(236 days)
Not Found
Unknown
While the HaGuide software performs complex analysis (detecting boundaries, recommending locations) and was validated against expert measurements, the summary does not explicitly mention the use of AI, ML, DNN, or describe a training set in a way that confirms an AI/ML approach. The description of the software's function could potentially be achieved through other algorithmic methods.
No
The device is intended to assist neurosurgeons in the placement of depth electrodes and to record/stimulate neurons, but it does not directly treat or mitigate a disease or condition. It is a tool for diagnostic and guidance purposes during functional neurosurgery.
Cannot answer.
The provided text describes a system that assists in surgical procedures and records neural activity, which typically falls under treatment or monitoring. While it helps identify anatomical regions and aids in electrode placement, it isn't explicitly stated to diagnose a medical condition in the traditional sense of identifying a disease or condition as described in the input. Its primary role seems to be guiding a therapeutic intervention (DBS electrode placement) based on previously established diagnoses.
No
The device description explicitly mentions hardware components like the "NeuroNav Drive system" and compatibility with "Alpha Omega's Microprobes" and "other manufacturers' compatible electrodes." While the HaGuide software is a key component, the overall system includes hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The NeuroNav System / NeuroSmart System and NeuroNav Drive are used during surgery to assist neurosurgeons in the placement of depth electrodes within the brain. They record electrical signals from brain tissue and can stimulate the brain.
- Lack of Specimen Analysis: The device does not analyze any specimens taken from the body. It interacts directly with the brain tissue in situ.
Therefore, the device's function and intended use clearly fall outside the scope of an In Vitro Diagnostic device. It is a surgical navigation and monitoring system.
N/A
Intended Use / Indications for Use
The NeuroNav System / NeuroSmart System, incorporated the installed HaGuide software, is intended to be used in assisting neurosurgeons, in the operating functional neurosurgery, and to record from and stimulate brain motor and sensory neurons and to aid in the placement of depth electrode.
The NeuroNav Drive is intended to be used in assisting neurosurgeons, in the operating room during functional neurosurgery, to aid in the placement of depth electrodes.
Product codes
GZL
Device Description
Alpha Omega's NeuroNav System is an accurate electrodes navigation system to aid the neurosurgeon in placement of DBS electrodes. The system is designed to be used in the operating room during neurosurgery.
The NeuroNav Drive system is designed for compatibility with Alpha Omega's Microprobes (NeuroProbes K120098) or with other manufacturers' compatible electrodes, and is compatible with all the existing Stereotactic Frames and Frameless procedures.
NeuroNav system can record signals from the brain cells (Micro-Electrode Recording -MER) or stimulate the brain target zone during movement disorders neurosurgery procedure.
In addition, the NeuroNav system is planned to include additional sub model, will be traded as "NeuroSmart", this sub model is identical to the NeuroNav system, the subject device, and incorporated the installed HaGuide software, will be elaborated hereunder.
The installed HaGuide software is a user option tool, which is a real-time software solution designed to accurately detects the Sub Thalamic Nucleus region, its entrance and exit boundaries as well gives the user a stimulation location recommendation.
The HaGuide software robustly detects intra STN detection of Dorso lateral Oscillatory Region (DLOR) and Ventro Medical Non-Oscillatory Region (VMNR) boundary.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Deep Brain
Indicated Patient Age Range
Adults and children
Intended User / Care Setting
Neurosurgeon and Neurosurgery staff / Operating Room
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
Test Method Summary: A Retrospective, Multi-centre, Clinical Validation of HaGuide Software module accuracy in mapping sub-thalamic nucleus (STN) boundaries in Parkinson's disease patients who underwent Deep Brain Stimulation (DBS) procedure
Level of evidence: Single-arm study with Objective Performance Criteria
Location of Study: Both in United States and Outside United States
Patient Accountability:
Stage: Primary Effectivness Endpoint Analysis
Investigational Device Arm total: 81
Control Arm total: -
Total: 81
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
HaGuide Clinical Study:
Study Type: Retrospective, Multi-centre, Clinical Validation
Sample Size: 81 patients (105 surgeries, 213 electrodes evaluated)
Key Results:
- Percent agreement between HaGuide and Neurosurgeon/Electrophysiologist expert is 90.34% (95% CI, 85.27, 93.85 %)
- Correlation between the HaGuide measurements and expert Neurosurgeon/Electrophysiologist measurements in depth of STN entry site and exit site was found very strong (coefficient = 0.9492 and 0.9317 respectively and both lower 95% Confidence Limit >0.91).
