(179 days)
ISIS Headbox 5042xx products:
The products are intended for intraoperative neuromonitoring; for recording of electrophysiological signals and stimulating of nerve and muscle tissues.
The products are intended for use in the operating room to measure and display the electrical signals generated by muscle, peripheral nerves and the central nervous system. The products support the clinical application of Electroencephalography (EEG), Electromyography (EMG), Somatosensory Evoked Potentials (SEP), Motor Evoked Potentials (MEP), and Auditory Evoked Potentials (AEP).
The products are not intended for monitoring life-sustaining functions.
ISIS Neurostimulator 504180:
The ISIS Neurostimulator is intended for provision of neurophysiological stimulation when used in surgical procedures and for diagnostics. It is suitable for continuous operation and can be used in the following fields:
- Transcranial electrical stimulation (TES)
- Direct cortical stimulation (DCS)
- Direct nerve stimulation (DNS)
- Transcutaneous electrical nerve stimulation (TNS)
- Direct muscle stimulation (DMS)
The ISIS Headboxes and the ISIS Neurostimulator constitute multimodality intraoperative neuromonitoring systems called ISIS IOM Systems. These systems consist of custom stimulation and recording hardware, a standard laptop or desktop personal computer running an off-the-shelf operating system, and operating software called NeuroExplorer. As an option, these systems mount on device carriers or housings tailored for intraoperative use.
The ISIS IOM Systems support the following measurement modalities:
- Auditory Evoked Potentials
- Transcranial and cortical Motor Evoked Potentials
- Somatosensory Evoked Potentials
- Freerunning and triggered Electromyography
- Electroencephalography
- Train of Four
The provided text describes a 510(k) summary for the Inomed Medizintechnik GmbH's "ISIS Headboxes and ISIS Neurostimulator" (ISIS IOM Systems: ISIS Xpert®, ISIS Xpert®Plus, ISIS Xpress). This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device (Cadwell Industries Inc./Cascade Intraoperative Monitor K162199).
Crucially, this document does not contain acceptance criteria or a study proving device performance in the way a clinical study for a new diagnostic or AI-driven imaging device would. Instead, it focuses on demonstrating substantial equivalence to a predicate device through engineering performance testing (bench testing, electrical safety, EMC, software validation) and a comparison of technical specifications and intended uses.
Therefore, I cannot populate all sections of your requested table and provide information on aspects like sample size for test sets, ground truth establishment, expert adjudication, or MRMC studies, as these types of studies were explicitly not performed for this 510(k) submission. The document states: "No additional clinical testing was performed for the ISIS Headboxes and ISIS Neurostimulator... Therefore, this section does not apply."
Here's the information that can be extracted relevant to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission relying on engineering performance and comparison to a predicate, the "acceptance criteria" are primarily adherence to relevant electrical safety and electromagnetic compatibility (EMC) standards, and meeting predetermined specifications during bench testing and software validation. The "reported device performance" is the successful compliance with these standards and specifications.
| Acceptance Criteria Type | Specific Criteria / Standard | Reported Device Performance | Notes |
|---|---|---|---|
| Software Validation | - Compliance with predetermined specifications. - Adherence to FDA guidance: "The content of premarket submissions for software contained in medical devices, May 11, 2005" - Adherence to FDA guidance: "Off-the-shelf software use in medical devices, Sep 27, 2019" - Adherence to FDA guidance: "General principles of software validation: Final guidance for industry and FDA staff, Jan 02, 2002" - Adherence to FDA guidance: "Content of premarket submissions for management of cybersecurity in medical devices. Oct 02, 2014" - Adherence to IEC 62304:2006, Medical device software - Software life cycle processes | "Test results demonstrate that the inomed NeuroExplorer Software complies with its predetermined specifications, the applicable guidance documents, and standards." | The software ("NeuroExplorer") is categorized as a "MODERATE level of concern software." |
| Electrical Safety | - Compliance with IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (or IEC 60601-1: 2012 reprint). - Compliance with IEC 80601-2-26:2019 (electroencephalographs). - Compliance with IEC 60601-2-40:2016 (electromyographs and evoked response equipment). | "Test results demonstrate that the products comply with the applicable standards." | The document compares specific technical aspects like A/D resolution, hardware bandpass, sampling frequency, notch filter, CMRR, and amplifier noise to the predicate device, indicating equivalent or compliant performance with relevant standards. |
| Electromagnetic Compatibility (EMC) | - Compliance with IEC 60601-1-2:2014. | "Test results demonstrate that the products comply with the applicable standards." | |
| Bench/Performance Testing | - Fulfillment of requirements formulated at multiple levels: electrical medical systems, system carrier, amplifier (Headboxes) and stimulator (Neurostimulator) modules, operating software (NeuroExplorer) incl. firmware, and accessories. - Assessment of human factors influence on safety. | "The products successfully underwent the bench testing to confirm the fulfillment of the requirements at these levels as part of the verification and validation process." "The testing of the influence of human factors on the devices demonstrates that the products are safe to use and that no further improvement of the user interface design relating to safety is necessary." | This testing is internal to the manufacturer's verification and validation process. The specific quantitative "requirements" are not detailed in this public summary but are typically part of internal design specifications. |
| Biocompatibility | N/A | N/A | The devices do not have patient contact materials, therefore testing was not applicable. |
2. Sample Size Used for the Test Set and the Data Provenance
This information is not applicable and not provided in the document. As stated, "No additional clinical testing was performed for the ISIS Headboxes and ISIS Neurostimulator... Therefore, this section does not apply." The testing described are engineering verification and validation tests, not clinical studies with patients or data sets in the typical sense for AI/diagnostic devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable. The performance testing was based on engineering standards and internal requirements, not expert-established ground truth from clinical data.
