(28 days)
Not Found
No
The summary describes a system for intraoperative neuromonitoring using standard signal processing techniques (evoked potentials, EEG, EMG, etc.) and does not mention any AI or ML components in the device description, intended use, or performance testing.
No
The "Intended Use / Indications for Use" section explicitly states that the product is for "non-therapeutic clinical use."
Yes
The device is used for "intraoperative monitoring and testing" and "to examine neuronal tissue by recording and stimulation" using various measurement modalities like EEG, EMG, and evoked potentials. This process of collecting data to assess the state of the nervous system is a diagnostic function.
No
The device description explicitly states that the system consists of "custom stimulation and recording hardware" in addition to the software. The performance testing also includes verification and validation of the hardware components (ISIS Headboxes and ISIS Neurostimulator).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the product is used for "intraoperative monitoring and testing during surgical procedures" to "examine neuronal tissue" by recording and stimulation. This involves directly interacting with the patient's nervous system in vivo.
- Device Description: The device description details hardware for stimulation and recording, a computer, and software. This aligns with a system used for physiological monitoring and stimulation in vivo.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not process or analyze such specimens.
The device is a medical device used for neuromonitoring and stimulation during surgery, which is an in vivo application.
N/A
Intended Use / Indications for Use
The product is used for intraoperative monitoring and testing during surgical procedures
- to examine neuronal tissue (central and peripheral nervous system) by recording and stimulation
The product can be used during surgical procedures that justify non-therapeutic clinical use of the following modalities or their combinations:
- Measurement:
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)
Product codes
GWF, GWJ, GWQ, ETN, IKN
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central and peripheral nervous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Neurophysiologists (clinical neurophysiologists, neurosurgeons, neurologists or medical technical assistants for functional diagnostics)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The ISIS Headboxes and ISIS Neurostimulator including accessories as part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress) have no patient contact materials, and therefore this section does not apply.
Software: The 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:
- 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
Test results demonstrate that the inomed NeuroExplorer software complies with its predetermined specifications, the applicable guidance documents, and standards.
Electrical Safety: The ISIS Headboxes and ISIS Neurostimulator including accessories as part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress) were tested according to the following standards:
- IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (or IEC 60601-1: 2012 reprint), Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
- IEC 80601-2-26:2019, Medical electrical equipments – Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
- IEC 60601-2-40:2016, Medical electrical equipments - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
Test results demonstrate that the products comply with the applicable standards.
Electromagnetic Compatibility: The ISIS Headboxes and ISIS Neurostimulator including accessories as part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress) were tested according to the following standards:
- IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.
Test results demonstrate that the products comply with the applicable standards.
Performance Testing – Bench: The essential performance and safety of the ISIS Headboxes and ISIS Neurostimulator including accessories as part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress) were tested for performance in accordance with internal requirements. The devices including their accessories and corresponding intended combinations with further products have been designed according to requirement specifications 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 (adaptor boxes) Custom Microsoft® Windows 10 image
The products successfully underwent the bench testing to confirm the fulfillment of the requirements at these levels as part of the verification and validation process.
Moreover, the testing of the influence of human factors on the devices demonstrates that the products are safe to use and that no further improvement of the user interface design relating to safety is necessary.
The non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device predicate.
Performance Testing – Clinical: No additional clinical testing was performed for the ISIS Headboxes and ISIS Neurostimulator including accessories as part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress). Therefore, this section does not apply.
Conclusion: In order to establish the performance and safety characteristics, the ISIS Headboxes and ISIS Neurostimulator including accessories as part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress) underwent successful testing in terms of the device software, electrical safety, electromagnetic compatibility, bench testing, and human factors engineering. The results of these activities demonstrate that the devices are as safe, effective and perform as well as or better than the predicate device.
Therefore, the ISIS Headboxes and ISIS Neurostimulator including accessories as part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress) are considered substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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.
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 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.
