ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION September 24, 2026 inomed Medizintechnik GmbH Johannes Hoerth Regulatory Affairs Manager Im Hausgruen 29 Emmendingen, BW 79312 Germany Re: K263010 Trade/Device Name: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF, GWE, GWJ, GWQ, ETN, IKN Dated: August 28, 2026 Received: August 28, 2026 Dear Johannes Hoerth: 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 (the 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 available 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K263010 - Johannes Hoerth Page 2 Before making any change significantly affecting the safety or effectiveness of the device, you must submit a new premarket notification in accordance with 21 CFR 807.81. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the {2} K263010 - Johannes Hoerth Page 3 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-devices/device-advice-comprehensive-regulatory-assistance/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, # Patrick Antkowiak -S Patrick Antkowiak 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 {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # **Indications for Use** Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K263010 Device Name ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress Indications for Use (Describe) Indications for Use: The product is used for intraoperative monitoring and testing during surgical procedures to examine neuronal tissue (central and peripheral nervous system) by recording and stimulation. The product can be used during surgical procedures that justify non-therapeutic clinical use of the following modalities or their combinations: •Measurement: -Auditory evoked potentials (AEP) -Electroencephalography (EEG) -Electrocorticography (ECoG) -E-ectromyography (EMG) -Somatosensory evoked potentials (SSEP) -Motor evoked potentials (MEP) -Visual evoked potentials (VEP) -Train of Four (TOF) •Stimulation: -Transcranial electrical stimulation (TES) -Direct cortical and subcortical stimulation (DCS) -Direct nerve stimulation (DNS) -Transcutaneous intraoperative nerve stimulation (TINS) -Direct muscle stimulation (DMS) -Stimulation for visual evoked potentials (VEP) 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) **CONTINUE ON A SEPARATE PAGE IF NEEDED.** This section applies only to requirements of the Paperwork Reduction Act of 1995. **\*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.\*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} inomed 510(k) Summary FM 3.3-002 Revision: 3 ## 510(k) Summary ### ISIS Headboxes and ISIS Neurostimulator (ISIS Systems: ISIS Xpertplus, ISIS Xpert, ISIS Xpress) Date of preparation: 2026-09-24 510(k) Holder: inomed Medizintechnik GmbH Im Hausgruen 29 79312 Emmendingen, Germany Submitter and Application Correspondent: Johannes Hoerth Regulatory Affairs Manager Phone: +49 7641 9414 836 Email: RA@inomed.com Hannah Barth Product Manager Active Devices Phone: +49 7641 94 14 546 Email: H.Barth@inomed.com Manufacturing Site: inomed Medizintechnik GmbH Im Hausgruen 29 79312 Emmendingen, Germany Trade Name: ISIS Headboxes and ISIS Neurostimulator (ISIS Systems: ISIS Xpertplus, ISIS Xpert, ISIS Xpress) Regulation Medical Specialty: Neurology Classification Regulation: 21 CFR §882.1870 – Evoked response electrical stimulator Product Code: GWF (Class II) – Evoked Response Electrical Stimulator Subsequent Product Codes: GWE, GWJ, GWQ, ETN, IKN 1 / 19 {5} inomed 510(k) Summary FM 3.3-002 Revision: 3 Substantially Equivalent Devices: Predicate device 510(k) number Predicate device Manufacturer/Model K233292 (Primary Predicate device) inomed Medizintechnik GmbH / ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress K162199 (Secondary Predicate device) Cadwell Industries, Inc. / Cascade IOMAX Intraoperative Monitor Device Description: The ISIS Headboxes are equipped with referential or differential measurement technology or with a mixture of both. They amplify and digitize the incoming biosignals and transmit the results to a PC unit. The ISIS Neurostimulator is an evoked response stimulator and has 12 channels for high current stimulation as well as one channel for low-current direct nerve stimulation (DNS). The NeuroExplorer software, which forms an integral part of the ISIS Headboxes and ISIS Neurostimulator, is used as operating software for control and signal interpretation. The ISIS Headbox 5042XX and the ISIS Neurostimulator 504180 products need to be used in combination with corresponding accessories and other products in order to operate in accordance with their intended use. The functionality of the ISIS Headboxes and the ISIS Neurostimulator is assured only when used in combination with a PC unit and peripheral input devices, a system carrier, ISIS adaptor boxes (pods), and additional patient accessories for stimulation and recording. inomed Medizintechnik GmbH supplies the systems already pre-configured in the form of medical systems. These