(28 days)
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)
The ISIS Headboxes and the ISIS Neurostimulator constitute 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 -
The provided document is a 510(k) summary for the ISIS Headboxes and ISIS Neurostimulator, which are intraoperative neuromonitoring systems. It focuses on demonstrating substantial equivalence to a predicate device (K212166) rather than establishing novel acceptance criteria and proving performance against them in a clinical study.
The document states that no additional clinical testing was performed for the subject devices. Instead, the submission relies on bench testing against established standards and internal requirements to demonstrate safety, effectiveness, and performance that is "as well as or better than" the predicate device.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of a de novo AI/ML device (which often involves clinical performance metrics like sensitivity, specificity, etc.) are not directly applicable or available in this document.
Here's an attempt to extract the relevant information based on the provided text, acknowledging the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission demonstrating substantial equivalence to a predicate device through bench testing rather than a de novo AI/ML device with pre-defined performance metrics, the acceptance criteria are primarily related to adherence to international standards and internal requirements for electrical safety, EMC, and software validation.
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit in Document) | Reported Device Performance |
|---|---|---|
| Biocompatibility | No patient contact materials | Not applicable |
| Software | Conformance to: | Demonstrated compliance with predetermined specifications, applicable guidance documents, and standards. |
| - FDA Guidance: Content of Premarket Submissions for Device Software Functions, Jun 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, Jan 02, 2002 | ||
| - FDA guidance: Content of premarket submissions for management of cybersecurity in medical devices, Oct 02, 2014 | ||
| - IEC 62304:2006/AMD1:2015, Medical device software - Software life cycle processes | ||
| Electrical Safety | Conformance to: | Test results demonstrate compliance with applicable standards. |
| - IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (or IEC 60601-1: 2012 reprint) | ||
| - IEC 80601-2-26:2019 (Electroencephalographs) | ||
| - IEC 60601-2-40:2016 (Electromyographs and evoked response equipment) | ||
| Electromagnetic Compatibility | Conformance to: | Test results demonstrate compliance with applicable standards. |
| - IEC 60601-1-2:2014 | ||
| Performance Testing – Bench | Fulfillment of internal requirement specifications for: | Products successfully underwent bench testing, confirming fulfillment of requirements. |
| - Electrical medical systems | ||
| - System carrier | ||
| - Amplifier (ISIS Headboxes) and stimulator (ISIS Neurostimulator) modules | ||
| - Operating software (NeuroExplorer) incl. firmware | ||
| - Accessories (adaptor boxes) | ||
| - Custom Microsoft® Windows 10 image | ||
| Human Factors | Demonstrates safety and no need for further UI improvement | Testing confirms products are safe to use. |
| Overall Performance | As safe, as effective, and performs as well as or better than the legally marketed predicate. | Demonstrated. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not applicable in the traditional sense of a clinical test set with patient data. The testing was primarily bench and software validation. The "sample size" would refer to the number of units tested, which is not specified, but implied to be sufficient for type testing.
- Data Provenance: The data refers to the results of internal bench tests and software validation activities, conducted by the manufacturer (inomed Medizintechnik GmbH) in Germany. It is entirely retrospective in the sense that it's performed on a developed product to meet predefined standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not provided because no clinical test set with expert-established ground truth was used. The ground truth for functional verification would be the expected output or behavior according to engineering specifications and regulatory standards.
4. Adjudication Method for the Test Set
- Not applicable as there was no clinical test set requiring expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was done. The device is a neuromonitoring system, not an AI-assisted diagnostic or interpretive tool that would inherently involve "human readers" in that sense. The submission explicitly states: "No additional clinical testing was performed".
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies that the "software validation" and "bench testing" constitutes a standalone performance evaluation of the device's functional integrity as an algorithm/system. The software (NeuroExplorer) and hardware components were tested to ensure they meet their predetermined specifications and comply with relevant standards independently of human interpretation of clinical outcomes. However, this is not an "AI algorithm only" type of standalone performance, but rather functional performance of medical device software/hardware.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the bench and software testing, the "ground truth" would be established by the engineering specifications, international performance standards (e.g., IEC 60601 series), and documented functional requirements of the device. This is a technical (rather than clinical/biological) ground truth.
