(236 days)
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.
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.
The provided text describes a 510(k) premarket notification for the NeuroNav System, NeuroSmart System, and NeuroNav Drive. The key focus for this request is the "HaGuide Clinical Study" which assesses the performance of the HaGuide software module.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria for the HaGuide software's performance, but rather presents the results of a single-arm study evaluating its accuracy against expert measurements. Based on the "Primary Effectiveness Endpoint Analysis" and "Results" section of the HaGuide Clinical Study, an implicit acceptance goal was likely a high percentage agreement and strong correlation.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| High Percent agreement between HaGuide software measurements and expert Neurosurgeon/Electrophysiologist measurements for STN entry point vs. exit point depth. | Percent agreement between HaGuide and Neurosurgeon/Electrophysiologist expert is 90.34% (95% CI, 85.27, 93.85 %). |
| Strong Correlation between HaGuide measurements and expert Neurosurgeon/Electrophysiologist measurements in depth of STN entry site and exit site. | Correlation between the HaGuide measurements and expert Neurosurgeon/Electrophysiologist measurements in depth of STN entry site and exit site was very strong (coefficient = 0.9492 and 0.9317 respectively and both lower 95% Confidence Limit >0.91). |
| Low average difference between HaGuide and expert measurements (Bland-Altman analysis) for STN entry and exit points. | 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). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 81 patients, leading to 105 surgeries and 213 electrodes evaluated.
- Data Provenance: Retrospective, Multi-centre, with data collected from both the United States and Outside United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated as a number, but referred to as "qualified user (Neurosurgeon/Electrophysiologist)".
- Qualifications of Experts: Neurosurgeon/Electrophysiologist. No specific years of experience are provided, but they are described as "qualified users."
4. Adjudication Method for the Test Set
The document implicitly describes the adjudication method as a direct comparison between the "HaGuide software measurements" and "expert Neurosurgeon/Electrophysiologist measurements." There is no mention of a formal multi-reader adjudication process like 2+1 or 3+1; the expert opinion is considered the "gold standard."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focuses on the accuracy of the algorithm (HaGuide software) compared to expert opinion (the "gold standard"), not on how human readers' performance improves with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone study was done. The "HaGuide Clinical Study" specifically evaluates the "HaGuide software module accuracy" by comparing its measurements directly against expert measurements, indicating that the algorithm's performance was assessed independently of active human-in-the-loop use.
7. The Type of Ground Truth Used
The ground truth used was expert consensus/opinion. The document states that "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."
8. The Sample Size for the Training Set
The document does not provide information regarding the sample size for the training set used to develop the HaGuide software. The "HaGuide Clinical Study" describes a clinical validation of the software, implying it was already developed when this study was performed.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established, as details about the software's development (including training data and ground truth establishment) are not covered in this 510(k) summary.
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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);
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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
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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 andNeuroSmart 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 andNeuroNav Drive | Predicate device:NeuroNav System andNeuroNav 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 SystemAlpha Omega's NeuroNav system, including theNeuroNav Drive, is intended tobe used in assistingneurosurgeons, in the operatingroom during functionalneurosurgery, and to record | NeuroNav SystemAlpha Omega's NeuroNav system, including theNeuroNav Drive, is intended tobe used in assistingneurosurgeons, in the operatingroom during functionalneurosurgery, and to record | Similarities:Same intended use and indicationsDifferences: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.
| # | Comparisonparameter | Subject device:Modified NeuroNav System andNeuroNav Drive | Predicate device:NeuroNav System andNeuroNav Drive | Substantial Equivalent discussion |
|---|---|---|---|---|
| from and stimulate brain motorand sensory neurons and to aidin the placement of depthelectrode.NeuroNav DriveAlpha Omega NeuroNav Driveis intended to be used inassisting neurosurgeons, in theoperating room duringfunctional neurosurgery, to aidin the placement of depthelectrodes. | from and stimulate brain motorand sensory neurons and to aidin the placement of depthelectrode.NeuroNav DriveAlpha Omega NeuroNav Driveis intended to be used inassisting neurosurgeons, in theoperating room duringfunctional neurosurgery, to aidin the placement of depthelectrodes. | |||
| 4 | Device code andregulation | Product Code: GZLRegulation #: 21CFR882.1330 | Product Code: GZLRegulation #: 21CFR882.1330 | Similarities:Same product code and regulationDifferences:None |
Performance Comparison .
