(255 days)
Not Found
No
The summary describes a device that uses electrical stimulation and EMG monitoring to locate nerves, with no mention of AI or ML technologies.
No
The device is intended to assist surgeons in locating motor nerves and monitoring EMG, which is a diagnostic and monitoring function, not a therapeutic one. It does not treat or cure a condition.
Yes
The device is intended to assist the surgeon in locating motor nerves and provides evoked EMG monitoring, which is a diagnostic function to inform surgical decisions.
No
The device description explicitly states it is an "electronic device consisting of a surgical nerve stimulator and an evoked EMG Monitor," and mentions "pulsed nerve stimulation" and "accessory cable," all of which indicate hardware components are integral to the device's function.
Based on the provided information, the Neurovision Nerve Locator Monitor is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Neurovision Nerve Locator Monitor Function: The description clearly states the device is an electronic device consisting of a surgical nerve stimulator and an evoked EMG Monitor. Its intended use is to assist the surgeon in locating motor nerves during surgical procedures. It works by stimulating nerves and monitoring the resulting muscle activity (EMG).
- No Sample Analysis: The device does not analyze any samples taken from the body. It interacts directly with the patient's nerves and muscles during surgery.
Therefore, the Neurovision Nerve Locator Monitor falls under the category of a surgical device or neuromonitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Neurovision Nerve Locator Monitor is an electronic device consisting of a surgical nerve stimulator and an evoked EMG Monitor with integrated detecting or warning capability. The device is intended to assist the surgeon in locating motor nerves that are at risk in surgical procedures.
Product codes
GWF, ETN
Device Description
The Neurovision Nerve Locator Monitor Model NV006 is a single channel evoked EMG device for surgical nerve location and monitoring. The device operates exactly as the predicate model NV004. The stimulation range for the predicate device (Model NV004) as a proactive nerve locator is up to 5.0 mA of pulsed nerve stimulation. An accessory cable adds optional "high level" stimulation (Model NV006) ranging from 3.0 to 12 mA.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
motor nerves
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, qualified, trained medical practioners who perform operative surgery
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
Preclinical testing verified the design of this device and that all specified requirements were fulfilled.
Key Metrics
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
Image /page/0/Picture/1 description: The image shows the logo for Neurovision Medical. The word "neurovision" is written in bold, black letters on the top line. Below that, there is a black line with a heartbeat symbol in the middle, and the word "MEDICAL" is written in bold, black letters to the right of the heartbeat symbol.
30
2011
Traditional 510k - Neurovision Nerve Locator/Monitor Model NV006
510K Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807 and in particular 21 CFR §807.92, the following summary of information is provided:
Applicant Information
Christine Vergely Regulatory Affairs Manager Neurovision Medical Products, Inc. 2225 Sperry Ave., Suite 1000 Ventura, CA 93003 Ph 805-866-6999 Fax: 413-410-4579 christie@neurovisionmedical.com
Date of Summary: 5/02/11
Device Identification:
Trade Name: Neurovision Nerve Locator Monitor NV006 (tbd) Common Name: Nerve Monitor/Locator System Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF, ETN
Predicate Devices
Neurovision, Nerve Locator/Monitor System Modification NV004 model (K954601) NuVasive, INS-1 Intraoperative Nerve Surveillance System (K002677)
Device Description
The Neurovision Nerve Locator Monitor Model NV006 is a single channel evoked EMG device for surgical nerve location and monitoring. The device operates exactly as the predicate model NV004. The stimulation range for the predicate device (Model NV004) as a proactive nerve locator is up to 5.0 mA of pulsed nerve stimulation. An accessory cable adds optional "high level" stimulation (Model NV006) ranging from 3.0 to 12 mA.
Intended Use
The Neurovision Nerve Locator Monitor is an electronic device consisting of a surgical nerve stimulator and an evoked EMG Monitor with integrated detecting or warning capability. The device is intended to assist the surgeon in locating motor nerves that are at risk in surgical procedures.