8. The sample size for the training set
- This device is not described as an AI/ML device that requires a "training set" in the context of machine learning model development. Therefore, this question is not applicable. The software development follows a traditional software lifecycle process, not a machine learning training paradigm.
9. How the ground truth for the training set was established
- Not applicable, as there is no mention of an AI/ML training set.
{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
| SubmissionDate: | 29 September 2023 | ||||
|---|---|---|---|---|---|
| 510(k) Holder: | inomed Medizintechnik GmbHIm Hausgrün 2979312 Emmendingen, Germany | ||||
| Submitter andApplicationCorrespondent: | Tomasz Moszkowski, Ph.D.Phone: +49 7641 6414 583Email: t.moszkowski@inomed.com | ||||
| ManufacturingSite: | inomed Medizintechnik GmbHIm Hausgrün 2979312 Emmendingen, Germany | ||||
| Trade Name: | ISIS Headbox 5042XX and ISIS Neurostimulator(ISIS IOM Systems: ISIS Xpert®, ISIS Xpert®Plus, ISIS Xpress) | ||||
| Common andClassificationName: | Evoked response stimulator and intraoperative monitor | ||||
| ClassificationRegulation: | 21 CFR §882.1870 | ||||
| Product Code: | GWF | ||||
| SubsequentProduct Codes: | GWJ, GWQ, ETN, IKN | ||||
| RegulationMedicalSpecialty: | Neurology | ||||
| SubstantiallyEquivalentDevices: | PredicateNumber | 510(k) | PredicateModel | Manufacturer | |
| Predicate Device: | K212166 | inomed medizintechnikGmbH / ISIS Headbox5042XX and ISISNeurostimulator |
{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 5042XXand ISISNeurostimulatorwith NeuroExplorer 8 | ISIS Headbox 5042XXand ISISNeurostimulatorwith NeuroExplorer 7 | |
| Manufacturer | inomed MedizintechnikGmbH | inomed MedizintechnikGmbH | |
| Picture | Image: Subject devices | Image: Predicate device | |
| 510(k)Number | K233292 | K212166 | |
| Device Class | II | II | Equal |
| ProductCode | GWF | GWF | Equal |
| SubsequentProductCodes | GWJ, GWQ, ETN, IKN | GWJ, GWQ, ETN, IKN | GWJ - EqualGWQ - EqualETN - EqualIKN – Equal |
| Main function, site of usage, intended user group | |||
| Mainfunction | "The product is used forintraoperativemonitoring and testingduring surgicalproceduresto examine neuronaltissue (central andperipheral nervoussystem) by recordingand stimulation" | ISIS Headboxes 5042XX:"The products areintended for use in theoperating room tomeasure and display theelectrical signalsgenerated by muscle,peripheral nerves andthe central nervoussystem." | EqualBoth the predicate and subjectdevices can acquire, displayand store physiologic datafrom peripheral nerves,muscles, and the centralnervous system. Thestatements use differentwording, but do not differ interms of the clinical aspects. |
| Site of usage | "The product is used forintraoperative monitoringand testing duringsurgical procedures.(…)” | ISIS Headboxes 5042XX:"The products areintended for | EqualThe predicate and the subjectdevice are intended for useduring surgical procedures. |
| "The product can beused during surgicalprocedures (...)" | intraoperativeneuromonitoring""The products areintended for use in theoperating room (...)" | ||
| Intendeduser group | Neurophysiologists(clinicalneurophysiologists,neurosurgeons,neurologists or medicaltechnical assistants forfunctional diagnostics) | Neurophysiologists(clinicalneurophysiologists,neurosurgeons,neurologists or medicaltechnical assistants forfunctional diagnostics) | Equal |