4. Adjudication Method for the Test Set
This information is not applicable. There was no clinical test set requiring adjudication in the context of this 510(k) submission.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. This device is an intraoperative neuromonitoring system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting AI output.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is an intraoperative neuromonitoring system, not primarily an algorithm performing a standalone diagnostic task. Its function is to measure and display electrophysiological signals and provide stimulation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth or reference for device performance was established through engineering standards, technical specifications, and internal functional requirements. For example, electrical outputs meet specified ranges, and input signals are recorded with specified fidelity according to IEC standards. This is not clinical ground truth (e.g., pathology report, expert diagnosis).
8. The Sample Size for the Training Set
This information is not applicable. The document does not describe the use of an AI algorithm that requires a training set in the context of a machine learning model for diagnosis or interpretation. The software validation refers to standard software development practices, not AI model training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there was no mention of a training set for an AI algorithm.
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January 7, 2022
Image /page/0/Picture/1 description: The image contains the logo of 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
inomed Medizintechnik GmbH Tomasz Moszkowski, PhD Product Manager IOM Im Hausgruen 29 Emmendingen, 79312 Germany
Re: K212166
Trade/Device Name: ISIS Headboxes and ISIS Neurostimulator (ISIS IOM Systems: ISIS Xpert®, ISIS Xpert®Plus, ISIS Xpress) Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF Dated: December 2, 2021 Received: December 6, 2021
Dear Alexander Maier:
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
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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) 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 (OS) 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 mediation-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 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
ISIS Headboxes and ISIS Neurostimulator (ISIS IOM Systems: ISIS Xpert®, ISIS Xpert®Plus, ISIS Xpress)
Indications for Use (Describe) ISIS Headbox 5042xx products:
The products are intended for intraoperative neuromonitoring; for recording of electrophysiological signals and stimulating of nerve and muscle tissues.
The products are intended for use in the operating room to measure and display the electrical signals generated by muscle, peripheral nerves and the central nervous system. The products support the clinical application of Electroencephalography (EEG), Electromyography (EMG), Somatosensory Evoked Potentials (SEP), Motor Evoked Potentials (MEP), and Auditory Evoked Potentials (AEP).
The products are not intended for monitoring life-sustaining functions.
ISIS Neurostimulator 504180:
The ISIS Neurostimulator is intended for provision of neurophysiological stimulation when used in surgical procedures and for diagnostics. It is suitable for continuous operation and can be used in the following fields:
- Transcranial electrical stimulation (TES)
- Direct cortical stimulation (DCS)
- Direct nerve stimulation (DNS)
- Transcutaneous electrical nerve stimulation (TNS)
- Direct muscle stimulation (DMS)
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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ISIS Headboxes and ISIS Neurostimulator
510(k) Summary
| SubmissionDate: | 07 July 2021 | |||
|---|---|---|---|---|
| 510(k) Holder: | inomed Medizintechnik GmbH | |||
| Im Hausgrün 29 | ||||
| 79312 Emmendingen, Germany | ||||
| Submitter andApplicationCorrespondent: | Tomasz Moszkowski, Ph.D.Phone: +49 7641 6414 583Email: t.moszkowski@inomed.com | |||
| ManufacturingSite: | inomed Medizintechnik GmbHIm Hausgrün 2979312 Emmendingen, Germany | |||
| Trade Name: | ISIS Headboxes and ISIS Neurostimulator(ISIS IOM Systems: ISIS Xpert®, ISIS Xpert®Plus, ISIS Xpress) | |||
| Common andClassificationName: | Evoked response stimulator and intraoperative monitor | |||
| ClassificationRegulation: | Primary: 21 CFR §882.1870Secondary: 21 CFR §882.1400, 21 CFR §882.1375, 21 CFR §882.1900 | |||
| Product Code: | GWF | |||
| SubsequentProduct Codes: | GWJ, GWQ, ETN, IKN | |||
| RegulationMedicalSpecialty: | Neurology | |||
| SubstantiallyEquivalentDevices: | Predicate Device: | PredicateNumber | 510(k)Model | Manufacturer/ |
| K162199 | Cadwell Industries Inc./CascadeIntraoperative Monitor | IOMAX |
