What is the FDA product code for ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress?

GWF. It is classified under 21 CFR 882.1870 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress?

510(k) clearance (submission type: Special).

What are the predicate devices for ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress?

ISIS Headbox 5042XX and ISIS Neurostimulator (K212166).

Who can help prepare an FDA 510(k) submission like ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

Q: Who is the manufacturer of ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress?

Inomed Medizintechnik GmbH filed the 510(k) submission for ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (K233292).

K233292 · Inomed Medizintechnik GmbH · GWF · Oct 27, 2023 · Neurology

Device Facts

Record ID	K233292
Device Name	ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
Applicant	Inomed Medizintechnik GmbH
Product Code	GWF · Neurology
Decision Date	Oct 27, 2023
Decision	SESE
Submission Type	Special
Regulation	21 CFR 882.1870
Device Class	Class 2

Intended 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), 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).

Device Story

Multimodal intraoperative neuromonitoring (IOM) system; comprises custom stimulation/recording hardware (ISIS Headboxes, ISIS Neurostimulator) and PC running NeuroExplorer software. Inputs: physiological signals from peripheral nerves, muscles, and central nervous system via electrodes. Operation: system records evoked potentials (AEP, SSEP, MEP), EEG, ECoG, EMG, and TOF; delivers electrical stimulation (TES, DCS, DNS, TINS, DMS) for monitoring. Used in OR by neurophysiologists, neurosurgeons, neurologists, or medical technical assistants. Output: real-time display and storage of electrophysiological data. Healthcare providers use output to assess neuronal integrity during surgery, potentially preventing neurological injury. System supports continuous operation; integrates with device carriers.

Clinical Evidence

No clinical data. Performance established via bench testing, software verification/validation, electrical safety (IEC 60601-1, IEC 80601-2-26, IEC 60601-2-40), and electromagnetic compatibility (IEC 60601-1-2) testing.

Technological Characteristics

Class I protection, Type BF patient leads. Computer-based system with 64-channel amplifier capacity. 16-bit A/D resolution; 20 kHz sampling frequency. Hardware filters: 0.5-120 Hz (high-pass), 2500/5000 Hz (low-pass). Constant current stimulators (HC and DNS modules) with 12 outputs (HC) or 1 output (DNS). Connectivity: PC-based. Software: NeuroExplorer 8. Sterilization: N/A (device components).

Indications for Use

Indicated for intraoperative monitoring and testing of neuronal tissue (central and peripheral nervous system) in patients undergoing surgical procedures requiring neurophysiological recording and stimulation.

Regulatory Classification

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.

Predicate Devices

ISIS Headbox 5042XX and ISIS Neurostimulator (K212166)

