C2 Xplore

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. January 27, 2023 Inomed Medizintechnik GmbH Anja Riesterer, M.Sc. Regulatory Affairs Manager Im Hausgruen 29 Emmendingen, 79312 Germany Re: K223254 Trade/Device Name: C2 Xplore Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN, GWF Dated: October 14, 2022 Received: October 21, 2022 Dear Anja Riesterer: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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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, # Joyce C. Lin -S for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K223254 Device Name C2 Xplore Indications for Use (Describe) The C2 Xplore is designed for use in the operating room to measure and display the neurophysiological signals. The system supports the application of Electromyography (EMG) for the purposes of intraoperative neuromonitoring of the peripheral nervous system. The system is not intended for monitoring life-sustaining functions. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------------------------------------------------------| | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | #### 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. 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Below the logo is the website address "www.inomed.com". ## 510(k) Summary | Submission Date: | 2022-10-14 | | |------------------------------------------------|-----------------------------------------------------------------------------|------------------------------------------------------| | Subject 510(k) number | K223254 | | | 510(k) Holder: | inomed Medizintechnik GmbH<br>Im Hausgruen 29<br>79312 Emmendingen, Germany | | | Submitter and<br>Application<br>Correspondent: | Maximilian Wimmer<br>Phone: +49 7641 6414 545<br>Email: m.wimmer@inomed.com | | | Manufacturing<br>Site: | inomed Medizintechnik GmbH<br>Im Hausgruen 29<br>79312 Emmendingen, Germany | | | Trade Name: | C2 Xplore | | | Classification<br>Regulation: | Surgical nerve stimulator/locator 21 CFR §874.1820 | | | Product Code: | ETN, GWF | | | Regulation<br>Medical<br>Specialty: | Ear, Nose, and Throat | | | Substantially<br>Equivalent<br>Devices: | Predicate device 510(k) number | Predicate device Manufacturer/<br>Model | | | K152505 | inomed Medizintechnik GmbH<br>C2 NerveMonitor System | | | Reference device 510(k) number | Reference device Manufacturer/<br>Model | | | K083124 | Medtronic Xomed, Inc<br>Nerve Integrity Monitor 3.0 | {4}------------------------------------------------ The C2 Xplore is an electromyography (EMG) monitor for the Device Description: purposes of intraoperative neuromonitoring of the peripheral nervous system. The C2 Xplore assists the surgeon in nerve identification, helping to locate and identify nerves at risk in the surgical field. The device records the EMG activity from the innervated nerves and provides visual and audible feedback for the surgeon, helping to preserve the nerve structures throughout the procedure. The device is equipped with 8 differential amplifier channels and with two independent stimulators. The C2 Xplore is operated via mechanical turning knobs and a touchscreen on the front. The audio feedback is generated by an integrated loudspeaker. The nerve monitoring provides information about the amplitude and latency of the EMG responses. Intended Use of The C2 Xplore is intended for intraoperative neuromonitoring; for Subject Device: recording of electrophysiological signals and stimulating of nerve and muscle tissues. C2 Xplore The C2 Xplore is designed for use in the operating room to measure Indications for and display the neurophysiological signals. Use of Subject Device: The system supports the application of Electromyography (EMG) for the purposes of intraoperative neuromonitoring of the peripheral C2 Xplore nervous system. The system is not intended for monitoring life-sustaining functions. Intended Use of The C2 NerveMonitor System is intended for intra-operative Predicate Device: monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery. C2 NerveMonitor including spinal nerve roots. System K152505 Indications for The C2 NerveMonitor device with the integrated user interface is only Use of Predicate allowed for the surveillance, documentation and functional test of motor nerves. It can be used as an additional helping tool during Device surgical procedures for diagnostic issues. Its basic functions are C2 NerveMonitor similar to those of an EMG diagnostic device. System Indications for C2 NerveMonitor System Monitoring Procedures K152505 include: Extracranial, Intratemporal, Extratemporal, Neck Dissections, and Upper and Lower Extremities. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Inomed. The logo consists of the word "inomed" in bold, black letters, followed by a black square containing a white "i" with two curved arrows around it. Below the word "inomed" is the website address "www.inomed.com". Indications for C2 NerveMonitor System monitoring of Spinal procedures include: Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Orthopedic Surgery, Open and Percutaneous Lumbar and Cervical Surgical Procedures. The system is not intended for monitoring life preserving functions. The system may not be used for diagnosing brain death. Conclusion of the inomed Medizintechnik GmbH claims that the predicate and subject intended use devices are substantially equivalent in terms of the intended use and evaluation: indications for use. Both the predicate and subject devices can be used for the recording of electrophysiological signals and stimulating nerve and muscle tissues for intraoperative neuromonitoring. Technology technological characteristics of the C2 Xplore and The the Comparison: predecessor device (predicate device) are equivalent. | | Subject device | Predicate device | |----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| | System | C2 Xplore | C2 NerveMonitor System | | Manufacturer | inomed Medizintechnik GmbH | inomed Medizintechnik GmbH | | Energy Type | | | | Power | 100 V - 240 V and 50/60 Hz electrical<br>outlet connection | 100 V - 240 V and 50/60 Hz electrical<br>outlet connection | | Performance Specifications - EMG Recording Unit | | | | Measurement<br>principle | Amplifiers based on differential<br>(bipolar) type of recording | Amplifiers based on differential<br>(bipolar) type of recording | | Recording<br>channels | 8 differential channels | 8 differential channels | | Measurement<br>range | 1 mVpp - 500 mVpp (programmable) | 800 $\mu$ Vpp - 800 mVpp<br>(programmable) | | A/D resolution | 16-bit | 16-bit | | Common-mode<br>rejection ratio<br>(CMRR) | > 100 dB (50 Hz) | > 100 dB (50 Hz) | | Input noise level | < 1.5 $\mu$ VEff (with hardware filter 30 Hz<br>to 2.5 kHz) | < 1.2 $\mu$ VEff (with hardware filter 30 Hz<br>to 1.25 kHz) | | Input Impedance | > 100 MΩ | > 100 MΩ | | Hardware<br>bandpass | 0.5 Hz - 5 kHz | 0.5 Hz - 5 kHz | | Scanning rate | 20 kHz | 20 kHz | | Blanking | 1 - 4 ms | 1 – 4 ms | | Performance Specifications - Stimulation Unit | | | | Stimulation<br>channels | 2 | 2 | | Frequency | Programmable 0.1 – 30 Hz | Programmable 1 - 30Hz | | Polarity | Unipolar, negative rectangular pulse | Unipolar, negative rectangular pulse | | Voltage limit | 100 V | 100 V | | Load Impedance | 0 - 10 kΩ | 0 – 10 kΩ | | Current sensor | Display of current flow (confirm current) | Display of current flow (confirm current) | | Visual Output | Visual display shows waveform amplitude and latency time of stimulated and recorded signals | Visual display shows waveform amplitude and latency time of stimulated and recorded signals | | Stimulation parameters | | | | Stimulation intensity (I) and pulse width (PW) | Image: Stimulation intensity (I) and pulse width (PW) | Image: PW | | Stimulation frequency (f) range | Image: 1/f | | | Stimulator 1 (direct nerve stimulator) | | | | Frequency (f) | Programmable 0.1 – 30 Hz | Programmable 1 - 30Hz | | Pulse width (PW) | 200 µs | 200 µs | | Current (I) | 0.01 – 5 mA | 0.01-5 mA | | Maximum RMS stimulation intensity | 0.39 mA | 0.39 mA | | Minimum electrode size | 0.001 cm² | 0.001 cm² | | Maximum current density | 390 mA/cm² | 390 mA/cm² | | Maximum power density | 25 W/cm² | 25 W/cm² | | Maximum charge density | 78 µC/cm² | 78 µC/cm² | | Stimulator 2 (continuous stimulator in combination with Medtronic APS electrode) | | | | Frequency (f) | max. 2 Hz | Predicate device: ---<br>Reference device: max. 2 Hz | | Pulse width (PW) | 100 µs | Predicate device: ---<br>Reference device: 100 µs | | Current (I) | 0.1 - 3 mA | Predicate device: ---<br>Reference device: 0.1 - 3 mA | | Maximum RMS<br>stimulation<br>intensity | 0.04 mA | Predicate device: ---<br>Reference device: 0.04 mA | | Minimum<br>electrode size | 0.0097 cm2 | Predicate device: ---<br>Reference device: 0.0097 cm2 | | Maximum current<br>density | 4.12 mA/cm2 | Predicate device: ---<br>Reference device: 4.12 mA/cm2 | | Maximum power<br>density | 0.93 W/cm2 | Predicate device: ---<br>Reference device: 0.93 W/cm2 | | Maximum charge<br>density | 0.41 $\mu$ C/cm2 | Predicate device: ---<br>Reference device: 0.41 $\mu$ C/cm2 | | Hardware | | | | Workstation | Standard personal computer (PC)<br>components | Standard personal computer (PC)<br>components | | Printer