medical systems make up the ISIS System family and are named as follows: ISIS Xpertplus, ISIS Xpert, and ISIS Xpress. The patient accessories are out of scope of this 510(k). Intended Use of Subject Device: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress The product is used for intraoperative monitoring and testing during surgical procedures - to examine neuronal tissue (central and peripheral nervous system) by recording and stimulation The product can be used during surgical procedures that justify non-therapeutic clinical use of the following modalities or their combinations: - Measurement: - Auditory evoked potentials (AEP) - Electroencephalography (EEG) - Electrocorticography (ECoG) - Electromyography (EMG) - Somatosensory evoked potentials (SSEP) - Motor evoked potentials (MEP) - Visual evoked potentials (VEP) - Train of Four (TOF) 2 / 19 {6} inomed 510(k) Summary FM 3.3-002 Revision: 3 # Intended Use of Primary Predicate Device: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress - Stimulation: - Transcranial electrical stimulation (TES) - Direct cortical and subcortical stimulation (DCS) - Direct nerve stimulation (DNS) - Transcutaneous intraoperative nerve stimulation (TINS) - Direct muscle stimulation (DMS) - Stimulation for visual evoked potentials (VEP) The product is used for intraoperative monitoring and testing during surgical procedures - to examine neuronal tissue (central and peripheral nervous system) by recording and stimulation The product can be used during surgical procedures that justify non-therapeutic clinical use of the following modalities or their combinations: - Measurement: - Auditory evoked potentials (AEP) - Electroencephalography (EEG) - Electrocorticography (ECoG) - Electromyography (EMG) - Somatosensory evoked potentials (SSEP) - Motor evoked potentials (MEP) - Train of Four (TOF) - Stimulation: - Transcranial electrical stimulation (TES) - Direct cortical and subcortical stimulation (DCS) - Direct nerve stimulation (DNS) - Transcutaneous intraoperative nerve stimulation (TINS) - Direct muscle stimulation (DMS) # Intended Use of Secondary Predicate Device: Cascade IOMAX Intraoperative Monitor The Cascade IOMAX™ Intraoperative Monitor with Surgical Studio software (IOMAX) is an electroneurodiagnostic device that acquires, displays and stores physiologic data from peripheral sensory and motor nerves, muscles and the central nervous system, generated either spontaneously or elicited by well-defined stimuli. The acquired data are necessary to perform somatosensory, auditory and visual evoked potentials (EPs), electroencephalography (EEG), electromyography (EMG), transcranial motor evoked potentials (TcMEPs), direct cortical stimulation, nerve conduction studies and Train of Four (TOF) analysis. SpO2 measures and displays oxygen saturation and heart rate information. The system also delivers direct nerve stimulation required for specific surgical procedures. Evoked Potentials (EPs): IOMAX provides electrical, auditory or visual stimulation and measures, displays, records, and stores 3 / 19 {7} inomed 510(k) Summary FM 3.3-002 Revision: 3 the electrical activity of the nervous system in response to the stimulation. EEG: IOMAX measures, displays, records, and stores electrical activity of the brain from two or more electrodes on the head. 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. TcMEP: IOMAX delivers transcranial stimulation via dedicated outputs for intraoperative assessment. Cortical Stimulation: IOMAX delivers Low Current Stimulation (LCS) during surgical procedures to map various areas of the cortex. Triggered EMG (TEMG): IOMAX electrically stimulates the motor nerves, and displays, records, and stores the resulting compound muscle action potentials in the innervated muscle. Nerve Conduction Study (NCS): IOMAX measures, displays, records, and stores sensory and motor nerve conduction time (latency) by applying a stimulus to peripheral nerves, the spinal cord, and the central nervous system. Train of Four (TOF) or Twitch Test: IOMAX delivers a train of four pulses and measures, displays, records, and stores the compound muscle action potential amplitude fade for analysis. SpO2: IOMAX measures and displays oxygen saturation and heart rate information. Remote Reader: IOMAX provides passive, real time remote review of intraoperative monitoring for a physician outside of the operating room. IOMAX is used by or under the direction of a licensed physician, surgeon, or neurologist in a professional healthcare facility environment for pre-operative, intraoperative and post-operative testing. inomed Medizintechnik GmbH claims that the subject device and the predicate devices have the same intended use and indications for use. Both the predicate and subject devices can be used for the recording of electrophysiological signals and stimulating nerve and muscle tissues for intraoperative neuromonitoring. Conclusion of the intended use evaluation: 4 / 19 {8} inomed 510(k) Summary