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K Number
K102084
Device Name
STIMPOD NMS450 NERVE STIMULATOR
Manufacturer
XAVANT TECHNOLOGY (PTY), LTD.
Date Cleared
2010-12-16

(143 days)

Product Code
BXN
Regulation Number
868.2775
Type
Traditional
Panel
AN
Reference & Predicate Devices
K023342,K093591,K954505
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This product is a nerve stimulation device designed to be used by an anesthetist during

  1. General Anaesthesia, for the purpose of establishing the efficacy of a Neuromuscular Blocking Agent using non-invasive surface electrodes (not supplied).
  2. Regional Anaesthesia for the purpose of
    a. Nerve mapping using the non-invasive Nerve Mapping Probe (supplied).
    b. Nerve locating using invasive electrodes/needles (not supplied).
Device Description

The STIMPOD NMS450 is a battery powered peripheral nerve stimulators that can be used for

  • nerve mapping using the non-invasive Nerve Mapping Probe (supplied)
  • nerve locating using invasive electrodes/needles (not supplied)
  • general anesthesia, for the purpose of establishing the efficacy of a Neuromuscular Blocking Agent using non-invasive surface electrodes (not supplied)
    The stimulus is generated by a constant current source. The waveform is a square wave with various pulse width options.
    The anode comprises of an ECG electrode (not supplied). The cathode comprises of
  • a permanently attached nerve mapping probe (supplied) for nerve mapping,
  • and/or a separate nerve locating needle (not supplied) for nerve locating,
  • and/or another ECG electrode (not supplied) for NMBA monitoring, depending on the mode of the unit.
AI/ML Overview

The provided text is a 510(k) summary for the STIMPOD NMS450 Nerve Stimulator. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing de novo acceptance criteria and proving independent device performance against those criteria through a new study.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies, is not present in this 510(k) summary.

The document states:

  • "There are no significant differences between the STIMPOD NMS450 Nerve Stimulator and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, operational principles and intended use."
  • "The STIMPOD NMS450 has been subjected to extensive safety, performance and product validations prior to release." (However, no details of these validations or their acceptance criteria are provided in the public summary).
  • The conclusion emphasizes substantial equivalence based on "clinical use, technical and biological considerations" to predicate devices, and that it "does not raise any new questions of safety and effectiveness."

In the context of a 510(k) submission for substantial equivalence, a manufacturer generally demonstrates that their new device is as safe and effective as a legally marketed predicate device. This often involves showing that the technical characteristics, intended use, and performance are similar or identical, rather than conducting a new clinical study to establish and meet novel acceptance criteria for a new device type.

§ 868.2775 Electrical peripheral nerve stimulator.

(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).