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K Number
K024258
Device Name
NEUROTECH KNEEHAB
Manufacturer
BIO-MEDICAL RESEARCH, LTD.
Date Cleared
2005-03-04

(802 days)

Product Code
IPF
Regulation Number
890.5850
Type
Traditional
Panel
PM
Reference & Predicate Devices
K926510
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The device is indicated for the following:

  • Muscle re-education of the quadriceps.
  • Maintaining or increasing range of motion of the knee joint.
  • Prevention or retardation of disuse atrophy in the quadriceps.
Device Description

The NeuroTech© Kneehab™ is a battery operated, portable neuromuscular electrical stimulator. The device is intended to provide a non-invasive, prescriptive therapy.
In use, the device delivers brief electrical pulses through the skin contact adhesive electrodes. It uses constant current pulses to stimulate the nerves in the quadriceps area of the body. These pulses cause muscular contraction the quadrie application of stimulation to the peripheral nervous system.
The NeuroTech© Kneehab™ is a garment based solution comprising of a two-piece construction, worn above the knee. It is a one-programme unit.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. This document is a 510(k) summary for the NeuroTech© Kneehab™ device, focusing on its description, intended use, and substantial equivalence to a predicate device, as required for FDA clearance.

The summary outlines:

  • Device Description: A battery-operated, portable neuromuscular electrical stimulator.
  • Intended Use: Muscle re-education of the quadriceps, maintaining or increasing range of motion of the knee joint, and prevention or retardation of disuse atrophy in the quadriceps.
  • Technological Comparison: Compares the NeuroTech© Kneehab™ to a predicate device, the Staodyn EMS+2, noting similar electrical outputs and compliance with various IEC standards for medical electrical equipment, EMC, and radiated emissions.
  • Non-clinical Tests: Mentions that comparisons of electrical outputs show similar results to the predicate device and that both have been independently tested to specific IEC and EN standards. It also states that a hazard analysis, risk analysis, and failure mode effects analysis have been carried out.

Missing Information:
The document does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for any test sets.
  3. Number or qualifications of experts for ground truth establishment.
  4. Adjudication methods.
  5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes of human reader improvement with AI.
  6. Information on a standalone algorithm performance study.
  7. The type of ground truth used (e.g., pathology, outcomes data).
  8. Sample size for a training set.
  9. How ground truth for a training set was established.

This document is a regulatory submission demonstrating substantial equivalence, not a clinical study report or a performance validation study. Therefore, the detailed information requested regarding acceptance criteria and performance studies is not available within the provided text.

§ 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).