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K Number
K141919
Device Name
VEINOPLUS SPORT NEUROMUSCULAR STIMULATOR
Manufacturer
AD REM TECHNOLOGY SARL
Date Cleared
2015-06-16

(336 days)

Product Code
NGX,GXY
Regulation Number
890.5850
Type
Traditional
Panel
PM
Reference & Predicate Devices
K072252,K083140
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The VEINOPLUS® SPORT is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

Device Description

The VEINOPLUS® SPORT, like a number of legally marketed predicate devices is a traditional battery powered muscle stimulator. It is portable, hand-held device, equipped with one single channel intended to stimulate the calf muscles or other muscles of the body (for example thighs, arms, buttock, back, shoulder or abdomen). The VEINOPLUS® SPORT device has only one operating mode, called program, stored in the internal memory.

The output stimulus is low-voltage, low frequency with rectangular voltage waveform. The device is housed in a plastic enclosure, and it is powered by an alkaline 9V primary battery. The accessories include the output cables, battery, user manual and electrode pads. No provisions are made for AC adapters, so the device cannot be connected to line under any circumstances.

The VEINOPLUS® SPORT device is supplied with all accessories (as listed below) necessary for a safe and effective session of stimulation. Main unit, cable, the pair of electrodes, battery, lanyard and user manual are packaged in carrying case then packaged in a carton box with printed messages. Refer to the picture in Section 12 Device Description.

List of accessories:

  • 1pair of electrodes VEINOPLUS® Pack. Self-adhesive. Oval shape. Size 8x13 cm. Low resistance. This includes a Hydrogel for the electrodes (Refer to Sections 19 and 23F).
  • 1 conductor cable for connecting the electrodes. Approximate length (w/o plug) 135 cm.
  • 1 instruction manual
  • 1 9V alkaline battery
  • 1 lanyard
  • 1 carrying case: L22.5W4.5H17cm.
AI/ML Overview

This document describes the Veinoplus® Sport Neuromuscular Stimulator. However, it does not include information about specific acceptance criteria, study details, or performance data that would allow a comprehensive answer to your request. The document primarily focuses on establishing substantial equivalence to predicate devices (Veinoplus® and Compex® Sport Plus) for FDA 510(k) clearance, rather than presenting a performance study with detailed acceptance criteria and results.

Specifically, the document states:

  • "The safety and performance of the device is supported by testing with safety and performance standards IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-10 standards."
  • "The gel of electrodes was tested according ISO 10993-5 and ISO 10993-10 Biocompatibility standards."
  • "In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA guidance for the content of premarket submissions for software contained in Medical Devices."
  • "A usability study support as well that the user can operate the device in a safe and effective manner with labeling supplied with the device."

These statements indicate that the device met certain safety, electrical, EMC, biocompatibility, software verification, and usability standards. However, they do not provide quantitative performance metrics specific to its intended use (stimulating healthy muscles to improve and facilitate muscle performance) with defined acceptance criteria.

Therefore, I cannot provide the requested information in the format you specified. The supplied text does not contain:

  1. A table of acceptance criteria and reported device performance related to its muscle stimulation effectiveness.
  2. Sample size, data provenance, number of experts, adjudication method for a performance study.
  3. Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
  4. Information on standalone algorithm performance.
  5. Type of ground truth used for performance metrics.
  6. Sample size for the training set or how its ground truth was established, as this is a physical device, not an AI/ML algorithm requiring training data in the traditional sense.

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).