- Bland-Altman analysis of average against the difference between Haguide and expert measurements for the location of STN entry was 0.18 mm (95% CI, -0.9, 1.2 mm) and exit points was -0.15 mm (95% CI, -1.25, 1 mm).
- No adverse events and complications observed in the study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Percent agreement: 90.34% (95% CI, 85.27, 93.85 %)
- Correlation coefficient: 0.9492 (STN entry), 0.9317 (STN exit)
- Bland-Altman mean difference (bias): 0.18 mm (STN entry), -0.15 mm (STN exit)
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).
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Image /page/0/Picture/0 description: The image contains two logos. The first logo is the Department of Health & Human Services - USA logo, which features a stylized human figure. The second logo is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the administration in blue text.
February 27, 2018
Alpha Omega Engineering Ltd. Maysana Mousa QA RA Manager Nazareth Industrial Park, Mount Precipice, St. 2015 Nazareth, 1612102 Il
Re: K172042
Trade/Device Name: NeuroNav System, NeuroSmart System, and NeuroNav Drive Regulation Number: 21 CFR 882.1330 Regulation Name: Depth Electrode Regulatory Class: Class II Product Code: GZL Dated: December 27, 2017 Received: January 11, 2018
Dear Maysana Mousa:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Hoffmann -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172042
Device Name
NeuroNav System, NeuroSmart System, and NeuroNav Drive
Indications for Use (Describe)
The NeuroNav System / NeuroSmart System, incorporated the installed HaGuide software, is intended to be used in assisting neurosurgeons, in the operating functional neurosurgery, and to record from and stimulate brain motor and sensory neurons and to aid in the placement of depth electrode.
The NeuroNav Drive is intended to be used in assisting neurosurgeons, in the operating room during functional neurosurgery, 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) |
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Image /page/3/Picture/0 description: The image shows the logo for Alpha Omega. The logo consists of a stylized letter "A" in maroon color, with a gray bridge-like structure at the bottom. To the right of the "A" is the word "omega" in gray. Below the logo is the text "Defining Neuroscience Technology" in maroon color.
510(k) Summary
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.92
Submitter Information
Alpha Omega Engineering Ltd. Mount Precipice 2015 P.O. Box 2268 Nazareth 1612102, Israel Tel:+972-4-6563-327 Fax:+972-4-6574-075
Submission contact person:
Mrs. Maysana Mousa Tel:+972-4-6563-327 Fax:+972-4-6574-075 Mobile: +972-54-9043303
Device Classification
| Proprietary Device Name: | NeuroNav System, NeuroNav Drive and
NeuroSmart System | | | | |
|----------------------------|--------------------------------------------------------------------|--|--|--|--|
| Common name: | Intraoperative neurophysiological recording and stimulating device | | | | |
| Product Code: | GZL | | | | |
| Subsequent Product Code: | | | | | |
| Classification Name: | Depth Electrode | | | | |
| Classification Regulation: | 21 CFR §882.1330 | | | | |
| Regulatory Class: | II | | | | |
Identification of Legally Marketed Predicate Devices
NeuroNav System and NeuroNav Drive device -K071697
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Image /page/4/Picture/0 description: The image is a logo for Alpha Omega. The logo features the letters "Alpha" in a stylized font, with a red line running through the letters. The word "omega" is in gray, and the tagline "Defining Neuroscience Technology" is below the logo. The logo is likely used to represent a company or organization that specializes in neuroscience technology.
Device Description 1.
Alpha Omega's NeuroNav System is an accurate electrodes navigation system to aid the neurosurgeon in placement of DBS electrodes. The system is designed to be used in the operating room during neurosurgery.
The NeuroNav Drive system is designed for compatibility with Alpha Omega's Microprobes (NeuroProbes K120098) or with other manufacturers' compatible electrodes, and is compatible with all the existing Stereotactic Frames and Frameless procedures.
