(69 days)
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on hardware components and basic neurological monitoring.
No.
The device is strictly for neurological monitoring and status assessment, and assisting in controlled access to the spine, which are diagnostic and procedural assistance functions, not therapeutic.
Yes
The device is used for "neurological monitoring and status assessment," which involves evaluating a patient's neurological state to inform medical decisions, fitting the definition of a diagnostic device.
No
The device description explicitly lists hardware components such as a Patient Module, Control Unit (with embedded computer and touch screen), probes, electrodes, and leads. This indicates it is a system with both hardware and software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "neurological monitoring and status assessment" and assisting in "gaining controlled access to the spine." This describes a device used on a patient during a procedure, not a device used to test samples from a patient outside the body.
- Device Description: The components listed (Patient Module, Control Unit, probes, electrodes, leads) are consistent with a device used for physiological monitoring and surgical assistance, not for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is related to monitoring neurological activity and assisting in surgical procedures, which falls outside the scope of an IVD.
N/A
Intended Use / Indications for Use
The NeuroVision System is intended for use in the operating room and non-critical care clinical environment for neurological monitoring and status assessment. The System may be used alone or in conjunction with other NuVasive devices to assist in gaining controlled access to the spine.
Product codes
77ETN, 84GWF
Device Description
The NeuroVision JJB System consists of a 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
operating room and non-critical care clinical environment
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
Summary of Non-Clinical Tests (Not Applicable).
Summary of Clinical Tests (Not Applicable).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
5. 510(K) SUMMARY
NUVASI
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, California 92121 Telephone: (858) 909-1868 Fax: (858) 909-2068
B. Device Name
Trade or Proprietary Name: NuVasive NeuroVision JJB System Electromyography (EMG) monitor/stimulator Common or Usual Name: Surgical nerve stimulator/locator Classification Name: Class II Device Class: $874.1820, §882.1870 Classification: 77ETN, 84GWF Product Code:
C. Predicate Devices
510(k) Number:
The subject device is substantially equivalent to the following previously cleared devices.
| Trade or Proprietary Name: | NuVasive NeuroVision JJB System |
|---|---|
| Manufacturer: | NuVasive, Inc. |
| Classification Name: | Surgical nerve stimulator/locator |
| Device Class: | Class II |
| Classification: | §874.1820, §882.1870 |
| Product Code: | 77ETN, 84GWF |
| 510(k) Number: | K062765 |
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| Trade or Proprietary Name: | Epoch XP |
|---|---|
| Manufacturer: | Axon Systems |
| Classification Name: | Electroencephalograph |
| Device Class: | Class II |
| Classification: | §882.1400 |
| Product Code: | GWQ, GWE, GWF, GW- |
| 510(k) Number: | K032741 |
D. Device Description
The NeuroVision JJB System consists of a 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 System is intended for use in the operating room and non-critical care clinical environment for neurological monitoring and status assessment. The System may be used alone or in conjunction with other NuVasive devices to assist in gaining controlled access to the spine.
F. Substantial Equivalence
Data was provided which demonstrated the NuVasive NeuroVision JJB to be substantially The substantial equivalence is based upon equivalent to previously cleared devices. equivalence in indications for use, design, material, and function.
G. Summary of Non-Clinical Tests (Not Applicable).
- H. Summary of Clinical Tests (Not Applicable).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 2007
Nuvasive, Inc. % Ms. Laetitia Cousin 4545 Towne Centre Court San Diego, California 92121
K072343 Trade/Device Name: Neurovision JJB System Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: Class II Product Code: GWF Dated: August 20, 2007 Received: August 21, 2007
Dear Ms. Cousin:
Re:
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, listing 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 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); 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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vou
Mark N. Melkerson Director Division of General Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K072343
Device Name: NeuroVision® JJB System
Indications For Use:
The NeuroVision System is intended for use in the operating room and non-critical care clinical environment for neurological monitoring and status assessment. The System may be used alone or in conjunction with other NuVasive devices to assist in gaining controlled access to the spine.
Prescription Use XI (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)
Page 1 of 1
Dion
Division of General, Restora and Neurological Devices
510(k) Number.