| Intended use | The product is used forintraoperative monitoringand testing duringsurgical procedures- to examineneuronal tissue(central andperipheral nervoussystem) byrecording andstimulation | ISIS Headbox 5042XX:"The products areintended forintraoperativeneuromonitoring; for therecording ofelectrophysiologicalsignals and stimulatingof nerve and muscletissues. (...)"ISIS Neurostimulator504180:"The ISISNeurostimulator isintended for theprovision ofneurophysiologicalstimulation when used insurgical procedures andfor diagnostics. (...)" | EqualBoth the subject and predicatedevice are intended for therecording ofelectrophysiological signalsand stimulation of neuronaltissue during intraoperativeneuromonitoring. |
| Indicationsfor use | "The product can beused during surgicalprocedures that justifynon-therapeutic clinicaluse of the followingmodalities or theircombinations:- Measurement:Auditory evokedpotentials (AEP)(...)- Stimulation:Transcranialelectricalstimulation (TES)- Direct cortical andsubcorticalstimulation (DCS)- Direct nervestimulation (DNS)- Transcutaneousintraoperativenerve stimulation(TINS)- Direct musclestimulation (DMS)" | ISIS Headbox 5042XX:"The products supportthe clinical application of(...) Auditory EvokedPotentials (AEP) (...)"ISIS Neurostimulator504180:The ISISNeurostimulator isintended for theprovision ofneurophysiologicalstimulation (...). It issuitable for continuousoperation and can beused in the followingfields:- Transcranialelectricalstimulation (TES)- Direct corticalstimulation (DCS)- Direct nervestimulation (DNS) | EqualAEP: EqualTES: EqualDCS: EqualDNS: EqualTINS and TNS: Equal, thestatement was reformulatedfrom transcutaneous electricalnerve stimulation totranscutaneous intraoperativenerve stimulation to highlightthe non-therapeutic aspect.DMS: EqualBoth the subject and predicatedevice are indicated for useduring surgical proceduresthat justify the use ofaforementioned monitoringmodalities. |
| - 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)" | EqualBoth 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)." | EqualBoth 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)." | EqualBoth 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)." | EqualBoth 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: | EqualBoth 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 nervestimulation (DNS)." | "It is suitable forcontinuous operationand can be used in thefollowing fields: (...)direct nerve stimulation(DNS)." | stimulation (DNS) using theISIS Neurostimulator. | |
| "The product can beused during surgicalprocedures that justifynon-therapeutic clinicaluse of the followingmodalities or theircombinations:combinations:Measurement:• (...) Train of Four (TOF)Stimulation:• (...) Transcutaneousintraoperative nervestimulation (TINS)." | ISIS Headboxes5042XX:"The products supportthe clinical applicationof (...)Electromyography(EMG)."ISIS Neurostimulator504180:"The ISISNeurostimulator isintended for theprovision ofneurophysiologicalstimulation (...) in thefollowing fields: (...)transcutaneouselectrical nervestimulation (TNS)." | EqualBoth products can be used forperforming twitch tests tomeasure the level of musclerelaxation due to muscularblockers. This measurementis performed by employing asimultaneous transcutaneouselectrical nerve stimulationand EMG measurement. | |
| "The products are notintended for monitoringlife-sustaining functions." | ISIS Headbox 5042XX:"The products are notintended for monitoringlife-sustainingfunctions." | EqualBoth products are notintended 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.
510(k) Summary
ISIS Headboxes and ISIS Neurostimulator
FM 3-1
{8}------------------------------------------------
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 ISISNeurostimulatorWith NeuroExplorer 8 | ISIS Headbox 5042XX and ISISNeurostimulatorWith NeuroExplorer 7 |
| Manufacturer | inomed Medizintechnik GmbH | inomed Medizintechnik GmbH |
| Technical aspects | ||
| Protectionagainstelectricalshock | Class I protection | Class I protection |
| Protectionagainst | 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
