(109 days)
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Not Found
No
The summary describes a neurophysiological monitoring system using conventional stimulus-evoked electromyography and does not mention any AI or ML components.
No
The device is used for stimulating spinal nerves and monitoring electromyographic (EMG) responses during surgery to assist in locating and identifying nerves, not for treating a disease or condition itself.
Yes
The device provides "intraoperative electromyographic (EMG) nerve surveillance" and uses "stimulus evoked electromyography to determine changes in nerves" and "stimulation is used to detect nerve responses," which are all diagnostic functions during surgery to locate, evaluate, and identify spinal nerves.
No
The device description explicitly states that the system consists of a reusable Patient Module, a Control Unit with an embedded computer and interface card, and an assortment of disposable and reusable conductive probes, electrodes, and electrode leads. These are all hardware components.
Based on the provided information, the NeuroVision JJB System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- NeuroVision JJB System Function: The NeuroVision JJB System works by providing electrical stimulation directly to tissues and nerves at the operative site during surgery and monitoring the resulting muscle responses (EMG). This is an in vivo (within the living body) process, not an in vitro process.
- Intended Use: The intended use clearly states it's for "stimulation of spinal nerves during surgery of the spine, and intraoperative electromyographic (EMG) nerve surveillance." This is a procedure performed directly on the patient during surgery.
Therefore, the NeuroVision JJB System falls under the category of a surgical or monitoring device used in vivo, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NeuroVision JJB System is intended to provide stimulation of spinal nerves during surgery of the spine, and intraoperative electromyographic (EMG) nerve surveillance to assist, by administration of brief electrical stimulus pulses to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves, in the following: a) Location and evaluation of spinal nerves, using the System's Screw Test, Detection, and/or Free Run EMG Functions; and b) Location and identification of spinal nerves, using the System's Nerve Retraction Function.
The Neuro Vision JJB System is designed for use in conjunction with other NuVasive devices to assist in gaining controlled access to, and visualization of, the spinal nerve root, foramina, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal approach, where anatomical restrictions safely permit.
Product codes (comma separated list FDA assigned to the subject device)
77ETN, 84GWF
Device Description
The NVJJB System utilizes conventional neurophysiogic monitoring to reduce the incidence of injury to nerve roots during instrumented spine surgery. In the procedure, stimulus evoked electromyography is used to determine changes in nerves. Corresponding muscle groups are monitored using surface electrodes, while stimulation is used to detect nerve responses.
The NeuroVision JJB System consists of a reusable Patient Module, a Control Unit comprised of an embedded computer with touch screen controls and an interface card, and an assortment of disposable and reusable conductive probes, electrodes, and electrode leads.
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
spinal nerves, spinal nerve root, foramina, intervertebral disc, and surrounding tissues of the spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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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.
Not Found
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.
Not Found
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.
0
VII. 510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular §807.92, the following summary of information is provided:
A. Submitted by:
Laetitia Bernard Manager of Regulatory Affairs and Quality Assurance NuVasive, Incorporated 10065 Old Grove Road San Diego, California 92131 Telephone: (858) 271-7070 Telefacsimile: (858) 271-7101
B. Device Name
| Trade or Proprietary Name: | NuVasive NeuroVision JJB System |
|---|---|
| Common or Usual Name: | Electromyography (EMG) monitor/stimulator |
| Classification Name: | Surgical nerve stimulator/locator |
| Device Class: | Class II |
| Classification: | §874.1820, §882.1870 |
| Product Code: | 77ETN, 84GWF |
C. Predicate Devices
The subject NeuroVision JJB System is substantially equivalent to the NeuroVision JJB System currently manufactured and distributed commercially in the U.S. by NuVasive.
D. Device Description
The NVJJB System utilizes conventional neurophysiogic monitoring to reduce the incidence of injury to nerve roots during instrumented spine surgery. In the procedure, stimulus evoked electromyography is used to determine changes in nerves. Corresponding muscle groups are monitored using surface electrodes, while stimulation is used to detect nerve responses.
1
NuVasive®, Inc.
The NeuroVision JJB System consists of a reusable Patient Module, a Control Unit comprised of an embedded computer with touch screen controls and an interface card, and an assortment of disposable and reusable conductive probes, electrodes, and electrode leads.
E. Intended Use
The NeuroVision JJB System is intended to provide stimulation of spinal nerves during surgery of the spine, and intraoperative electromyographic (EMG) nerve surveillance to assist, by administration of brief electrical stimulus pulses to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves, in the following: a) Location and evaluation of spinal nerves, using the System's Screw Test, Detection, and/or Free Run EMG Functions; and b) Location and identification of spinal nerves, using the System's Nerve Retraction Function.
The NeuroVision JJB System is designed for use in conjunction with other NuVasive devices to assist in gaining controlled access to, and visualization of, the spinal nerve root, foramina, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal approach, where anatomical restrictions safely permit.
F. Comparison to Predicate Devices
The subject device has indications for use identical to those of its predicate, and employs the same principles of operation. Due to this equivalency, the device raises no new safety or effectiveness issues.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a logo with a stylized bird inside a circle. The bird is composed of three curved lines that suggest movement or flight. The circle surrounding the bird is not a solid line but appears to be made up of small, indistinct shapes, possibly letters or symbols. The overall design is simple and abstract, focusing on conveying a sense of freedom or progress.
Public Health Service
OCT 2 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Laetitia Bernard Manager of Regulatory Affairs and Quality Assurance Nuvasive , Inc. 10065 Old Grove Road San Diego, California 92131
Re: K032083
Trade/Device Name: NeuroVision JJB System Regulation Number: 21 CFR 874.1820, 890.1375 Regulation Name: Surgical nerve stimulator/locator Diagnostic electromyograph Regulatory Class: II Product Code: ETN, GWP
Dated: September 24, 2003 Received: September 25, 2003
Dear Ms. Bernard:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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 mav 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); 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.
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Page 2 - Ms. Laetitia Bernard
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark N Millburn
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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D. Indications for Use Statement
510(k) Number (if known): Ko320 83
Device Name: NeuroVision JJB System
Indications for Use:
The NeuroVision JJB System is intended to provide stimulation of spinal nerves during surgery of the spine, and intraoperative electromyographic (EMG) nerve surveillance to assist, by administration of brief electrical stimulus pulses to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves, in the following: a) Location and evaluation of spinal nerves, using the System's Screw Test, Detection, and/or Free Run EMG Functions; and b) Location and identification of spinal nerves, using the System's Nerve Retraction Function.
The Neuro Vision JJB System is designed for use in conjunction with other NuVasive devices to assist in gaining controlled access to, and visualization of, the spinal nerve root, foramina, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal approach, where anatomical restrictions safely permit.
Mark A. Milliken
Jivision Sign-Off Division of General, Restorative and Neurological Devices
KO32093 10(k) Number -
Image /page/4/Picture/11 description: The image shows the text "Concurrence of CDRH, Office of Device Evaluation (ODE)" at the top. Below this text, there is an arrow pointing to the text "Prescription Use (Per 21 CFR 801.109)". The word "OR" is in the middle of the image, and the text "Over-The-Counter Use" is on the right side of the image.