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510(k) Data Aggregation
K Number
K013215Device Name
MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM
Manufacturer
NUVASIVE, INC.
Date Cleared
2001-10-16
(20 days)
Product Code
BXM
Regulation Number
868.2775Why did this record match?
Product Code :
BXM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NeuroVision IJB System is intended to provide intraoperative electromyographic (EMG) surveillance to assist in the location of nerves during percutaneous surgery of the spine, 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. The NeuroVision JJB System is designed for use in conjunction with the NuVasive guided spinal arthroscopy system to assist in gaining controlled percutaneous access to the spinal nerve root, foramina, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal posterior or posterolateral approach, where anatomical restrictions safely permit.
Device Description
The NeuroVision JJB System (NV JJB) is an electronic device which uses arthroscopic surgical instruments, electrodes, and probes to stimulate nerves with electrical energy, and through the use of electromyography (EMG) electrodes, monitors the sensitivity, and assists in determining the location of nerves during percutaneous surgery of the spine.
The device employs a "Detection" routine which directs brief electrical stimulus pulses through the distal tip of the NuVasive Dilating Cannula as it penetrates tissue to the operative target. Through a series of EMG electrodes placed on the muscle groups associated with the nerves at the operative level of the spine, the NeuroVision JJB System monitors EMG activity in these muscle groups and, when the Cannula tip draws sufficiently near to one such nerve that the electrical energy it emits is strong enough to depolarize the nerve and evoke an EMG response, alerts the surgeon that the Cannula tip is in proximity to that nerve.
By the same method, a "Direction" routine may be used to sequentially activate four orthogonal stimulation electrodes surrounding the Cannula tip, and thereby determine the orthogolial similation closest nerve lies. This direction is displayed on a graphical touch screen.
An additional feature of the NeuroVision JJB System is a hand-held electrical probe which is used to abonain whomer a the screw hole prior to screw insertion or placed on The ban tip of the prooe is placed in as been breached by the screw or tap, the the mstalled screw nead. If the pearlers was the adjacent nerve roots and they will depolarize at a lower stimulation current. The screw test algorithm determines the depolarization (threshold) current for all 8 EMG channels. The surgeon may also set a baseline threshold) current by stimulating a nerve root directly with the probe. The surgeon may choose to display the screw test threshold current relative to this baseline.
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, comprised of an emboduced compater ressable conductive probe cables, electrodes, and electrode leads.
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K Number
K002677Device Name
NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM
Manufacturer
NUVASIVE, INC.
Date Cleared
2000-11-13
(77 days)
Product Code
BXM
Regulation Number
868.2775Why did this record match?
Product Code :
BXM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The INS-1 Intraoperative Nerve Surveillance System is intended to provide intraoperative electromyographic (EMG) surveillance to assist in the location and evaluation of spinal nerves during percutaneous surgery of the spine, by administration of low amperage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves. The INS-1 System is designed for use in conjunction with the NuVasive Guided Spinal Arthroscopy System to assist in gaining controlled percutaneous access to the spinal nerve root, foramina, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal posterior or posterolateral approach, where anatomical restrictions safely permit.
Device Description
The subject INS-1 System is an electronic device which uses arthroscopic surgical instruments, electrodes, and probes to stimulate spinal nerves with electrical energy, and through the use of electromyography (EMG) electrodes. monitors the sensitivity, and assists in determining the location, of spinal nerves during percutaneous surgery of the spine. The device employs a "Status" routine to determine the baseline functional status of exiting spinal nerves in the area of the operative target, and directs low amperage current through the distal tip of the NuVasive Expanding Cannula as it penetrates tissue to the operative target. Through a series of EMG electrodes placed on the muscle groups associated with the spinal nerves at the operative level of the spine, the INS-1 System monitors EMG activity in these muscle groups and, when the Cannula tip draws sufficiently near to one such nerve that the electrical energy it emits is strong enough to depolarize the nerve and create an EMG response, alerts the surgeon that the Cannula tip is in proximity to that nerve. An additional feature of the INS-1 System is a hand-held electrical probe which can assist the surgeon in determining if a nerve lies directly in the path of the instrumentation, and may also be used to ascertain whether a transpedicular screw has violated the pedicle wall. The INS-1 System consists of a reusable Control Unit and PreAmp module, and an assortment of disposable and reusable conductive probe cables, electrodes, and electrode leads.
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