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| Device Description: | The ISIS Headboxes and the ISIS Neurostimulator constitute multimodality intraoperative neuromonitoring systems called ISIS IOM Systems. These systems consist of custom stimulation and recording hardware, a standard laptop or desktop personal computer running an off-the-shelf operating system, and operating software called NeuroExplorer. As an option, these systems mount on device carriers or housings tailored for intraoperative use.The ISIS IOM Systems support the following measurement modalities:- Auditory Evoked Potentials- Transcranial and cortical Motor Evoked Potentials- Somatosensory Evoked Potentials- Freerunning and triggered Electromyography- Electroencephalography- Train of Four | ||||||
|---|---|---|---|---|---|---|---|
| Intended Use and Indications for Use: | ISIS Headbox 5042XX:The products are intended for intraoperative neuromonitoring; for the recording of electrophysiological signals and stimulating nerve and muscle tissues.The products are intended for use in the operating room to measure and display the electrical signals generated by muscle, peripheral nerves, and the central nervous system. The products support the clinical application of Electroencephalography (EEG), Electromyography (EMG), Somatosensory Evoked Potentials (SEP), Motor Evoked Potentials (MEP), and Auditory Evoked Potentials (AEP).The products are not intended for monitoring life-sustaining functions.The members of the ISIS Headbox 5042XX family and their indications for use are listed as follows:Table 1: Product-specific indications for the use of the ISIS Headbox 5042XX medical product family Product Indications 504285 ISIS Headbox 8 Ch. DIF – 8 Ch. REF – AEP EEG, SSEP, AEP, EMG, MEP 504381 ISIS Headbox 16Ch. REF AEP EEG, SSEP, AEP |
EMG, MEP EEG, SSEP
504271 ISIS Headbox 16 Ch. DIF
504261 ISIS Headbox 16Ch. REF
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Image /page/5/Picture/0 description: The image shows the logo for Inomed. The logo consists of the word "inomed" in a bold, sans-serif font, with a small square containing a stylized "i" to the right. Below the logo is the website address "www.inomed.com" in a smaller font.
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ISIS Neurostimulator 504180:
The ાડાડ Neurostimulator is intended for the provision of neurophysiological stimulation when used in surgical procedures and for diagnostics. It is suitable for continuous operation and can be used in the following fields:
- Transcranial electrical stimulation (TES) --
- -Direct cortical stimulation (DCS)
- -Direct nerve stimulation (DNS)
- -Transcutaneous electrical nerve stimulation (TNS)
- Direct muscle stimulation (DMS) -
Comparison of Intended Use and Indications for Use:
The ISIS Headboxes and ISIS Neurostimulator including accessories as part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress) are equivalent in terms of intended use and indications for use to the predicate device. Compared to the predicate device, the subject device is not intended for measuring visually evoked potentials (VEP), galvanic skin response, heart rate, and oxygen saturation (SpOz). These differences, however, do not result in deteriorated clinical performance of the subject device in terms of its intended use nor do they raise questions in terms of safety. The current performance corresponds to the state of the art and adheres to up-to-date guidelines of intraoperative neuromonitoring.
| Subject devices | Predicate device | Claimed Equivalence | |
|---|---|---|---|
| System | ISIS Headbox 5042XXand ISISNeurostimulator | Cascade IOMAX | - |
| Manufacturer | inomed MedizintechnikGmbH | Cadwell Industries, Inc. | - |
| Picture | Image: ISIS Headbox 5042XX and ISIS Neurostimulator | Image: Cascade IOMAX | - |
| 510(k)Number | K212166 | K162199 | - |
| Device Class | II | II | Equal |
| ProductCode | GWF | GWF | Equal |
| SubsequentProductCodes | GWJ, GWQ, ETN, IKN | DQA, ETN, GWE, GWJ,GWQ, GZO, IKN, JXE, OLT | GWJ – EqualGWQ – EqualETN – EqualIKN – EqualGWE, DQA, GZO, JXE, OLT are not within thescope of the intendeduse and indications forthe use of the ISISHeadbox and ISISNeurostimulator |
| Main function, site of usage, intended user group | |||
| Mainfunction | ISIS Headboxes5042XX:"The products areintended for use in theoperating room tomeasure and display theelectrical signalsgenerated by muscle,peripheral nerves andthe central nervoussystem." | "The Cascade IOMAXTMIntraoperative Monitor withSurgical Studio software(IOMAX) is anelectroneurodiagnostic devicethat acquires, displays andstores physiologic data fromperipheral sensory and motornerves, muscles and thecentral nervous system,generated eitherspontaneously or elicited bywell-defined stimuli." | EqualBoth the predicate andsubject devices canacquire, display andstore physiologic datafrom peripheral nerves,muscles and the centralnervous system. |
| Site of usage | ISIS Headboxes5042XX:"The products areintended forintraoperativeneuromonitoring""The products areintended for use in theoperating room (...)" | "IOMAX is used (...) in aprofessional healthcare facilityenvironment for pre-operative,intraoperative andpost-operative testing." | EquivalentThe predicate and thesubject device areintended forintraoperative testing.The Cadwell IOMAXmay in addition be usedfor pre-operative andpost-operativemonitoring, which thesubject device is notintended for. Thisdifference is clearlystated within theintended use statementof the subject deviceand thus does not raisequestions in terms ofproduct safety andeffectiveness. |
