(259 days)
The BioWave BioWraps are cutaneous electrodes to be used with legally marketed BioWave branded neurostimulators. The knitted garment electrodes are non-sterile reusable prescription-use and OTC conductive garments that are intended to deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts include hand/wrist, elbow, foot/ankle, knee, and lower back.
The BioWave BioWraps are washable, wrappable bands made from a stretchable neoprene-like outer and silver fiber conductive inner fabric. The electrodes are secured to the skin through the wrapping of the bands. The BioWraps are intended for use on the hand/wrist, elbow, foot/ankle, knee, and lower back. When used alongside a conductive cream, the electrodes provide a low current density with uniform current distribution. The BioWraps are to be used alongside cleared BioWave neurostimulator devices (the BioWavePRO® RX (K052289), BioWaveHOME® RX (K152437), and BioWaveGO® OTC (K180943)).
The BioWave BioWraps are cutaneous electrodes designed for use with BioWave neurostimulators. The provided document is a 510(k) premarket notification and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed clinical study proving the device meets specific acceptance criteria in a comparative effectiveness study with human readers.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in the format of a clinical trial endpoint. Instead, it describes performance characteristics for substantial equivalence to predicate devices.
| Performance Characteristic | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (BioWave BioWraps) |
|---|---|---|
| Conductivity | Similar to predicate devices | Highly conductive, less than 1.27 ohms resistance per inch (similar or less than predicates) |
| Resistivity | Similar to predicate devices | Meets design controls |
| Impedance | Similar to predicate devices | Meets design controls; 1.27 ohms resistance per inch (compared to predicate's 7 ohms/inch and 2 ohms/inch) |
| Uniform Current Delivery | Consistent with predicate devices | Uniform delivery of low doses of current |
| Reusability | Demonstrated by predicate devices | Duly demonstrated, no significant adverse effect on conductivity after multiple washings |
| Biocompatibility | Compliant with ISO 10993-5 and 10993-10 | Compliant with ISO 10993-5 and 10993-10 (cytotoxicity, sensitization, cutaneous reactivity met established acceptance criteria) |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable. The "study" described is bench testing, not a clinical trial with a test set of patients or medical images.
- Data Provenance: Not applicable for clinical data. The testing described is laboratory-based bench testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. Ground truth as typically understood in medical device AI (e.g., expert consensus on diagnosis) is not relevant for this type of bench testing. The "ground truth" here is the adherence to engineering specifications and international standards.
4. Adjudication Method for the Test Set:
- Not applicable. There was no clinical test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. This document describes a 510(k) submission for cutaneous electrodes, which does not typically involve such studies. The device is not an AI-powered diagnostic tool, but rather an accessory to a neurostimulator. It does not involve human readers for interpretation in the way AI in radiology would.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not applicable. This device is not an algorithm. The performance described is the physical and electrical characteristics of the garment electrodes themselves.
7. The Type of Ground Truth Used:
- The "ground truth" for the bench testing was based on engineering specifications, material science principles, and compliance with international standards (e.g., ISO 10993 for biocompatibility) and comparisons to the performance characteristics of legally marketed predicate devices.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. No training set was used.
§ 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).