| # | Comparisonparameter | Subject device:Modified NeuroNav Systemand NeuroNav Drive | Predicate device:NeuroNav System andNeuroNav Drive | Substantial Equivalent discussion |
|---|---|---|---|---|
| 1 | Legally | Subject device | K071697 | |
| # | Comparisonparameter | Subject device:Modified NeuroNav Systemand NeuroNav Drive | Predicate device:NeuroNav System andNeuroNav Drive | Substantial Equivalent discussion |
| distributionclearance No. | ||||
| 2 | Owner | Alpha Omega EngineeringLtd. | Alpha Omega EngineeringLtd. | |
| 3 | Target Area | Deep Brain | Deep Brain | Similarities:Same target body target areaDifferences:None |
| 4 | Target population | Adults and children | Adults and children | Similarities:Same target populationDifferences:None |
| 5 | Users | Neurosurgeon andNeurosurgery staff | Neurosurgeon andNeurosurgery staff | Similarities:Same usersDifferences:None |
| 4 | Use environment | Operating Room | Operating Room | Similarities:Same use environmentDifferences: |
| # | Comparisonparameter | Subject device:Modified NeuroNav Systemand NeuroNav Drive | Predicate device:NeuroNav System andNeuroNav Drive | Substantial Equivalent discussion |
| 6 | Usability and HumanFactors | ISO 62366, IEC 60601-1-6and FDA guidance # 1497 -Incorporating Human Factorsin Risk Management datedJuly 18 2000. | ISO 60601-1-6 and FDAguidance #1497 - Incorporating HumanFactors in Risk Managementdated July 18 2000. | NoneSimilarities:Conformity to same or newerHuman Factors standardsDifferences:The modified device usability designcomplies to a newer medical deviceusability standard (ISO 62366) |
| 7 | AC PowerSupply | 100 - 240V AC50/ 60 Hz | 100-120 V AC,220-240V AC50/ 60 Hz | Similarities:Same AC Power inputDifferences:None |
| 8 | Softwareapplications | GUI, Monitoring, display,Audio, signal processing,Recording, Stimulation | GUI, Monitoring, display,Recording, Stimulation | Similarities:Same application controlled by thedevice's softwareDifferences:New and improved applicationsimplemented by the software.The differences do not raise concernsin safety and effectiveness |
| # | Comparisonparameter | Subject device:Modified NeuroNav Systemand NeuroNav Drive | Predicate device:NeuroNav System andNeuroNav 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 newersafety standardDifferences:The modified device was tested forcompliance to a newer (3rd edition)medical device safety standard |
| 10. | Particular safety | Risk analysis (ISO 14971) | Risk analysis (ISO 14971) | Similarities:Risk assessment performedaccording to the same standardDifferences:Non |
| 11 | ElectromagneticCompatibility | IEC 60601-1-2, 3rd Ed. +Risk analysis (ISO 14971) | IEC 60601-1-2 +Risk analysis (ISO 14971) | Similarities:Conformity to the same or newerEMC standardDifferences:The modified device was tested forcompliance to a newer (3rd edition)medical device EMC standard |
| 12 | Sterility andSterilization standards | Sterility of the sterileable | Sterility of the sterileable | Similarities: |
| # | Comparisonparameter | Subject device:Modified NeuroNav Systemand NeuroNav Drive | Predicate device:NeuroNav System andNeuroNav Drive | Substantial Equivalent discussion |
| components is performed bythe hospital clinical staff andwas validated to comply withthe following standards: ISO17665-1, ST77 | components is performed bythe hospital clinical staff andwas validated to comply withthe following standards: ISO17665-1, ISO 11135, ISO10993-7, ST77 | Conformity to the same or newersterility validation standardsDifferences:The modified device head-stageelectronic components werevalidated for compliance withdifferent types of STERRADsterilization processes instead ofETO sterilization process that is notused for electronic componentssterilization. | ||
| 13 | Software developmentstandard | ISO 62304 | ISO 60601-1-4 | Similarities:Conformity to the same or newermedical device software standardDifferences:The modified device softwaredevelopment process complies to anewer medical device life cyclesoftware development standard (ISO62304) |
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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 |
|---|---|---|
| SoftwareVerification | This verification performed onfull system, the subject device(SW & HW) includingaccessories, and checked thatthe design output meets the SWdesign input. | NeuroNav SW has been testedunder a complete SW verificationplan traceable to NeuroNav SRS.All samples passed the acceptancecriteria which determines theeffectiveness of NeuroNav System,the subject device, with HaGuidesoftware. |
| SystemVerification | This verification performed onfull system, the subject device(SW & HW), and checked thatthe design output meets thesystem (HW & MECH) designinput | NeuroNav system has been verifiedunder a complete systemverification plan traceable toNeuroNav system design input. Allsamples passed the acceptancecriteria which determines theeffectiveness of NeuroNav System,the subject device, with HaGuidesoftware. |
| Steam SterilizationValidation | Mechanical accessories of thesubject device | Each test article was evaluated to asterility assurance level (SAL) of ≤10-6 using the biological indicator(BI) overkill method. Geobacillusstearothermophilus, ATCC #7953,was the indicator organism. All testmethod acceptance criteria weremet.In addition to the SAL validation,dry times were validated using fullcycle parameters. |
| STERRAD NXsterilizationvalidation | Electrical accessories of thesubject device | NeuroNav was validated to asterility assurance level (SAL) of ≤10-6 using the biological indicator(BI) overkill method. Geobacillusstearothermophilus, ATCC #7953,was the indicator organism.Results validated the individual test |
| articles for the STERRAD® NX | ||
| Standard cycle. | ||
| STERRAD 100NXsterilizationvalidation | Electrical accessories of thesubject device | Results from testing validate thatthe Alpha Omega Engineering, Ltd.Neuro Omega Tray is able toachieve a 10-6 SAL in aSTERRAD® 100NX Standardsterilization 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 DeviceArm total | Control ArmTotal | Total |
|---|---|---|---|
| Enrollment | 81 | - | 81 |
| Treatment | 81 | - | 81 |
| Primary EffectivnessEndpoint 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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Image /page/15/Picture/0 description: The image shows the logo for Alpha Omega. The logo consists of the letters "ALPHA" in a dark red color, with a line running through the letters. Below the word "ALPHA" is the word "omega" in gray.
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
§ 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).