| Intendeduser group | Neurophysiologists(clinicalneurophysiologists,neurosurgeons,neurologists or medicaltechnical assistants forfunctional diagnostics) | "IOMAX is used by or underthe direction of a licensedphysician, surgeon, orneurologist (...)" | EquivalentBoth the predicate andsubject devices may beused by licensedphysicians (the ISISHeadbox intended usestatement specifies the |
| physicians to personswith clinicalneurophysiologicbackground andmedical technicalassistants) andneurologists. Also, boththe predicate andsubject devices may beused by surgeons. Thenotion is morespecifically stated withinthe documentation ofthe ISIS Headbox, i.e., itrestricts the use toneurosurgeons that arelicensedneurophysiologists. | |||
| Indended Use and Indications for Use | |||
| Intended use | ISIS Headbox 5042XX:"The products areintended forintraoperativeneuromonitoring; for therecording ofelectrophysiologicalsignals and stimulatingof nerve and muscletissues. (...)"ISIS Neurostimulator504180:"The ISISNeurostimulator isintended for theprovision ofneurophysiologicalstimulation when used insurgical procedures andfor diagnostics. (...)" | "The Cascade IOMAX™Intraoperative Monitor withSurgical Studio software(IOMAX) is anelectroneurodiagnostic devicethat acquires, displays andstores physiologic data fromperipheral sensory and motornerves, muscles and thecentral nervous system,generated eitherspontaneously or elicited bywell-defined stimuli. (...)The system also delivers directnerve stimulation required forspecific surgical procedures." | EqualBoth the subject andpredicate device areintended for therecording ofelectrophysiologicalsignals and stimulationof nerve and muscletissues duringintraoperativeneuromonitoring. |
| Indicationsfor use | ISIS Headbox 5042XX:"The products supportthe clinical application of(...) Auditory EvokedPotentials (AEP) (...)"ISIS Neurostimulator504180:The ISISNeurostimulator isintended for theprovision ofneurophysiologicalstimulation (...). It issuitable for continuousoperation and can beused in the followingfields:- Transcranialelectricalstimulation (TES) | "Evoked Potentials (Eps):IOMAX provides electrical,auditory or visual stimulation(...). " | EquivalentBoth the subject andpredicate device areintended for provision ofelectrical and auditorystimulation. The ISISHeadbox 504281 and504285 incorporate anAEP stimulator. TheISIS Neurostimulator isintended to be used fordifferent modes ofelectrical stimulation.The modes of electricalstimulation in the ISISNeurostimulator aredescribed in more detailwith regard to TES,DCS, DNS, TNS, andDMS than within thestatement of Cadwell |
| - Direct cortical stimulation (DCS)- Direct nerve stimulation (DNS)- Transcutaneous electrical nerve stimulation (TNS)- Direct muscle stimulation (DMS) | difference in the formulation of the statement and it doesnot raise questions in terms of device safety and effectiveness.The subject device is not intended for VEP stimulation and recording. | ||
| ISIS Headbox 5042XX:"The products support the clinical application ofElectroencephalography (EEG)" | "EEG: IOMAX measures, displays, records, and stores electrical activity of the brain from two or more electrodes on the head." | EqualBoth the subject and predicate devices are intended for electroencephalography (EEG). | |
| ISIS Headbox 5042XX:"The products support the clinical application of(...) Electromyography (EMG)." | "Free Run EMG: IOMAX acquires, displays, records, and stores spontaneous EMG activity of motor nerves by continually displaying a live stream of mechanically induced myotome contractions." | EqualBoth the subject and predicate devices are intended for electromyography (EMG). | |
| ISIS Headbox 5042XX:"The products support the clinical application of(...) Motor Evoked Potentials (MEP)."ISIS Neurostimulator 504180:"It is suitable for continuous operation and can be used in the following fields: (...) transcranial electrical stimulation (TES)." | "TcMEP: IOMAX delivers transcranial stimulation via dedicated outputs for intraoperative assessment." | EqualBoth devices are capable of delivering transcranial stimulation via dedicated outputs.The ISIS Headbox is capable of recording MEP signals during transcranial electrical stimulation provided by the ISIS Neurostimulator. | |
| ISIS Neurostimulator 504180:"It is suitable for continuous operation and can be used in the following fields: (...) direct cortical stimulation (DCS)." | "Cortical Stimulation: IOMAX delivers Low Current Stimulation (LCS) during surgical procedures to map various areas of the cortex." | EqualBoth devices are capable of delivering electrical current for direct cortical stimulation. | |
| ISIS Headbox 5042XX:"The products support the clinical application of(...) Electromyography (EMG)."ISIS Neurostimulator 504180:"It is suitable for continuous operation and can be used in the following fields: (...) direct nerve stimulation (DNS)." | "Triggered EMG (TEMG): IOMAX electrically stimulates the motor nerves, and displays, records, and stores the resulting compound muscle action potentials in the innervated muscle." | EqualBoth devices are capable of measuring triggered EMG signals.The subject devices achieve this by combining the EMG measurement using the ISIS Headboxes and direct nerve stimulation (DNS) using the ISIS Neurostimulator. | |