FM 3.3-002 Revision: 3 ## Technology Comparison: The technological characteristics of the ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress and the predicate devices are equivalent: | | Subject device | Primary predicate device | Secondary predicate device | | --- | --- | --- | --- | | Device | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Cascade IOMAX Intraoperative Monitor | | Software | NeuroExplorer 8.1 | NeuroExplorer 8.0 | Surgical Studio | | Manufacturer | inomed Medizintechnik GmbH | inomed Medizintechnik GmbH | Cadwell Industries, Inc. | | Clinical aspects | | | | | Intended Use and Indications for use: | The product is used for intraoperative monitoring and testing during surgical proceduresto examine neuronal tissue (central and peripheral nervous system) by recording and stimulationThe product can be used during surgical procedures that justify non-therapeutic clinical use of the following modalities or their combinations:Measurement:Auditory evoked potentials (AEP)Electroencephalography (EEG)Electrocorticography (ECoG)Electromyography (EMG)Somatosensory evoked potentials (SSEP)Motor evoked potentials (MEP)Visual evoked potentials (VEP)Train of Four (TOF)Stimulation:Transcranial electrical stimulation (TES)Direct cortical and subcortical stimulation (DCS)Direct nerve stimulation (DNS)Transcutaneous intraoperative nerve stimulation (TINS)Direct muscle stimulation (DMS)Stimulation for visual evoked potentials (VEP) | The product is used for intraoperative monitoring and testing during surgical proceduresto examine neuronal tissue (central and peripheral nervous system) by recording and stimulationThe product can be used during surgical procedures that justify non-therapeutic clinical use of the following modalities or their combinations:Measurement:Auditory evoked potentials (AEP)Electroencephalography (EEG)Electrocorticography (ECoG)Electromyography (EMG)Somatosensory evoked potentials (SSEP)Motor evoked potentials (MEP)Train of Four (TOF)Stimulation:Transcranial electrical stimulation (TES)Direct cortical and subcortical stimulation (DCS)Direct nerve stimulation (DNS)Transcutaneous intraoperative nerve stimulation (TINS)Direct muscle stimulation (DMS) | The Cascade IOMAXTMIntraoperative Monitor with Surgical Studio software (IOMAX) is an electroneurodiagnostic device that acquires, displays and stores physiologic data from peripheral sensory and motor nerves, muscles and the central nervous system, generated either spontaneously or elicited by well-defined stimuli. The acquired data are necessary to perform somatosensory, auditory and visual evoked potentials (EPs), electroencephalography (EEG), electromyography (EMG), transcranial motor evoked potentials (TcMEPs), direct cortical stimulation, nerve conduction studies and Train of Four (TOF) analysis. SpO2 measures and displays oxygen saturation and heart rate information.The system also delivers direct nerve stimulation required for specific surgical procedures.Evoked Potentials (EPs): IOMAX provides electrical, auditory or visual stimulation and measures, displays, records, and stores the electrical activity of the nervous system in response to the stimulation.EEG: IOMAX measures, displays, records, and stores electrical activity of the brain from two or more electrodes on the head.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.TcMEP: IOMAX delivers transcranial stimulation via dedicated outputs for intraoperative assessment. Cortical Stimulation: IOMAX delivers Low Current Stimulation (LCS) during | 5 / 19 {9} inomed 510(k) Summary FM 3.3-002 Revision: 3 | | Subject device | Primary predicate device | Secondary predicate device | | --- | --- | --- | --- | | | | | surgical procedures to map various areas of the cortex.Triggered EMG (TEMG): IOMAX electrically stimulates the motor nerves, and displays, records, and stores the resulting compound muscle action potentials in the innervated muscle.Nerve Conduction Study (NCS): IOMAX measures, displays, records, and stores sensory and motor nerve conduction time (latency) by applying a stimulus to peripheral nerves, the spinal cord, and the central nervous system.Train of Four (TOF) or Twitch Test: IOMAX delivers a train of four pulses and measures, displays, records, and stores the compound muscle action potential amplitude fade for analysis.SpO2: IOMAX measures and displays oxygen saturation and heart rate information.Remote Reader: IOMAX provides passive, real time remote review of intraoperative monitoring for a physician outside of the operating room.IOMAX is used by or under the direction of a licensed physician, surgeon, or neurologist in a professional healthcare facility environment for pre-operative, intraoperative and post-operative testing. | | Biological aspects | | | | | Tissue contact | "The ISIS Headboxes and ISIS Neurostimulator including accessories as part of ISIS systems (ISIS Xpertplus, ISIS Xpert, ISIS Xpress) have no patient contact materials (...)" | "The ISIS Headboxes