NeuroNav system can record signals from the brain cells (Micro-Electrode Recording -MER) or stimulate the brain target zone during movement disorders neurosurgery procedure.
In addition, the NeuroNav system is planned to include additional sub model, will be traded as "NeuroSmart", this sub model is identical to the NeuroNav system, the subject device, and incorporated the installed HaGuide software, will be elaborated hereunder.
The installed HaGuide software is a user option tool, which is a real-time software solution designed to accurately detects the Sub Thalamic Nucleus region, its entrance and exit boundaries as well gives the user a stimulation location recommendation.
The HaGuide software robustly detects intra STN detection of Dorso lateral Oscillatory Region (DLOR) and Ventro Medical Non-Oscillatory Region (VMNR) boundary.
Intended Use of Device 2.
The NeuroNav system / NeuroSmart System, incorporated the installed HaGuide software, is intended to be used in assisting 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 electrode.
The NeuroNav Drive is intended to be used in assisting neurosurgeons, in the operating room during functional neurosurgery, to aid in the placement of depth electrodes.
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Image /page/5/Picture/0 description: The image is a logo for Alpha Omega, a company that defines neuroscience technology. The logo features the words "ALPHA" and "omega" in a stylized font, with a red line connecting the two words. The word "omega" is in gray, and the tagline "Defining Neuroscience Technology" is below the logo.
3. Safety & Effectiveness
The NeuroNav system has been compared to the predicate device, NeuroNav device (K071697), in terms of intended use, indications for use, components, principles of operation, technological characteristics and safety features.
Intended Use Comparison .
| # | Comparison parameter | Subject device:
Modified NeuroNav System and
NeuroNav Drive | Predicate device:
NeuroNav System and
NeuroNav Drive | Substantial Equivalent discussion |
|---|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| 1 | Legally distribution clearance No. | Subject device | K071697 | |
| 2 | Owner | Alpha Omega Engineering Ltd. | Alpha Omega Engineering Ltd. | |
| 3 | Intended use and indications for use. | NeuroNav System
Alpha Omega's NeuroNav system, including the
NeuroNav Drive, is intended to
be used in assisting
neurosurgeons, in the operating
room during functional
neurosurgery, and to record | NeuroNav System
Alpha Omega's NeuroNav system, including the
NeuroNav Drive, is intended to
be used in assisting
neurosurgeons, in the operating
room during functional
neurosurgery, and to record | Similarities:
Same intended use and indications
Differences:
None |
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Image /page/6/Picture/0 description: The image shows the logo for Alpha Omega. The logo consists of the letters "Alpha" and "Omega" in a stylized font. The word "Alpha" is in a dark red color, while the word "Omega" is in gray. The "A" in Alpha is also represented by a symbol to the left of the word.
| # | Comparison
parameter | Subject device:
Modified NeuroNav System and
NeuroNav Drive | Predicate device:
NeuroNav System and
NeuroNav Drive | Substantial Equivalent discussion |
|---|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| | | from and stimulate brain motor
and sensory neurons and to aid
in the placement of depth
electrode.
NeuroNav Drive
Alpha Omega NeuroNav Drive
is intended to be used in
assisting neurosurgeons, in the
operating room during
functional neurosurgery, to aid
in the placement of depth
electrodes. | from and stimulate brain motor
and sensory neurons and to aid
in the placement of depth
electrode.
NeuroNav Drive
Alpha Omega NeuroNav Drive
is intended to be used in
assisting neurosurgeons, in the
operating room during
functional neurosurgery, to aid
in the placement of depth
electrodes. | |
| 4 | Device code and
regulation | Product Code: GZL
Regulation #: 21CFR882.1330 | Product Code: GZL
Regulation #: 21CFR882.1330 | Similarities:
Same product code and regulation
Differences:
None |
Performance Comparison .
