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The AvivaFix Conductive Garment – Knee, AvivaFix Conductive Garment – Shoulder, and AvivaFix Conductive Garment - Upper Back (all Type 420) devices are intended for use with Neurotech Stimulator devices. It is intended to aid in the repeatable placement of electrodes (under the guidance of a clinician) and secure them in place.

The AvivaFix Conductive Garment - Knee, AvivaFix Conductive Garment - Shoulder, and AvivaFix Conductive Garment - Upper Back (all Type 420) devices also maintain a level of compression in the areas of electrode placement to maintain electrode placement during treatment.

The AvivaFix Conductive Garment - Knee, Type 420 is intended for use on the knee. The AvivaFix Conductive Garment - Shoulder, Type 420 is intended for use on the shoulder. The AvivaFix Conductive Garment - Upper Back, Type 420 is intended for use on the upper back (cervical) area.

The AvivaFix Conductive Garment - Knee, AvivaFix Conductive Garment - Shoulder, and AvivaFix Conductive Garment - Upper Back (all Type 420) devices and associated accessories are indicated for use with Neurotech Stimulators to facilitate the frequent and correct positioning and repositioning of large, multiple, and/or difficult to reach stimulation sites associated with the shoulder, knee and upper back (cervical) areas.

The AvivaFix Conductive Garment - Knee, AvivaFix Conductive Garment -- Shoulder, and AvivaFix Conductive Garment - Upper Back (all Type 420) are intended for use in conjunction with transcutaneous electrical nerve stimulation (TENS) and neuromuscular electrical stimulation (NMES). The garments aid in the placement of electrodes and secure the electrodes in place. The inner layer of the garment is constructed of Breathoprene", which is a breathable, stretchable fabric developed by AccuMed Technologies as a neoprene substitute to keep skin cooler and drier by wicking away perspiration.

The provided 510(k) summary for the AvivaFix Conductive Garments states that no new clinical studies have been submitted as part of this premarket notification. The submission relies on demonstrating substantial equivalence to legally marketed predicate devices. Therefore, the information requested regarding acceptance criteria, device performance, study details (sample sizes, ground truth, experts, adjudication, MRMC, standalone performance), and training set details for a study proving the device meets acceptance criteria is not applicable or not available in this document.

The document indicates that the device complies with several standards, which are typically used to demonstrate design and manufacturing quality rather than clinical performance against specific acceptance criteria. These standards include:

• 21 CFR 898: Performance standard for electrode lead wires and patient cables.
• ISO 14971:2007: Medical Devices Application of risk management to medical devices.
• ISO 10993-5: Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity.
• ISO 10993-10:2002/Amd. 1:2006: Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization.

The 510(k) summary focuses on the technological characteristics being similar to predicate devices and the device's adherence to relevant safety and biocompatibility standards. It does not contain a study explicitly designed to assess the device's performance against pre-defined acceptance criteria for its intended use through human or AI-based performance metrics.

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