Technological Characteristics of Device in Relation to Predicate Devices
The Neurovision High-Stim Nerve Locator/Monitor modification uses a dedicated stimulation cable assembly, the CSTI-HS, to activate an embedded capability to deliver nerve stimulation at higher levels (to 12 mA pulsed stimulation) as sometimes required for spinal screw testing purposes. The "HighStim" Cable Assembly, which activates higher level stimulation, is provided to the user as an accessory with the NV006 model in addition to the standard Stimulating Cable Assembly (CSTI).
P. 1 of 4
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Image /page/1/Picture/0 description: The image shows the logo for Neurovision Medical. The word "neurovision" is in large, bold, sans-serif font. Below the word "neurovision" is a horizontal line with a small upward spike in the middle. To the right of the line is the word "MEDICAL" in a smaller, sans-serif font.
Traditional 510k – Neurovision Nerve Locator/Monitor Model NV006
| Table 1: NV004 to NV006 Modification Comparison | |||
|---|---|---|---|
| Feature | NV004 (K954601) | NV006 (High-Stim version) | |
| Indications for Use | Per 510(k) | Same plus addition of spinal | |
| procedures | |||
| Digital Display | N/A | Provides electrode | |
| impedance readings | |||
| Firmware | Assembly Language | Same | |
| Logical Algorithm | Neurovision proactive nerve | ||
| location algorithm | Same | ||
| Stim voltage limit | 38 v | Same | |
| Stimulation output | Max 5mA, 5 steps, constant | ||
| current | Max 5mA/12 mA, 10 steps, | ||
| high range by separate cable. | |||
| Lowest setting 0.1mA | |||
| conforms to ISO 60601-2-40 | |||
| Stim delivered audio | "Tic-tic" audio alert | Same | |
| Stimulation calibration | None | Accurate within 5% of | |
| delivered current | |||
| EMG | Variable gain | Same | |
| Channels | One | Same | |
| Electrode off | 4 beep alarm | Same | |
| Impedance measure | >15 k fixed alert | Actual measurement with | |
| digital display | |||
| Audio out | Sounder | Speaker | |
| Audio mode | Fixed alarms only | Alarms only, raw EMG only, | |
| or both, user select | |||
| Audio alarm tone | Beep | Same | |
| Volume | Variable, no zero | Same | |
| Self-test feature | Analog CAP internal | Same | |
| Event LED | Present | Same | |
| Battery LED | Present | Same | |
| Data out | Analog raw EMG out | Serial USB out; raw EMG and | |
| status data | |||
| Data collection | Digital PC oscilloscope | Dedicated digital EMGView | |
| oscilloscope software | |||
| (K102861) | |||
| Cable Assembly | EMG and Stimulation (low) | Same plus additional High- | |
| Stimulation cable | |||
| Stimulating Lead Wire | Reusable / user sterilizable | ||
| wire, disposable sterile | Disposable sterile wire | ||
| Circuitry | Analog/digital | Same | |
| Layout | Thru-hole components | Same plus surface mount | |
| Isolation | Per design | Improved physical isolation; | |
| shielding by Opto Isolators | |||
| High Stim LED | N/A | Activated when High Stim | |
| cable in use | |||
| Power | 20 v AC Power | ||
| Supply/Charger; not | |||
| certified | 12 V DC Power | ||
| Supply/Charger; certified | |||
| Nerve Location Indication | Detection circuitry always | ||
| active | Detection circuitry active only | ||
| during stimulation. Helps | |||
| prevent false alarms | |||
| Laryngeal Surface electrode- | |||
| accessory | Accessory sold separately | Cleared through K003745 | |
| Stimulating Hemostat- | |||
| accessory | Accessory included with | ||
| System | Cleared through K895676 | ||
| Hydrogel Ground-accessory | Accessory sold separately | Cleared through K092744 | |
| and K110138 | |||
| Needle Ground Electrode - | |||
| accessory | Accessory sold separately | Cleared through K091056 |
. .
110140 p.2 of 4
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Image /page/2/Picture/0 description: The image shows the logo for Neurovision Medical. The word "neurovision" is in large, bold, black letters. Underneath the word "neurovision" is a black line with a heartbeat symbol in the middle, followed by the word "MEDICAL" in bold, black letters.
