(226 days)
The Orion LifeSpan™ MEG non-invasively measures the magnetoencephalographic (MEG) (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, and somatosensory in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by the device may be used, in conjunction with other diagnostic data, as an aid in neurosurgical planning.
It is assumed that the users of the Orion LifeSpan™ MEG are physicians or neurology laboratory technicians who have received training in the following areas:
• Hospital procedures
• Physiological monitoring of patients
• Training relevant to the specific discipline or disorder under investigation
Note: This indication for use specifically excludes use of the Orion LifeSpan™ MEG as life support equipment, for example vital signs monitoring in intensive care units.
The Orion LifeSpan™ MEG is a magnetoencephalograph (MEG) which records magnetic signals from the human brain. The Orion LifeSpan™ MEG uses the CURRY software platform (K001781) to acquire, process and display these signals. Optionally EEG can be recorded simultaneously with the MEG using an integrated SynAmps2 (K023771) hardware system.
The Orion LifeSpan™ MEG can optionally be provided with adult, child or both sized helmets.
The Orion LifeSpan™ MEG is used by skilled operators or physicians trained in the acquisition and interpretation of such signals. It is used as an adjunct as part of a range of measurements performed, such as imaging and other studies, to form a more complete picture of the patient's pathology alongside a standard clinical workup.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device Name: Orion LifeSpan™ MEG
Predicate Device: Elekta Neuromag
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Empty-room noise performance: Noise level not greater than the predicate (Elekta Neuromag) | Measured average noise performance was comparable to Elekta Neuromag (Orion: 10.54 fTrms/√Hz; Elekta: 11.31fTrms/√Hz). |
| Phantom Localization Accuracy: Average localization error and maximum localization error less than one standard deviation away from the predicate (0.7mm total error across all 3 dimensions) | Average localization error difference was 0.4mm (Orion: 2.3mm; Elekta: 1.9mm). Maximum localization error difference was 0.5mm (Orion: 4.22mm; Elekta: 3.72mm). Both are less than one standard deviation away (0.7mm). |
| Device Compatibility: Addition of compatible devices (HPI Coils, EEG System, evoked response stimulators) should not significantly increase the noise level and not exceed the noise threshold (10fTrms/√Hz at around 100Hz) | The empty room test results showed that the addition of each compatible device did not significantly increase the noise level of the Orion LifeSpan™ MEG and did not exceed the noise threshold. |
| CURRY Software Verification and Validation: All relevant CURRY Software specifications verified and validated in accordance with IEC 62304:2006. | CURRY Software verification and validation tests show that the CURRY Software supports the Orion device functionalities in a manner comparable to the predicate (i.e., processing, display, localization, MEG control functions). |
| Limited Channel Operation: Average localization error below 2mm, and maximum localization error below 4mm, when operating at 80% full channel capacity. | Average localization error range: 0.05-0.09mm. Maximum localization error range: 0.14-0.17mm when operating without 20% of its channels (80% full channel capacity). These values are well within the specified limits. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "sample size" in terms of number of patients or cases for the non-clinical performance studies. Instead, it describes:
- Empty-room noise performance & Device compatibility tests: Performed using the Orion LifeSpan™ MEG and the predicate Elekta Neuromag devices themselves in an empty, magnetically shielded room. The data provenance includes a specific measurement of the Elekta Neuromag TRIUX MEG at Swinburne University of Technology, dated November 6th, 2019. This indicates retrospective use of the predicate device's data for comparison.
- Phantom Comparison Test: An "identical phantom signal" was recorded with both systems. This implies one or more phantom measurements. Data provenance again includes the Elekta Neuromag TRIUX MEG measured at Swinburne University of Technology.
- Limited Channel Operation Test: Phantom localization testing was performed. The number of phantom trials or repetitions for this test is not specified, but it was performed at three different degrees of channel operation (95%, 90%, and 80% of full channel capacity).
There is no mention of human subject data (clinical data) in these performance studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The ground truth for the non-clinical tests (empty-room noise, phantom localization, device compatibility, software verification) was established by physical measurements and engineering specifications, not by human expert interpretation of medical images or signals.
