(205 days)
The subject device, the Neuro Omega System incorporated the installed HaGuide software, including the Drive HeadStage unit, is intended to assist neurosurgeons in the operating room during functional neurosurgery and to record from and stimulate brain motor and sensory neurons and to aid in the placement of depth electrodes. The subject device, the Neuro Omega System incorporated the installed 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 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 seizure disorder.
The device is intended for intraoperative use by medical personnel. Within hospitals, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional. The device may also be placed in the intensive care unit or operating room for continuous recording.
The Neuro Omega system is designed for different neurosurgery and neurophysiologic clinical applications including recording from and stimulate brain motor and sensory neurons to accurate navigation of electrodes for neurosurgery target localization in treatment of movement disorders by and to aid in the placement of depth electrodes. The device is also designed for measuring bioelectric signals produced by muscles and stimulate peripheral nerves to aid in the diagnosis and prognosis of neuromuscular disease (EMG).
The device may also be used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head (EEG).
The subject device, the Neuro Omega System may also be used to measure, display and record the electrical activity of the patient's brain obtained from ECOG strip and grid electrodes.
The subject device, the Neuro Omega System may also be used to provide stimulation via electrode pairs or a hand held bipolar probe for use in functional brain mapping procedures during treatment of patients with seizure disorder.
The subject device, the Neuro Omega System incorporated the installed HaGuide software as 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 tool presents real time graphs of power spectrum density and RMS of each region.
The Neuro Omega System, equipped with the HaGuide software, is designed to assist neurosurgeons in functional neurosurgery, specifically aiding in the placement of depth electrodes by accurately detecting the Sub Thalamic Nucleus (STN) region.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria & Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than explicitly listing quantitative acceptance criteria for the HaGuide software's performance, as would be typical for an AI/ML device approval under current guidelines. However, the one clear performance metric and its result are presented in the clinical performance test:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Accuracy of STN Entry/Exit Point Detection | Percent agreement between HaGuide software measurements and expert Neurosurgeon/Electrophysiologist measurements for STN entry point vs. exit point depth: 90.34% (95% CI, 85.27, 93.85%) |
| Correlation with Expert Measurements (STN Depth) | Correlation between HaGuide measurements and expert Neurosurgeon/Electrophysiologist measurements for STN entry site depth: 0.9492 (95% CL >0.91) Correlation for STN exit site depth: 0.9317 (95% CL >0.91) |
| Bland-Altman Analysis for Location Agreement | Bland-Altman analysis for the difference between HaGuide and expert measurements for STN entry site: 0.18 mm (95% CI, -0.9, 1.2 mm) Bland-Altman analysis for STN exit site: -0.15 mm (95% CI, -1.25, 1 mm) |
| Safety (No adverse events and complications observed) | "No adverse events and complications observed in the study." |
| Software Verification (Design output meets SW design input) | "All samples passed the acceptance criteria which determines the effectiveness of Neuro Omega System, the subject device, with HaGuide software." (This is a general statement about software quality, not specific performance metrics.) |
| System Verification (Design output meets system design input) | "All samples passed the acceptance criteria which determines the effectiveness of Neuro Omega System, the subject device, with HaGuide software." (Similar to software verification, a general statement about system quality.) |
Sterilization Validation (SAL of <= 10^-6) | All test articles for Steam Sterilization and STERRAD NX/100NX Sterilization were evaluated to a sterility assurance level (SAL) of $\le 10^{-6}$ using the biological indicator (BI) overkill method, and all test method acceptance criteria were met. Results validate individual test articles for the STERRAD NX standard cycle and the STERRAD® 100NX Standard sterilization process. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size:
- Patients enrolled: 81
- Surgeries evaluated: 105
- Electrodes evaluated: 213 (This indicates multiple electrodes were evaluated per surgery/patient)
- Data Provenance: Retrospective, Multi-centre study.