| ISIS Headbox 5042XX:"The products areintended for use in theoperating room tomeasure and display theelectrical signalsgenerated by muscle,peripheral nerves andthe central nervoussystem."ISIS Neurostimulator504180:"The ISISNeurostimulator isintended for theprovision ofneurophysiologicalstimulation (...) in thefollowing fields: (...)Direct nerve stimulation(DNS)." | "Nerve Conduction Study(NCS): IOMAX measures,displays, records, and storessensory and motor nerveconduction time (latency) byapplying a stimulus toperipheral nerves, the spinalcord, and the central nervoussystem." | EquivalentBoth devices can beused to apply stimuli tothe peripheral nervesand to the centralnervous system. Thesubject device iscapable of measuring,displaying and storingelectrical signalsgenerated by peripheralnerves (for which thenerve conductionvelocity is normallymeasured). The subjectdevice can alsomeasure the latencyand latency differencesbetween evokedpotentials from differentsources. This differencecan be used to calculatethe nerve conductionvelocity. The calculatedresult is, however, notdirectly stored. Thisdifference does notpose any questions interms of safety andperformance, becausethe user can still performthe nerve conductionvelocity measurementand document theresults within the patientreport via manualcomment input. | |
| ISIS Headboxes5042XX:"The products supportthe clinical application of(...) Electromyography(EMG)."ISIS Neurostimulator504180:"The ISISNeurostimulator isintended for theprovision ofneurophysiologicalstimulation (...) in thefollowing fields: (...)transcutaneouselectrical nervestimulation (TNS)." | "Train of Four (TOF) or TwitchTest: IOMAX delivers a train offour pulses and measures,displays, records, and storesthe compound muscle actionpotential amplitude fade foranalysis." | EqualBoth products can beused for performingtwitch tests in order tomeasure the level ofmuscle relaxation due tomuscular blockers. Thismeasurement isperformed by employinga simultaneoustranscutaneouselectrical nervestimulation and EMGmeasurement. Althoughthe indications for usestatement of the subjectdevice does notexplicitly refer to theTOF measurement, themodality is availablewithin the device design(software) and theproduct labelling. Thisdifference in theformulation of theindications for use | |
| statement does notpose any questions interms of safety andperformance. | |||
| ISIS Headbox 5042XX:"The products are notintended for monitoringlife-sustainingfunctions." | "SpO2: IOMAX measures anddisplays oxygen saturation andheart rate information. RemoteReader: IOMAX providespassive, real time remotereview of intraoperativemonitoring for a physicianoutside of the operating room." | Not applicableThe subject device isnot intended formeasuring anddisplaying oxygensaturation and heartrate. Vital parametermeasurement is out ofscope of the subjectdevice. SpO2 and heartrate measurements areone of severalphysiologicalparameters that arenormally tracked byanesthesia andavailable for IONMpersonnel to considerwhen interpretingneurophysiologicsignals. The IONMguidelines published upto date do not specifythe SpO2 monitoring asa required component ofneurophysiologicmonitoring systems(MacDonald et al., 2013,2019; Nuwer et al.,2012; Sutter et al., 2007;Tyner, FS., 1994). |
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Technology The ISIS Headboxes and ISIS Neurostimulator including accessories Comparison: as part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress) and the predicate device are equivalent in terms of the technological characteristics. Among others, the technological differences exist predominantly within the technology used for signal
recording and electrical stimulation.
The subject device can acquire physiological signals with a sampling rate and bandwidth lower than the predicate devices but using a higher number of recording channels. The differences in the recording technology do not raise questions in terms of performance because both the subject and predicate device employ oversampling and are capable of measuring signals within the clinically relevant bandwidth.
The stimulator of the subject device can deliver more energy than the predicate device, which results from the subject device being able to supply longer stimulation pulses or pulses at a higher frequency than the predicate. This is although the predicate can provide a higher current intensity in TcMEP mode than the subject device. This difference does not raise questions in terms of safety of the subject
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device because the resulting current densities for the cleared accessories are equivalent to those of the predicate device. Moreover, clinical performance is assured because the performance specifications of the predicate and subject devices fall within the wide range of stimulation parameters, pulse widths and intensities that are employed by well-established clinical methods to elicit physiological responses relevant for intraoperative neuromonitoring.
