles and nerves for diagnosis, measure/record brain electrical activity, and provide stimulation for functional brain mapping, all of which are therapeutic or diagnostic functions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is 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)." This directly indicates a diagnostic purpose. Additionally, it mentions recording and displaying electrical activity of the brain (EEG, ECOG), which can also be used for diagnostic purposes.
No
The device description explicitly states that the HaGuide Software is "incorporated in Neuro Omega/NeuroSmart systems" and mentions the "Drive Headstage unit" as part of the Neuro Omega System. Furthermore, the performance studies include EMC and Safety reports based on IEC 60601-1-2 and IEC 60601-1, which are standards for electrical medical equipment, indicating the presence of hardware components. While the software can be used offline, its primary intended use is integrated with the Neuro Omega/NeuroSmart systems.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The Neuro Omega System and NeuroSmart System, with the HaGuide Software, are described as being used intraoperatively (during surgery) and for monitoring and recording electrical activity within the body (brain, muscles, nerves). They are used to assist neurosurgeons, aid in electrode placement, and diagnose neuromuscular disease by measuring bioelectric signals directly from the patient.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the patient's body. Its function is based on real-time measurement and analysis of electrical signals generated by the patient's nervous and muscular systems.
Therefore, the device's intended use and functionality clearly fall outside the scope of an In Vitro Diagnostic. It is an in-vivo diagnostic and therapeutic device used directly on or within the patient.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The relevant section "Control Plan Authorized (PCCP) and relevant text" is marked as "Not Found."
Intended Use / Indications for Use
Neuro Omega System:
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
Product codes
GZL, GWF, IKN, GWQ, GYC
Device Description
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:
-
- The HaGuide Software can be installed on the Neuro Omega/NeuroSmart PC and used on the system.
-
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
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)
Software / System Verification: This verification performed on the HaGuide Software, and checked that the design output meets the SW design input. This Verification was conducted similar to the reports that were presented in previous submission under K220553. The verification was made according to: ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes and ISO 14971: 2019 Medical devices - Application of risk management to medical devices and IEC 62304:2006/A12015 Medical device software - Software life cycle processes. All tests passed the acceptance criteria.
Penetration Testing: The cybersecurity risk management activities for the Neuro Omega/ NeuroSmart Systems and HaGuide Software, was conducted in compliance with AAMI TIR57 and NIST SP 800-30. The execution of this assessment resulted in a risk analysis, risk evaluation, risk acceptability, and security control implementation/traceability, and a summary of cybersecurity-related labelling. 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 based on IEC 60601-1-2: Alpha Omega conducted EMC tests for the Neuro Omega and NeuroSmart incorporated the HaGuide Software according to 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. All tests passed the acceptance criteria.
Safety Reports based on IEC 60601-1: Alpha Omega conducted Safety tests for the Neuro Omega and NeuroSmart incorporated the HaGuide Software according to IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance and checked that the design output meets the standard requirements. All tests passed the acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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
2
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
3
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, 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
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 Recording |
| and 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
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:
-
- The HaGuide Software can be installed on the Neuro Omega/NeuroSmart PC and used on the system.
-
- 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.
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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
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 sensory neurons and to aid in the placement of depth electrodes.
7
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.
| # | Comparison
parameter | Subject device:
HaGuide Software | Predicate device:
Neuro Omega/NeuroSmart
incorporated with the
HaGuide Software | SE comparison discussion |
|---|---------------------------------------------|-------------------------------------|------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| 1 | Legally
distribution
clearance
No. | Subject device | K220553 | |
| 2 | Owner | Alpha Omega Engineering
Ltd. | Alpha Omega Engineering
Ltd. | |
| 3 | Operating
System | Windows 10,11 64bit | Same | Similarity
Identical for the subject
device and the predicate
Differences
None |
| 4 | Communication
protocols | HTTPS and FTPS secured
protocols | Same | Similarity
Identical for the subject
device and the predicate
Differences
None |
| 5 | Software
version | HaGuide Software V6.0.0 | HaGuide Software
(previously named
Navigation Tool) V4.0.8 | Similarity
The purpose of the
software 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."
| # | Comparison
parameter | Subject device:
HaGuide Software | Predicate device:
Neuro Omega/NeuroSmart
incorporated with the
HaGuide Software | SE comparison discussion |
|---|-------------------------|-------------------------------------|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | the subject device and
the predicate
Differences
new infrastructure and
GUI but the purpose still
the same, also risks and
security aspects, were
taken into consideration
during the Risk
management phase, and
covered all the Hazards. |
Summary of non-clinical performance tests: 5
| Test
Performed | Test Method/Applicable
Standards | Acceptance Criteria | Unexpected
Results/Significant | Results | |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software
/System
Verification | This verification performed
on the HaGuide Software, and checked that the
design output meets the SW design input.
This Verification was
conducted similar to the
reports that were
presented in previous
submission under K220553.
The verification was made
according to:
• ISO 13485:2016
Medical devices –
Quality
management
systems –
Requirements for
regulatory purposes
• ISO 14971: 2019
Medical devices - | 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 | |
| Test
Performed | Test
Standards | Method/Applicable | Acceptance Criteria | Unexpected
Results/Significant | Results |
| | Application of risk
management to
medical devices
• IEC
62304:2006/A12015
Medical device
software - Software
life cycle processes | | | | |
| Penetration
Testing | The cybersecurity risk
management activities for the
Neuro Omega/ NeuroSmart
Systems and HaGuide
Software, was conducted in
compliance with AAMI TIR57
and NIST SP 800-30. The
execution of this assessment
resulted in a risk analysis, risk
evaluation, risk acceptability,
and security control
implementation/traceability,
and a summary of
cybersecurity-related
labelling. | | The identified risks are
determined, than 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
based on IEC
60601-1-2 | Alpha Omega conducted EMC
tests for the Neuro Omega and
NeuroSmart incorporated the
HaGuide Software according
to IEC 60601-1-2 Medical
electrical equipment Part 1-2:
General requirements for | | 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 |
| Test
Performed | Test Method/Applicable
Standards | Acceptance Criteria | Unexpected
Results/Significant | Results | |
| | basic safety and essential
performance Collateral
Standard: Electromagnetic
Compatibility and checked
that the design output meets
the standard requirements | | | | |
| Safety
Reports
based on IEC
60601-1 | Alpha Omega conducted
Safety tests for the Neuro
Omega and NeuroSmart
incorporated the HaGuide
Software according to IEC
60601-1 Medical electrical
equipment Part 1: General
requirements for basic safety
and essential performance
and checked that the design
output meets the standard
requirements | Neuro Omega/NeuroSmart
systems incorporated the
HaGuide Software are safe
and effective and meet the
requirements of IEC 60601-
IEC 60601-1:2005, IEC
60601-1:2005/AMD1:2012,
IEC 60601-
1:2005/AMD2:2020 | -- | All tests passed
the acceptance
criteria | |
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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.