- Country of Origin: Both in United States and Outside United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not explicitly stated as a specific number. The document refers to "expert Neurosurgeon/Electrophysiologist" (singular and plural) consistently. It's implied there were qualified experts, but not how many participated in the ground truth labeling for the test set.
- Qualifications of Experts: "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." No specific years of experience or board certification are mentioned, but their professional roles imply expertise in functional neurosurgery and electrophysiology.
4. Adjudication Method for the Test Set:
- 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." This implies that the expert's determination was considered the ground truth without further multi-expert adjudication described (e.g., 2+1 or 3+1). It is a single expert (or single group of experts acting as one unit) making the determination.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. without AI Assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study of human readers with and without AI assistance was not reported. The study focused on the standalone performance of the HaGuide software compared to expert consensus.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Yes, the clinical study appears to evaluate the HaGuide software in a standalone capacity, comparing its automatic measurements ("HaGuide software measurements") directly to "expert Neurosurgeon/Electrophysiologist measurements." The software provides "in mapping sub-thalamic nucleus (STN) boundaries" and "gives the user a stimulation location recommendation," which implies an algorithmic output.
7. The Type of Ground Truth Used:
- The type of ground truth used was expert consensus/determination based on visual and audio recording patterns during Deep Brain Stimulation (DBS) procedures. The document explicitly states: "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 used for the training set of the HaGuide software. It only describes the "clinical performance test" which is an evaluation on a test set (81 patients, 105 surgeries, 213 electrodes).
9. How the Ground Truth for the Training Set Was Established:
- The document does not provide information on how the ground truth for any potential training set was established. It only details the ground truth for the clinical validation (test) set.
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Image /page/0/Picture/0 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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration" in a sans-serif font. The word "Administration" is on a separate line below "U.S. Food & Drug".
December 22, 2017
Alpha Omega Engineering Ltd, Maysana Mousa QA/RA Manager Nazareth Industrial Park, Mount Precipice, St.2015 Nazareth, 1612102 IL
Re: K171581
Trade/Device Name: Neuro Omega System Regulation Number: 21 CFR 882.1330 Regulation Name: Depth Electrode Regulatory Class: Class II Product Code: GZL, GWF, IKN, GWQ, GYC Dated: November 13, 2017 Received: November 20, 2017
Dear Ms. 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 medical devices and radiation-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,
William J. Heetderks -S 2017.12.22 14:03:23 -05'00'
for Carlos L. Peña, PhD, MS 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) K171581
Device Name Neuro Omega System
Indications for Use (Describe)
The subject device, the Neuro Omega System incorporated the installed HaGuide software, including the Drive HeadStage unit, is intended to assist neurosurgeons in the operating room during functional neurosurgery and to record from and stimulate brain motor and sensory neurons and to aid in the placement of depth electrodes. The subject device, the Neuro Omega System incorporated the installed 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 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 seizure disorder.
The device is intended for intraoperative use by medical personnel. Within hospitals, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional. The device may also be placed in the intensive care unit or operating room for continuous recording.
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 is a logo for Alpha Omega. The logo features a stylized letter "A" in maroon, with a gray omega symbol underneath. The words "ALPHA" in maroon and "omega" in gray are to the right of the symbols. The tagline "Defining Neuroscience Technology" is in maroon below the logo.
510(k) Summary
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.92
Submitter Information
Alpha Omega Engineering Ltd. 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:Common name: | Neuro Omega SystemIntraoperative neurophysiological recording andstimulating device | ||
|---|---|---|---|
| Product Code: | GZL | ||
| Subsequent Product Code: | GWF, IKN, GWQ, GYC | ||
| Classification Name: | Depth Electrode | ||
| Subsequent Classification names: | Electroencephalograph,electrical,electromyograph,electrode | evokeddiagnostic, | stimulator,response,cortical |
| Classification Regulation:Regulatory Class: | 21 CFR §882.1330II | ||
| Identification of Legally Marketed Predicate Devices | |||
| Neuro Omega System -For cortical recording and stimulation | K123796 | ||
| Nicolet Cortical Stimulator - | K072964 |
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1. Device Description
The Neuro Omega system is designed for different neurosurgery and neurophysiologic clinical applications including recording from and stimulate brain motor and sensory neurons to accurate navigation of electrodes for neurosurgery target localization in treatment of movement disorders by and to aid in the placement of depth electrodes. The device is also designed for measuring bioelectric signals produced by muscles and stimulate peripheral nerves to aid in the diagnosis and prognosis of neuromuscular disease (EMG).