The technological differences do not raise questions in terms of safety and effectiveness of the device and are substantially equivalent for the use of the device for intraoperative neuromonitoring.
| Subject device | Predicate device | ||||
|---|---|---|---|---|---|
| System | ISIS Headbox 5042XX and ISISNeurostimulator | Cascade IOMAX | |||
| Manufacturer | inomed Medizintechnik GmbH | Cadwell Industries, Inc. | |||
| Technical aspects | |||||
| Protectionagainstelectrical shock | Class I protection | Class I protection | |||
| Protectionagainstelectrical shock ofpatient leads | Device type BF (Body Floating) | Device type BF (Body Floating) | |||
| Systemconfiguration | Computer-based equipment withdedicated hardware and softwarecomponents | Computer-based equipment withdedicated hardware and softwarecomponents | |||
| Signal recording | |||||
| Measurementprinciple | Amplifiers based on differential(bipolar) and referential (unipolar)type of recording | Amplifiers based on differential (bipolar)and referential (unipolar) type of recording | |||
| Amplifiercomponents | Desired combination of ISISHeadboxes with a total of 64channels | One (1) Cortical ModuleUp to four (4) Limb Modules | |||
| Up to 64: | Up to 48: | ||||
| Module | Channels | Module | Channels | ||
| ISIS Headbox16 Ch. REF(504261) | Unipolar: 16Bipolar: 0 | Cortical Module | Unipolar: 13Bipolar: 3 | ||
| Number ofamplifierchannels | ISIS Headbox16 Ch. DIF(504271) | Unipolar: 0Bipolar: 16 | Limb Module | Unipolar: 0Bipolar: 8 | |
| ISIS Headbox16 Ch. REF –AEP (504281) | Unipolar: 16Bipolar: 0 | ||||
| ISIS Headbox 8Ch. DIF – 8 Ch.REF – AEP(504285) | Unipolar: 8Bipolar: 8 |
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| A/Dresolution | 16-bit | 16-bit |
|---|---|---|
| Hardwarebandpass | Hardware high-pass filter:0.5-120 Hz on all modulesHardware low-pass filter:2500, 5000 Hz on all modules | Hardware high-pass filter:0.3-100 Hz on cortical module0.5-100 Hz on limb moduleHardware low-pass filter:30-5000 Hz on cortical module30-10000 Hz on limb module |
| Samplingfrequency | 20 kHz | 25 kHz |
| Notch filter | 50, 60 Hz | 50, 60 Hz |
| Common-moderejection ratio(CMRR) | > 100 dBConformant with IEC 80601-2-26:2019, clause 201.12.1.106Common mode rejection. | > 115 dBConformant with IEC 60601-2-26:2012clause 201.12.1.101.5 Common moderejection |
| Amplifiernoise | Conformant with IEC 80601-2-26:2019, clause 201.12.1.104Input noise | Conformant with IEC 60601-2-26:2012clause 201.12.1.101.3 Input noise |
| Stimulation | ||
| TcMEPstimulation | Realized by High CurrentStimulator (HC) intranscranial stimulationmode | Realized by Cortical Module in TcMEPmode |
| Stimulatortype | Current controlled | Current controlledand optional voltage controlled |
| No. ofoutputs | 12 | 9 |
| Stimulationintensity (I)and pulsewidth (PW) | Current controlled: up to 250 mA(voltage limit of 410 V)Voltage controlled: n/a | Image: Pulse width diagram |
| Current controlled: up to 1500 mA (voltagelimit of 1000 V)Voltage controlled: up to 1000 V | ||
| 0.05 - 0.5 ms | ||
| Intensity step | Constant current: 0.1 mAConstant voltage: n/a | Constant current: 10 mAConstant voltage: 5 V |
| No. ofstimuluspulses | 1-9 | 1-9 |
| Stimulationfrequency (f)range | Image: Stimulation frequency diagram | |
| Limitation ofstimulationfrequency | 1/10 pulse width to stimulationperiod ratio | None |
| Limitation ofinter-stimulusinterval | Image: ISI | Image: Pulses |
| Absoluteminimuminter-stimulusinterval | Limited to ½ pulse width to ISI | Minimum ISI: 0.1 ms0.1 ms |
| Maximumcharge perphase | 189.66 μC | 750 μC |
| MaximumRMSstimulationintensity | 30 mA RMS | 7.1 mA RMS |
| Minimumelectrode size | 0.39 cm² | Low EP: 0.04 cm²TcMEP: 0.5 cm |
| Maximumcurrentdensity | 76.92 mA/cm² | Low EP: 90.8 mA/cm²TCMEP: 14.1 mA/cm² |
| Maximumchargedensity | 61.5 μC/cm² | Low EP: 275 μC/cm²TCMEP: 100 μC/cm² |
| Maximumpowerdensity | 160 W/cm² | Low EP: 10 W/cm²TCMEP: 2,000 W/cm² |
| Powerlimitation | ≤50 mJ/pulseConformant to IEC 60601-2-40:2016, clause 201.12.4.103. | ≤50 mJ/pulseIEC 60601-2-40:1998 (1st ed.), clause201.12.4.103. |
| High-currentstimulator forSEP and TOF | Realized by High CurrentStimulator (HC) in subcutaneousstimulation (SEP, TOF) mode | Realized by Limb Module in High EP mode |
| Stimulatortype | Constant current | Constant current |
| No. ofoutputs | 12 | 5 |
| Stimulationintensity (I) | Image: Stimulation intensity | Image: Stimulation intensity |
| Up to 75 mA | Up to 100 mA | |
| Intensity step | 0.1 mA | 0.5 mA |
| Pulse width(PW) | 0.05 – 2 ms | 0.05 – 1 ms |
| No. ofstimuluspulses | 1-9 | 1 |
| Stimulationfrequency (f)range | Image: Stimulation frequency diagram | Image: Stimulation frequency diagram |