and ISIS Neurostimulator including accessories as part of ISIS IOM Systems (ISIS Xpertplus, ISIS Xpert, ISIS Xpress) have no patient contact materials (...)" | "The IOMAX has no patient contact materials, and therefore this section does not apply to them.The SpO2 sensor and accessories for use with the IOMAX have patient contact materials and are made from medical grade biocompatible materials. (...)" | | Technical aspects | | | | | Electrical safety | Complete basic safety testing accredited by CSA Group attesting to the conformity with following standards: IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 | Complete basic safety testing accredited by CSA Group attesting to the conformity with following standards: IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (or IEC 60601-1: 2012 reprint) | Cascade IOMAX fulfills the following internationally recognized safety standards for electrical medical devices: ANSI/AAMI ES60601-1: 2005/(R)2012, C1:2009/(R)2012, A2:2010/(R)2012 | 6 / 19 {10} inomed 510(k) Summary FM 3.3-002 Revision: 3 | | Subject device | Primary predicate device | Secondary predicate device | | --- | --- | --- | --- | | Electro-magnetic compatibility | Electromagnetic compatibility tests according to the standards: IEC 60601-1-2 Ed4.1 (2020) | Electromagnetic compatibility tests according to the standards: IEC 60601-1-2, Ed. 4.0, 2014 | Electromagnetic compatibility tests according to the standards: IEC 60601-1-2, Ed. 4.0, 2014 | | Performance testing standards | Performance testing according to the standards: | Performance testing according to the standards: | Performance testing according to the standards: | | | IEC 60601-1-6:2010, AMD1:2013, AMD2:2020 for use in conjunction with IEC 62366-1:2015, AMD1:2020, and IEC 60601-1:2005, AMD1:2012, AMD2:2020 | IEC 60601-1-6:2010, AMD1:2013 for use in conjunction with IEC 62366:2007, AMD1:2014 and IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1: 2012 or equivalent consolidated version IEC 60601-1:2012 (Edition 3.1) | IEC 60601-1-6:2010 | | | IEC 60601-2-40:2016 for use in conjunction with IEC 60601-1:2005, CORR1:2006, CORR2:2007, AMD1:2012 | IEC 60601-2-40:2016 for use in conjunction with IEC 60601-1:2005, CORR1:2006, CORR2:2007, AMD1:2012 | IEC 60601-2-40:1998 | | | IEC 62304:2006+AMD1:2015 | IEC 62304:2006+AMD1:2015 | IEC 62304:2006 | | | IEC 62366-1:2015 | IEC 62366-1:2015 | IEC 62366:2007 | | | IEC 80601-2-26:2019 | IEC 80601-2-26:2019 | IEC 60601-2-26:2012 | | Essential performance | **Electrical, acoustic and visual stimulation** The product applies electrical and visual stimulation pulses within application-related specifications. The pulse amplitude, the pulse width and the stimulation frequency of the ISIS System stimulation signal meet the adjusted value with a tolerance of ±30 % (IEC 60601-2-40:2016, Section 201.12.1). | **Electrical and acoustic stimulation** The product applies electrical stimulation pulses within application-related specifications. The pulse amplitude, the pulse width and the stimulation frequency of the ISIS System stimulation signal meet the adjusted value with a tolerance of ±30 % (IEC 60601-2-40:2016, Section 201.12.1). | Cadwell checks for essential performance when the user's system is sent in for preventive maintenance. 1. The IOMAX system must deliver electrical stimulation as described in IEC 60601-2-40 without unintended stimulation. | | | **Signal acquisition** The product provides the biosignal feedback within defined latency of ≤ 3s. | **Signal acquisition** The product provides the biosignal feedback within defined latency of ≤ 3s. | - | | | The product meets all essential performance requirements as specified in IEC 80601-2-26:2019: | The product meets all essential performance requirements as specified in IEC 80601-2-26:2019: | 2. The IOMAX 16-channel amplifier must meet all essential performance requirements as specified in IEC 60601-2-26:2012: | | | 201.12.1.102 Accuracy of amplitude and rate of variation | 201.12.1.102 Accuracy of amplitude and rate of variation | 201.12.1.101.1 Signal reproduction accuracy | | | 201.12.1.103 Input dynamic range and differential offset voltage | 201.12.1.103 Input dynamic range and differential offset voltage | 201.12.1.101.2 Input dynamic range and differential offset voltage | | | 201.12.1.104 Input noise | 201.12.1.104 Input noise | 201.12.1.101.3 Input noise | | | 201.12.1.105 Frequency response | 201.12.1.105 Frequency response | 201.12.1.101.4 Frequency response | | | 201.12.1.106 Common mode rejection | 201.12.1.106 Common mode rejection | 201.12.1.101.5 Common mode rejection | | Protection against electrical shock | Class I protection | Class I protection | Class I protection | 7 / 19 {11} inomed 510(k) Summary FM 3.3-002 Revision: 3 | | Subject device | | Primary predicate device | | Secondary predicate device | | | --- | --- | --- | --- | --- | --- | --- | | Protection against electrical shock of patient leads | Device type BF (Body Floating) | | Device