(211 days)
Over-The-Counter Use:
TENS (Modes 1, 2, 4, 5, 6, 8):
PL-029K12 and PL-029K13 are used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
PL-029K12 and PL-029K13 are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
The device of PL-029K12 may be used during sleep. The device of PL-029K12 is labeled for use only with its own compatible electrodes.
PMS (also called EMS, Modes 1, 3, 7):
PL-029K12 and PL-029K13 are used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
PL-029K12 and PL-029K13 are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
Heating: The device of PL-029K13 is intended for temporary relief of minor aches and pains.
Prescription Use:
PL-029K12 and PL-029K13 are intended for the following use:
- Symptomatic relief and management of chronic, intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
- Relief of pain associated with arthritis
- Temporary relaxation of muscle spasm
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Maintaining or increasing range of motion
- Increase of local blood flow in the treatment area
- Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles
The subject device delivers electric pulses generated to the user's body areas such as the back and foot through the electrodes. The devices include operating of ON/OFF button, intensity increase button, intensity decrease button, and could be attached to electrodes. The device has multiple program modes of different pulse frequencies, covering TENS and PMS that is also called Electrical Muscle Stimulation (EMS). In addition, the device may also provide heat/temperature. While used in the heating mode, the device is coupled with electronically controlled electrodes to provide automatic thermal heat to the skin with the maximum temperature of 43 ℃ for temporary relief of minor aches and pains.
The device could be easily operated through its buttons to manually realize its functions, such as turning on/off and increasing/decreasing intensity, providing heat/temperature and displaying/burning calories if needed. The optional wireless control via a remote or Bluetooth APP could provide a secondary operation way to the user, who could be able to wirelessly realize the functions mentioned above.
The electrodes cleared include the electrode patches/pads and electrode garments, which could be packaged together with the 510(k)-cleared devices or packaged separately as the replacement electrodes for 510(k)-cleared devices.
The provided text is a 510(k) Summary for the JKH Stimulator Plus (K182203), which is a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulation (PMS) unit with heating capabilities. This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device's performance against pre-defined acceptance criteria through a specific study.
Therefore, the information typically required to describe acceptance criteria and a study proving a device meets them (as per the prompt's request for a table of acceptance criteria, sample size, expert involvement, etc.) is not explicitly present in this type of FDA submission document.
Here's a breakdown of why this information is missing and what is provided instead:
- No specific acceptance criteria table for performance: 510(k) submissions for substantial equivalence typically don't include a detailed table of acceptance criteria for clinical performance endpoints like accuracy, sensitivity, or specificity. Instead, they demonstrate that the new device's technical characteristics and intended use are similar enough to already legally marketed predicate devices such that it raises no new questions of safety or effectiveness.
- No dedicated "study" proving performance against acceptance criteria: The document refers to "Non-Clinical Tests Performed" (Section 8) but these are primarily bench tests and biocompatibility tests (e.g., IEC 60601 series, ISO 10993 series) to ensure electrical safety, electromagnetic compatibility, and safe material use, not a clinical trial or performance study against specific acceptance metrics for pain relief or muscle stimulation effectiveness.
- No information on sample size (clinical), expert involvement, adjudication, MRMC studies, or specific ground truth methodologies for performance: These elements are characteristic of clinical performance studies, which are generally not a requirement for 510(k) substantial equivalence for devices like TENS units unless new questions of safety or effectiveness are raised.
Based on the provided text, I can infer and extract information relevant to the prompt's structure, but it's crucial to understand that it's from the perspective of substantial equivalence rather than meeting specific performance acceptance criteria from a pre-defined study.
Attempted Interpretation of Acceptance Criteria and "Study" Information based on K182203:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) summary for substantial equivalence, the "acceptance criteria" are implied by the comparison to a predicate device. The "reported device performance" is framed in terms of technical specifications being within ranges demonstrated by legally marketed devices, indicating no new safety or effectiveness concerns.
| Category | Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance (JKH Stimulator Plus [PL-029K12 & PL-029K13]) |
|---|---|---|
| Intended Use | Must be substantially equivalent to predicate devices, addressing temporary pain relief, chronic pain, arthritis pain, muscle performance, and local blood circulation via TENS/PMS, and minor aches and pains via heating. | TENS (Modes 1, 2, 4, 5, 6, 8): Temporary relief of pain associated with sore/aching muscles (shoulder, waist, back, arm, leg from exercise/activities), symptomatic relief/management of chronic/intractable pain, relief of pain associated with arthritis. |
PMS (Modes 1, 3, 7): Stimulate healthy muscles to improve/facilitate muscle performance, improve muscle tone/firmness, strengthen muscles (arms, abdomen, legs, buttocks), temporarily increase local blood circulation in lower extremities.