The device may also be used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head (EEG).
The subject device, the Neuro Omega System may also be used to measure, display and record the electrical activity of the patient's brain obtained from ECOG strip and grid electrodes.
The subject device, the Neuro Omega System may also be used to provide stimulation via electrode pairs or a hand held bipolar probe for use in functional brain mapping procedures during treatment of patients with seizure disorder.
The subject device, the Neuro Omega System incorporated the installed HaGuide software as 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 tool presents real time graphs of power spectrum density and RMS of each region.
2. Intended Use of Device
The subject device, the Neuro Omega System incorporated the installed HaGuide software, including the Drive HeadStage unit, is intended to assist neurosurgeons in the operating room during functional neurosurgery and to record from and stimulate brain motor and sensory neurons and to aid in the placement of depth electrodes.
The subject device, the Neuro Omega System incorporated the installed 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 seizure disorder.
The device is intended for intraoperative use by medical personnel. Within hospitals, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional. The device may also be placed in the intensive care unit or operating room for continuous recording.
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3. Safety & Effectiveness
The Neuro Omega System has been compared to the New Omega System (K123796), in terms of intended use, indications for use, components, principles of operation, technological characteristics and safety features.
| # | Comparison parameter | Subject device:Neuro Omega | Primary Predicate device:Neuro Omega | Reference device forcortical recording andstimulation:Nicolet CorticalStimulator | SE comparisondiscussion |
|---|---|---|---|---|---|
| 1 | Legallydistribution clearanceNo. | Subject device | K123796 | K072964 | |
| 2 | Owner | Alpha Omega EngineeringLtd. | Alpha Omega EngineeringLtd. | Cardinal Health, Inc | |
| 3 | Intended useandindicationsfor use. | The subject device, the NeuroOmega System incorporatedthe installed HaGuide software,including the Drive HeadStageunit, is intended to assistneurosurgeons in the operatingroom during functionalneurosurgery and to recordfrom and stimulate brain motorand sensory neurons and to aidin the placement of depthelectrodes.The subject device, the NeuroOmega System incorporated | The Neuro Omega System,including the NeuroDrive unit,is intended to assistneurosurgeons in the operatingroom during functionalneurosurgery and to recordfrom and stimulate brain motorand sensory neurons and to aidin the placement of depthelectrodes.The Neuro Omega System isalso intended to monitor,record and display thebioelectric signals produced by | The Cortical Stimulator isintended for use infunctional brain mappingprocedures duringtreatment of patients withseizure disorder, providingstimulation via electrodepairs or a hand heldbipolar probe | SimilarityThe intended use andindications of the modifiedNeuro Omega is identical tothe intended use andindications of the legallymarketed Neuro Omega andthe Nicolet CorticalStimulator predicateDevices.DifferencesThe intended use andindications of the modified |
| # | Comparison parameter | Subject device:Neuro Omega | Primary Predicate device:Neuro Omega | Reference device for cortical recording and stimulation:Nicolet Cortical Stimulator | SE comparison discussion |
