(109 days)
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.
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.
The provided text describes a 510(k) summary for the NuVasive NeuroVision JJB System, an electromyography (EMG) monitor/stimulator. However, the document does not contain information regarding specific acceptance criteria, a study proving the device meets those criteria, or details of a validation study (sample size, ground truth, expert qualifications, etc.).
The document focuses on:
- Device Description: What the device is and how it works (neurophysiologic monitoring, stimulus evoked electromyography).
- Intended Use: Its purpose in spinal surgery (nerve location, evaluation, and identification).
- Comparison to Predicate Device: States that the subject device is substantially equivalent to a previously marketed NuVasive NeuroVision JJB System and has identical indications for use and principles of operation, raising no new safety or effectiveness issues.
- FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence to the predicate device.
Therefore, I cannot provide the requested information in the table or the subsequent points because the provided text does not contain any details about acceptance criteria, a study proving performance against those criteria, or validation study specifics.
The FDA’s clearance is based on the device being substantially equivalent to a predicate, meaning extensive new clinical performance studies demonstrating acceptance criteria were likely not required for this particular 510(k) submission.
To reiterate, the following information is not available in the provided text:
- A table of acceptance criteria and reported device performance.
- Sample size for the test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results of a standalone (algorithm only) performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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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.
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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.
§ 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.