| # | Comparison
parameter | Subject device:
Modified NeuroNav System
and NeuroNav Drive | Predicate device:
NeuroNav System and
NeuroNav Drive | Substantial Equivalent discussion |
|-----|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Legally | Subject device | K071697 | |
| # | Comparison
parameter | Subject device:
Modified NeuroNav System
and NeuroNav Drive | Predicate device:
NeuroNav System and
NeuroNav Drive | Substantial Equivalent discussion |
| | distribution
clearance No. | | | |
| 2 | Owner | Alpha Omega Engineering
Ltd. | Alpha Omega Engineering
Ltd. | |
| 3 | Target Area | Deep Brain | Deep Brain | Similarities:
Same target body target area
Differences:
None |
| 4 | Target population | Adults and children | Adults and children | Similarities:
Same target population
Differences:
None |
| 5 | Users | Neurosurgeon and
Neurosurgery staff | Neurosurgeon and
Neurosurgery staff | Similarities:
Same users
Differences:
None |
| 4 | Use environment | Operating Room | Operating Room | Similarities:
Same use environment
Differences: |
| # | Comparison
parameter | Subject device:
Modified NeuroNav System
and NeuroNav Drive | Predicate device:
NeuroNav System and
NeuroNav Drive | Substantial Equivalent discussion |
| 6 | Usability and Human
Factors | ISO 62366, IEC 60601-1-6
and FDA guidance # 1497 -
Incorporating Human Factors
in Risk Management dated
July 18 2000. | ISO 60601-1-6 and FDA
guidance #
1497 - Incorporating Human
Factors in Risk Management
dated July 18 2000. | None
Similarities:
Conformity to same or newer
Human Factors standards
Differences:
The modified device usability design
complies to a newer medical device
usability standard (ISO 62366) |
| 7 | AC Power
Supply | 100 - 240V AC
50/ 60 Hz | 100-120 V AC,220-240V AC
50/ 60 Hz | Similarities:
Same AC Power input
Differences:
None |
| 8 | Software
applications | GUI, Monitoring, display,
Audio, signal processing,
Recording, Stimulation | GUI, Monitoring, display,
Recording, Stimulation | Similarities:
Same application controlled by the
device's software
Differences:
New and improved applications
implemented by the software.
The differences do not raise concerns
in safety and effectiveness |
| # | Comparison
parameter | Subject device:
Modified NeuroNav System
and NeuroNav Drive | Predicate device:
NeuroNav System and
NeuroNav Drive | Substantial Equivalent discussion |
| 9. | Electrical Safety | IEC 60601-, 3rd Ed. +
Risk analysis (ISO 14971) | IEC 60601-1 +
Risk analysis (ISO 14971) | Similarities:
Conformity to the same or newer
safety standard
Differences:
The modified device was tested for
compliance to a newer (3rd edition)
medical device safety standard |
| 10. | Particular safety | Risk analysis (ISO 14971) | Risk analysis (ISO 14971) | Similarities:
Risk assessment performed
according to the same standard
Differences:
Non |
| 11 | Electromagnetic
Compatibility | IEC 60601-1-2, 3rd Ed. +
Risk analysis (ISO 14971) | IEC 60601-1-2 +
Risk analysis (ISO 14971) | Similarities:
Conformity to the same or newer
EMC standard
Differences:
The modified device was tested for
compliance to a newer (3rd edition)
medical device EMC standard |
| 12 | Sterility and
Sterilization standards | Sterility of the sterileable | Sterility of the sterileable | Similarities: |
| # | Comparison
parameter | Subject device:
Modified NeuroNav System
and NeuroNav Drive | Predicate device:
NeuroNav System and
NeuroNav Drive | Substantial Equivalent discussion |
| | | components is performed by
the hospital clinical staff and
was validated to comply with
the following standards: ISO
17665-1, ST77 | components is performed by
the hospital clinical staff and
was validated to comply with
the following standards: ISO
17665-1, ISO 11135, ISO
10993-7, ST77 | Conformity to the same or newer
sterility validation standards
Differences:
The modified device head-stage
electronic components were
validated for compliance with
different types of STERRAD
sterilization processes instead of
ETO sterilization process that is not
used for electronic components
sterilization. |
| 13 | Software development
standard | ISO 62304 | ISO 60601-1-4 | Similarities:
Conformity to the same or newer
medical device software standard
Differences:
The modified device software
development process complies to a
newer medical device life cycle
software development standard (ISO
62304) |
Page 4 of 13
Mount Precipice 2015 P.O. Box 2268 Alpha Omega Engineering Ltd. Nazareth 1612102, Israel Tel:+972-4-6563-327 Fax:+972-4-6574-075 info@alphaomega-eng.com www.alphaomega-eng.com
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Image /page/7/Picture/0 description: The image shows the logo for Alpha Omega. The logo consists of the letters "Alpha" and "Omega" in a stylized font. The "Alpha" is in a dark red color, and the "Omega" is in gray. The "Alpha" is also stylized with a line running through it.