4. Adjudication Method for the Test Set
Not applicable, as no human expert review or adjudication process was described for establishing ground truth in these non-clinical tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not performed." The studies presented are non-clinical, comparing device performance metrics directly to a predicate device or pre-defined engineering criteria, not evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device, the Orion LifeSpan™ MEG, is a medical instrument (magnetoencephalograph/electroencephalograph with associated software) for measuring brain signals, not an AI algorithm. Therefore, the concept of a "standalone algorithm performance" study as typically understood for AI/ML devices is not directly applicable. The non-clinical studies evaluate the standalone performance of the device itself (noise levels, localization accuracy) against established benchmarks. The CURRY software, while a component, is verified for its functionalities like processing, display, and localization, which are intrinsic to the device's operation.
7. The Type of Ground Truth Used
The ground truth for the non-clinical studies was based on:
- Physical measurements and established engineering benchmarks: For noise levels (fTrms/√Hz).
- Known phantom signal locations: For localization accuracy, where the true source location in the phantom is precisely known.
- Compliance with international standards: IEC 60601-1, IEC 60601-1-2, IEC 80601-2-26, IEC 62304, ISO 14971.
8. The Sample Size for the Training Set
Not applicable. This device is a measurement instrument, not an AI/ML algorithm that requires a "training set" in the context of machine learning. The software component, CURRY, undergoes verification and validation but not "training" in the AI sense.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI/ML algorithm described for this device.
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February 14, 2020
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Compumedics Limited William Alam Quality Engineering Manager 30-40 Flockhart Street Abbotsford, 3067 Au
Re: K191785
Trade/Device Name: Orion LifeSpan™ MEG Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLY, GWQ, OLX Dated: January 10, 2020 Received: January 13, 2020
Dear William Alam:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Jay Gupta, M.S.E. Assistant Director DHT5A: Division of Neurosurgical. Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Orion LifeSpan MEG
Indications for Use (Describe)
The Orion LifeSpan MEG non-invasively measures the magnetoencephalographic (MEG) (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, and somatosensory in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by the device may be used, in conjunction with other diagnostic data, as an aid in neurosurgical planning.
It is assumed that the users of the Orion LifeSpan™ MEG are physicians or neurology laboratory technicians who have received training in the following areas:
• Hospital procedures
- · Physiological monitoring of patients
- · Training relevant to the specific discipline or disorder under investigation
Note: This indication for use specifically excludes use of the Orion LifeSpan™ MEG as life support equipment, for example vital signs monitoring in intensive care units.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| [X] Prescription Use (Part 21 CFR 801 Subpart D) | [] Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------- |
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510(k) Summary
The following 510(k) summary is being submitted in accordance with 21CFR807.92.
| Device Information:Submitter: | Compumedics Limited |
|---|---|
| Address: | 30-40 Flockhart Street, Abbotsford 3067,Victoria, Australia |
| Phone number: | +61 (0) 3 8420 7300 |
| Fax number: | +61 (0) 3 8420 7399 |
| Contact person: | William Alam30-40 Flockhart Street, Abbotsford 3067,Victoria, Australia |
| Phone number: | +61 (0) 3 8420 7300 |
| Fax number: | +61 (0) 3 8420 7399 |
| Date prepared: | June 28, 2019 |
| Trade name: | Orion LifeSpan™ MEG |
| Common name: | Magnetoencephalograph (MEG) |
| Primary product code: | OLY |
| Secondary product code: | GWQ, OLX |
| Device class: | II |
| Regulation numbers: | 21 CFR 882.1400 |
Predicate Device Information:
| Trade Name: | Elekta Neuromag |
|---|---|
| Manufacturer: | Elekta Neuromag Oy |
| 510(k) number: | K041264 |
| Product code: | OLY, GWQ, OLX |
| Device class: | II |
| Regulation numbers: | 21 CFR 882.1400 |
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Device Description
The Orion LifeSpan™ MEG is a magnetoencephalograph (MEG) which records magnetic signals from the human brain. The Orion LifeSpan™ MEG uses the CURRY software platform (K001781) to acquire, process and display these signals. Optionally EEG can be recorded simultaneously with the MEG using an integrated SynAmps2 (K023771) hardware system.
The Orion LifeSpan™ MEG can optionally be provided with adult, child or both sized helmets.
