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

K212166 · Inomed Medizintechnik GmbH · GWF · Jan 7, 2022 · Neurology

Device Facts

• Record ID: K212166
• Device Name: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
• Applicant: Inomed Medizintechnik GmbH
• Product Code: GWF · Neurology
• Decision Date: Jan 7, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

Intended 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. ISIS Neurostimulator 504180: The ISIS 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).

Device Story

Multimodality intraoperative neuromonitoring (IONM) system; consists of ISIS Headboxes (recording) and ISIS Neurostimulator (stimulation) hardware; controlled by NeuroExplorer software on standard PC. Inputs: electrophysiological signals from muscle, peripheral nerves, central nervous system. Outputs: real-time display/recording of EEG, EMG, SEP, MEP, AEP, and Train of Four (TOF). Used in operating room by neurophysiologists, neurosurgeons, neurologists, or medical technical assistants. Provides electrical stimulation (TES, DCS, DNS, TNS, DMS) to elicit responses. Healthcare providers use visual output to monitor nerve/muscle integrity during surgery; aids clinical decision-making by identifying potential neural damage. Benefits patient by reducing risk of neurological injury during procedures.

Clinical Evidence

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

Technological Characteristics

Computer-based system with dedicated hardware/software. Amplifiers: differential/referential recording, 16-bit A/D resolution, 20 kHz sampling. Stimulation: constant current, 12 outputs (HC stimulator), 1 output (DNS). Connectivity: PC-based. Sterilization: N/A (no patient contact materials). Software: NeuroExplorer, moderate level of concern. Compliance: IEC 60601-1, IEC 80601-2-26, IEC 60601-2-40.

Indications for Use

Indicated for intraoperative neuromonitoring in surgical procedures and diagnostics. Supports EEG, EMG, SEP, MEP, and AEP in the operating room. Suitable for TES, DCS, DNS, TNS, and DMS. Not intended for monitoring life-sustaining functions.

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

• Cadwell Industries Inc./Cascade Intraoperative Monitor (K162199)

Submission Summary (Full Text)

{0}------------------------------------------------

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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

#### 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)

#### 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."

{3}------------------------------------------------

Page 1 of 17 Stand 1.1 vom 2017-11-02

# ISIS Headboxes and ISIS Neurostimulator

### 510(k) Summary

| Submission<br>Date: | 07 July 2021 | | | |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------|---------------------|---------------------------------------------------------------|---------------|
| 510(k) Holder: | inomed Medizintechnik GmbH | | | |
| | Im Hausgrün 29 | | | |
| | 79312 Emmendingen, Germany | | | |
| Submitter and<br>Application<br>Correspondent: | Tomasz Moszkowski, Ph.D.<br>Phone: [phone]<br>Email: [e-mail] | | | |
| Manufacturing<br>Site: | inomed Medizintechnik GmbH<br>Im Hausgrün 29<br>79312 Emmendingen, Germany | | | |
| Trade Name: | ISIS Headboxes and ISIS Neurostimulator<br>(ISIS IOM Systems: ISIS Xpert®, ISIS Xpert®Plus, ISIS Xpress) | | | |
| Common and<br>Classification<br>Name: | Evoked response stimulator and intraoperative monitor | | | |
| Classification<br>Regulation: | Primary: 21 CFR §882.1870<br>Secondary: 21 CFR §882.1400, 21 CFR §882.1375, 21 CFR §882.1900 | | | |
| Product Code: | GWF | | | |
| Subsequent<br>Product Codes: | GWJ, GWQ, ETN, IKN | | | |
| Regulation<br>Medical<br>Specialty: | Neurology | | | |
| Substantially<br>Equivalent<br>Devices: | Predicate Device: | Predicate<br>Number | 510(k)<br>Model | Manufacturer/ |
| | K162199 | | Cadwell Industries Inc./<br>Cascade<br>Intraoperative Monitor | IOMAX |