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Image /page/8/Picture/0 description: The image shows the logo for Alpha Omega. The word "Alpha" is written in a stylized font with a red line running through the letters. The word "Omega" is written in gray, with the "O" in the shape of the Greek letter omega. The logo is simple and modern, and the colors are eye-catching.
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Image /page/9/Picture/0 description: The image shows the logo for Alpha Omega. The logo has the letters "Alpha" in a dark red color, with a line going through the letters. The letters "omega" are in gray. The logo is simple and modern.
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Image /page/10/Picture/0 description: The image shows a logo with the words "ALPHA omega" in a stylized font. The word "ALPHA" is in a dark red color and has a line running through it that resembles a heartbeat. The word "omega" is in gray and is positioned below the word "ALPHA". To the left of the words is a symbol that combines the Greek letters alpha and omega.
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Image /page/11/Picture/0 description: The image is a logo for Alpha Omega. The logo has the word "ALPHA" in a dark red color, and the word "omega" in gray. Below the words is the phrase "Defining Neuroscience Technology" in black.
Based on the performance results provided in this submission (including test results) and the analysis of similarities and differences presented above, Alpha Omega Technologies Ltd. believes that the proposed device is substantially equivalent to the predicate device without raising new safety and/or effectiveness issues.
Rational for Substantial Equivalency
The proposed modified NeuroNav system and NeuroNav Drive has been compared to the predicate NeuroNav system and NeuroNav Drive in terms of intended use, indications for use, components, principles of operation, technological characteristics and safety features.
Based on the analysis results provided in this submission, including test results and bench performance tests and the analysis of similarities and differences discussed, Alpha Omega Engineering Ltd. believes that the proposed device is substantial equivalent to the predicate device without raising new safety and/or effectiveness issues.
Non Clinical and Clinical validation data
Verification and validation bench tests were performed, to demonstrate the safety and effectiveness of the proposed NeuroNav System.
The purposes of the design verification & validation processes were to verify the Device specifications and to verify the proper function of all device components and options.
After comparing the predicates device to the subject device, results show that with the above intended use, the device is equivalent in safety and effectiveness.
Therefore, the subject of this 510(k) notification, the NeuroNav system, did not require clinical studies to the device.
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Image /page/12/Picture/0 description: The image shows the logo for Alpha Omega, a company that defines neuroscience technology. The logo features the letters "ALPHA omega" in a stylized font, with a red line above the letters. Below the logo is the text "Defining Neuroscience Technology" and "Performance Tests".