| the installed HaGuide softwareis also intended:To monitor, record and displaythe bioelectric signals producedby muscles, to stimulateperipheral nerves, and tomonitor, record and display theelectrical activity produced bynerves to aid the clinician inthe diagnosis and prognosis ofneuromuscular disease (EMG).To measure, record and displaythe electrical activity of thepatient's brain obtained fromtwo or more electrodes on thehead (EEG).To measure, display and recordthe electrical activity of thepatient's brain obtained fromECOG strip and gridelectrodes.To provide stimulation viaelectrode pairs or a hand heldbipolar probe for use infunctional brain mappingprocedures during treatment ofpatients with seizure disorder.The device is intended for | muscles, to stimulateperipheral nerves, and tomonitor, record and display theelectrical activity produced bynerves to aid the clinician inthe diagnosis and prognosis ofneuromuscular disease (EMG).The device may also be usedto measure and record theelectrical activity of thepatient's brain obtained byplacing two or more electrodeson the head (EEG).The device is intended for useby medical personnel within ahospital, laboratory, clinic ornursing home setting oroutside of a medical facilityunder direct supervision of amedical professional. Thedevice may also be placed inthe intensive care unit oroperating room for continuousrecording. | Neuro Omega combines theintended use and indicationsof the predicate andreference devices. | |||
| # | Comparison parameter | Subject device:Neuro Omega | Primary Predicate device:Neuro Omega | Reference device for cortical recording and stimulation:Nicolet Cortical Stimulator | SE comparison discussion |
| intraoperative use by medicalpersonnel. Within hospitals,laboratory, clinic or nursinghome setting or outside of amedical facility under directsupervision of a medicalprofessional. The device mayalso be placed in the intensivecare unit or operating room forcontinuous recording.The device is intended forintraoperative use by medicalpersonnel. Within hospitals,laboratory, clinic or nursinghome setting or outside of amedical facility under directsupervision of a medicalprofessional. The device mayalso be placed in the intensivecare unit or operating room forcontinuous recording. | |||||
| 4 | Device code andregulation | Product Code: GZLRegulation #: 21CFR882.1330Subsequent Product Code:GWF, IKN, GWQ, GYCSubsequent Regulation #:21CFR882.1870, 21CFR | Product Code: GZLRegulation #:21CFR882.1330Subsequent Product Code:GWF, IKN, GWQSubsequent Regulation #:21CFR882.1870, 21CFR | Product Code: GYCRegulation #:21CFR882.1310 | SimilarityThe device code andregulation number of themodified Neuro Omega areidentical to the intended useand indications of thelegally marketed Neuro |
| # | Comparisonparameter | Subject device:Neuro Omega | Primary Predicate device:Neuro Omega | Reference device forcortical recording andstimulation:Nicolet CorticalStimulator | SE comparisondiscussion |
| 890.1375, 21CFR882.1400,21CFR882.1310 | 890.1375, 21CFR882.1400 | Omega and the NicoletCortical StimulatorPredicate Devices.DifferencesThe device code andregulation number of themodified Neuro Omegacombines the device codeand regulation number ofthe predicate and referencedevices. Additionally, themodified Neuro Omega doesnot include the ETN devicecode |
• Intended Use Comparison
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• Performance Comparison
| # | Comparisonparameter | Proposed device:Neuro Omega | Primary Predicate device:Neuro Omega | Reference device:Nicolet CorticalStimulator | SE comparisondiscussion |
|---|---|---|---|---|---|
| 1 | Legallydistributionclearance No. | Subject device | K123796 | K072964 | |
| 2 | Owner | Alpha Omega EngineeringLtd. | Alpha Omega EngineeringLtd. | Cardinal Health, Inc | |
| 3 | Body Areas | Deep brain, cranial surface,intracranial cortex and body | Deep brain, cranial surface andbody limbs | Intracranial brain cortex | SimilarityIdentical for Neuro Omega |
| # | Comparisonparameter | Proposed device:Neuro Omega | Primary Predicate device:Neuro Omega | Reference device:Nicolet CorticalStimulator | SE comparisondiscussion |