| electricalshock ofpatient leads | ||||
|---|---|---|---|---|
| Systemconfiguration | Computer-based equipment with dedicated hardware and software components | Computer-based equipment with dedicated hardware and software components | ||
| Signal recording | ||||
| Measurementprinciple | Amplifiers based on differential (bipolar) and referential (unipolar) type of recording | Amplifiers based on differential (bipolar) and referential (unipolar) type of recording | ||
| Amplifiercomponents | Desired combination of 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 16Ch. REF (504261) | Unipolar: 16Bipolar: 0 | ISIS Headbox 16Ch. REF (504261) | Unipolar: 16Bipolar: 0 | |
| Number ofamplifierchannels | ISIS Headbox 16Ch. DIF (504271) | Unipolar: 0Bipolar: 16 | ISIS Headbox 16Ch. DIF (504271) | Unipolar: 0Bipolar: 16 |
| ISIS Headbox 16Ch. REF - AEP(504281) | Unipolar: 16Bipolar: 0 | ISIS Headbox 16Ch. REF - AEP(504281) | Unipolar: 16Bipolar: 0 | |
| ISIS Headbox 8Ch. DIF - 8 Ch.REF - AEP(504285) | Unipolar: 8Bipolar: 8 | ISIS Headbox 8Ch. DIF - 8 Ch.REF - AEP(504285) | Unipolar: 8Bipolar: 8 | |
| A/Dresolution | 16-bit | 16-bit | ||
| Hardware high-pass filter: | Hardware high-pass filter: | |||
| Hardwarebandpass | 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 | |||
| Samplingfrequency | 20 kHz | 20 kHz | ||
| Notch filter | 50, 60 Hz | 50, 60 Hz | ||
| Common-moderejection ratio(CMRR) | > 100 dBConformant with IEC 80601-2-26:2019, clause 201.12.1.106 Common mode rejection. | > 100 dBConformant with IEC 80601-2-26:2019, clause 201.12.1.106 Common mode rejection. | ||
| Amplifiernoise | 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 | ||||
| TCMEPstimulation | Realized by High Current Stimulator (HC) in transcranial stimulation mode | Realized by High Current Stimulator (HC) in transcranial stimulation mode | ||
| Stimulatortype | Current controlled | Current controlled | ||
| No. ofoutputs | 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.
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 msConstant current: 0.1 mAConstant voltage: n/a | 0.05 – 2 msConstant current: 0.1 mAConstant voltage: n/a |
| No. of stimulus pulses | 1-9 | 1-9 |
| Stimulation frequency (f) range | Image: Stimulation frequency (f) rangeUp to 500 Hz | Image: Stimulation frequency (f) rangeUp 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 intervalLimited to ½ pulse width to ISI | Image: Limitation of inter-stimulus intervalLimited 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 |
| Maximumpowerdensity | 160 W/cm² | 160 W/cm² |
| Powerlimitation | ≤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. |
| High-currentstimulator forSEP 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 |
| Stimulatortype | Constant current | Constant current |
| No. ofoutputs | 12 | 12 |
| Stimulationintensity (I) | Image: Stimulation intensity (I) | Image: Stimulation intensity (I) |
| Accessory-dependent | Up to 75 mA | |
| Intensity step | 0.1 mA | 0.1 mA |
| Pulse width(PW) | 0.05 – 2 ms | 0.05 – 2 ms |
| No. ofstimuluspulses | 1-9 | 1-9 |
| Stimulationfrequency (f)range | Image: Stimulation frequency (f) range | Image: Stimulation frequency (f) range |
| SEP: Up to 500 HzTOF: 2 Hz (fixed) | SEP: Up to 500 HzTOF: 2 Hz (fixed) | |
| Limitation ofstimulationfrequency | 1/10 pulse width to stimulation periodratio | 1/10 pulse width to stimulation periodratio |
| Limitation ofinter-stimulusinterval | Image: Limitation of inter-stimulus interval | Image: Limitation of inter-stimulus interval |
| Limited to ½ pulse width to ISI | Limited to ½ pulse width to ISI | |
| Absoluteminimuminter-stimulusinterval | 0.1 ms | 0.1 ms |
| Maximumcharge perphase | 150 µC | 150 µC |
| MaximumRMS | Accessory-dependent | 23.7 mA RMS |
| stimulationintensity | ||
| Minimumelectrode size | n/a | 0.272 cm² |