The Orion LifeSpan™ MEG is used by skilled operators or physicians trained in the acquisition and interpretation of such signals. It is used as an adjunct as part of a range of measurements performed, such as imaging and other studies, to form a more complete picture of the patient's pathology alongside a standard clinical workup.
Indications for Use
The Orion LifeSpan™ MEG non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, and somatosensory in the brain when used in conjunction with evoked response stimulators. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by MEG may be used, in conjunction with other diagnostic data, as an aid in neurosurgical planning.
It is assumed that the users of the Orion LifeSpan™ MEG are physicians or neurology laboratory technicians who have received training in the following areas:
*Hospital procedures
*Physiological monitoring of patients
*Training relevant to the specific discipline or disorder under investigation
Note: This indication for use specifically excludes use of the Orion LifeSpan™ MEG as life support equipment, for example vital signs monitoring in intensive care units.
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Substantial Equivalence Discussion
The following technological differences exist between the Orion LifeSpan™ MEG and Elekta Neuromag.
| OrionLifeSpan™ MEG (K191785) | Elekta Neuromag(K041264) | Differences(if any) | |
|---|---|---|---|
| Indications for use | |||
| The Orion LifeSpan™ MEG non-invasivelymeasures the magnetoencephalographic(MEG) signals (and, optionally,electroencephalographic (EEG) signals)produced by electrically active tissue of thebrain. These signals are recorded by acomputerized data acquisition system,displayed, and may then be interpreted bytrained physicians to help localize theseactive areas. The locations may then becorrelated with anatomical information of thebrain. MEG is routinely used to identify thelocations of visual, auditory, andsomatosensory in the brain when used inconjunction with evoked responsestimulators. MEG is also used to non-invasively locate regions of epileptic activitywithin the brain. The localization informationprovided by MEG may be used, inconjunction with other diagnostic data, as anaid in neurosurgical planning.It is assumed that the users of the OrionLifeSpan™ MEG are physicians orneurology laboratory technicians who havereceived training in the following areas:*Hospital procedures*Physiological monitoring of patients*Training relevant to the specific disciplineor disorder under investigationNote: This indication for use specificallyexcludes use of the Orion LifeSpan™ MEGas life support equipment, for example vitalsigns monitoring in intensive care units. | The Elekta Neuromag non-invasively measures themagnetoencephalographic (meg)signals (and, optionally,electroencephalographic eegsignals) produced by electricallyactive tissue of the brain. Thesesignals are recorded by acomputerized data acquisitionsystem, displayed, and may thenbe interpreted by trainedphysicians to help localize theseactive areas. The locations maythen be correlated withanatomical information of thebrain. Meg is routinely used toidentify the locations of visual,auditory, somatosensory, andmotor cortex in the brain. Meg isalso used to non-invasivelylocate regions of epilepticactivity within the brain. Thelocalization informationprovided by meg may be used, inconjunction with otherdiagnostic data, in neurosurgicalplanning. | No significantdifference, exceptthe OrionLifeSpan™ MEGis notrecommended foruse with motorevoked responsestimulators.Assumptionsregarding evokedresponsestimulators, thetypes of userspermitted, and usecase exclusions aremade moreexplicitly clear tofurther ensure safeusage. | |
| Features | OrionLifeSpan™MEG(K191785) | ElektaNeuromag(K041264) | Differences (if any) |
| Technology | |||
| Site ofpatient | Head and Scalp | Head and Scalp | No difference. |
| PatientPosition | Supine | Supine andupright | No significant difference.Upright position is availablemostly for research purposes.Supine position is commonfor MEG study. |
| UnderlyingTechnology | Superconductingmagnetometry | Superconductingmagnetometry | No difference. |
| OverallSensitivity | 10fT/ $√$ Hz | 10fT/ $√$ Hz | No difference. See Non-Clinical Performance Data. |
| MEGSensingLocations | 186 (adult)138 (pediatric) | 102 | No significant difference. |