| limbs | modified and unmodifieddevicesDifferencesIn addition to deep brain, cranial surface and bodylimbs, the modified Neuro Omega may be usedmapping the brain by stimulation of the corticalsurface, which is equivalent to both predicate andreference devices. | ||||
| 4 | Targetpopulation | Adults and children | Adults and children | Adults and children | SimilarityIdentical.DifferencesNone |
| 5 | Users | Neurosurgeon, Neurosurgerystaff and professional medicalpersonnel. | Neurosurgeon, Neurosurgerystaff and professional medicalpersonnel. | Qualified medicalpersonnel | SimilarityIdentical for Neuro Omega modified and unmodifieddevicesDifferencesSubject device is equivalent to primary predicate device,Nicolet Cortical Stimulator can be used by qualifiedmedical personnel |
| 6 | Use | Within hospitals, laboratory, | Within hospitals, laboratory, | Within a hospital or | Similarity |
| # | Comparisonparameter | Proposed device:Neuro Omega | Primary Predicate device:Neuro Omega | Reference device:Nicolet CorticalStimulator | SE comparisondiscussion |
| environment | clinic or nursing home settingor outside of a medical facilityunder direct supervision of amedical professional. Thedevice may also be placed inthe intensive care unit oroperating room for continuousrecording | clinic or nursing home settingor outside of a medical facilityunder direct supervision of amedical professional. Thedevice may also be placed inthe intensive care unit oroperating room for continuousrecording | clinical environment. | Identical.DifferencesSubject device is equivalentto primary predicate device,Nicolet Cortical Stimulatorcan be used within a hospitalor clinical environment. | |
| 7 | Usability andHuman Factors | ISO 62366, IEC 60601-1-6 andFDA draft guidanceUCM259760 June 2011 | ISO 62366, IEC 60601-1-6andFDA draft guidanceUCM259760 June 2011 | Unknown | SimilarityIdentical for Neuro Omegamodified and unmodifieddevicesDifferencesNone |
| 8 | AC PowerSupply | 100-120 V AC,220-240V AC50/ 60 Hz | 100-120 V AC,220-240V AC50/ 60 Hz | 100-120 V AC,220-240VAC50/ 60 Hz | SimilarityIdentical.DifferencesNone |
| 9 | Softwareapplications | GUI, Monitoring, display,Audio, signal processing,Recording, Stimulation control,identify number of channelsconnected. | GUI, Monitoring, display,Audio, signal processing,Recording, Stimulationcontrol, identify number ofchannels connected. | GUI, display, signalprocessing and Stimulationcontrol | SimilarityIdentical.DifferencesNone |
| 10. | Electrical Safety | IEC 60601-1 3rd ED +Risk analysis (ISO 14971) | IEC 60601-1 +Risk analysis (ISO 14971) | IEC 60601-1 | SimilarityTested for same or moreresent safety standardsDifferences |
| # | Comparisonparameter | Proposed device:Neuro Omega | Primary Predicate device:Neuro Omega | Reference device:Nicolet CorticalStimulator | SE comparisondiscussion |
| 11 | Particular safety | IEC 60601-2-10,IEC 60601-2-26,IEC 60601-2-40 +Risk analysis (ISO 14971) | IEC 60601-2-10,IEC 60601-2-26,IEC 60601-2-40 +Risk analysis (ISO 14971) | IEC 60601-1,IEC 60601-2-26 | NoneSimilarityIdentical.DifferencesNone |
| 12 | ElectromagneticCompatibility | IEC 60601-1-2 +Risk analysis (ISO 14971) | IEC 60601-1-2 +Risk analysis (ISO 14971) | IEC 60601-1-2 | SimilarityIdentical.DifferencesNone |
| 13 | Sterility andSterilitystandards | Sterility of the reusablecomponents is performed bythe hospital clinical staff andwas validated to comply withthe following standards: ISO17665-1, ST81 and STERRAD | Sterility of the reusablecomponents is performed bythe hospital clinical staff andwas validated to comply withthe following standards: ISO11135, ISO 10993-7, ST77,ST81, ST67 | Not relevant for the ECoG. | SimilarityIdentical for Neuro Omegamodified and unmodifieddevicesDifferencesFor the modified NeuroOmega system onlySTERRAD sterilization isallowed for HeadStageelectronic components,while in the legally cleareddevice ETO and STERRADwere allowed. |