Capacity | Waveform data can be printed on an<br>external printer | Waveform data can be printed on an<br>external printer | | Protection<br>against electrical<br>shock | Class I protection<br>4000 V | Class I protection<br>4000 V | | Protection<br>against electrical<br>shock of patient<br>leads | Device type BF (Body Floating) | Device type BF (Body Floating) | | Housing material | Baydur 110 FR-6 | Baydur 110 FR-6 | | Display unit | White frame, 12-inch display, touch<br>screen buttons | Grey frame, 8.4-inch display, soft-key<br>buttons | | PC and storage<br>board | Advantech MIO-3260 | Advantech PCM-9361 | | | - IEC 62304:2006+A1:2015, Medical device software –<br>Software life cycle processes | | | | Test results demonstrate that the C2 Xplore software complies with<br>its predetermined specifications, the applicable guidance documents<br>and standards. | | | Electrical Safety: | The C2 Xplore was tested according to the following standards:<br>- IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR.<br>2:2007 + A1:2012 (or IEC 60601-1: 2012 reprint), Medical<br>electrical equipment – Part 1: General requirements for basic<br>safety and essential performance.<br>- IEC 60601-1-6:2010 + AMD1:2013, Medical electrical<br>equipment, Part 1-6: General requirements for basic safety<br>and essential performance - Collateral standard: Usability<br>- IEC 60601-2-40:2016, Medical electrical equipments – Part 2-<br>40: Particular requirements for the basic safety and essential<br>performance of electromyographs and evoked response<br>equipment<br>Test results demonstrate that the products comply with the<br>applicable standards. | | | Electromagnetic<br>Compatibility: | The essential performance and safety of the C2 Xplore was tested<br>according to the following standards:<br>- IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2:<br>General requirements for basic safety and essential<br>performance – Collateral standard: Electromagnetic<br>disturbances – Requirements and tests.<br>Test results demonstrate that the products comply with the<br>applicable standards | | | Performance<br>Testing - Bench | The essential performance and safety of C2 Xplore was tested for<br>performance in accordance with internal requirements. The device<br>including their accessories and corresponding intended combinations<br>with further products have been designed according to requirement<br>specifications describing the following aspects:<br>- General device requirements<br>- Functional requirements<br>- External interface requirements<br>- System accessory requirements<br>- C2 Xplore software, firmware, and operating system requirements | | {6}------------------------------------------------ # 510(k) Summary C2 Xplore {7}------------------------------------------------ ## 510(k) Summary C2 Xplore ## Summary of Performance Testing: Biocompatibility: The C2 Xplore does has no patient contact materials, and therefore this section does not apply. The C2 Xplore contains MAJOR level of concern software. The Software: 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: The content of premarket submissions for software contained in medical devices, May 11, 2005 - FDA guidance: Off-the-shelf software use in medical devices, -Sep 27, 2019 - -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 {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Inomed. The logo consists of the word "inomed" in bold, black letters, with a stylized "i" in a black square to the right. Below the logo is the website address "www.inomed.com". {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Inomed. The logo consists of the word "inomed" in a bold, sans-serif font, with a stylized "i" in a square to the right. Below the logo is the website address "www.inomed.com". The product successfully underwent the bench testing 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 device was conducted to demonstrate mitigation of potential use errors and safety of the user interface design. 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 No additional clinical testing was performed for the C2 Xplore. Testing - Clinical Therefore, this section does not apply. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Inomed. The logo consists of the word "inomed" in bold, black letters, followed by a black square with a white "i" inside. Below the logo is the website address "www.inomed.com". ### Conclusion In order to establish the performance and safety characteristics, the C2 Xplore 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 C2 Xplore including accessories are considered substantially equivalent to the predicate device.