(389 days)
For WL-2315C(M) and WL-2315E(M) models:
The WL-2315C(M) and WL-2315E(M) are designed for the symptomatic relief and management of pain. They offer temporary relief from pain associated with dysmenorrhea (menstrual cramps) when used with over-the- counter pain medication.
For WL-2405H(M) model:
The WL-2405H(M) is designed for symptomatic relief and management of chronic pain and provides temporary relief from sore and aching muscles in the shoulders, waist, back, upper extremities (arms), and lower extremities (legs) due to strain from exercise or daily activities. It also offers temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication.
Additionally, the WL-2405H(M) features EMS functionality for stimulating healthy muscles to enhance or facilitate muscle performance (select EMS modes). It also provides symptomatic relief and management of chronic, intractable pain and relief from pain associated with arthritis (select TENS mode P8).
The Well-Life Pain relief (Menstrual Plus) Electrical Stimulator is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower (extremities) leg due to strain from exercise or normal household work activities. It also provides symptomatic relief and management of chronic, intractable pain and relief from pain associated with arthritis This stimulator should be applied to the normal, healthy, dry, and clean skin of adult patients with the aim of stimulating healthy muscles and enhancing muscle performance.
There are three available models: WL-2405H(M), WL-2315E(M), and WL-2315C(M). WL-2405H(M) is derived from the WL-2405H (FDA 510K no. K172809) with modifications. It includes the original TENS modes P1-P8 and EMS modes P1-P6, along with two additional TENS modes (P9, P10). TENS P9 is used for Pain Relief/Menstrual pain relief, while TENS P10 is suitable for Pain Relief. The WL-2405H(M) model offers 16 preset modes, with 10 modes for TENS (Transcutaneous Electrical Nerve Stimulation) and 6 modes for EMS (Electrical Muscle Stimulation). It features an LCD/LED display and a user-friendly interface that allows for adjustments to preset modes, output signal intensity, and treatment duration. It also includes two output channels.
The WL-2315E(M)/WL-2315C(M) model is a distinct version that exclusively focuses on the TENS P9 mode for dysmenorrhea pain relief, derived from the WL-2405H(M) model. This series of products is an adaptation of the mini-TENS stimulator.
The provided document is a 510(k) premarket notification from Well-Life Healthcare Limited to the FDA for their "Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator." This document asserts substantial equivalence to predicate devices and describes non-clinical testing performed. It explicitly states that no clinical performance testing was conducted or necessary for this device and indications for use. Therefore, no study proving the device meets acceptance criteria through clinical data is available in this document. The acceptance criteria for this device seem to be based solely on non-clinical performance (electrical safety, EMC, software validation) and comparisons to predicate devices for substantial equivalence.
Here's the information about the acceptance criteria and the provided device performance, based on the non-clinical testing and comparison to predicate devices, as no clinical study information is available:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission, the "acceptance criteria" are primarily established against benchmark engineering standards and comparison with predicate devices to demonstrate substantial equivalence, rather than specific performance metrics from a clinical study for a novel device. The document focuses on demonstrating that the subject device's technical specifications and safety profile are comparable to or within acceptable limits of the predicate devices and relevant electrical safety standards.
| Acceptance Criteria (based on standards & predicate comparison) | Reported Device Performance (Subject Device) | Assessment (from document) |
|---|---|---|
| Electrical Safety & Performance (following standards) | ||
| Compliance with IEC 60601-1 (General basic safety) | Testing performed | Compliant (implied by "Testing was performed" and conclusion of substantial equivalence) |
| Compliance with IEC 60601-1-2 (EMC) | Testing performed | Compliant (implied by "Testing was performed" and conclusion of substantial equivalence) |
| Compliance with IEC 60601-1-11 (Home Healthcare) | Testing performed | Compliant (implied by "Testing was performed" and conclusion of substantial equivalence) |
| Compliance with IEC 60601-2-10 (Nerve & Muscle Stimulators) | Testing performed | Compliant (implied by "Testing was performed", assessment of voltage/current differences, and conclusion of substantial equivalence) |
| Compliance with AAMI NS4 (TENS) | Bench testing performed for output parameters | Compliant (implied by "Bench testing was performed" and conclusion of substantial equivalence) |
| Functional & Technical Equivalence to Predicates | ||
| Product Code (NUH, NGX, NYN) | NUH, NGX, NYN | Identical to primary predicate |
| Regulation Number (882.5890) | 882.5890 | Identical to both primary and secondary predicates |
| Power Source (3.7V Lithium-Ion Battery) | 3.7V Lithium-Ion Battery | Identical to both primary and secondary predicates |
