(177 days)
The AxioBionics® Wearable Therapy® Garments with cutaneous electrodes are intended to be used to apply electrical stimulation current to the patient's skin via electro conductive media gel.
Example of electrical stimulation applications of the garment are: a) Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief b) Neuromuscular Electrical Stimulation (NMES) for: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion c) Functional Electrical Stimulation (FES)
The AxioBionics Wearable Therapy Garments that are garments that are made of nylon/spandex and neoprene fabric that hold and position the system's electrodes. Channels are built into the garments to allow the wiring of the electrodes to be managed for the patient. The garments can be worn as produced or altered (tailored) as needed for user fitment. The conducting element is contained in a positionable electrode for electro-conductivity. The gel permeable electrode pocket is on the inside of the garment. The garment is re-usable and washable as is the electrode
This document does not describe an AI/ML device; therefore, it does not include information typically found in studies related to AI/ML device acceptance criteria and performance.
The document is a 510(k) premarket notification for the AxioBionics Wearable Therapy Garments. This device is a Class II cutaneous electrode, intended to apply electrical stimulation current to the patient's skin via electro-conductive media gel for various applications like TENS, NMES, and FES.
The regulatory review focuses on demonstrating substantial equivalence to a previously marketed predicate device (Bioflex Garments, K944543), not on the performance metrics of an AI/ML algorithm.
Therefore, the requested information elements related to AI/ML device studies (such as acceptance criteria tables, sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, standalone performance, etc.) are not present in this document.
Instead, the document details:
- Device Description: Garments made of nylon/spandex and neoprene fabric that hold and position the system's electrodes. They are reusable and washable.
- Indications for Use: Applying electrical stimulation current to the patient's skin for TENS, NMES (muscle spasms, disuse atrophy, blood circulation, muscle re-education, post-surgical stimulation, range of motion), and FES.
- Technological Comparison (with Predicate Device): Highlights similarities in intended use, product code, lead wire, electrical energy, number of electrodes, usage, replacement packaging, and latex content. It notes differences in resistivity/impedance, electrode area, average tissue electro-conductive media gel, conductive electrode element, top cover, and electrode placement (positionable in the subject device vs. fixed in the predicate).
- Non-Clinical Performance Testing:
- Study Goal: Demonstrate that the electrodes used in the AxioBionics Wearable Therapy Garments have uniform current distribution and do not cause "hot spots." Also, to compare performance to the predicate device electrodes.
- Tests Performed: Dispersion testing, simulated use, high-resolution dispersion evaluation, impedance, and wash cycles. Additional testing was performed on the subject device to assess electrode-to-electrode connection performance.
- Results: Test results demonstrated that the AxioBionics Wearable Therapy Garments electrodes perform as intended and did not raise any new issues of safety or efficacy when compared to the predicate device electrodes.
In summary, this document is a regulatory submission for a hardware medical device and does not contain the information requested about AI/ML algorithm performance.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).