| SEP: Up to 500 HzTOF: 2 Hz (fixed) | Up to 50 Hz | |
| Limitation ofstimulationfrequency | 1/10 pulse width to stimulationperiod ratio | None |
| Limitation ofinter-stimulusinterval | Image: Inter-stimulus interval diagram | Image: Inter-stimulus interval diagram |
| Limited to ½ pulse width to ISI | n/a (only 1 pulse possible) | |
| Absoluteminimuminter-stimulusinterval | 0.1 ms | n/a (only 1 pulse possible) |
| Maximumcharge perphase | 150 μC | 100 μC |
| MaximumRMSstimulationintensity | 23.7 mA RMS | Low EP: 3.6 mAHigh EP: 3.2 mA |
| Minimumelectrode size | 0.272 cm² | Low EP: 0.04 cm²High EP: 0.5 cm |
| Maximumcurrentdensity | 87.1 mA/cm² | Low EP: 90.8 mA/cm²High EP: 6.4 mA/cm² |
| Maximumchargedensity | 150.0 μC/cm² | Low EP: 275 μC/cm²High EP: - |
| Maximumpowerdensity | 20.7 W/cm² | Low EP: 10 W/cm²High EP: - |
| Powerlimitation | ≤50 mJ/pulseConformant to IEC 60601-2-40:2016, clause 201.12.4.103. | ≤50 mJ/pulseIEC 60601-2-40:1998 (1st ed.), clause201.12.4.103. |
| Low-currentstimulator fordirect corticalstimulation: | Realized by High CurrentStimulator (HC) in direct corticalstimulation mode | Realized by Cortical Module in Low EPmode |
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510(k) Summary ISIS Headboxes and ISIS Neurostimulator
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510(k) Summary
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Image /page/15/Picture/0 description: The image shows the word "inomed" in black font, followed by a square containing a stylized "i" with curved arrows around it. The "i" in the square is white, while the square itself is black. The word "inomed" is in lowercase letters and appears to be a company logo or brand name.
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| Stimulator type | Constant current | Constant current |
|---|---|---|
| Stimulation intensity (I) | ||
| Up to 30 mA | Up to 20 mA | |
| Intensity step | 0.01 mA | 0.01 mA |
| Pulse width (PW) | 0.05 - 2 ms | 0.05 - 1 ms |
| No. of stimulus pulses | 1 – 9 | 1 |
| Stimulation frequency (f) range | ||
| Up to 500 Hz | Up to 50 Hz | |
| Limitation of stimulation frequency | 1/10 pulse width to stimulation period ratio | None |
| Limitation of inter-stimulus interval | ||
| Limited to ½ pulse width to ISI | n/a (only 1 pulse possible) | |
| Absolute minimum inter-stimulus interval | 0.1 ms | n/a (only 1 pulse possible) |
| Maximum charge per pulse | 60 μC | 20 μC |
| Maximum RMS stimulation intensity | 9.5 mA RMS | 3.6 mA RMS |
| Minimum electrode size | 0.126 cm² | Low EP: 0.04 cm² |
| Maximum current density | 75.29 mA/cm² | Low EP: 90.8 mA/cm² |
| Maximum charge density | 150.8 μC/cm² | Low EP: 275 μC/cm² |
| Maximum power density | 7.1 W/cm² | Low EP: 10 W/cm² |
| Powerlimitation | ≤50 mJ/pulseConformant to IEC 60601-2-40:2016, clause 201.12.4.103. | ≤50 mJ/pulseIEC 60601-2-40:1998 (1st ed.), clause201.12.4.103. |
| Low-currentstimulator fordirect nervestimulation: | Realized by Direct NerveStimulator (DNS) in direct nervestimulation mode | Realized by Cortical Module in Low EPmode |
| Stimulatortype | Constant current | Constant current |
| No. ofoutputs | 1 | 1 + 1 (optional) |
| Stimulationintensity (I) | Image: Stimulation intensity waveform | Image: Stimulation intensity waveform |
| Up to 5 mA | Up to 20 mA | |
| Intensity step | 0.01 mA | 0.01 mA |
| Pulse width(PW) | 0.05 – 2 ms | 0.05 – 1 ms |
| No. ofstimuluspulses | 1 – 9 | 1 |
| Stimulationfrequency (f)range | Image: Stimulation frequency waveform | Image: Stimulation frequency waveform |
| Up to 500 Hz | Up to 50 Hz | |
| Limitation ofstimulationfrequency | 1/10 pulse width to stimulationperiod ratio | None |
| Limitation ofinter-stimulusinterval | Image: Inter-stimulus interval waveform | Image: Inter-stimulus interval waveform |
| Limited to ½ pulse width to ISI | n/a (only 1 pulse possible) | |
| Absoluteminimuminter-stimulusinterval | 0.1 ms | n/a (only 1 pulse possible) |
| Maximumcharge perpulse | 10 μC | 20 μC |
| MaximumRMSstimulationintensity | 1.58 mA RMS | 3.6 mA RMS |
| Minimumelectrode size | 0.020 cm² | Low EP: 0.04 cm² |
| Maximumcurrentdensity | 79 mA/cm² | Low EP: 90.8 mA/cm² |
| Maximumchargedensity | 158 µC/cm² | Low EP: 275 µC/cm² |
| Maximumpowerdensity | 1.25 W/cm² | Low EP: 10 W/cm² |
| Powerlimitation | ≤50 mJ/pulseConformant to IEC 60601-2-40:2016, clause 201.12.4.103. | ≤50 mJ/pulseIEC 60601-2-40:1998 (1st ed.), clause201.12.4.103. |
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Summary of Performance Testing:
Biocompatibility: The ISIS Headboxes and ISIS Neurostimulator including accessories as part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress) have no patient contact materials, and therefore this section does not apply.
