(419 days)
The Well Life Garment Electrodes (GM Series) are intended to be used with legally marketed TENS devices.
The Well-Life Garment Electrodes (GM Series) will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact.
They can be used on body parts such as arm and elbow.
Well-Life Garment Electrodes (GM, Series), Models AM and EB, are intended to be used with legally Marketed Transcutaneous Electrical Nerve Stimulation (TENS) devices which could be used in place of traditional cutaneous electrode patches. The Well-Life Garment Electrodes (GM Series) are blended with Nonconductive textiles (polyurethane, nylon and polyester) and conductive textiles (Silver Fabric). Non-conductive area is used to fix and support Well-Life Garment Electrodes (GM Series) on the body. Two types of Garment Electrodes are designed.
The different series of model means different placement of the garment electrode. For "AM" it is to be place around the arm with conductive areas are on the upper arm and lower arm and there are two sets of snap facing outward, finally for "EB" it is to be place around the elbow with conductive area surrounds the elbow and there are one sets of snap facing outward. There are three sizes for each series of model (S/M/L). The conductive area between different sizes is fixed. There is four conductive area divided into upper arm area and lower arm area on model "AM", the areas is a pair of 39 cm² and a pair of 39 cm². There is only two conductive area on model "EB", the areas is a pair of 25.5 cm2.
By adjusting the area of the non-conductive area, the customer's body curve can be fitted. Conductive area is used as a transmission interface which enabling electrical stimulation devices to transmit signals to the skin. The devices must be used wet when in contact with the skin. When using Well-Life Garment Electrodes (GM Series), buckle the one port of lead wire or any connection terminal from legally marketed stimulator to the set of closest snap buttons on Garment Electrodes. Make sure electrical signals could reach the path from electrical stimulation to the Garment Electrodes.
For Garment Electrodes with multiple sets of buttons, only one set of buttons can be used at a time. The surface of conductive area has a resistance of less than 14 ohms per inch. The signal is generated by an electrical stimulator, and is transmitted evenly through the wire to the conductive area of the Garment Electrodes, and transmitted to the skin.
Here's a breakdown of the acceptance criteria and study information for the Well-Life Garment Electrodes (GM Series) based on the provided FDA 510(k) summary:
This device is an electrode, specifically a cutaneous electrode, and not an AI/ML powered device. Therefore, a significant portion of the requested information (such as AI-specific components like training/test sets, ground truth methodology involving experts, MRMC studies, or standalone algorithm performance) is not applicable to this submission. The "study" here refers to non-clinical testing to demonstrate performance and safety, primarily through bench testing and biocompatibility assessments, rather than clinical trials with human readers or AI performance metrics.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily based on established standards for medical devices, particularly those related to biocompatibility and electrical safety/performance of electrodes. The reported performance demonstrates compliance with these standards.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1, -5, -10, -12 (Evaluation and testing within a risk management process, cytotoxicity, irritation and skin sensitization, sample preparation) | Patient-contacting components are in compliance with ISO 10993 requirements, confirmed by testing for cytotoxicity, sensitization, and irritation. |
| Electrical Safety & Performance | Compliance with IEC 60601-2-10 (Particular requirements for the basic safety and essential performance of nerve and muscle stimulators) | Bench testing performed to verify performance to specifications. The device meets the basic safety and essential performance requirements of nerve and muscle stimulators as per IEC 60601-2-10. |
| Impedance Distribution Uniformity | Uniform and safe impedance within specification, preventing "hot spots" leading to user discomfort or burns. | Testing confirmed uniform impedance distribution, preventing "hot spots." The conductive area has a resistance of less than 14 ohms per inch. (Note: This is an internal specification based on safety, compared to predicates of 2 and 7 ohms/inch). |
| Shelf Life | Compliance with ASTM F1980 (Accelerated Aging) | Accelerated Aging Testing (ASTM F1980:2016) was performed to demonstrate shelf life. |
| Reusability | Ability to withstand maximum duration, maximum number of uses, and maximum number of re-washes (In-house specification). | Reusability testing was performed (duration, number of uses, and re-washes) according to in-house specifications. The device is washable and reusable for a single patient. |
| Maximum Average Current Density | Not explicitly stated as an AC, but safety demonstrated by values. | 0.254 mA/cm² (arm) and 0.392 mA/cm² (elbow) at 500 Ω. These values are considered within safe limits, referencing "IEC60601-2-10 Clause 201.4.2" for comparison. |
| Maximum Peak Power Density | Not explicitly stated as an AC, but safety demonstrated by values. | 1.255 mW/cm² (arm) and 1.958 mW/cm² (elbow) at 500 Ω. These values are considered within safe limits, referencing "Guidance Document for Powered Muscle Stimulator 510K Section 3" for comparison. |
Specific Information Requested (and applicability to this device):
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as individual "test sets" in the context of clinical data. For bench testing of physical characteristics, samples of the device (GM Series electrodes) were tested in a laboratory setting. For biocompatibility, samples of the patient-contacting materials were tested.
- Data Provenance: All data appears to be prospective laboratory and bench testing conducted specifically for this 510(k) submission, following recognized standards. The country of origin for the testing is not specified but the submitter is Well-Life Healthcare Ltd. in New Taipei City, Taiwan.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a hardware medical device (cutaneous electrode) and not an AI/ML powered device requiring interpretation of medical images or other data by experts to establish ground truth for a test set. Ground truth here is defined by physical and electrical properties measured objectively in a lab.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. This is not a clinical study involving subjective interpretation or diagnostic accuracy where adjudication among experts would be needed. Bench testing and biocompatibility follow objective, standardized protocols.
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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:
- Not Applicable. This is not an AI-powered diagnostic device, so MRMC studies, human reader improvement with AI assistance, and effect sizes are irrelevant to this submission.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device contains no "algorithm" to be tested in a standalone fashion. It is a passive conductive garment electrode.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance and safety is established through:
- Objective measurements and physical properties: e.g., impedance readings, current density, power density, material composition.
- Standardized test methods: defined by ISO, IEC, and ASTM, which specify how to measure parameters and what constitutes acceptable performance/safety.
- Biocompatibility test results: conforming to ISO 10993 series.
- The "ground truth" for this device's performance and safety is established through:
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The sample size for the training set:
- Not Applicable. This device does not use an AI/ML algorithm that requires a "training set."
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How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
Summary of the Study:
The "study" for the Well-Life Garment Electrodes (GM Series) consisted of a series of non-clinical tests to demonstrate that the device meets established safety and performance standards for cutaneous electrodes. These tests include:
- Biocompatibility testing: Performed according to ISO 10993 series, confirming that the materials in contact with the patient's skin are safe (no cytotoxicity, sensitization, or irritation).
- Electrical performance and safety testing: Including compliance with IEC 60601-2-10 for nerve and muscle stimulators, impedance distribution uniformity testing to prevent "hot spots," and measurements of maximum average current density and maximum peak power density.
- Shelf life testing: Conducted via accelerated aging (ASTM F1980) to determine the product's stability over time.
- Reusability testing: To ensure the device maintains its performance after multiple uses and washes for a single patient, per in-house specifications.
The results of these tests were used to demonstrate substantial equivalence to legally marketed predicate devices, particularly in areas of intended use, principle of operation, and overall safety and performance profiles. The differences noted (e.g., specific impedance values, exact design/size) were evaluated and determined not to raise new questions of safety or effectiveness.
§ 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).