(98 days)
No
The summary describes a standard EMG monitor with hardware controls and basic signal processing (amplitude and latency). There is no mention of AI, ML, or any advanced analytical techniques that would suggest their use.
No
The device is described as a monitor that records and displays neurophysiological signals (EMG) to assist the surgeon in nerve identification and preservation during surgery. It does not actively treat or directly improve a medical condition.
Yes
The C2 Xplore measures and displays neurophysiological signals (EMG activity) to assist surgeons in nerve identification and preservation, providing information about amplitude and latency of EMG responses, which are diagnostic indicators during surgery.
No
The device description explicitly states the C2 Xplore is equipped with hardware components such as differential amplifier channels, independent stimulators, mechanical turning knobs, a touchscreen, and an integrated loudspeaker. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the C2 Xplore is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- C2 Xplore Function: The C2 Xplore directly measures and displays neurophysiological signals (EMG) from the patient's peripheral nervous system in vivo (within the living body) during surgery. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for intraoperative neuromonitoring of the peripheral nervous system, assisting the surgeon in nerve identification and preservation. This is a direct physiological measurement and monitoring function, not an in vitro diagnostic test.
Therefore, the C2 Xplore falls under the category of a medical device used for physiological monitoring and surgical assistance, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
ETN, GWF
Device Description
The C2 Xplore is an electromyography (EMG) monitor for the 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral nervous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon in the operating room
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)
Performance Testing - Bench: The essential performance and safety of C2 Xplore was tested for performance in accordance with internal requirements. The device including their accessories and corresponding intended combinations with further products have been designed according to requirement specifications describing the following aspects: General device requirements; Functional requirements; External interface requirements; System accessory requirements; C2 Xplore software, firmware, and operating system requirements. The product successfully underwent the bench testing of the requirements at these levels as part of the verification and validation process.
Performance Testing - Clinical: No additional clinical testing was performed for the C2 Xplore.
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.
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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. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Submission Date: | 2022-10-14 | |
|---|---|---|
| Subject 510(k) number | K223254 | |
| 510(k) Holder: | inomed Medizintechnik GmbH | |
| Im Hausgruen 29 | ||
| 79312 Emmendingen, Germany | ||
| Submitter and | ||
| Application | ||
| Correspondent: | Maximilian Wimmer | |
| Phone: +49 7641 6414 545 | ||
| Email: m.wimmer@inomed.com | ||
| Manufacturing | ||
| Site: | inomed Medizintechnik GmbH | |
| Im Hausgruen 29 | ||
| 79312 Emmendingen, Germany | ||
| Trade Name: | C2 Xplore | |
| Classification | ||
| Regulation: | Surgical nerve stimulator/locator 21 CFR §874.1820 | |
| Product Code: | ETN, GWF | |
| Regulation | ||
| Medical | ||
| Specialty: | Ear, Nose, and Throat | |
| Substantially | ||
| Equivalent | ||
| Devices: | Predicate device 510(k) number | Predicate device Manufacturer/ |
| Model | ||
| K152505 | inomed Medizintechnik GmbH | |
| C2 NerveMonitor System | ||
| Reference device 510(k) number | Reference device Manufacturer/ | |
| Model | ||
| K083124 | Medtronic Xomed, Inc | |
| 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.
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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 | |
| outlet connection | 100 V - 240 V and 50/60 Hz electrical | |
| outlet connection | ||
| Performance Specifications - EMG Recording Unit | ||
| Measurement | ||
| principle | Amplifiers based on differential | |
| (bipolar) type of recording | Amplifiers based on differential | |
| (bipolar) type of recording | ||
| Recording | ||
| channels | 8 differential channels | 8 differential channels |
| Measurement | ||
| range | 1 mVpp - 500 mVpp (programmable) | 800 $\mu$ Vpp - 800 mVpp |
| (programmable) | ||
| A/D resolution | 16-bit | 16-bit |
| Common-mode | ||
| rejection ratio | ||
| (CMRR) | > 100 dB (50 Hz) | > 100 dB (50 Hz) |
| Input noise level | 100 MΩ | > 100 MΩ |
| Hardware | ||
| 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 | ||
| 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: --- |
| Reference device: max. 2 Hz | ||
| Pulse width (PW) | 100 µs | Predicate device: --- |
| Reference device: 100 µs | ||
| Current (I) | 0.1 - 3 mA | Predicate device: --- |
| Reference device: 0.1 - 3 mA | ||
| Maximum RMS | ||
| stimulation | ||
| intensity | 0.04 mA | Predicate device: --- |
| Reference device: 0.04 mA | ||
| Minimum | ||
| electrode size | 0.0097 cm2 | Predicate device: --- |
| Reference device: 0.0097 cm2 | ||
| Maximum current | ||
| density | 4.12 mA/cm2 | Predicate device: --- |
| Reference device: 4.12 mA/cm2 | ||
| Maximum power | ||
| density | 0.93 W/cm2 | Predicate device: --- |
| Reference device: 0.93 W/cm2 | ||
| Maximum charge | ||
| density | 0.41 $\mu$ C/cm2 | Predicate device: --- |
| Reference device: 0.41 $\mu$ C/cm2 | ||
| Hardware | ||
| Workstation | Standard personal computer (PC) | |
| components | Standard personal computer (PC) | |
| components | ||
| Printer Capacity | Waveform data can be printed on an | |
| external printer | Waveform data can be printed on an | |
| external printer | ||
| Protection | ||
| against electrical | ||
| shock | Class I protection | |
| 4000 V | Class I protection | |
| 4000 V | ||
| Protection | ||
| against electrical | ||
| shock of patient | ||
| 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 | |
| screen buttons | Grey frame, 8.4-inch display, soft-key | |
| buttons | ||
| PC and storage | ||
| board | Advantech MIO-3260 | Advantech PCM-9361 |
| - IEC 62304:2006+A1:2015, Medical device software – | ||
| Software life cycle processes | ||
| Test results demonstrate that the C2 Xplore software complies with | ||
| its predetermined specifications, the applicable guidance documents | ||
| and standards. | ||
| Electrical Safety: | The C2 Xplore was 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 60601-1-6:2010 + AMD1:2013, Medical electrical
equipment, Part 1-6: General requirements for basic safety
and essential performance - Collateral standard: Usability - 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 essential performance and safety of the C2 Xplore was 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 C2 Xplore was tested for
performance in accordance with internal requirements. The device
including their accessories and corresponding intended combinations
with further products have been designed according to requirement
specifications describing the following aspects: - General device requirements
- Functional requirements
- External interface requirements
- System accessory requirements
- 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
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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.
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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.