| SQUIDReadout | Flux locked loop | Flux locked loop | No difference. |
| Features | OrionLifeSpan™MEG(K191785) | ElektaNeuromag(K041264) | Differences (if any) |
| Pickup CoilDesign | Axialgradiometer | Mix of planargradiometersandmagnetometers | Despite difference inorientation, each pickup coiltype measures components ofthe magnetic field generatedfrom the same brain sources.During source estimationthese signals are converted to(for example) equivalentcurrent dipole locations,orientations and strengths.Therefore, there is nosignificant difference arisingfrom the pickup coil designs. |
| AverageCoil-to-CoilSpacing | 27.3 mm (Adult),25 mm(Pediatric)average distanceb/w centers ofeach sensing loc. | 34 mm averagedistancebetween centersof each sensinglocation. | No difference. See Non-Clinical Performance Datafor discussion oflocalization accuracytesting. |
| DetectorArchitecture | DROS SQUID | dc SQUID | No significant difference.DROS SQUID is a type of dcSQUID. |
| InterferenceElimination(i.e., SSS,SPS) | SSP, DSSP | SSP, tSSS (whichhas supersededSSS) | Note that DSSP isconceptually equivalent totSSS in that it usestemporal information toseparate interference fromsignal.1 Therefore, nosignificant difference. |
| HeadPositionIndicator(Y/N) | Y | Y | No difference. |
| Features | OrionLifeSpan™MEG(K191785) | ElektaNeuromag(K041264) | Differences (if any) |
| OfflineAverageFunction toProcessRaw Data | Y | Y | No difference. |
| Number ofSQUIDSensorElements | 186 (adult) 138(pediatric) Eachat a uniquelocation | 306 at 102unique locations | Phantom dipole localizationaccuracy has shown thatsampling density is sufficientin the Orion. Therefore, nofunctionally significantdifference is noted due to thenumber of SQUID elements. |
| Number ofAuxiliaryChannelsfor OtherTypes ofData (i.e.,EEG) | Up to 256unipolar and16 bipolarEEG channelsUp to 8 ADCchannels. | Up to 124unipolar and4 bipolarEEGchannels.Up to 8ADCchannels. | No significant difference,provided that 128 EEGchannels are included withthe Orion, instead of themaximum (256). |
| Method ofCalculation(i.e.,idealized v.individualhead model) | Sphericalconductor modelfor idealizedhead shapes.Individualrealistic headmodels using theBoundaryElement Method(BEM) | Sphericalconductor modelfor idealizedhead shapes.Individualrealistic headmodels using theBoundaryElement Method(BEM) | No difference. |
| Features | OrionLifeSpan™MEG(K191785) | ElektaNeuromag(K041264) | Differences (if any) |
| SourceEstimateMethods | ECD for clinicalanalysis.Single- and multi-dipole timevarying sourceestimates. | ECD for clinicalanalysis.Single- and multi-dipole timevarying sourceestimates. | Equivalent Current Dipole(ECD) localization is theprimary method of sourcecalculation used in clinicalMEG. Various other methodsare available both from theCURRY software and in thesoftware included with theElekta MEG, but these are notgenerally used for clinicalapplications. |
| Forward (orinverse)head models | See above two rows/No differences | ||
| Design | |||
| PatientPopulation | Adult andpediatric | Adult | No significant difference. Thepediatric helmet is simply thesame as adult helmet exceptthe number of sensor and size. |
| Coverage | Whole cortex | Whole cortex | No difference. |
| CryogenUsed | Liquid Helium | Liquid Helium | No difference. |
| PowerSource | Mains power | Mains power | No difference. |
| Software | CURRYMultimodalNeuroimagingSoftware | Elekta NeuromagData AcquisitionSoftware | A clinical study that showsElekta Neuromag iscompatible with CURRYsoftware can be found ondocument VOL_020_017. |
| DataAcquisition | SynAmps2 | Inbuilt | A clinical study that showsElekta Neuromag iscompatible with SynAmps2for data acquisition can befound on documentVOL_020_017. |
| Features | OrionLifeSpan™MEG(K191785) | ElektaNeuromag(K041264) | Differences (if any) |
| MinimumRoom Height | 2.1m | 2.3 m | No significant difference. |
| 60601-1Classification | Type BF | Type BF | No difference. |
| Material | |||
| DewarHelmetMaterial | Fiberglasscomposite | Fiberglasscomposite | No difference. |
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1 Sekihara, K., Kawabata, Y., Ushio, S., Sumiya, S., Kawabata, S., Adachi, Y. and Nagarajan, S.S., 2016. Dual signal subspace projection (DSSP): a novel algorithm for removing large interference in biomagnetic measurements. Journal of neural engineering, 13(3), p.036007.
