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510(k) Data Aggregation
K Number
K213049Device Name
STIMPOD NMS450 Nerve Stimulator
Manufacturer
Xavant Technology (Pty) Ltd
Date Cleared
2022-10-16
(389 days)
Product Code
BXN
Regulation Number
868.2775Why did this record match?
Applicant Name (Manufacturer) :
Xavant Technology (Pty) Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is a nerve stimulation device designed to be used by an anesthetist during:
1. General anesthesia, for the purpose of establishing the efficacy of a Neuromuscular Blocking Agent using non-invasive surface electrodes.
2. Regional anesthesia, for the purpose of:
i. nerve mapping using the non-invasive Nerve Mapping Probe (supplied)
ii. nerve locating using invasive needles (not supplied)
Device Description
The STIMPOD NMS450 is a quantitative Neuromuscular Transmission (NMT) Monitor which provides real-time quantitative feedback utilizing tri-axial accelerometery.
The STIMPOD NMS450 is also a precision nerve locating tool used for localizing specific neural pathways. Localization of nerves by electrical stimulation involves connecting the nerve stimulator to a conducting needle through which local anaesthetics can be injected. The distance of the needle (cathode) from the nerve can be estimated by establishing the minimum threshold current required, to facilitate a neuromuscular response.
The STIMPOD NMS450 currently makes use of 3 dimensional acceleromyography (AMG) as the measurement technology of choice for objective Neuromuscular Transmission (NMT) monitoring in surgery. Although AMG is still the de-facto standard in industry, the use of electromyography (EMG) has gained renewed interest in NMT monitoring applications where the introduction of robotic surgeries, new surgical techniques, and changes in workflow, for instance, made the use of AMG impracticable.
In order to address this steadily increasing market demand for EMG sensor technology in NMT monitoring applications, Xavant identified the need to design and develop a dedicated NMT Monitoring Cable (EMG) that could be used interchangeably with the existing NMT Monitoring Cable (AMG) already in use with the STIMPOD NMS450.
The NMT Monitoring Cable (EMG) was specifically designed for use with the STIMPOD NMS450 to assist anaesthesiologists in theatre with monitoring the efficacy of Neuromuscular Blocking Agents (NMBAs).
The NMT Monitoring Cable (EMG) was designed with an intelligent EMG signal processing module (henceforth referred to as the µEMG) on one end of the cable for connection to an EMG electrode, and with a standard FireWire connector on the other end for connection to the STIMPOD NMS450.
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K Number
K161091Device Name
STIMPOD NMS460 Nerve Stimulator
Manufacturer
XAVANT TECHNOLOGY (PTY) LTD
Date Cleared
2017-01-18
(275 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
XAVANT TECHNOLOGY (PTY) LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The STIMPOD NMS460 Nerve Stimulator is a Transcutaneous Electrical Nerve Stimulation (TENS) device used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment of post-surgical pain, post traumatic acute pain problems, as well as an adjunct for pain control due to rehabilitation.
Device Description
The STIMPOD NMS460 Nerve Stimulator is a hand held low frequency neuromodulation Transcutaneous Electrical Nerve Stimulation (TENS) device, used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical pain, post traumatic acute pain, as well as an adjunct for pain control due to rehabilitation exercises. The STIMPOD NMS460 Nerve Stimulator offers two types of waveforms for the management of pain. The first is a Monophasic Square Wave, which is typical of normal TENS machines. The second waveform is a Hybrid RF waveform which consists of a Monophasic Square Wave with a superimposed Radio Frequency waveform. This waveform is proprietary and is unique to STIMPOD NMS460 Nerve Stimulator.
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K Number
K140853Device Name
STIMPOD ST2-3010 NERVE STIMULATOR
Manufacturer
XAVANT TECHNOLOGY (PTY) LTD
Date Cleared
2014-11-06
(217 days)
Product Code
BXN
Regulation Number
868.2775Why did this record match?
Applicant Name (Manufacturer) :
XAVANT TECHNOLOGY (PTY) LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The STIMPOD ST2-3010 is a nerve stimulation device designed to be used for the purpose of nerve locating using invasive electrodes or needles (not supplied)
Device Description
The STIMPOD ST2-3010 device is a battery powered peripheral nerve stimulator that can be used for the purpose of nerve locating using invasive electrodes or needles (not supplied). The STIMPOD ST2-3010 is a precision nerve locating tool used for localizing specific neural pathways. Localization of nerves by electrical stimulation involves connecting the nerve stimulator to a conducting needle. The stimulus is generated by a constant current source. The waveform is a monophasic square wave with 3 options for pulse width. These are: 0.1, 0.2 and 0.3 milliseconds. The unit dimensions are 145mm x 90mm x 30mm with a weight of 130 g
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