(30 days)
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No
The description focuses on real-time monitoring and data display, with no mention of AI/ML algorithms for analysis, interpretation, or prediction.
No.
The device is used to locate nerves and monitor nerve integrity during surgery, which aids the surgeon but does not directly treat a disease or condition.
Yes
The device is intended to assist in locating motor nerves and monitoring their integrity during surgical procedures by providing real-time EMG waveforms and status monitoring data, which are diagnostic functions.
No
The device description clearly states that the Neurovision Nerve LocatorMonitor is an electronic device consisting of a surgical nerve stimulator and an evoked EMG monitor, which are hardware components. The EMGView software is described as an accessory to this hardware device.
Based on the provided information, the Neurovision Nerve LocatorMonitor and its accessory software EMGView are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The Neurovision Nerve LocatorMonitor and EMGView software are used during surgical procedures to stimulate motor nerves and monitor evoked EMG responses. This is a direct interaction with the patient's body during surgery, not an examination of a specimen outside the body.
- Intended Use: The intended use is to "assist the surgeon in locating these nerves" and "assist the surgeon with nerve integrity monitoring" during surgery. This is an intraoperative tool, not a diagnostic test performed on a sample.
Therefore, the device falls under the category of a surgical or monitoring device used directly on the patient, not an IVD.
N/A
Intended Use / Indications for Use
The Neurovision Nerve LocatorMonitor is an electronic device consisting of a surgical nerve stimulator and an evoked EMG monitor with integrated detecting and warning capability. This device is intended for use in surgical procedures where motor nerves are at risk to assist the surgeon in locating these nerves. This device is intended for use only by qualified, trained medical practitioners who perform operative surgery and who fully understand that this device is only an adjuvant to proper surgical technique and good surgical judgment.
The EMGView software is an accessory to the Neurovision Nerve Locator/Monitor. When the dedicated USB output of the EMG unit is connected to a personal computer, the PC installed software provides status monitoring data, troubleshooting data, real-time EMG waveforms, and digital backup of all data obtained during clinical use of the device. The real-time display of EMG waveforms is intended to assist the surgeon with nerve integrity monitoring.
Product codes
GWF, ETN
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
qualified, trained medical practitioners who perform operative surgery
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 5, 2017
Neurovision Medical Product Inc. Christine Vergély Director of Quality and Regulatory 353 San Jon Rd Ventura, California 93001
Re: K170677
Trade/Device Name: Neurovision Nerve Locator Monitor (Nerveana) and EMGView Software Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Codes: GWF, ETN Dated: February 8, 2017 Received: March 6, 2017
Dear Ms. Vergély:
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. 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael J. Hoffmann -S
for
Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170677
Device Name
Neurovision Nerve Locator Monitor (Nerveana) and EMGView Software
Indications for Use (Describe)
The Neurovision Nerve LocatorMonitor is an electronic device consisting of a surgical nerve stimulator and an evoked EMG monitor with integrated detecting and warning capability. This device is intended for use in surgical procedures where motor nerves are at risk to assist the surgeon in locating these nerves. This device is intended for use only by qualified, trained medical practitioners who perform operative surgery and who fully understand that this device is only an adjuvant to proper surgical technique and good surgical judgment.
The EMGView software is an accessory to the Neurovision Nerve Locator/Monitor. When the dedicated USB output of the EMG unit is connected to a personal computer, the PC installed software provides status monitoring data, troubleshooting data, real-time EMG waveforms, and digital backup of all data obtained during clinical use of the device. The real-time display of EMG waveforms is intended to assist the surgeon with nerve integrity monitoring.
| 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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