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Non-Clinical Performance Data
The following non-clinical performance data were provided in support of the substantial equivalence determination.
| Test | Test method summary | Results |
|---|---|---|
| Empty-roomnoiseperformancecomparisontesting | Compare the noise floor of theOrion LifeSpan™ MEG to that ofthe Elekta Neuromag usingspectral analysis.2 The MEGsystem was activated in an emptymagnetically shielded room(MSR), and noise spectra acrossclinically relevant frequencies(0.5-50 Hz, per the IEC60601-2-26 standard) wererecorded. The average noise levelshould not be greater than the(predicate). | The measured average noiseperformance was comparable tothat of the Elekta Neuromag(Orion: 10.54 fTrms/√Hz;Elekta: 11.31fTrms/√Hz) |
| PhantomComparisonTest | Compare the localizationaccuracy of the Orion LifeSpan™MEG and Elekta Neuromag bytaking an identical phantom signaland recording it with bothsystems. 2 The averagelocalization error and themaximum localization error needsto be less than one standarddeviation away from that of thepredicate (0.7mm, total erroracross all 3 dimensions). | The localization accuracy resultswere less than one standarddeviation away from the ElektaNeuromag. The averagelocalization error difference was0.4mm (Orion: 2.3mm; Elekta:1.9mm), and maximumlocalization error difference was0.5mm (Orion: 4.22mm; Elekta:3.72mm). |
| DeviceCompatibilityTest | The Orion LifeSpan™ MEG wastested upon integration ofcompatible devices (HPI Coils,EEG System, and evokedresponse stimulators, includingSomatosensory, Visual andAuditory). Standard empty roomrecordings with each compatibledevice configuration were made.The average noise level (around100Hz) of each deviceconfiguration was compared withthe reference noise threshold(10fTrms/ $\sqrt$ Hz). | The empty room test resultsshowed that the addition of eachcompatible device did notsignificantly increase the noiselevel of the Orion LifeSpan™MEG when used withoutcompatible devices, nor didintegration of each device resultin exceeding the noise threshold(at around 100Hz). |
| CURRYSoftwareVerificationandValidationtests | All relevant CURRY Softwarespecifications were verified andvalidated in accordance with IEC62304:2006. | CURRY Software verificationand validation tests show that theCURRY Software supports theOrion device functionalities in amanner comparable to thepredicate, (i.e., processing,display, localization, MEGcontrol functions). |
| LimitedChannelOperationTest | Phantom localization testingwas performed to demonstratedevice functionality and abilityto meet source localizationaccuracy criteria whileoperating at three differentdegrees of channel operation(95%, 90%, and 80% of fullchannel capacity). The averagelocalization error needs to bebelow 2mm, and the maximumlocalization error needs to bebelow 4mm. | The limited channel operation testdemonstrates the devicefunctionality and ability to meetsource localization accuracycriteria ( average localizationerror range: 0.05-0.09mm;maximum localization errorrange: 0.14-0.17mm) whenoperating without 20% of itschannels (80% full channelcapacity). |
2 The Elekta Neuromag TRIUX MEG was measured at Swinburne University of Technology. Data dated: November 6th, 2019
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Additionally, evaluations were conducted in accordance with the following performance standards:
- · IEC 60601-1:2005+A1: 2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance.
- . IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests
- IEC 80601-2-26:2019 Medical electrical equipment Part 2-26: Particular . requirements for the basic safety and essential performance of electroencephalographs
- IEC 62304:2006 Medical device software Software lifecycle process .
- ISO 14971:2007 Medical devices Application of risk management to . medical devices
Clinical Performance Data
Clinical testing was not performed.
Conclusion
Based on the non-clinical performance, the Orion LifeSpan™ MEG was found to have a safety and effectiveness profile that is similar to the predicate device. The Orion LifeSpan™ MEG also demonstrates meeting the same minimum safety and performance requirements for medically acceptable, commercial MEGs.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).