Heating (PL-029K13): Temporary relief of minor aches and pains. (All match predicates). |
| Safety Standards | Compliance with recognized electrical safety, EMC, and biological evaluation standards. | Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-5, ISO 10993-10, and FDA Guidance for software. |
| Maximum Skin Temp. | For heating function, must be within safe limits (matches predicate's max temp.). | 43 °C (PL-029K13 only), matches K162517 predicate. |
| Electrical Output | Electrical parameters (Max. Output Voltage, Max. Output Current, Pulse Width, Frequency, Max Phase Charge, Max Current Density, Max Avg. Power Density) must be within the range of cleared predicate devices, such that they do not raise new safety or effectiveness concerns. | Values provided for both PL-029K12 and PL-029K13 across 500Ω, 2KΩ, and 10KΩ loads. These values are identical to the K162517 predicate and are stated to be within the range of other FDA-cleared transcutaneous electrical nerve stimulators, and differences from some predicates do not raise new safety/effectiveness questions. |
| Electrode Compatibility | Labels must ensure safe and proper use of compatible electrodes. | Labeled for use only with its own compatible electrodes. Concerns for safe and proper use fully addressed through labeling. Electrodes are the same as or biocompatible with those cleared for predicates. |
| Device Operation | Manual and optional wireless control should facilitate user operation without raising safety concerns. | Easily operated through buttons (ON/OFF, intensity, heat, display/burning calories). Optional wireless control via remote or Bluetooth APP. |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of clinical performance for this 510(k). The "test set" here refers to the actual device units subjected to engineering bench tests and biocompatibility tests. The document does not specify the number of units tested.
- Data Provenance: The tests performed are non-clinical (bench testing, biocompatibility) of the manufactured device. These tests are presumably conducted by the manufacturer or contracted labs. The origin isn't stated in terms of country or retrospective/prospective as it relates to clinical data, but rather reflects standard engineering and safety evaluations for device manufacturing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Experts for Ground Truth: Not applicable. For demonstrating substantial equivalence, "ground truth" (clinical diagnosis) is not established by experts for a specific test set. Rather, the device's technical specifications are compared to those of established, legally marketed predicate devices. The expertise involved would be internal engineering and regulatory expert(s) at JKH USA, LLC, and the FDA reviewers themselves, evaluating the submission for regulatory compliance and equivalence.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. There is no clinical test set requiring adjudication in the context of this 510(k) submission.
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
- MRMC Study: No. This device is a TENS/PMS unit, not an AI-powered diagnostic imaging tool. Therefore, an MRMC comparative effectiveness study is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable. This device does not have an AI algorithm. It is a direct electrical stimulation device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable in the clinical sense. For a 510(k) demonstrating substantial equivalence for a TENS/PMS device, the "ground truth" for regulatory approval lies in conforming to recognized safety and performance standards (bench testing) and demonstrating that its technological characteristics and intended uses are the same as or similar enough to already legally marketed predicate devices that it does not raise new questions of safety or effectiveness. The effectiveness of the class of device is established through prior predicate device clearances.
8. The sample size for the training set
- Sample Size for 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
- Ground Truth for Training Set: Not applicable. This is not an AI/ML device that requires a training set.
Summary of what the document does provide regarding "proof":
The "proof" in this 510(k) summary is based on technical comparison and compliance with voluntary standards, not clinical performance studies against specific acceptance criteria.
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Technical Comparison (Section 6 & 7): The core of the substantial equivalence argument is presented in "Table 1. Comparison between the subject device and the predicate device" and the subsequent "Summary of Substantial Equivalence" (Section 7). This table systematically compares the JKH Stimulator Plus (K182203) to multiple predicate devices (K162517, K031017, K140333, K153704) across various features including:
- Intended Use (for both OTC and Prescription uses)
- Power Source
- Compliance with Voluntary Standards (electrical safety, EMC, biocompatibility)
- Functions and Design (Electrical stimulation and heat)
- Maximum skin temperature (for heating mode)
- Electrical Output Parameters (Maximum output voltage, current, pulse width, frequency, phase charge, current density, average power density at various loads).
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Conclusion of Equivalence (Section 7): The document argues that:
- The subject device (JKH Stimulator Plus) is identical to one of the predicates (K162517) from the same manufacturer for core electrical stimulation and heating features.
- Any differences in technical specifications (e.g., specific pulse width or frequency ranges, output parameters) compared to the other predicate devices are within accepted ranges for TENS/PMS devices and do not raise new questions of safety or effectiveness. This is supported by explanations such as "neither device gives the user control over frequency," "both devices are using standard TENS stimulation frequencies," and the output parameters are "therapeutically effective with either device."
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Non-Clinical Testing (Section 8): JKH USA, LLC performed bench tests to ensure the device's design conforms to recognized consensus standards for electrical safety (IEC 60601-1, IEC 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993-5, ISO 10993-10). Software verification was also conducted per FDA guidance. These tests serve as "proof" that the device is built safely and functions as intended within engineering parameters.
In essence, the "study" proving the device met "acceptance criteria" here is the aggregated body of evidence presented in the 510(k) to demonstrate substantial equivalence to existing, legally marketed devices, rather than a de novo clinical trial with specific performance endpoints.
§ 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).