| 14 | Softwaredevelopmentstandard | ISO 62304 | ISO 62304 | Not relevant for the ECoG. | SimilarityIdentical for Neuro Omegamodified and unmodified |
| # | Comparisonparameter | Proposed device:Neuro Omega | Primary Predicate device:Neuro Omega | Reference device:Nicolet CorticalStimulator | SE comparisondiscussion |
| devicesDifferencesNone | |||||
| 15 | Electrical Class | I | I | Not relevant for the ECoG. | SimilarityIdentical for Neuro Omegamodified and unmodifieddevicesDifferencesNone |
| 16 | Protective Type | BF | BF | BF | SimilarityIdenticalDifferencesNone |
| # | Comparisonparameter | Proposed device:Neuro Omega | Primary Predicate device:Neuro Omega | Reference device:Nicolet CorticalStimulator | SE comparisondiscussion |
| 1 | Legallydistribution clearanceNo. | Subject device | K123796 | K072964 | |
| 2 | Owner | Alpha Omega EngineeringLtd. | Alpha Omega EngineeringLtd. | Cardinal Health, Inc | |
| 3 | DeviceComponents | Main Unit including: MobileRack, Power Supply, IsolationTransformer, PC, Monitor,keyboard, mouse, Speakers,I/O analog/ Digital unit andFront End unit.Head Stage components: HeadBox, Connection Box. DriveHeadStage System, Remotecontrol handpiece, Head stagecables, and single useelectrodes cable. | Main Unit including: MobileTrolley, Power Supply,Isolation Transformer, PanelPC, Monitor, keyboard,mouse, Speakers and FrontEnd unit.Head Stage components: HeadBox module, NeuroDriveSystem, Remote controlhandpiece, Head stagerecording cable, Head stagecables and single useelectrodes cable. | Hand-held unit including;display, power supply andcontrol knob | SimilarityIdentical for Neuro Omegamodified and unmodifieddevicesDifferencesNone |
| 4 | OperatingSystem | Windows 7, 64bit | Same | Not relevant for the ECoGHeadBox. | SimilarityIdentical for Neuro Omegamodified and unmodifieddevicesDifferencesNone |
| 5 | Computer | Touch screen PC | Industrial PC | Not relevant for the ECoG | Similarity |
| # | Comparisonparameter | Proposed device:Neuro Omega | Primary Predicate device:Neuro Omega | Reference device:Nicolet CorticalStimulator | SE comparisondiscussion |
| 6 | TrolleyConnectors | 4 USB ports | 4 USB ports | Not relevant | SimilarityIdentical for Neuro Omegamodified and unmodifieddevicesDifferencesNone |
| 7 | Main Unitsystemconnectors | •Ethernet ports•1 Remote port•2 Audio out | Same | Not relevant | SimilarityIdentical for Neuro Omegamodified and unmodifieddevicesDifferencesNone |
| 8 | Communication | Ethernet protocol | Same | Not relevant | SimilarityIdentical for Neuro Omegamodified and unmodifieddevicesDifferencesNone |
| # | Comparisonparameter | Proposed device:Neuro Omega | Primary Predicate device:Neuro Omega | Reference device:Nicolet CorticalStimulator | SE comparisondiscussion |
| 9 | Peripherals | Microsoft Wireless keyboardand mouse | Wired keyboard and mouse | Not relevant | SimilarityIdentical for Neuro Omegamodified and unmodifieddevicesDifferencesWireless KB and Mouse ismore comfortable thanwired ones |
| 10 | Number ofChannels | •Up to 10 MER channels•Up to 112 EEG/EMG/ECOGchannels. | Same | Not Applicable | SimilarityIdentical for Neuro Omegamodified and unmodifieddevicesDifferencesNone |
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• Technology Comparison
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Image /page/16/Picture/0 description: The image is a logo for Alpha Omega. The logo features the letters "Alpha" in a stylized font, with the "A" in red and the rest of the letters in gray. Below the letters is the phrase "Defining Neuroscience Technology" in a smaller font. The logo is likely used to represent a company or organization that specializes in neuroscience technology.