| Maximumcurrentdensity | 90.8 mA/cm² | 87.1 mA/cm² |
| Maximumchargedensity | 150.0 µC/cm² | 150.0 µC/cm² |
| Maximumpowerdensity | 20.7 W/cm² | 20.7 W/cm² |
| Powerlimitation | ≤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. |
| Low-currentstimulator fordirect corticalstimulation: | Realized by High Current Stimulator(HC) in direct cortical stimulation mode | Realized by High Current Stimulator(HC) in direct cortical stimulation mode |
| Stimulatortype | Constant current | Constant current |
| Stimulationintensity (I) | Image: Stimulation intensity | Image: Stimulation intensity |
| Accessory-dependent | Up to 30 mA | |
| Intensity step | 0.01 mA | 0.01 mA |
| Pulse width(PW) | 0.05 - 2 ms | 0.05 - 2 ms |
| No. ofstimuluspulses | 1 - 9 | 1 - 9 |
| Stimulationfrequency (f)range | Image: Stimulation frequency | Image: Stimulation frequency |
| Up to 500 Hz | Up to 500 Hz | |
| Limitation ofstimulationfrequency | 1/10 pulse width to stimulation periodratio | 1/10 pulse width to stimulation periodratio |
| Limitation ofinter-stimulusinterval | Image: Inter-stimulus interval | Image: Inter-stimulus interval |
| Limited to ½ pulse width to ISI | Limited to ½ pulse width to ISI | |
| Absoluteminimuminter-stimulusinterval | 0.1 ms | 0.1 ms |
| Maximumcharge perpulse | 60 µC | 60 µC |
| MaximumRMSstimulationintensity | Accessory-dependent | 9.5 mA RMS |
| Minimumelectrode size | n/a | 0.126 cm² |
| Maximumcurrentdensity | 90.8 mA/cm² | 75.29 mA/cm² |
| Maximumchargedensity | 150.8 µC/cm² | 150.8 µC/cm² |
| Maximumpowerdensity | 7.1 W/cm² | 7.1 W/cm² |
| Powerlimitation | ≤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. |
| Low-currentstimulator fordirect nervestimulation: | Realized by Direct Nerve Stimulator(DNS) in direct nerve stimulation mode | Realized by Direct Nerve Stimulator(DNS) in direct nerve stimulation mode |
| Stimulatortype | Constant current | Constant current |
| No. ofoutputs | 1 | 1 |
| Stimulationintensity (I) | Image: Stimulation intensity | |
| Accessory-dependent | Up to 5 mA | |
| Intensity step | 0.01 mA | 0.01 mA |
| Pulse width(PW) | 0.05 - 2 ms | 0.05 - 2 ms |
| No. ofstimuluspulses | 1 - 9 | 1 - 9 |
| Stimulationfrequency (f)range | Image: Stimulation frequency | |
| Up to 500 Hz | Up to 500 Hz | |
| Limitation ofstimulationfrequency | 1/10 pulse width to stimulation periodratio | 1/10 pulse width to stimulation periodratio |
| Limitation ofinter-stimulusinterval | Image: ISI diagramLimited to ½ pulse width to ISI | Image: ISI diagramLimited to ½ pulse width to ISI |
| Absoluteminimuminter-stimulusinterval | 0.1 ms | 0.1 ms |
| Maximumcharge perpulse | 10 µC | 10 µC |
| MaximumRMSstimulationintensity | Accessory-dependent | 1.58 mA RMS |
| Minimumelectrode size | n/a | 0.020 cm² |
| Maximumcurrentdensity | 90.8 mA/cm² | 79 mA/cm² |
| Maximumchargedensity | 158 µC/cm² | 158 µC/cm² |
| Maximumpowerdensity | 1.25 W/cm² | 1.25 W/cm² |
| Powerlimitation | ≤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. |
{12}------------------------------------------------
ISIS Headboxes and ISIS Neurostimulator
FM 3-1
Page 9 of 15
{13}------------------------------------------------
ISIS Headboxes and ISIS Neurostimulator
FM 3-1
Page 10 of 15
{14}------------------------------------------------
ISIS Headboxes and ISIS Neurostimulator
FM 3-1
Page 11 of 15
Stand 1.1 vom 2017-11-02
001_510(k) Summary-2023-10-26.docx
{15}------------------------------------------------
FM 3-1
ISIS Headboxes and ISIS Neurostimulator
Page 12 of 15
Stand 1.1 vom 2017-11-02
Summary of Performance Testing:
The ISIS Headboxes and ISIS Neurostimulator including accessories Biocompatibility: as part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress) have no patient contact materials, and therefore this section does not apply.