Related Devices

K212166 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress · Inomed Medizintechnik GmbH · Jan 7, 2022
K234080 — MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) · Soterix Medical, Inc. · Mar 25, 2024
K162199 — Cascade IOMAX Intraoperative Monitor · Cadwell Industries, Inc. · Mar 2, 2017
K230415 — Cadwell Guardian · Cadwell Industries, Inc. · Aug 17, 2023
K190703 — Neuro-IOM system with Neuro-IOM.NET software · Neurosoft , Ltd. · May 22, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ October 27, 2023 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. inomed Medizintechnik GmbH Shuofei Cheng, Ph.D. Regulatory Affairs Im Hausgruen 29 Emmendingen, Baden-Wuerttemberg 79312 Germany #### Re: K233292 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, GWJ, GWQ, ETN, IKN Dated: September 29, 2023 Received: September 29, 2023 #### Dear Shuofei Cheng: 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. 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). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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. 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Patrick Antkowiak -S for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological {2}------------------------------------------------ and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K233292 #### Device Name ISIS Headbox and ISIS Neurostimulator (ISIS IOM Systems: ISIS Xpert®, ISIS Xpert®Plus, ISIS Xpress) #### Indications for Use (Describe) 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: - o Auditory evoked potentials (AEP) - o Electroencephalography (EEG) - o Electrocorticography (ECoG) - o Electromyography (EMG) - o Somatosensory evoked potentials (SSEP) - o Motor evoked potentials (MEP) - o Train of Four (TOF) - · Stimulation: - o Transcranial electrical stimulation (TES) - o Direct cortical and subcortical stimulation (DCS) - o Direct nerve stimulation (DNS) - o Transcutaneous intraoperative nerve stimulation (TINS) - o Direct muscle stimulation (DMS) Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### 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." {4}------------------------------------------------ Page 1 of 15 Stand 1.1 vom 2017-11-02 # ISIS Headboxes and ISIS Neurostimulator # 510(k) Summary | Submission Date: | 29 September 2023 | | | | | |------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------|--------|------------------------------------------------------------------------------------|--------------| | 510(k) Holder: | inomed Medizintechnik GmbH Im Hausgrün 29 79312 Emmendingen, Germany | | | | | | Submitter and Application Correspondent: | Tomasz Moszkowski, Ph.D. Phone: +49 7641 6414 583 Email: t.moszkowski@inomed.com | | | | | | Manufacturing Site: | inomed Medizintechnik GmbH Im Hausgrün 29 79312 Emmendingen, Germany | | | | | | Trade Name: | ISIS Headbox 5042XX and ISIS Neurostimulator (ISIS IOM Systems: ISIS Xpert®, ISIS Xpert®Plus, ISIS Xpress) | | | | | | Common and Classification Name: | Evoked response stimulator and intraoperative monitor | | | | | | Classification Regulation: | 21 CFR §882.1870 | | | | | | Product Code: | GWF | | | | | | Subsequent Product Codes: | GWJ, GWQ, ETN, IKN | | | | | | Regulation Medical Specialty: | Neurology | | | | | | Substantially Equivalent Devices: | | Predicate Number | 510(k) | Predicate Model | Manufacturer | | | Predicate Device: | K212166 | | inomed medizintechnik GmbH / ISIS Headbox 5042XX and ISIS Neurostimulator | | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "inomed" in a bold, sans-serif font. To the right of the word is a black square with a white "i" inside, with a circular arrow above it. Below the word "inomed" is the website address "www.inomed.com". ISIS Headboxes and ISIS Neurostimulator (ISIS IOM Systems: ISIS Xpert®, ISIS Xpert®Plus, ISIS Xpress) Device The ISIS Headboxes and the ISIS Neurostimulator constitute Description: multimodal 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 - - Free-running and triggered Electromyography - - Electroencephalography - - Train of Four - Intended Use The product is used for intraoperative monitoring and testing during and Indications surqical procedures: - for Use: - to examine neuronal tissue (central and peripheral nervous system) by recording and stimulation The product can be used during surgical procedures that justify nontherapeutic clinical use of the following modalities or their combinations: - . Measurement: - Auditory evoked potentials (AEP) o - Electroencephalography (EEG) O - Electrocorticography (ECoG) O - Electromyography (EMG) O - Somatosensory evoked potentials (SSEP) O - Motor evoked potentials (MEP) O - Train of Four (TOF) O - Stimulation: - Transcranial electrical stimulation (TES) o - Direct cortical and subcortical stimulation (DCS) O - Direct nerve stimulation (DNS) O - Transcutaneous intraoperative nerve stimulation O (TINS) - Direct muscle stimulation (DMS) O {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Inomed. The logo consists of the word "inomed" in a bold, sans-serif font, followed by a square containing a stylized "i" with circular arrows around it. Below the logo is the website address "www.inomed.com". FM 3-1 ISIS Headboxes and ISIS Neurostimulator Page 3 of 15 Stand 1.1 vom 2017-11-02 #### 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 equal in terms of intended use and indications for use to the predicate device compared to the predicate device. The subject device employs the same technological characteristics as the predicate device. | | Subject devices | Predicate device | Claimed Equivalence | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | System | ISIS Headbox 5042XX and ISIS Neurostimulator with NeuroExplorer 8 | ISIS Headbox 5042XX and ISIS Neurostimulator with NeuroExplorer 7 | | | Manufacturer | inomed Medizintechnik GmbH | inomed Medizintechnik GmbH | | | Picture | Image: Subject devices | Image: Predicate device | | | 510(k) Number | K233292 | K212166 | | | Device Class | II | II | Equal | | Product Code | GWF | GWF | Equal | | Subsequent Product Codes | GWJ, GWQ, ETN, IKN | GWJ, GWQ, ETN, IKN | GWJ - Equal GWQ - Equal ETN - Equal IKN – Equal | | Main function, site of usage, intended user group | | | | | Main function | "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" | ISIS Headboxes 5042XX: "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." | Equal Both the predicate and subject devices can acquire, display and store physiologic data from peripheral nerves, muscles, and the central nervous system. The statements use different wording, but do not differ in terms of the clinical aspects. | | Site of usage | "The product is used for intraoperative monitoring and testing during surgical procedures. (…)” | ISIS Headboxes 5042XX: "The products are intended for | Equal The predicate and the subject device are intended for use during surgical procedures. | | | | | | | | "The product can be used during surgical procedures (...)" | intraoperative neuromonitoring" "The products are intended for use in the operating room (...)" | | | Intended user group | Neurophysiologists (clinical neurophysiologists, neurosurgeons, neurologists or medical technical assistants for functional diagnostics) | Neurophysiologists (clinical neurophysiologists, neurosurgeons, neurologists or medical technical assistants for functional diagnostics) | Equal | | Intended 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 | ISIS Headbox 5042XX: "The products are intended for intraoperative neuromonitoring; for the recording of electrophysiological signals and stimulating of nerve and muscle tissues. (...)" ISIS Neurostimulator 504180: "The ISIS Neurostimulator is intended for the provision of neurophysiological stimulation when used in surgical procedures and for diagnostics. (...)" | Equal Both the subject and predicate device are intended for the recording of electrophysiological signals and stimulation of neuronal tissue during intraoperative neuromonitoring. | | Indications for use | "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) (...) - Stimulation: Transcranial electrical stimulation (TES) - Direct cortical and subcortical stimulation (DCS) - Direct nerve stimulation (DNS) - Transcutaneous intraoperative nerve stimulation (TINS) - Direct muscle stimulation (DMS)" | ISIS Headbox 5042XX: "The products support the clinical application of (...) Auditory Evoked Potentials (AEP) (...)" ISIS Neurostimulator 504180: The ISIS Neurostimulator is intended for the provision of neurophysiological stimulation (...). 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) | Equal AEP: Equal TES: Equal DCS: Equal DNS: Equal TINS and TNS: Equal, the statement was reformulated from transcutaneous electrical nerve stimulation to transcutaneous intraoperative nerve stimulation to highlight the non-therapeutic aspect. DMS: Equal Both the subject and predicate device are indicated for use during surgical procedures that justify the use of aforementioned monitoring modalities. | | | - Transcutaneous electrical nerve stimulation (TNS) - Direct muscle stimulation (DMS) | | | | "The product can be used during surgical procedures that justify non-therapeutic clinical use of the following modalities (...) • Measurement: (...) Electroencephalography (EEG)" | ISIS Headbox 5042XX: "The products support the clinical application of Electroencephalography (EEG)" | Equal Both the subject and predicate devices are intended for electroencephalography (EEG). | | | "The product can be used during surgical procedures that justify non-therapeutic clinical use of the following modalities (...) • Measurement: (...) Electromyography (EMG)." | ISIS Headbox 5042XX: "The products support the clinical application of (...) Electromyography (EMG)." | Equal Both the subject and predicate devices are intended for electromyography (EMG). | | | "The product can be used during surgical procedures that justify non-therapeutic clinical use of the following modalities or their combinations: • Measurement: (...) Motor Evoked Potentials (MEP). (...) • Stimulation: (...) transcranial electrical stimulation (TES)." | 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)." | Equal Both devices can deliver transcranial stimulation via dedicated outputs. The ISIS Headbox is capable of recording MEP signals during transcranial electrical stimulation provided by the ISIS Neurostimulator. | | | "The product can be used during surgical procedures that justify non-therapeutic clinical use of the following modalities (...) • Stimulation: (...) direct cortical stimulation (DCS)." | ISIS Neurostimulator 504180: "It is suitable for continuous operation and can be used in the following fields: (...) direct cortical stimulation (DCS)." | Equal Both devices can deliver electrical current for direct cortical stimulation. | | | "The product can be used during surgical procedures that justify non-therapeutic clinical use of the following modalities or their combinations: | ISIS Headbox 5042XX: "The products support the clinical application of (...) Electromyography (EMG)." ISIS Neurostimulator 504180: | Equal Both devices can measure triggered EMG signals. The subject devices achieve this by combining the EMG measurement using the ISIS Headboxes and direct nerve | | | | | | | | Measurement: • (...) Electromyography (EMG)." Stimulation: • (...) direct nerve stimulation (DNS)." | "It is suitable for continuous operation and can be used in the following fields: (...) direct nerve stimulation (DNS)." | stimulation (DNS) using the ISIS Neurostimulator. | | | "The product can be used during surgical procedures that justify non-therapeutic clinical use of the following modalities or their combinations: combinations: Measurement: • (...) Train of Four (TOF) Stimulation: • (...) Transcutaneous intraoperative nerve stimulation (TINS)." | ISIS Headboxes 5042XX: "The products support the clinical application of (...) Electromyography (EMG)." ISIS Neurostimulator 504180: "The ISIS Neurostimulator is intended for the provision of neurophysiological stimulation (...) in the following fields: (...) transcutaneous electrical nerve stimulation (TNS)." | Equal Both products can be used for performing twitch tests to measure the level of muscle relaxation due to muscular blockers. This measurement is performed by employing a simultaneous transcutaneous electrical nerve stimulation and EMG measurement. | | | "The products are not intended for monitoring life-sustaining functions." | ISIS Headbox 5042XX: "The products are not intended for monitoring life-sustaining functions." | Equal Both products are not intended for monitoring of life- sustaining function. | | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "inomed" in black font, followed by a black square with a white "i" inside. There are curved lines around the "i" in the square. The font of the word "inomed" is sans-serif. www.inomed.com ## 510(k) Summary ISIS Headboxes and ISIS Neurostimulator FM 3-1 {8}------------------------------------------------ www.inomed.com ## 510(k) Summary ISIS Headboxes and ISIS Neurostimulator FM 3-1 {9}------------------------------------------------ FM 3-1 ISIS Headboxes and ISIS Neurostimulator Stand 1.1 vom 2017-11-02 The ISIS Headboxes and ISIS Neurostimulator including accessories Technology Comparison: as part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress) exhibit technological characteristics equivalent to those of the predicate device. | | Subject device | Predicate device | |----------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------| | System | ISIS Headbox 5042XX and ISIS Neurostimulator With NeuroExplorer 8 | ISIS Headbox 5042XX and ISIS Neurostimulator With NeuroExplorer 7 | | Manufacturer | inomed Medizintechnik GmbH | inomed Medizintechnik GmbH | | Technical aspects | | | | Protection against electrical shock | Class I protection | Class I protection | | Protection against | Device type BF (Body Floating) | Device type BF (Body Floating) | 001_510(k) Summary-2023-10-26.docx {10}------------------------------------------------ ISIS Headboxes and ISIS Neurostimulator FM 3-1 #### Page 7 of 15 | electrical shock of patient leads | | | | | |----------------------------------------------|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|----------------------------| | System configuration | 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 | | | | Amplifier components | Desired combination of ISIS Headboxes with a total of 64 channels | Desired combination of ISIS Headboxes with a total of 64 channels | | | | | Up to 64: | Up to 64: | | | | | Module | Channels | Module | Channels | | | ISIS Headbox 16 Ch. REF (504261) | Unipolar: 16 Bipolar: 0 | ISIS Headbox 16 Ch. REF (504261) | Unipolar: 16 Bipolar: 0 | | Number of amplifier channels | ISIS Headbox 16 Ch. DIF (504271) | Unipolar: 0 Bipolar: 16 | ISIS Headbox 16 Ch. DIF (504271) | Unipolar: 0 Bipolar: 16 | | | 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 | | A/D resolution | 16-bit | | 16-bit | | | | Hardware high-pass filter: | | Hardware high-pass filter: | | | Hardware bandpass | 0.5-120 Hz on all modules | | 0.5-120 Hz on all modules | | | | Hardware low-pass filter: | | Hardware low-pass filter: | | | | 2500, 5000 Hz on all modules | | 2500, 5000 Hz on all modules | | | Sampling frequency | 20 kHz | | 20 kHz | | | Notch filter | 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. | | | 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 | | | | Stimulation | | | | | TCMEP stimulation | Realized by High Current Stimulator (HC) in transcranial stimulation mode | | Realized by High Current Stimulator (HC) in transcranial stimulation mode | | | Stimulator type | Current controlled | | Current controlled | | | No. of outputs | 12 | | 12 | | {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the word "inomed" in black font, followed by a black square with a white "i" inside. There are curved lines around the "i" in the square. The font of the word "inomed" is sans-serif. www.inomed.com ## 510(k) Summary FM 3-1 | Stimulation intensity (I) and pulse width (PW) | Current controlled: up to 250 mA (voltage limit of 410 V) Voltage controlled: n/a | Current controlled: up to 250 mA (voltage limit of 410 V) Voltage controlled: n/a | |------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------| | Intensity step | 0.05 – 2 ms Constant current: 0.1 mA Constant voltage: n/a | 0.05 – 2 ms Constant current: 0.1 mA Constant voltage: n/a | | No. of stimulus pulses | 1-9 | 1-9 | | Stimulation frequency (f) range | Image: Stimulation frequency (f) range Up to 500 Hz | Image: Stimulation frequency (f) range Up to 500 Hz | | Limitation of stimulation frequency | 1/10 pulse width to stimulation period ratio | 1/10 pulse width to stimulation period ratio | | Limitation of inter-stimulus interval | Image: Limitation of inter-stimulus interval Limited to ½ pulse width to ISI | Image: Limitation of inter-stimulus interval Limited to ½ pulse width to ISI | | Absolute minimum inter-stimulus interval | 0.1 ms | 0.1 ms | | Maximum charge per phase | $189.66 \mu C$ | $189.66 \mu C$ | | Maximum RMS stimulation intensity | 30 mA RMS | 30 mA RMS | | Minimum electrode size | n/a | 0.39 cm² | | Maximum current density | 90,8 mA/cm² | 76.92 mA/cm² | | Maximum charge density | 61.5 µC/cm² | 61.5 µC/cm² | | Maximum power density | 160 W/cm² | 160 W/cm² | | Power limitation | ≤50 mJ/pulse Conformant to IEC 60601-2-40:2016, clause 201.12.4.103. | ≤50 mJ/pulse Conformant to IEC 60601-2-40:2016, 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 | | Stimulator type | Constant current | Constant current | | No. of outputs | 12 | 12…