{4}------------------------------------------------

inomed fr

# www.inomed.com

#### FM 3-1

### ISIS Headboxes and ISIS Neurostimulator

510(k) Summary

Page 2 of 17 Stand 1.1 vom 2017-11-02

| 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.<br><br>The ISIS IOM Systems support the following measurement modalities:<br>- Auditory Evoked Potentials<br>- Transcranial and cortical Motor Evoked Potentials<br>- Somatosensory Evoked Potentials<br>- Freerunning and triggered Electromyography<br>- Electroencephalography<br>- Train of Four | | | | | | |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|
| Intended Use and Indications for Use: | ISIS Headbox 5042XX:<br>The products are intended for intraoperative neuromonitoring; for the recording of electrophysiological signals and stimulating nerve and muscle tissues.<br><br>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).<br><br>The products are not intended for monitoring life-sustaining functions.<br><br>The members of the ISIS Headbox 5042XX family and their indications for use are listed as follows:<br>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

{5}------------------------------------------------

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.

Page 3 of 17 Stand 1.1 vom 2017-11-02

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 5042XX<br>and ISIS<br>Neurostimulator | Cascade IOMAX | - |
| Manufacturer | inomed Medizintechnik<br>GmbH | Cadwell Industries, Inc. | - |
| Picture | Image: ISIS Headbox 5042XX and ISIS Neurostimulator | Image: Cascade IOMAX | - |
| 510(k)<br>Number | K212166 | K162199 | - |
| Device Class | II | II | Equal |
| Product<br>Code | GWF | GWF | Equal |
| Subsequent<br>Product<br>Codes | GWJ, GWQ, ETN, IKN | DQA, ETN, GWE, GWJ,<br>GWQ, GZO, IKN, JXE, OLT | GWJ – Equal<br>GWQ – Equal<br>ETN – Equal<br>IKN – Equal<br>GWE, DQA, GZO, JXE, OLT are not within the<br>scope of the intended<br>use and indications for<br>the use of the ISIS<br>Headbox and ISIS<br>Neurostimulator |
| Main function, site of usage, intended user group | | | |
| Main<br>function | ISIS Headboxes<br>5042XX:<br>"The products are<br>intended for use in the<br>operating room to<br>measure and display the<br>electrical signals<br>generated by muscle,<br>peripheral nerves and<br>the central nervous<br>system." | "The Cascade IOMAXTM<br>Intraoperative Monitor with<br>Surgical Studio software<br>(IOMAX) is an<br>electroneurodiagnostic device<br>that acquires, displays and<br>stores physiologic data from<br>peripheral sensory and motor<br>nerves, muscles and the<br>central nervous system,<br>generated either<br>spontaneously or elicited by<br>well-defined stimuli." | Equal<br>Both the predicate and<br>subject devices can<br>acquire, display and<br>store physiologic data<br>from peripheral nerves,<br>muscles and the central<br>nervous system. |
| Site of usage | ISIS Headboxes<br>5042XX:<br>"The products are<br>intended for<br>intraoperative<br>neuromonitoring"<br>"The products are<br>intended for use in the<br>operating room (...)" | "IOMAX is used (...) in a<br>professional healthcare facility<br>environment for pre-operative,<br>intraoperative and<br>post-operative testing." | Equivalent<br>The predicate and the<br>subject device are<br>intended for<br>intraoperative testing.<br>The Cadwell IOMAX<br>may in addition be used<br>for pre-operative and<br>post-operative<br>monitoring, which the<br>subject device is not<br>intended for. This<br>difference is clearly<br>stated within the<br>intended use statement<br>of the subject device<br>and thus does not raise<br>questions in terms of<br>product safety and<br>effectiveness. |
| Intended<br>user group | Neurophysiologists<br>(clinical<br>neurophysiologists,<br>neurosurgeons,<br>neurologists or medical<br>technical assistants for<br>functional diagnostics) | "IOMAX is used by or under<br>the direction of a licensed<br>physician, surgeon, or<br>neurologist (...)" | Equivalent<br>Both the predicate and<br>subject devices may be<br>used by licensed<br>physicians (the ISIS<br>Headbox intended use<br>statement specifies the |