Software: The Documentation Level of 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:
{16}------------------------------------------------
ISIS Headboxes and ISIS Neurostimulator
Page 13 of 15 Stand 1.1 vom 2017-11-02
| FDA Guidance: Content of Premarket Submissions for Device-Software Functions, Jun 14, 2023FDA guidance: Off-the-shelf software use in medical devices,-August 11, 2023FDA guidance: General principles of software validation: Final-guidance for industry and FDA staff, Jan 02, 2002FDA guidance: Content of premarket submissions for-management of cybersecurity in medical devices, Oct 02, 2014IEC 62304:2006/AMD1:2015, Medical device software --Software life cycle processesTest results demonstrate that the inomed NeuroExplorer softwarecomplies with its predetermined specifications, the applicableguidance documents, and standards. | |
|---|---|
| Electrical Safety: | The ISIS Headboxes and ISIS Neurostimulator including accessoriesas part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS Xpert®, ISISXpress) were tested according to the following standards:IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR.-2:2007 + A1:2012 (or IEC 60601-1: 2012 reprint), Medicalelectrical equipment – Part 1: General requirements for basicsafety and essential performance.IEC 80601-2-26:2019, Medical electrical equipments – Part 2--26: Particular requirements for the basic safety and essentialperformance of electroencephalographsIEC 60601-2-40:2016, Medical electrical equipments - Part 2--40: Particular requirements for the basic safety and essentialperformance of electromyographs and evoked responseequipment |
| Test results demonstrate that the products comply with the applicablestandards. | |
| ElectromagneticCompatibility: | The ISIS Headboxes and ISIS Neurostimulator including accessoriesas part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS Xpert®, ISISXpress) were tested according to the following standards:IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2:-General requirements for basic safety and essentialperformance - Collateral standard: Electromagneticdisturbances - Requirements and tests. |
| Test results demonstrate that the products comply with the applicablestandards. | |
| PerformanceTesting – Bench | The essential performance and safety of the ISIS Headboxes and ISISNeurostimulator including accessories as part of ISIS IOM Systems(ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress) were tested forperformance in accordance with internal requirements. The devicesincluding their accessories and corresponding intended combinationswith further products have been designed according to requirementspecifications formulated at the following levels:Requirements for electrical medical systems Requirements for the system carrier Requirements for the amplifier (ISIS Headboxes) and stimulator(ISIS Neurostimulator) modules Requirements for the operating software (NeuroExplorer) incl.ISIS Headbox and ISIS Neurostimulator firmware ISIS Headbox and ISIS Neurostimulator accessories (adaptorboxes) Custom Microsoft® Windows 10 image |
| The products successfully underwent the bench testing to confirm thefulfillment of the requirements at these levels as part of the verificationand validation process. | |
| Moreover, the testing of the influence of human factors on the devicesdemonstrates that the products are safe to use and that no furtherimprovement of the user interface design relating to safety isnecessary. | |
| The non-clinical tests demonstrate that the device is as safe, aseffective, and performs as well as or better than the legally marketeddevice predicate. | |
| PerformanceTesting –Clinical | No additional clinical testing was performed for the ISIS Headboxesand ISIS Neurostimulator including accessories as part of ISIS IOMSystems (ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress). Therefore, thissection does not apply. |
| Conclusion | In order to establish the performance and safety characteristics, theISIS Headboxes and ISIS Neurostimulator including accessories aspart of ISIS IOM Systems (ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress)underwent successful testing in terms of the device software, electricalsafety, electromagnetic compatibility, bench testing, and humanfactors engineering. The results of these activities demonstrate thatthe devices are as safe, effective and perform as well as or better thanthe predicate device.Therefore, the ISIS Headboxes and ISIS Neurostimulator includingaccessories as part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS |
{17}------------------------------------------------
inomed fi
www.inomed.com
510(k) Summary
ISIS Headboxes and ISIS Neurostimulator
FM 3-1
Page 14 of 15 Stand 1.1 vom 2017-11-02
{18}------------------------------------------------
Image /page/18/Picture/0 description: The image shows the logo for Inomed. The logo consists of the word "inomed" in black font, with a stylized "i" in a black square to the right. Below the logo is the website address "www.inomed.com".
ISIS Headboxes and ISIS Neurostimulator
Page 15 of 15 Stand 1.1 vom 2017-11-02
Xpert®, ISIS Xpress) are considered substantially equivalent to the predicate device.
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).