For non-clinical performance tests:
| Test | Test Method Summary | Results |
|---|---|---|
| Software | ||
| Verification | This verification performed on | |
| full system, the subject device | ||
| (SW & HW) including | ||
| accessories, and checked that | ||
| the design output meets the SW | ||
| design input. | NeuroNav SW has been tested | |
| under a complete SW verification | ||
| plan traceable to NeuroNav SRS. | ||
| All samples passed the acceptance | ||
| criteria which determines the | ||
| effectiveness of NeuroNav System, | ||
| the subject device, with HaGuide | ||
| software. | ||
| System | ||
| Verification | This verification performed on | |
| full system, the subject device | ||
| (SW & HW), and checked that | ||
| the design output meets the | ||
| system (HW & MECH) design | ||
| input | NeuroNav system has been verified | |
| under a complete system | ||
| verification plan traceable to | ||
| NeuroNav system design input. All | ||
| samples passed the acceptance | ||
| criteria which determines the | ||
| effectiveness of NeuroNav System, | ||
| the subject device, with HaGuide | ||
| software. | ||
| Steam Sterilization | ||
| Validation | Mechanical accessories of the | |
| subject device | Each test article was evaluated to a | |
| sterility assurance level (SAL) of ≤ | ||
| 10-6 using the biological indicator | ||
| (BI) overkill method. Geobacillus | ||
| stearothermophilus, ATCC #7953, | ||
| was the indicator organism. All test | ||
| method acceptance criteria were | ||
| met. | ||
| In addition to the SAL validation, | ||
| dry times were validated using full | ||
| cycle parameters. | ||
| STERRAD NX | ||
| sterilization | ||
| validation | Electrical accessories of the | |
| subject device | NeuroNav was validated to a | |
| sterility assurance level (SAL) of ≤ | ||
| 10-6 using the biological indicator | ||
| (BI) overkill method. Geobacillus | ||
| stearothermophilus, ATCC #7953, | ||
| was the indicator organism. | ||
| Results validated the individual test | ||
| articles for the STERRAD® NX | ||
| Standard cycle. | ||
| STERRAD 100NX | ||
| sterilization | ||
| validation | Electrical accessories of the | |
| subject device | Results from testing validate that | |
| the Alpha Omega Engineering, Ltd. | ||
| Neuro Omega Tray is able to | ||
| achieve a 10-6 SAL in a | ||
| STERRAD® 100NX Standard | ||
| sterilization process. |
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Image /page/13/Picture/0 description: The image shows the logo for Alpha Omega. The logo consists of the letters 'A' and 'O' stacked on top of each other, with the word 'ALPHA' written in red above the letters and the word 'omega' written in gray below the letters. The 'A' and 'O' are also in red and gray, respectively.
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Image /page/14/Picture/0 description: The image is a logo for Alpha Omega. The logo features the letters "Alpha" in a stylized font, with a red line running through the letters. The letters "Omega" are in gray, and the tagline "Defining Neuroscience Technology" is below the logo. The logo is likely used to represent a company or organization that specializes in neuroscience technology.
For clinical performance test:
HaGuide Clinical Study:
● Test Method Summary:
A Retrospective, Multi-centre, Clinical Validation of HaGuide Software module accuracy in mapping sub-thalamic nucleus (STN) boundaries in Parkinson's disease patients who underwent Deep Brain Stimulation (DBS) procedure
Level of evidence: ●
Single-arm study with Objective Performance Criteria
Location of Study: ●
Both in United States and Outside Unitest States
● Primary Effectiveness Endpoint:
Percent agreement between HaGuide software measurements and expert Neurosurgeon/Electrophysiologist measurements, for STN entry point vs. exit point depth (in mm).
| Stage | Investigational Device
Arm total | Control Arm
Total | Total |
|-------------------------------------------|-------------------------------------|----------------------|-------|
| Enrollment | 81 | - | 81 |
| Treatment | 81 | - | 81 |
| Primary Effectivness
Endpoint Analysis | 81 | - | 81 |
Patient Accountability: ●
The study met the primary endpoint: ●
The reference against which the accuracy of HaGuide mapping was compared is the gold standard being the qualified user (Neurosurgeon/Electrophysiologist) concluding about the location of the entry and exit points of the sub-thalamic nucleus (STN) from the visual and audio recording patterns.
. Results:
In total 81 patients were enrolled. In total 105 surgeries, as 213 electrodes were evaluated for percent agreement between HaGuide software measurements and expert Neurosurgeon/Electrophysiologist measurements about the location of the entry and exit points of the sub-thalamic nucleus (STN).
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Percent agreement between Haguide and Neurosurgeon/Electrophysiologist expert is 90.34% (95% CI, 85.27, 93.85 %)
Correlation between the HaGuide measurements and and expert Neurosurgeon/Electrophysiologist measurements in depth of STN entry site and exit site and was found very strong (coefficient = 0.9492 and 0.9317 respectively and both lower 95% Confidence Limit >0.91).
Bland-Altman analysis of average against the difference between Haguide and expert measurements for the location of STN entry was 0.18 mm (95% CI, -0.9, 1.2 mm) and exit points was -0.15 mm (95% CI, -1.25, 1 mm).
- . No adverse events and complications observed in the study