| | | | physicians to persons<br>with clinical<br>neurophysiologic<br>background and<br>medical technical<br>assistants) and<br>neurologists. Also, both<br>the predicate and<br>subject devices may be<br>used by surgeons. The<br>notion is more<br>specifically stated within<br>the documentation of<br>the ISIS Headbox, i.e., it<br>restricts the use to<br>neurosurgeons that are<br>licensed<br>neurophysiologists. |
| | | Indended Use and Indications for Use | |
| Intended use | ISIS Headbox 5042XX:<br>"The products are<br>intended for<br>intraoperative<br>neuromonitoring; for the<br>recording of<br>electrophysiological<br>signals and stimulating<br>of nerve and muscle<br>tissues. (...)"<br><br>ISIS Neurostimulator<br>504180:<br>"The ISIS<br>Neurostimulator is<br>intended for the<br>provision of<br>neurophysiological<br>stimulation when used in<br>surgical procedures and<br>for diagnostics. (...)" | "The Cascade IOMAX™<br>Intraoperative Monitor with<br>Surgical Studio software<br>(IOMAX) is an<br>electroneurodiagnostic device<br>that acquires, displays and<br>stores physiologic data from<br>peripheral sensory and motor<br>nerves, muscles and the<br>central nervous system,<br>generated either<br>spontaneously or elicited by<br>well-defined stimuli. (...)<br>The system also delivers direct<br>nerve stimulation required for<br>specific surgical procedures." | Equal<br>Both the subject and<br>predicate device are<br>intended for the<br>recording of<br>electrophysiological<br>signals and stimulation<br>of nerve and muscle<br>tissues during<br>intraoperative<br>neuromonitoring. |
| Indications<br>for use | ISIS Headbox 5042XX:<br>"The products support<br>the clinical application of<br>(...) Auditory Evoked<br>Potentials (AEP) (...)"<br><br>ISIS Neurostimulator<br>504180:<br>The ISIS<br>Neurostimulator is<br>intended for the<br>provision of<br>neurophysiological<br>stimulation (...). It is<br>suitable for continuous<br>operation and can be<br>used in the following<br>fields:<br>- Transcranial<br>electrical<br>stimulation (TES) | "Evoked Potentials (Eps):<br>IOMAX provides electrical,<br>auditory or visual stimulation<br>(...). " | Equivalent<br>Both the subject and<br>predicate device are<br>intended for provision of<br>electrical and auditory<br>stimulation. The ISIS<br>Headbox 504281 and<br>504285 incorporate an<br>AEP stimulator. The<br>ISIS Neurostimulator is<br>intended to be used for<br>different modes of<br>electrical stimulation.<br>The modes of electrical<br>stimulation in the ISIS<br>Neurostimulator are<br>described in more detail<br>with regard to TES,<br>DCS, DNS, TNS, and<br>DMS than within the<br>statement of Cadwell |
| | - Direct cortical stimulation (DCS)<br>- Direct nerve stimulation (DNS)<br>- Transcutaneous electrical nerve stimulation (TNS)<br>- Direct muscle stimulation (DMS) | | difference in the formulation of the statement and it does<br>not raise questions in terms of device safety and effectiveness.<br>The subject device is not intended for VEP stimulation and recording. |
| | ISIS Headbox 5042XX:<br>"The products support the clinical application of<br>Electroencephalography (EEG)" | "EEG: IOMAX measures, displays, records, and stores electrical activity of the brain from two or more electrodes on the head." | Equal<br>Both the subject and predicate devices are intended for electroencephalography (EEG). |
| | ISIS Headbox 5042XX:<br>"The products support the clinical application of<br>(...) 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." | Equal<br>Both the subject and predicate devices are intended for electromyography (EMG). |
| | ISIS Headbox 5042XX:<br>"The products support the clinical application of<br>(...) Motor Evoked Potentials (MEP)."<br>ISIS Neurostimulator 504180:<br>"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." | Equal<br>Both devices are capable of delivering transcranial stimulation via dedicated outputs.<br>The ISIS Headbox is capable of recording MEP signals during transcranial electrical stimulation provided by the ISIS Neurostimulator. |
| | ISIS Neurostimulator 504180:<br>"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." | Equal<br>Both devices are capable of delivering electrical current for direct cortical stimulation. |