Software: The inomed NeuroExplorer Software is a MODERATE level of concern software. The software was designed and developed according to a rigorous development process, including software verification and validation. Software information is provided in accordance with internal requirements and the following guidance documents and standards:
- FDA guidance: The content of premarket submissions for software contained in medical devices, May 11, 2005
- FDA guidance: Off-the-shelf software use in medical devices, Sep 27, 2019
- -FDA guidance: General principles of software validation: Final guidance for industry and FDA staff, Jan 02, 2002
- -FDA guidance: Content of premarket submissions for management of cybersecurity in medical devices. Oct 02, 2014
- -IEC 62304:2006, Medical device software - Software life cycle processes
Test results demonstrate that the inomed NeuroExplorer Software complies with its predetermined specifications, the applicable guidance documents, and standards.
- Electrical Safety: The ISIS Headboxes and ISIS Neurostimulator including accessories as part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress) were tested according to the following standards:
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inomed fi www.inomed.com
510(k) Summary
ISIS Headboxes and ISIS Neurostimulator
| IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR.2:2007 + A1:2012 (or IEC 60601-1: 2012 reprint), Medicalelectrical equipment – Part 1: General requirements for basicsafety and essential performance. | |
|---|---|
| IEC 80601-2-26:2019, Medical electrical equipments – Part 2-26: Particular requirements for the basic safety and essentialperformance of electroencephalographs | |
| IEC 60601-2-40:2016, Medical electrical equipments – Part 2-40: Particular requirements for the basic safety and essentialperformance of electromyographs and evoked responseequipment | |
| Test results demonstrate that the products comply with the applicablestandards. | |
| ElectromagneticCompatibility: | The ISIS Headboxes and ISIS Neurostimulator including accessoriesas part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS Xpert®, ISISXpress) were tested according to the following standards: |
| - IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2:General requirements for basic safety and essentialperformance – Collateral standard: Electromagneticdisturbances – Requirements and tests. | |
| Test results demonstrate that the products comply with the applicablestandards. | |
| PerformanceTesting - Bench | The essential performance and safety of the ISIS Headboxes and ISISNeurostimulator including accessories as part of ISIS IOM Systems(ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress) were tested forperformance in accordance with internal requirements. The devicesincluding their accessories and corresponding intended combinationswith further products have been designed according to requirementspecifications formulated at the following levels: |
| - Requirements for electrical medical systems- Requirements for the system carrier- Requirements for the amplifier (ISIS Headboxes) and stimulator(ISIS Neurostimulator) modules- Requirements for the operating software (NeuroExplorer) incl.ISIS Headbox and ISIS Neurostimulator firmware- ISIS Headbox and ISIS Neurostimulator accessories (adaptorboxes) | |
| - Custom Microsoft® Windows 10 imageThe products successfully underwent the bench testing to confirm thefulfillment of the requirements at these levels as part of the verificationand validation process. |
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Image /page/19/Picture/0 description: The image shows the logo for Inomed. The logo consists of the word "inomed" in bold, black letters, with a stylized "i" in a black square to the right. Below the logo is the website address "www.inomed.com".
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Moreover, the testing of the influence of human factors on the devices demonstrates that the products are safe to use and that no further improvement of the user interface design relating to safety is necessary.
The non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device predicate.
- Performance No additional clinical testing was performed for the ISIS Headboxes Testing and ISIS Neurostimulator including accessories as part of ISIS IOM Clinical Systems (ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress). Therefore, this section does not apply.
- Conclusion In order to establish the performance and safety characteristics, the ISIS Headboxes and ISIS Neurostimulator including accessories as part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress) underwent successful testing in terms of the device software, electrical safety, electromagnetic compatibility, bench testing, and human factors engineering. The results of these activities demonstrate that the devices are as safe, effective and perform as well as or better than the predicate device.
Therefore, the ISIS Headboxes and ISIS Neurostimulator including accessories as part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress) are considered substantially equivalent to the predicate device.
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).