type BF (Body Floating) | | Device type BF (Body Floating) | | | Risk management | Risk Management according to standard: DIN EN ISO 14971:2022-04 | | Risk Management according to standard: ISO 14971: 2019 | | Risk Management according to standard: ISO 14971: 2007 | | | System configuration | Computer-based equipment with dedicated hardware and software components | | Computer-based equipment with dedicated hardware and software components | | Computer-based equipment with dedicated hardware and software components | | | Signal recording | | | | | | | | Measurement principle | Amplifiers based on differential (bipolar) and referential (unipolar) type of recording | | Amplifiers based on differential (bipolar) and referential (unipolar) type of recording | | Amplifiers based on differential (bipolar) and referential (unipolar) type of recording | | | Amplifier components | Desired combination of ISIS Headboxes with a total of 64 channels | | Desired combination of ISIS Headboxes with a total of 64 channels | | One (1) Cortical Module Up to four (4) Limb Modules | | | Number of amplifier channels | Up to 64: | | Up to 64: | | Up to 48: | | | | Module | Channels | Module | Channels | Module | Channels | | | ISIS Headbox 16 Ch. REF (504261) | Unipolar: 16 Bipolar: 0 | ISIS Headbox 16 Ch. REF (504261) | Unipolar: 16 Bipolar: 0 | Cortical Module | Unipolar: 13 Bipolar: 3 | | | ISIS Headbox 16 Ch. DIF (504271) | Unipolar: 0 Bipolar: 16 | ISIS Headbox 16 Ch. DIF (504271) | Unipolar: 0 Bipolar: 16 | Limb Module | Unipolar: 0 Bipolar: 8 | | | ISIS Headbox 16 Ch. REF – AEP (504281) | Unipolar: 16 Bipolar: 0 | ISIS Headbox 16 Ch. REF – AEP (504281) | Unipolar: 16 Bipolar: 0 | | | | | ISIS Headbox 8 Ch. DIF – 8 Ch. REF – AEP (504285) | Unipolar: 8 Bipolar: 8 | ISIS Headbox 8 Ch. DIF – 8 Ch. REF – AEP (504285) | Unipolar: 8 Bipolar: 8 | | | | | | | | | | | | Measurement range | Conformant with IEC 80601-2-26:2019, clause 201.12.1.103 Input dynamic range and differential offset voltage. | | Conformant with IEC 80601-2-26:2019, clause 201.12.1.103 Input dynamic range and differential offset voltage. | | Conformant with IEC 60601-2-26:2012, clause 201.12.1.101.2 Input dynamic range and differential offset voltage | | | A/D resolution | 16-bit | | 16-bit | | 16-bit | | | Hardware bandpass | Hardware high-pass filter: 0.5-120 Hz on all modules | | Hardware high-pass filter: 0.5-120 Hz on all modules | | Hardware high-pass filter: 0.3-100 Hz on Cortical Module 0.5-100 Hz on Limb Module | | | | Hardware low-pass filter: 2500, 5000 Hz on all modules | | Hardware low-pass filter: 2500, 5000 Hz on all modules | | Hardware low-pass filter: 30-5000 Hz on Cortical Module 30-10000 Hz on Limb Module | | | Sampling frequency | 20 kHz | | 20 kHz | | 25 kHz | | | Notch filter | 50, 60 Hz | | 50, 60 Hz | | 50, 60 Hz | | | Common-mode rejection ratio (CMRR) | >100 dB Conformant with IEC 80601-2-26:2019, clause 201.12.1.106 Common mode rejection. | | >100 dB Conformant with IEC 80601-2-26:2019, clause 201.12.1.106 Common mode rejection. | | >115 dB Conformant with IEC 60601-2-26:2012, clause 201.12.1.101.5 Common mode rejection | | 8 / 19 {12} inomed 510(k) Summary FM 3.3-002 Revision: 3 | | Subject device | Primary predicate device | Secondary predicate device | | --- | --- | --- | --- | | Amplifier noise | Conformant with IEC 80601-2-26:2019, clause 201.12.1.104 Input noise | Conformant with IEC 80601-2-26:2019, clause 201.12.1.104 Input noise | Conformant with IEC 60601-2-26:2012, clause 201.12.1.101.3 Input noise | | Stimulation | | | | | Stimulation components | Max. one (1) ISIS Neurostimulator including:High: High Current (HC) Stimulator with max. twelve (12) outputsLow: Direct Nerve Stimulator (DNS) with one (1) output | Max. one (1) ISIS Neurostimulator including:High: High Current (HC) Stimulator with max. twelve (12) outputsLow: Direct Nerve Stimulator (DNS) with one (1) output | High: Up to four (4) Limb ModulesLow: One (1) Cortical Module | | Normative conformity | Conformant to IEC 60601-2-40:2016 | Conformant to IEC 60601-2-40:2016 | Conformant to IEC 60601-2-40:1998 | | TcMEP stimulation | Realized by High Current Stimulator (HC) in transcranial stimulation mode | Realized by High Current Stimulator (HC) in transcranial stimulation mode | Realized by Cortical Module in TcMEP mode | | Stimulator type | Current controlled | Current controlled | Current controlled and optional voltage controlled | | No. of outputs | 12 | 12 | 9 | | Stimulation intensity (I) and pulse width (PW) |  | | | | | Current controlled: up to 250 mA (voltage limit of 410 V)Voltage controlled: n/a0.05 – 2 ms | Current controlled: up to 250 mA (voltage limit of 410 V)Voltage controlled: n/a0.05 – 2 ms | Current controlled: up to 1500 mA (voltage limit of 1000 V)Voltage controlled: up to 1000 V0.05 – 0.5 ms | | Intensity step | Constant current: 0.1 mAConstant voltage: n/a | Constant current: 0.1 mAConstant voltage: n/a | Constant current: 10 mAConstant voltage: 5 V | | No. of stimulus pulses | 1-9 | 1-9 | 1-9 | 9 / 19 {13} inomed 510(k) Summary FM 3.3-002 Revision: 3 | | Subject device | Primary predicate device | Secondary predicate device | | --- | --- | --- | --- | | Stimulation frequency (f) range |  | | | | | Up to 500 Hz | Up to 500 Hz | Up to 1 Hz | | Limitation of stimulation frequency (f) | 1/10 pulse width to stimulation period ratio | 1/10 pulse width to stimulation period ratio | None | | Limitation of inter-stimulus interval (ISI) |  | | | | | Limited to 1⁄2 pulse width to ISI | Limited to 1⁄2 pulse width to ISI | Minimum ISI: 0.1 ms | | Absolute minimum inter-stimulus interval (ISI) | 0.1 ms | 0.1 ms | 0.1 ms | | Maximum charge per phase | 189.66 μC | 189.66 μC | 50 μC | | Maximum RMS stimulation intensity @ 1 kΩ | 30 mA RMS | 30 mA RMS | 7.1 mA RMS | | Minimum electrode size | n/a | n/a | Low EP: 0.04 cm2TcMEP: 0.5 cm2 | | Maximum current density | 90.8 mA/cm2 | 90.8 mA/cm2 | Low EP: 90.8 mA/cm2TcMEP: 14.1 mA/cm2 | | Maximum charge density | 61.5 μC/cm2 | 61.5 μC/cm2 | Low EP: 275 μC/cm2TcMEP: 100 μC/cm2 | | Maximum power density @ 1 kΩ | 160 W/cm2 | 160 W/cm2 | Low EP: 10 W/cm2TcMEP: 2,000 W/cm2 | 10 / 19 {14} inomed 510(k) Summary FM 3.3-002 Revision: 3 | | Subject device | Primary predicate device | Secondary predicate device | | --- | --- | --- | --- | | Power limitation | <50 mJ/pulseConformant to IEC 60601-2-40:2016, clause 201.12.4.103. | <50 mJ/pulseConformant to IEC 60601-2-40:2016, clause 201.12.4.103. | <50 mJ/pulseIEC 60601-2-40:1998 (1st ed.), clause 201.12.4.103. | | High-current stimulator for SEP and TOF | Realized by High Current Stimulator (HC) in subcutaneous stimulation (SEP, TOF) mode | Realized by High Current Stimulator (HC) in subcutaneous stimulation (SEP, TOF) mode | Realized by Limb Module in High EP mode | | Stimulator type | Constant current | Constant current | Constant current | | No. of outputs | 12 | 12 | 5 | | Stimulation intensity (I) |  | | | | | Accessory-dependent | Accessory-dependent | Up to 100 mA | | Intensity step | 0.1 mA | 0.1 mA | 0.5 mA | | Pulse width (PW) | 0.05 – 2 ms | 0.05 – 2 ms | 0.05 – 1 ms | | No. of stimulus pulses | 1-9 | 1-9 | 1 | | Stimulation frequency (f) range |  | | | | | SEP: Up to 500 HzTOF: 2 Hz (fixed) | SEP: Up to 500 HzTOF: 2 Hz (fixed) | Up to 50 Hz | | Limitation of stimulation frequency (f) | 1/10 pulse width to stimulation period ratio | 1/10 pulse width to stimulation period ratio | None | | | | | | 11 / 19 {15} inomed 510(k) Summary FM 3.3-002 Revision: 3 | | Subject device | Primary predicate device | Secondary predicate device | | --- | --- | --- | --- | | Limitation of inter-stimulus interval (ISI) |  | | | | | Limited to 1⁄2 pulse width to ISI | Limited to 1⁄2 pulse width to ISI | n/a (only 1 pulse possible) | | Absolute minimum inter-stimulus interval (ISI) | 0.1 ms | 0.1 ms | n/a (only 1 pulse possible) | | Maximum charge per phase | 150 μC | 150 μC | 30 μC | | Maximum RMS stimulation intensity | Accessory-dependent | Accessory-dependent | Low EP: 3.6 mAHigh EP: 3.2 mA | | Minimum electrode size | n/a | n/a | Low EP: 0.04 cm2High EP: 0.5 cm2 | | Maximum current density | 90.8 mA/cm2 | 90.8 mA/cm2 | Low EP: 90.8 mA/cm2High EP: 6.4 mA/cm2 | | Maximum charge density | 150.0 μC/cm2 | 150.0 μC/cm2 | Low EP: 275 μC/cm2High EP: - | | Maximum power density | 20.7 W/cm2 | 20.7 W/cm2 | Low EP: 10 W/cm2High EP: - | | Power limitation | <50 mJ/pulseConformant to IEC 60601-2-40:2016, clause 201.12.4.103. | <50 mJ/pulseConformant to IEC 60601-2-40:2016, clause 201.12.4.103. | <50 mJ/pulseIEC 60601-2-40:1998, clause 201.12.4.103. | | Low-current stimulator for direct cortical stimulation: | Realized by High Current Stimulator (HC) in direct cortical stimulation mode | Realized by High Current Stimulator (HC) in direct cortical stimulation mode | Realized by Cortical Module in Low EP mode | | Stimulator type | Constant current | Constant current | Constant current | 12 / 19 {16} inomed 510(k) Summary FM 3.3-002 Revision: 3 | | Subject device | Primary predicate device | Secondary predicate device | | --- | --- | --- | --- | | Stimulation intensity (I) |  | | | | | Accessory-dependent | Accessory-dependent | Up to 20 mA | | Intensity step | 0.01 mA | 0.01 mA | 0.01 mA | | Pulse width (PW) | 0.05 – 2 ms | 0.05 – 2 ms | 0.05 – 1 ms | | No. of stimulus pulses | 1 – 9 | 1 – 9 | 1 | | Stimulation frequency (f) range |  | | | | | Up to 500 Hz | Up to 500 Hz | Up to 50 Hz | | Limitation of stimulation frequency (f) | 1/10 pulse width to stimulation period ratio | 1/10 pulse width to stimulation period ratio | None | | Limitation of inter-stimulus interval (ISI) |  | | | | | Limited to 1⁄2 pulse width to ISI | Limited to 1⁄2 pulse width to ISI | n/a (only 1 pulse possible) | | Absolute minimum inter-stimulus interval (ISI) | 0.1 ms | 0.1 ms | n/a (only 1 pulse possible) | 13 / 19 {17} inomed 510(k) Summary FM 3.3-002 Revision: 3 | | Subject device | Primary predicate device | Secondary predicate device | | --- | --- | --- | --- | | Maximum charge per pulse | 60 μC | 60 μC | 20 μC | | Maximum RMS stimulation intensity | Accessory-dependent | Accessory-dependent | 3.6 mA RMS | | Minimum electrode size | n/a | n/a | Low EP: 0.04 cm2 | | Maximum current density | 90.8 mA/cm2 | 90.8 mA/cm2 | Low EP: 90.8 mA/cm2 | | Maximum charge density | 150.8 μC/cm2 | 150.8 μC/cm2 | Low EP: 275 μC/cm2 | | Maximum power density | 7.1 W/cm2 | 7.1 W/cm2 | Low EP: 10 W/cm2 | | Power limitation | ≤50 mJ/pulseConformant to IEC 60601-2-40:2016, clause 201.12.4.103. | ≤50 mJ/pulseConformant to IEC 60601-2-40:2016, clause 201.12.4.103. | <50 mJ/pulseIEC 60601-2-40:1998, clause 201.12.4.103. | | Low-current stimulator for direct nerve stimulation: | Realized by Direct Nerve Stimulator (DNS) in direct nerve stimulation mode | Realized by Direct Nerve Stimulator (DNS) in direct nerve stimulation mode | Realized by Cortical Module in Low EP mode | | Stimulator type | Constant current | Constant current | Constant current | | No. of outputs | 1 | 1 | 1 + 1 (optional) | | Stimulation intensity (I) |  | | | | | Accessory-dependent | Accessory-dependent | Up to 20 mA | | Intensity step | 0.01 mA | 0.01 mA | 0.01 mA | | Pulse width (PW) | 0.05 – 2 ms | 0.05 – 2 ms | 0.05 – 1 ms | | No. of stimulus pulses | 1 – 9 | 1 – 9 | 1 | 14 / 19 {18} inomed 510(k) Summary FM 3.3-002 Revision: 3 | | Subject device | Primary predicate device | Secondary predicate device | | --- | --- | --- | --- | | Stimulation frequency (f) range |  | | | | | Up to 500 Hz | Up to 500 Hz | Up to 50 Hz | | Limitation of stimulation frequency (f) | 1/10 pulse width to stimulation period ratio | 1/10 pulse width to stimulation period ratio | None | | Limitation of inter-stimulus interval (ISI) |  | | | | | Limited to 1⁄2 pulse width to ISI | Limited to 1⁄2 pulse width to ISI | n/a (only 1 pulse possible) | | Absolute minimum inter-stimulus interval (ISI) | 0.1 ms | 0.1 ms | n/a (only 1 pulse possible) | | Maximum charge per pulse | 10 μC | 10 μC | 20 μC | | Maximum RMS stimulation intensity | Accessory-dependent | Accessory-dependent | 3.6 mA RMS | | Minimum electrode size | n/a | n/a | Low EP: 0.04 cm2 | | Maximum current density | 90.8 mA/cm2 | 90.8 mA/cm2 | Low EP: 90.8 mA/cm2 | | Maximum charge density | 158 μC/cm2 | 158 μC/cm2 | Low EP: 275 μC/cm2 | | Maximum power density | 1.25 W/cm2 | 1.25 W/cm2 | Low EP: 10 W/cm2 | | Power limitation | <50 mJ/pulse | <50 mJ/pulse | <50 mJ/pulse | 15 / 19 {19} inomed 510(k) Summary FM 3.3-002 Revision: 3 | | Subject device | Primary predicate device | Secondary predicate device | | --- | --- | --- | --- | | | Conformant to IEC 60601-2-40:2016, clause 201.12.4.103. | Conformant to IEC 60601-2-40:2016, clause 201.12.4.103. | IEC 60601-2-40:1998 (1st ed.), clause 201.12.4.103. | | Other | | | | | Operating principle | The device is an active medical product controlled using operating software. The product provides visual feedback using a separate display. The product provides auditory feedback using the PC loudspeakers. The user interacts with the system using a keyboard and mouse. The software controls are displayed on the screen and are accessible using the mouse and software. Additionally, the system offers redundant mouse functionality by providing a touch interface. | The device is an active medical product controlled using operating software. The product provides visual feedback using a separate display. The product provides auditory feedback using the PC loudspeakers. The user interacts with the system using a keyboard and mouse. The software controls are displayed on the screen and are accessible using the mouse and software. Additionally, the system offers redundant mouse functionality by providing a touch interface. | The device is an active medical product controlled using operating software The product provides visual feedback using a separate display. The product provides auditory feedback using the PC loudspeakers. The user interacts with the system using a keyboard and mouse. The software controls are displayed on the screen and are accessible using the mouse and software. | | Accessories/components | 540559 Grid-TES-Stimulation Matrix (for 8-channel electrodes) 540560 Grid-TES-Stimulation Matrix (for 16-channel electrodes) | 540559 Grid-TES-Stimulation Matrix (for 8-channel electrodes) 540560 Grid-TES-Stimulation Matrix (for 16-channel electrodes) | LCSwap | | | 540501 SEP Stimulation Adaptor for ISIS Neurostimulator 540510 MEP Stimulation Adaptor for Grid/TES Stimulation matrix 540511 MEP Stimulation Adaptor for ISIS Neurostimulator | 540501 SEP Stimulation Adaptor for ISIS Neurostimulator 540510 MEP Stimulation Adaptor for Grid/TES Stimulation matrix 540511 MEP Stimulation Adaptor for ISIS Neurostimulator | TCS-9 Output Extender | | | 540522 EP Adaptor for ISIS Headbox 16 Ch. REF – AEP 540523 EP Adaptor for ISIS Headbox 8 Ch. DIF – 8 Ch. REF – AEP 540524 EP Adaptor for ISIS Headbox 16 Ch. REF 540525 EP Adaptor for 504285 EP Adaptor for ISIS