| | ISIS Headbox 5042XX:<br>"The products support the clinical application of<br>(...) Electromyography (EMG)."<br>ISIS Neurostimulator 504180:<br>"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." | Equal<br>Both devices are capable of measuring triggered EMG signals.<br>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:<br>"The products are<br>intended for use in the<br>operating room to<br>measure and display the<br>electrical signals<br>generated by muscle,<br>peripheral nerves and<br>the central nervous<br>system."<br><br>ISIS Neurostimulator<br>504180:<br>"The ISIS<br>Neurostimulator is<br>intended for the<br>provision of<br>neurophysiological<br>stimulation (...) in the<br>following fields: (...)<br>Direct nerve stimulation<br>(DNS)." | "Nerve Conduction Study<br>(NCS): IOMAX measures,<br>displays, records, and stores<br>sensory and motor nerve<br>conduction time (latency) by<br>applying a stimulus to<br>peripheral nerves, the spinal<br>cord, and the central nervous<br>system." | Equivalent<br>Both devices can be<br>used to apply stimuli to<br>the peripheral nerves<br>and to the central<br>nervous system. The<br>subject device is<br>capable of measuring,<br>displaying and storing<br>electrical signals<br>generated by peripheral<br>nerves (for which the<br>nerve conduction<br>velocity is normally<br>measured). The subject<br>device can also<br>measure the latency<br>and latency differences<br>between evoked<br>potentials from different<br>sources. This difference<br>can be used to calculate<br>the nerve conduction<br>velocity. The calculated<br>result is, however, not<br>directly stored. This<br>difference does not<br>pose any questions in<br>terms of safety and<br>performance, because<br>the user can still perform<br>the nerve conduction<br>velocity measurement<br>and document the<br>results within the patient<br>report via manual<br>comment input. | |
| ISIS Headboxes<br>5042XX:<br>"The products support<br>the clinical application of<br>(...) Electromyography<br>(EMG)."<br><br>ISIS Neurostimulator<br>504180:<br>"The ISIS<br>Neurostimulator is<br>intended for the<br>provision of<br>neurophysiological<br>stimulation (...) in the<br>following fields: (...)<br>transcutaneous<br>electrical nerve<br>stimulation (TNS)." | "Train of Four (TOF) or Twitch<br>Test: IOMAX delivers a train of<br>four pulses and measures,<br>displays, records, and stores<br>the compound muscle action<br>potential amplitude fade for<br>analysis." | Equal<br>Both products can be<br>used for performing<br>twitch tests in order to<br>measure the level of<br>muscle relaxation due to<br>muscular blockers. This<br>measurement is<br>performed by employing<br>a simultaneous<br>transcutaneous<br>electrical nerve<br>stimulation and EMG<br>measurement. Although<br>the indications for use<br>statement of the subject<br>device does not<br>explicitly refer to the<br>TOF measurement, the<br>modality is available<br>within the device design<br>(software) and the<br>product labelling. This<br>difference in the<br>formulation of the<br>indications for use | |
| | | | |
| | | statement does not<br>pose any questions in<br>terms of safety and<br>performance. | |
| ISIS Headbox 5042XX:<br>"The products are not<br>intended for monitoring<br>life-sustaining<br>functions." | "SpO2: IOMAX measures and<br>displays oxygen saturation and<br>heart rate information. Remote<br>Reader: IOMAX provides<br>passive, real time remote<br>review of intraoperative<br>monitoring for a physician<br>outside of the operating room." | Not applicable<br>The subject device is<br>not intended for<br>measuring and<br>displaying oxygen<br>saturation and heart<br>rate. Vital parameter<br>measurement is out of<br>scope of the subject<br>device. SpO2 and heart<br>rate measurements are<br>one of several<br>physiological<br>parameters that are<br>normally tracked by<br>anesthesia and<br>available for IONM<br>personnel to consider<br>when interpreting<br>neurophysiologic<br>signals. The IONM<br>guidelines published up<br>to date do not specify<br>the SpO2 monitoring as<br>a required component of<br>neurophysiologic<br>monitoring systems<br>(MacDonald et al., 2013,<br>2019; Nuwer et al.,<br>2012; Sutter et al., 2007;<br>Tyner, FS., 1994).…