(80 days)
Not Found
Not Found
No
The summary describes conventional neurophysiologic monitoring techniques and does not mention AI or ML.
No
The device is used for intraoperative monitoring and assessment, providing information about neurological status by stimulating nerves and monitoring muscle responses. It does not exert a therapeutic effect on the patient.
Yes
The device is used for "neurological status assessment" and "to determine changes in nerves" during surgery, which are diagnostic purposes to monitor the patient's condition.
No
The device description explicitly states that the system consists of hardware components including a reusable Patient Module, a Control Unit with an embedded computer, and various probes, electrodes, and leads.
Based on the provided information, this device 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.
- Device Function: The NeuroVision JJB System operates by applying electrical stimuli to neural tissues and monitoring muscle responses (EMG). This is an in vivo process, meaning it is performed directly on the living body, not on a sample taken from the body.
- Intended Use: The intended use clearly states "intraoperative monitoring and neurological status assessment by the administration of brief electrical stimulus pulses to neural tissues and the EMG monitoring of the associated muscle groups." This describes a procedure performed on the patient during surgery.
Therefore, the NeuroVision JJB System falls under the category of a medical device used for physiological monitoring and assessment during surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NeuroVision JJB System is used for intraoperative monitoring and neurological status assessment by the administration of brief electrical stimulus pulses to neural tissues and the EMG monitoring of the associated muscle groups. The System is used in conjunction with other NuVasive devices to assist in gaining controlled access to, and visualization of, the spine.
Product codes
ETN, GWF
Device Description
The NVJJB System utilizes conventional neurophysiologic 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:
A. Submitted by
Laetitia Cousin Director of Regulatory Affairs and Quality Assurance NuVasive, Incorporated 4545 Towne Centre Court San Diego, CA 92121 Telephone: (858) 909-1868 Date Prepared: June 22, 2005.
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 | |
| Evoked response electrical stimulator |
C. Predicate Devices
The subject device is substantially equivalent to similar previously cleared devices.
D. Device Description
The NVJJB System utilizes conventional neurophysiologic 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.
E. Intended Use
The NeuroVision JJB System is used for intraoperative monitoring and neurological status assessment by the administration of brief electrical stimulus pulses to neural tissues and the EMG monitoring of the associated muscle groups. The System is used in conjunction with other NuVasive devices to assist in gaining controlled access to, and visualization of, the spine.
1
F. Substantial Equivalence
As was established in this submission, the subject device is substantially equivalent to other devices cleared by the agency for commercial distribution in the United States.
Engineering specifications and labeling have demonstrated that the subject device is substantially equivalent, if not identical, to its predicate devices in terms of design, materials of composition, indications for use, and such other characteristics as may be associated with the manufacture of any medical device.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
SEP 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Laetitia Cousin Director of Regulatory Affairs and Quality Assurance NuVasive, Incorporated 4545 Towne Centre Court San Diego, California 92121
Re: K051718
Trade/Device Name: NuVasive NeuroVision JJB System Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical nerve stimulator/locator Regulatory Class: II Product Code: ETN, GWF Dated: June 24, 2005 Received: June 27, 2005
Dear Ms. Cousin:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector of the device is substantially equivalent (for the indications felerenced above and have acterially marketed predicate devices marketed in interstate for use stated in the encrosure) to tegans the Medical Device Amendments, or to comments proc to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmette Act (7107) that do november 1 r ou may, mercere, mains of the Act include requirements for annual registration, listing of general controls provisions of wactice, 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 If your device to such additional controls. Existing major regulations affecting your device can may be subject to back as a sateral Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ourcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a associations administered by other Federal agencies. You must of any I cutures and the regulations sincluding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI I art 6077, adoning (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quand provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Laetitia Cousin
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 (240) 276-0120. 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,
Barbara Rauchus
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
A. Indications for Use
510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: NuVasive NeuroVision JJB System
Indications for Use:
The NeuroVision JJB System is used for intraoperative monitoring and neurological status The Nearont by the administration of brief electrical stimulus pulses to neural tissues and the assessment by the associated muscle groups. The System is used in conjunction with other Nu Vasive devices to assist in gaining controlled access to, and visualization of, the spine.
Prescription Use X (Part 21 CFR 801 Subpart D)
ﻨﻤﺎ ﺑ
AND/OR
Over-The-Counter Use __ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K051718 |
|---|---|
| --------------- | --------- |