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 |
| Stimulation
intensity (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. of
stimulus
pulses | 1-9 | 1-9 |
| Stimulation
frequency (f)
range | Image: Stimulation frequency (f) range | Image: Stimulation frequency (f) range |
| | SEP: Up to 500 Hz
TOF: 2 Hz (fixed) | SEP: Up to 500 Hz
TOF: 2 Hz (fixed) |
| 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 | Image: Limitation of inter-stimulus interval |
| | Limited to ½ pulse width to ISI | Limited to ½ pulse width to ISI |
| Absolute
minimum
inter-stimulus
interval | 0.1 ms | 0.1 ms |
| Maximum
charge per
phase | 150 µC | 150 µC |
| Maximum
RMS | Accessory-dependent | 23.7 mA RMS |
| stimulation
intensity | | |
| Minimum
electrode size | n/a | 0.272 cm² |
| Maximum
current
density | 90.8 mA/cm² | 87.1 mA/cm² |
| Maximum
charge
density | 150.0 µC/cm² | 150.0 µC/cm² |
| Maximum
power
density | 20.7 W/cm² | 20.7 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. |
| Low-current
stimulator for
direct cortical
stimulation: | Realized by High Current Stimulator
(HC) in direct cortical stimulation mode | Realized by High Current Stimulator
(HC) in direct cortical stimulation mode |
| Stimulator
type | Constant current | Constant current |
| Stimulation
intensity (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. of
stimulus
pulses | 1 - 9 | 1 - 9 |
| Stimulation
frequency (f)
range | Image: Stimulation frequency | Image: Stimulation frequency |
| | Up to 500 Hz | 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: Inter-stimulus interval | Image: Inter-stimulus interval |
| | Limited to ½ pulse width to ISI | Limited to ½ pulse width to ISI |
| Absolute
minimum
inter-stimulus
interval | 0.1 ms | 0.1 ms |
| Maximum
charge per
pulse | 60 µC | 60 µC |
| Maximum
RMS
stimulation
intensity | Accessory-dependent | 9.5 mA RMS |
| Minimum
electrode size | n/a | 0.126 cm² |
| Maximum
current
density | 90.8 mA/cm² | 75.29 mA/cm² |
| Maximum
charge
density | 150.8 µC/cm² | 150.8 µC/cm² |
| Maximum
power
density | 7.1 W/cm² | 7.1 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. |
| Low-current
stimulator for
direct nerve
stimulation: | Realized by Direct Nerve Stimulator
(DNS) in direct nerve stimulation mode | Realized by Direct Nerve Stimulator
(DNS) in direct nerve stimulation mode |
| Stimulator
type | Constant current | Constant current |
| No. of
outputs | 1 | 1 |
| Stimulation
intensity (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. of
stimulus
pulses | 1 - 9 | 1 - 9 |
| Stimulation
frequency (f)
range | Image: Stimulation frequency | |
| | Up to 500 Hz | 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: ISI diagram
Limited to ½ pulse width to ISI | Image: ISI diagram
Limited to ½ pulse width to ISI |
| Absolute
minimum
inter-stimulus
interval | 0.1 ms | 0.1 ms |
| Maximum
charge per
pulse | 10 µC | 10 µC |
| Maximum
RMS
stimulation
intensity | Accessory-dependent | 1.58 mA RMS |
| Minimum
electrode size | n/a | 0.020 cm² |
| Maximum
current
density | 90.8 mA/cm² | 79 mA/cm² |
| Maximum
charge
density | 158 µC/cm² | 158 µC/cm² |
| Maximum
power
density | 1.25 W/cm² | 1.25 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. |
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, 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
Test results demonstrate that the inomed NeuroExplorer software
complies with its predetermined specifications, the applicable
guidance documents, and standards. |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical Safety: | The ISIS Headboxes and ISIS Neurostimulator including accessories
as part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS Xpert®, ISIS
Xpress) were tested according to the following standards:
IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR.
2:2007 + A1:2012 (or IEC 60601-1: 2012 reprint), Medical
electrical equipment – Part 1: General requirements for basic
safety and essential performance.
IEC 80601-2-26:2019, Medical electrical equipments – Part 2-
26: Particular requirements for the basic safety and essential
performance of electroencephalographs
IEC 60601-2-40:2016, Medical electrical equipments - Part 2-
40: Particular requirements for the basic safety and essential
performance of electromyographs and evoked response
equipment |
| | Test results demonstrate that the products comply with the applicable
standards. |
| Electromagnetic
Compatibility: | The ISIS Headboxes and ISIS Neurostimulator including accessories
as part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS Xpert®, ISIS
Xpress) were tested according to the following standards:
IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2:
General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
disturbances - Requirements and tests. |
| | Test results demonstrate that the products comply with the applicable
standards. |
| Performance
Testing – Bench | The essential performance and safety of the ISIS Headboxes and ISIS
Neurostimulator including accessories as part of ISIS IOM Systems
(ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress) were tested for
performance in accordance with internal requirements. The devices
including their accessories and corresponding intended combinations
with further products have been designed according to requirement
specifications 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 (adaptor
boxes) Custom Microsoft® Windows 10 image |
| | The products successfully underwent the bench testing to confirm the
fulfillment of the requirements at these levels as part of the verification
and validation process. |
| | Moreover, the testing of the influence of human factors on the devices
demonstrates that the products are safe to use and that no further
improvement of the user interface design relating to safety is
necessary. |
| | The non-clinical tests demonstrate that the device is as safe, as
effective, and performs as well as or better than the legally marketed
device predicate. |
| Performance
Testing –
Clinical | No additional clinical testing was performed for the ISIS Headboxes
and ISIS Neurostimulator including accessories as part of ISIS IOM
Systems (ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress). Therefore, this
section does not apply. |
| Conclusion | In order to establish the performance and safety characteristics, the
ISIS Headboxes and ISIS Neurostimulator including accessories as
part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress)
underwent successful testing in terms of the device software, electrical
safety, electromagnetic compatibility, bench testing, and human
factors engineering. The results of these activities demonstrate that
the devices are as safe, effective and perform as well as or better than
the predicate device.
Therefore, the ISIS Headboxes and ISIS Neurostimulator including
accessories as part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS |
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.