Headbox 8Ch.DIF-8Ch.REF-AEP 540531 EMG/MEP-Adaptor Ch. 1-8 for 504271 for ISIS Headbox 16 Ch. DIF 540532 EMG/MEP-Adaptor Ch. 9-16 for 504271 for ISIS Headbox 16 Ch. DIF | 540522 EP Adaptor for ISIS Headbox 16 Ch. REF – AEP 540523 EP Adaptor for ISIS Headbox 8 Ch. DIF – 8 Ch. REF – AEP 540524 EP Adaptor for ISIS Headbox 16 Ch. REF 540525 EP Adaptor for 504285 EP Adaptor for ISIS Headbox 8Ch.DIF-8Ch.REF-AEP 540531 EMG/MEP-Adaptor Ch. 1-8 for 504271 for ISIS Headbox 16 Ch. DIF 540532 EMG/MEP-Adaptor Ch. 9-16 for 504271 for ISIS Headbox 16 Ch. DIF | 16 Channel Input Extender | 16 / 19 {20} inomed 510(k) Summary FM 3.3-002 Revision: 3 | | Subject device | Primary predicate device | Secondary predicate device | | --- | --- | --- | --- | | | 540533 EMG/MEP-Adaptor Ch. 1-8 for 504271 | 540533 EMG/MEP-Adaptor Ch. 1-8 for 504271 | | | | SightSaver Visual Stimulator | - | LED Goggles with disposable foam for visual stimulation | | | 540340 AEP Insert Earphones | 540340 AEP Insert Earphones | Insert Earphones for auditory stimulation | ### Optional accessory: SightSaver Visual Stimulator The SightSaverMini™ Visual Stimulator was previously cleared under K113785 and may be used as an optional accessory for VEP testing. Stimulation characteristics include: - Intensity: 5.875 lm to 7.65 lm (This parameter reflects the inherent light output variation of the SightSaver Visual Stimulator at 20mA input current provided by the ISIS Neurostimulator.) - Pulse width: 5 ms • Frequency: 0.5 Hz to 1 Hz - Pulse form: Flash • Pulse types: Left, right, both sides ### Summary of Performance Testing: Biocompatibility: The ISIS Headboxes and ISIS Neurostimulator (ISIS Systems: ISIS Xpert Plus, ISIS Xpert, ISIS Xpress) have no patient contact materials, and therefore this section does not apply. Software: The Documentation Level of the inomed NeuroExplorer Software is ENHANCED DOCUMENTATION. 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: Content of Premarket Submissions for Device Software Functions, June 14, 2023 - FDA Guidance: Off-The-Shelf Software Use in Medical Devices, August 11, 2023 - FDA Guidance: General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 11, 2002 - FDA Guidance: Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions, February 2026 - FDA Guidance: Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act, March 30, 2023 - IEC 62304:2006+A1:2015, Medical device software - Software life cycle processes 17 / 19 {21} inomed 510(k) Summary FM 3.3-002 Revision: 3 | | Test results indicate that the inomed NeuroExplorer Software complies with its predetermined specifications and the applicable guidance documents and standards. | | --- | --- | | Electrical. Mechanical and Thermal Testing: | The ISIS Headboxes and ISIS Neurostimulator including accessories as part of ISIS Systems (ISIS Xpert Plus, ISIS Xpert, ISIS Xpress) were tested according to the following standards: - IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. - IEC 80601-2-26:2019, Medical electrical equipments – Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs - IEC 60601-2-40:2016, Medical electrical equipments – Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipmentTest results demonstrate that the products comply with the applicable standards. | | Electromagnetic Compatibility Testing: | The ISIS Headboxes and ISIS Neurostimulator including accessories as part of ISISSystems (ISIS Xpert Plus, ISIS Xpert, ISIS Xpress) were tested according to the following standards: - IEC 60601-1-2:2014 + AMD1: 2020, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests.Test results demonstrate that the products comply with the applicable standards. | | Performance Testing – Bench: | The ISIS Headboxes and ISIS Neurostimulator (ISIS Systems: ISIS Xpert Plus, ISIS Xpert, ISIS Xpress) were evaluated in accordance with internal verification and validation requirements as part of the design control process. The results of these activities demonstrate that the device continues to meet its predetermined specifications and intended performance characteristics. | | Performance Testing – Clinical: | No additional clinical testing was performed for the ISIS Headboxes and ISIS Neurostimulator (ISIS Systems: ISIS Xpert Plus, ISIS Xpert, ISIS Xpress). Therefore, this section does not apply. | | Conclusion: | Verification and validation activities were undertaken in order to establish the performance and safety characteristics of the ISIS Headboxes and ISIS Neurostimulator (ISIS Systems: ISIS Xpert Plus, ISIS Xpert, ISIS Xpress), including NeuroExplorer 8 software and associated accessories. The results of these | 18 / 19 {22} inomed 510(k) Summary FM 3.3-002 Revision: 3 activities demonstrate that the devices perform as intended and are at least as safe and effective as the predicate devices. Therefore, the ISIS Headboxes and ISIS Neurostimulator (ISIS Systems: ISIS Xpert Plus, ISIS Xpert, ISIS Xpress) are considered substantially equivalent to the predicate devices. 19 / 19