| Output Isolation (Electrical disabled when connected to charger) | Output is electrically disabled when connect to charger, by microprocessor charging circuit | Identical to both primary and secondary predicates |
| Max Output Voltage (e.g., 40V @500 ohm for WL-2405H(M)) | WL-2405H(M): 40V @500 ohm; WL-2315E(M): 30V @500 ohm. Livia (secondary predicate): 50V @500 ohms, 64V @2000 ohms, 64V @2700 ohms. Subject devices (WL-2315C/E(M), WL-2405H(M)-P9) show differences at 500 ohms but are similar at higher impedances (2000-2700 ohms, where typical skin impedance falls). | Similar. Differences in voltage/current at 500 ohms are acknowledged but deemed not to compromise safety or effectiveness after evaluation against IEC 60601-2-10 and AAMI NS4 standards, particularly considering typical skin impedance (2000-2700 ohms) where values are closer to the predicate. |
| Max Output Current (e.g., 80mA @500 ohm for WL-2405H(M)) | WL-2405H(M): 80mA @500 ohm; WL-2315E(M): 60mA @500 ohm. Livia (secondary predicate): 130.4mA @500 ohm. | Similar. Differences in voltage/current at 500 ohms are acknowledged but deemed not to compromise safety or effectiveness after evaluation against IEC 60601-2-10 and AAMI NS4 standards, particularly considering typical skin impedance (2000-2700 ohms) where values are closer to the predicate. |
| Pulse Width (e.g., TENS 2-245 us for WL-2405H(M)) | WL-2405H(M): TENS 2-245 us, EMS 4-99 us. WL-2405H (primary predicate): TENS 2-245 us, EMS 4-99 us. Livia (secondary predicate): 100 us. WL-2315E/C(M): 100us vs. Reference 150-260 us. | Similar. "Electrical signal patterns utilized for relevant applications are consistent." Differences noted but considered not to compromise safety or effectiveness after evaluation vs. IEC 60601-2-10 and AAMI NS4. |
| Frequency (e.g., TENS 100-260 Hz for WL-2405H(M)) | WL-2405H(M): TENS 100-260 Hz, EMS 200-300 Hz. WL-2405H (primary predicate): TENS 156-260 Hz, EMS 200-300 Hz. Livia (secondary predicate): 100 Hz. WL-2315E/C(M): 100Hz vs. Reference 15-120 Hz. | Similar. "Electrical signal patterns utilized for relevant applications are consistent." Differences noted but considered not to compromise safety or effectiveness after evaluation vs. IEC 60601-2-10 and AAMI NS4. |
| Indications for Use | Expands upon primary predicate (chronic pain, muscle soreness, EMS) by adding painful dysmenorrhea relief. Matches secondary predicate (Livia) for dysmenorrhea relief. | Substantially equivalent. The menstrual pain relief indication is supported by comparison to the Livia predicate. General pain and EMS indications are covered by the primary predicate. |
| Software Validation (per FDA guidance) | Required documentation provided in accordance with "General Principles of Software Validation: Final Guidance for Industry and FDA Staff" (11/05/2005). | Compliant. |
| Shelf Life & Sterilization | Shelf life for electrodes: 2 years (following FDA-2020-D-0957 and ASTM F1980-16). | Adequate. |
| Biocompatibility | No biocompatibility testing performed for subject device; electrodes used have already been cleared in K082065 and K200942. | Compliant (electrodes are pre-cleared). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable. The document explicitly states: "No clinical performance testing was conducted or necessary for this device and indications for use." The testing described is non-clinical bench testing.
- Data Provenance: The bench testing likely occurred at the manufacturer's facilities or a certified testing lab. The country of origin of the device manufacturer is Taiwan (Well-Life Healthcare Ltd., New Taipei City, Taiwan). The nature of this testing (electrical, EMC, software validation) means it's not "data provenance" in the clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. As no clinical performance testing was conducted, there were no "experts" establishing ground truth in a diagnostic or clinical efficacy sense. Ground truth, in the context of electrical safety and performance, is established by adherence to recognized international standards (e.g., IEC 60601 series, AAMI NS4) and internal design specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable, as no clinical performance testing involving human adjudication was conducted. Assessment for non-clinical testing is typically pass/fail against predefined acceptance criteria for each test according to the relevant 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
- Not applicable. This device is an electrical stimulator, not an AI-powered diagnostic or assistive tool for human readers (e.g., radiologists). No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an electrical stimulator and does not involve an AI algorithm with standalone performance characteristics. Its function is to deliver electrical impulses.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical testing, the "ground truth" is defined by:
- International standards: e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, AAMI NS4.
- Manufacturer's design specifications: Bench testing verified output parameter specifications against these.
- FDA guidance documents: For software validation ("General Principles of Software Validation: Final Guidance for Industry and FDA Staff") and shelf life ("Shelf Life of Medical Devices").
- Predicate devices' established performance and safety profiles: For demonstrating substantial equivalence.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI/ML device that requires a training set.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).