Traditional 510k – Neurovision Nerve Locator/Monitor Model NV006
| Table 2: Substantial Equivalence Comparison | |||
|---|---|---|---|
| Predicate | Subject Device | ||
| Feature | Neurovision Nerve | ||
| Locator/Monitor | |||
| System Modification | |||
| NV004 (K954601) | NuVasive INS-1 | ||
| (K002677) | Neurovision Nerve | ||
| Locator Monitor | |||
| Model NV006 | |||
| Description | Evoked EMG nerve | ||
| locator/monitor | Evoked EMG nerve | ||
| locator/monitor | Evoked EMG nerve | ||
| locator/monitor | |||
| Intended Use | The Neurovision Nerve | ||
| Locator/Monitor 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 | The INS-1 Intraoperative | ||
| Nerve Surveillance | |||
| System is intended to | |||
| provide intraoperative | |||
| electromyographic | |||
| (EMG) surveillance to | |||
| assist in the location and | |||
| evaluation of spinal | |||
| nerves during | |||
| percutaneous surgery of | |||
| the spine, by | The Neurovision | ||
| Nerve Locator | |||
| Monitor is an | |||
| electronic device | |||
| consisting of a | |||
| surgical nerve | |||
| stimulator and an | |||
| evoked EMG Monitor | |||
| with integrated | |||
| detecting or warning |
110140 P-3 of 4
3
Image /page/3/Picture/0 description: The image shows the logo for Neurovision Medical. The word "neurovision" is in bold, black letters on the top line. Underneath, there are two horizontal lines with a small, jagged line in the middle, followed by the word "MEDICAL" in bold, black letters.
Traditional 510k – Neurovision Nerve Locator/Monitor Model NV006
| | at risk to assist the
surgeon in locating
these nerves. This
device is intended for
use only by qualified,
trained medical
practioners who perform
operative surgery and
fully understand that this
device is only and
adjuvant to proper
surgical technique and
good surgical judgment. | administration of low
amperage electrical
energy to tissues and
nerves at the operative
site, and EMG monitoring
of muscle groups
associated with those
nerves. The INS-1
System is designed for
use in conjunction with
the Nuvasive Guided
Spinal Arthroscopy
System to assist in
gaining controlled
percutaneous access to
the spinal nerve root,
foramina, intervertebral
disk, and surrounding
tissues of the spine via
uniportal or biportal
posterior or
posterolateral approach,
where anatomical
restrictions safely permit. | capability. The
device is intended to
assist the surgeon in
locating motor nerves
that are at risk in
surgical procedures. |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Stimulation
Intensity | 150 microsecond
square pulse, 4 per
second, (0.1-5.0 mA, 10
steps); Maximum 42
VDC, 5 mA | 200 microsecond square
pulse, 4 per second,
0.4mA -12mA, Maximum
240 VDC | 150 microsecond
square pulse, 4 per
second, 0.1-5.0 mA
(Low) and 3.0-12 mA
(High) 10 steps;
Maximum 42 VDC,
12 mA |
Performance Testing
Preclinical testing verified the design of this device and that all specified requirements were fulfilled
110140 p.48/4
4
Image /page/4/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH &" is vertically oriented along the left side of the logo, with "HUMAN SERVICES" appearing below it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Neurovision Medical Products, Inc. c/o Ms. Christine Vergely Regulatory Manager 2225 Sperry Avenue, Suite 1000 Ventura, CA 93003
SEP 3 0 2011
Re: K110140
Trade/Device Name: Nerve Locator Monitor (NV006) Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF, ETN Dated: September 20, 2011 Received: September 22, 2011
Dear Ms. Vergely:
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, forug 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/jability 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 801); medical device reporting (reporting of medical
5
device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR) 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Debra Falls
Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological. and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K110140
Device Name: Neurovision Nerve Locator/Monitor Model NV006
Indications for Use:
The Neurovision Nerve Locator Monitor is an electronic device consisting of a surgical nerve stimulator and an evoked EMG Monitor with integrated detecting or warning capability. The device is intended to assist the surgeon in locating motor nerves that are at risk in surgical procedures.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Prescription Use.
| (Per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------- |
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices
| 510(k) Number | K110140 |
|---|---|
| --------------- | --------- |
510(k) Number_