(45 days)
Not Found
Not Found
No
The description focuses on conventional neurophysiologic monitoring and stimulus evoked electromyography, with no mention of AI or ML terms or functionalities.
No
The device is described as assisting in stimulating, locating, evaluating, and monitoring spinal nerves during surgery to reduce the risk of nerve injury. Its primary functions are diagnostic and assistive during surgical procedures, rather than directly treating a disease or condition.
Yes
The device is described as providing "intraoperative electrical stimulus pulses to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves" for "Location and evaluation of spinal nerves" and "Location and identification of spinal nerves." This function of monitoring and evaluating nerve responses during surgery to identify and locate nerves aligns with the definition of a diagnostic device.
No
The device description explicitly lists hardware components such as a reusable Patient Module, a Control Unit with an embedded computer and interface card, and reusable conductive probes, electrodes, and electrode leads.
Based on the provided information, the NeuroVision JJB System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The NeuroVision JJB System directly interacts with the patient's body during surgery (stimulation of spinal nerves, EMG monitoring of muscle groups).
- The intended use describes a surgical guidance and monitoring system. It's used to locate and evaluate nerves during a surgical procedure, not to analyze samples taken from the patient.
- The device description confirms direct interaction with the patient. It uses probes, electrodes, and leads applied to the patient.
Therefore, the NeuroVision JJB System falls under the category of a medical device used for intraoperative monitoring and guidance, not an IVD.
N/A
Intended Use / Indications for Use
The NeuroVision JJB System is intended to provide stimulation of spinal nerves during intraoperative electromyographic (EMG) nerve surveillance to surgery of the spine, and 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, and surrounding tissues of the spine via uniportal or biportal approach, where anatomical restrictions safely permit.
Product codes
77ETN, 84GWF
Device Description
The NVJJB System utilizes conventional neurophysiologic monitoring to reduce the occurrences of iatrogenic nerve injury during instrumented spine surgery. In the procedure, stimulus evoked electromyography is used to determine changes in nerves. Corresponding Stimulus evoked electromyography is used as 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 and control with touch screen controls and an interface card, 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
Spinal nerves, 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)
The subject NeuroVision JJB System is substantially equivalent to the NeuroVision JJB System which has been cleared and distributed commercially in the U.S. by NuVasive.
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
KOSI 384
JUL 11 2005
VII. 510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular nraceorgance of owing summary of information is provided:
Submitted by: A.
Laetitia Cousin Director of Regulatory Affairs and Quality Assurance NuVasive, Incorporated 4545 Towne Centre Court San Diego, California 92121 Telephone: (858) 909-1868 Fax: (858) 909-2068
Device Name B.
| 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 The subject real o ranth over and distributed commercially in the U.S. by NuVasive.
Device Description D.
The NVJJB System utilizes conventional neurophysiologic monitoring to reduce the I he NYSD Bystem admiss overs during instrumented spine surgery. In the procedure, minulus evoked electromyography is used to determine changes in nerves. Corresponding Stimulus CVOKED Cleculonyoghaptiy 15 usee as cetrodes, while stimulation is used to detect nerve responses.
1
The NeuroVision JJB System consists of a reusable Patient Module, a Control Unit The Neuro v Ision 93D Dystem control with touch screen controls and an interface card, and comprisod of an embeded compares and reusable conductive probes, electrodes, and electrode leads.
Intended Use E.
The NeuroVision JJB System is intended to provide stimulation of spinal nerves during The Neurovilsion JJD bystein is internet electromyographic (EMG) nerve surveillance to surgery of the spine, and madoperative electrical stimulus pulses to tissues and nerves at the assist, by administration of brief elect reason as ociated with those nerves, in the operative site, and ENIC monitorial 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 IJB System is designed for use in conjunction with other NuVasive I he redro vision 302 by wom to ecess to, and visualization of, the spinal nerve root, de vices to assist in gaming cound surrounding tissues of the spine via uniportal or biportal approach, where anatomical restrictions safely permit.
Comparison to Predicate Devices F.
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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing the feathers.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 1 2005
Ms. Laetitia Cousin Director of Regulatory Affairs and Quality Assurance NuVasive Incorporated 4545 Towne Centre Court San Diego, California 92121
Re: K051384
Trade/Device Name: NeuroVision JJB System Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: II Product Code: GWF Dated: June 21, 2005 Received: June 22, 2005
Dear Ms. Cousin:
We have reviewed your Section 510(k) premarket notification of intent to market the indicati we nave reviewed your becaon 910(s) presidentially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule, to regally manative of the Medical Device Amendments, or to commerce prior to May 28, 1976, the encordance with the provisions of the Federal Food, Drug, devices mail have been require approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require species the general controls provisions of the Act. The You may, ulerelore, market the dovres, basjon to use as annual registration, listing of general controls provisions of the rist lieveling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (360 a00 v) irrols. Existing major regulations affecting your device . EDA it may be subject to saon additions. Title 21, Parts 800 to 898. In addition, FDA can be found in the Court of Peacharts concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issuance or a becession with other requirements of the Act that FDA has made a decemmations administered by other Federal agencies. You must or any Federal Statutes and regulations annuding, but not limited to: registration and listing (21 comply with an the Act 3 requirements, mercess on anufacturing practice requirements as set CFK Fart 807), adoling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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)
The start of the first of all on of a lot a tick as witness of your device to a This letter will allow you to begin marketing your averalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence than permits vou premarket notification. The FDA Inding of substantal of a larger 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
rs the results of the may of 10 10 10 115 : Alles makess note the regulatio If you desire specific advice for your de nec on our ... Also, please note the regulation entitled, the may obtain contact the Office of Colliptialicc at (240) 270 - 1 (2107R Part 807.97). You may obtain
"Misbranding by reference to premarket notification the Division of Small "Misbranding by reference to pour responsibilities under the Act from the Division of Small
other general information on your responsibilities under (800) 638-204 other general information on your responsion its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free were index html Manufacturers, International and Consumer Assistance at to votes of the results of the stress of the
Sincerely yours,
Miriam C. Provost
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):_
Device Name:____NeuroVision JJB System
Indications For Use:
The NeuroVision JJB System is intended to provide stimulation of spinal nerves during The Neurovision JJD System is intended opprovince (EMG) neve surveillance to surgery of the spine, and miraoperative olocitical stimuly pulses to tissues and newes at the assist, by administration of biler electical called with those nerves, in
operative site, and EMG monitoring of muscle groups associated with the System's Screw operative site, and EMC mond evaluation of spiral newes, using the System's Screw
the following: a) Location and evaluation of spiral newes, using the System's single the following: a) Location and evaluation of opinal news in and identification of
Test, Detection, and/or Free Run EMG Functions; and b) Location and identification of Test, Delection, andror "Firstem's Nerve Retraction Function.
Spinal Web System is designed for use in conjunction with other NuVasive The Neurovision JJD System's designounce to, and visualization of, the spinal newe
devices to assist in gaining controlled access to, and visualization of the enjoctal on devices to assist in gaming controlled docos not to the spine via uniportal or root, foramina, into.vorteoral arestrictions safely permit.
Prescription Use (Part 21 CFR 801 Subpart D) 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)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
Page 1 of 1
510(k) Number K051384