Based on the performance results provided in this submission (including test results and clinical evaluation) 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
Similarities:
- The Neuro Omega System and the predicate legally cleared Neuro Omega System 1. (K123796) share the same device code and have the same intended use and indications for use for Depth Electrode Recording and Stimulation, EEG and EMG. Both devices are intended for the same body target organs (Human Brain), same population, same users, same operation environment (operation room) and tested for compliance to the same development control, safety standards and use same technologies i.e. main unit base of standard PC with application software.
For cortical recording and stimulation, the legally cleared predicate device, Nicolet Cortical Stimulator (K072964) has the same device code and have the same intended use and indications for use.
The device code and regulation number of the subject device, the modified Neuro Omega, combines the device code and regulation number of the two predicate devices.
Sterileable components (head stage, Drive HeadStage) that are located inside the sterile operation area are intended for re-sterilization by the hospital staff. Sterileable components where validated for cleaning and sterilization procedures described in the manual.
Differences:
-
- In addition to deep brain, cranial surface and body limbs, the modified Neuro Omega may be used mapping the brain by stimulation of the cortical surface, which is equivalent to the predicate device Nicolet Cortical Stimulator (K072964).
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- For the modified Neuro Omega system only STERRAD sterilization is allowed for HeadStage electronic components, while in the legally cleared device ETO and STERRAD were allowed.
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4. Performance Tests For non-clinical performance tests:
| Test | Test Method Summary | Results |
|---|---|---|
| SoftwareVerification | This verification performed on fullsystem, the subject device (SW &HW) including accessories, andchecked that the design outputmeets the SW design input. | Neuro Omega SW has been testedunder a complete SW verification plantraceable to Neuro Omega SRS.All samples passed the acceptancecriteria which determines theeffectiveness of Neuro Omega System,the subject device, with HaGuidesoftware. |
| System Verification | This verification performed on fullsystem, the subject device (SW &HW), and checked that the designoutput meets the system (HW &MECH) design input | Neuro Omega system has beenverified under a complete systemverification plan traceable to NeuroOmega system design input. Allsamples passed the acceptance criteriawhich determines the effectiveness ofNeuro Omega System, the subjectdevice, with HaGuide software. |
| Steam SterilizationValidation | Mechanical accessories of thesubject device | Each test article was evaluated to asterility assurance level (SAL) of ≤ 10-6using the biological indicator (BI)overkill method. Geobacillusstearothermophilus, ATCC #7953, wasthe indicator organism. All test methodacceptance criteria were met.In addition to the SAL validation, drytimes were validated using full cycleparameters. |
| STERRAD NXsterilizationvalidation | Electrical accessories of thesubject device | Each test article was evaluated to asterility assurance level (SAL) of ≤ 10-6using the biological indicator (BI)overkill method. Geobacillusstearothermophilus, ATCC #7953, wasthe indicator organism.Results validate the individual testarticles for the STERRAD® NXstandard cycle. |
| STERRAD 100NXsterilizationvalidation | Electrical accessories of the subjectdevice | Results from testing validate that theAlpha Omega Engineering, Ltd. NeuroOmega Tray is able to achieve a 10-6SAL in a STERRAD® 100NXStandard sterilization process |
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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 Effectivness 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).
Percent agreement between Haguide and Neurosurgeon/Electrophysiologist expert is 90.34% (95% CI, 85.27, 93.85 %)
Correlation between be the HaGuide measurements 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).
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- No adverse events and complications observed in the study ●
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5. Substantial Equivalence Statement
Based on the above, it is Alpha Omega's opinion that the proposed modified Neuro Omega System is substantially equivalent in terms of design principles, performance features and of safety & effectiveness to the predicate legally cleared devices referred to in section 3 of this document.
§ 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).