(161 days)
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No
The summary describes a standard EMG and nerve stimulation device with no mention of AI or ML capabilities in its function, description, or performance studies.
No
The device is described as an EMG machine and nerve stimulator intended to monitor and stimulate cranial motor nerves, which are diagnostic and monitoring functions rather than therapeutic.
Yes
The device is intended to "monitor cranial motor nerves" and detect "EMG activity." Monitoring nerve function and EMG activity are diagnostic activities, as they provide information about the physiological state of the nerves and muscles to aid in diagnosis or assessment.
No
The device description explicitly states it consists of a central control unit, pre-amplifier pod, electrodes, stimulator pod, and stimulating probe, all of which are hardware components.
Based on the provided information, the Neurosign 800 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "monitor and to stimulate cranial motor nerves" by detecting EMG activity in muscles. This involves direct interaction with the patient's body (in vivo) to measure physiological signals.
- Device Description: The device description confirms this by mentioning electrodes attached to the patient for EMG recordings and a stimulating probe that delivers current to nerve tissue.
- Definition of IVD: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a physiological state, health, or disease. The Neurosign 800 does not analyze specimens taken from the body.
Therefore, the Neurosign 800 is an in vivo diagnostic and therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Neurosign 800 is intended to monitor and to stimulate cranial motor nerves. The motor nerves are monitored by detecting EMG activity in the muscles they innervate.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Neurosign 800 is an EMG machine and nerve stimulator. The machine consists of a central control unit to which a pre-amplifier pod and intramuscular or surface electrodes are attached for EMG recordings. Additionally connected to the main unit is a stimulator pod to which a stimulating probe which delivers current to nerve tissue may be connected.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cranial motor nerves
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The safety and effectiveness of the Neurosign 800 has been established through various techniques. The history of the similar products listed above lacks complaints related to safety and effectiveness, and as far as we are aware there been no reports of adverse effects or reportable incidents connected with them, or in any published papers on nerve monitoring. The Magstim Company performs extensive in-house and on-site clinical evaluation of all its products both prior to and after product release for distribution. Our methods and procedures for acceptance of products as well as our techniques for clinical evaluation are performed using team participation. Team members include, but are not limited to, Marketing, Manufacturing, Engineering, Clinical Engineering, Manufacturing Engineering and Quality Assurance. The Neurosign 800 has met all specifications and expectations for its intended use based on the evaluations conducted thus far.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
Neurosign 800 Motor Nerve Monitor 510(k)
K96 4869
Summary of Safety and Effectiveness Section 2:
MAY 14 1997
Neurosign 800 Motor Nerve Monitor
The Neurosign 800 is an EMG machine and nerve stimulator. The machine consists of a central control unit to which a pre-amplifier pod and intramuscular or surface electrodes are attached for EMG recordings. Additionally connected to the main unit is a stimulator pod to which a stimulating probe which delivers current to nerve tissue may be connected.
The Neurosign 800 is intended to monitor and to stimulate cranial motor nerves. The motor nerves are monitored by detecting EMG activity in the muscles they innervate.
The Neurosign 800 is similar to the following products which are currently in commercial distribution:
- a) Neurosign 100. The Magstim Company
- b) Brackmann II, WR Medical
- c) NIM-2XL Nerve Integrity Monitor, Xomed
The safety and effectiveness of the Neurosign 800 has been established through various techniques. The history of the similar products listed above lacks complaints related to safety and effectiveness, and as far as we are aware there been no reports of adverse effects or reportable incidents connected with them, or in any published papers on nerve monitoring.
The Magstim Company performs extensive in-house and on-site clinical evaluation of all its products both prior to and after product release for distribution. Our methods and procedures for acceptance of products as well as our techniques for clinical evaluation are performed using team participation. Team members include, but are not limited to, Marketing, Manufacturing, Engineering, Clinical Engineering, Manufacturing Engineering and Quality Assurance. The Neurosign 800 has met all specifications and expectations for its intended use based on the evaluations conducted thus far.
The materials and methods used to manufacture the Neurosign 800 do not vary from the current materials and methods used by The Magstim Company in the manufacture of the Neurosign 100. We will incorporate new proven technologies as they become available; however, these improvements support product performance through greater reliability.
The Magstim Company concludes that the Neurosign 800 is safe and effective for its intended use.