(132 days)
SM Electrodes are intended to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limit to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use.
SM Electrode pad is used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current of electrode pad is first transmitted via the snap button then transmitted to the conductive gel which is adhered to patient skin.
SM Electrode Pad is composed of a top cover material, connector snap button, conductive carbon film, conductive hydrogel media, and a carrier line.
It is non-sterile and intended for single adult patient multiple application use. The SM Electrode has various shapes and sizes.
To connect with a nerve or muscle stimulator, this SM Electrode Pad has male snap button. The electrical pad connecting two separated gels together through a non-woven fabric has a pair of male snap button and the diameter is 3mm. The electrical pad with only one male snap button are to be used in pairs and the diameter of snap button is 4mm.
When not in use, the hydrogel face is covered by a PET(polyethylene terephthalate) carrier line.
The provided text describes the submission for K183154, "SM Electrodes," a cutaneous electrode. It details non-clinical testing performed to establish substantial equivalence to predicate devices.
Here's the information broken down as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Shelf life testing (ASTM F1980:2016) | Device complies with the standard. (Specific results like duration or remaining strength are not detailed, but compliance implies meeting the established criteria for shelf life.) |
| Biocompatibility (ANSI AAMI ISO 10993-5:2009/(R) 2014) - In Vitro Cytotoxicity | Device complies with the standard, indicating an absence of unacceptable cytotoxic effects. |
| Biocompatibility (ISO 10993-10 Third Edition 2010-08-01) - Irritation and Skin Sensitization | Device complies with the standard, indicating an absence of unacceptable irritation and skin sensitization potential. |
| Contact Impedance Test (per ANSI AAMI IEC 60601-2-2:2009, 201.15.101.6) | Test results demonstrated compliance with the standard (specific numerical values for impedance are not provided, but compliance is stated). |
| Adhesion Test (per ANSI AAMI IEC 60601-2-2:2009, 201.15.101.7) | Test results demonstrated compliance with the standard (specific numerical values for adhesion are not provided, but compliance is stated). |
| Connector Retention Force (snap button with male snap connector) | 9.62 N (for the subject device, compared to 9.60 N and 9.61 N for predicates, implying this value falls within acceptable limits for substantial equivalence). |
| Hydrogel thickness | 1.0mm ± 0.2mm (for the subject device, matching the predicates, implying it meets the specified thickness). |
| Electrical Conductivity & Adhesive Property | "Good electrical conductivity, good adhesive property" (Qualitative assessment, noted as equivalent to predicates). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for each specific bench test (e.g., how many electrodes were tested for impedance, adhesion, or biocompatibility). It only states that "Bench tests were conducted on SM Electrodes."
The data provenance is from non-clinical bench tests. The location where these tests were conducted is not specified, but the manufacturer is Hong Qiangxing (Shen Zhen) Electronics Limited in Guangdong, China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission relies solely on non-clinical bench testing against established international and national standards, not on expert-driven ground truth for clinical performance. The "ground truth" here is the adherence to the defined parameters and limits within those standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical study with a test set requiring adjudication. The assessment was based on objective measurements against engineering and biocompatibility standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was performed or included in this submission. The device is a cutaneous electrode, an accessory for stimulation devices, and does not involve AI or human "readers" in the context of image interpretation or diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical cutaneous electrode, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests was established by recognized international and national standards. Compliance with these standards (ASTM, ISO, ANSI AAMI IEC) served as the basis for determining the device's acceptable performance and safety characteristics.
8. The sample size for the training set
Not applicable. This device is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML algorithm, no ground truth needed to be established for it.
§ 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).