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510(k) Data Aggregation
(333 days)
TENS: To be used 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. PMS: It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
SM TENS & PMS is a portable and DC 3.7V battery powered multi function device, offering both Transcutancous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities in one device. SM TENS & PMS has 6 operation modes, which can give certain electrical pulses through electrode adhesive pads to the suggested area of the body where the electrodes are placed. The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key, Intensity Modification keys, Timing key, Pause key, Output socket, and USB port for battery charging. The display screen can show battery power, selected mode, current intensity, time remaining of an application mode, and indication of a pause. The device is equipped with accessories of electrode pads, electrode cables, battery chargers, and USB cables. The electrode cables are used to connect the pads to the device; the USB cable is used to connect the charger and the built-in lithium battery. All accessories, including USB cables, electrode pads, electrode cables, chargers can only be changed by special person. The electrodes are interchangeable. The application area of electrode pads must be larger than 4cm². The electrode pads are provided by GMDASZ Manufacturing Co., Ltd. with 510(k) cleared Number K092546.
This submission is for a Traditional 510(k) for a new device, the "SM TENS & PMS" from Hong Qiangxing (Shen Zhen) Electronics Limited. The device is a portable, battery-powered multi-function device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) functionalities. The 510(k) submission seeks to demonstrate substantial equivalence to a predicate device, the "Powered Muscle Stimulator, JQ-5C" (K102598).
The acceptance criteria are established through a comparison of the new device's technical characteristics and performance against the predicate device and relevant safety standards. The study proving the device meets the acceptance criteria is a safety testing protocol, which demonstrates compliance with recognized electrical and medical device standards.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria, for the purpose of a 510(k) for substantial equivalence, are primarily that the new device performs equivalently to the predicate device in its intended use and meets relevant safety standards, without raising new questions of safety or effectiveness. The reported device performance is based on the results of the safety testing.
| Acceptance Criteria Category | Specific Acceptance Criteria (Derived from comparison to predicate and standards) | Reported Device Performance |
|---|---|---|
| Intended Use | Identical indications for use as the predicate device (TENS for temporary pain relief, PMS for muscle performance improvement). | Met: Both SM TENS & PMS and the predicate (JQ-5C) have identical TENS and PMS indications for use. |
| Technological Characteristics | Similar design, power source, number of output modes, number of output channels, synchronization, channel isolation method, timer range, waveform, and wave shape. | Met: The new device is reported to have the same intended use, power supply, components, 6 modes, 2 channels, software control, standards compliance, same waveform and wave shape, same pulse width, and net charge. |
| Electrical Safety | Compliance with IEC 60601-1 (General Safety), IEC 60601-2-10 (Nerve and Muscle Stimulators), and IEC 60601-1-2 (EMC). | Met: The new device passed testing according to IEC 60601-1: 2005, IEC 60601-2-10: 2001, and IEC 60601-1-2: 2001. |
| Battery Safety | Compliance with IEC 62133 (Secondary cells and batteries safety). | Met: The new device passed testing according to IEC 62133: 2002. |
| Electromagnetic Compatibility (EMC) | Compliance with FCC 47 CFR Part 18 (Industrial, Scientific, and Medical Equipment - Conducted Emissions). | Met: The new device passed testing according to FCC 47 CFR Part 18. |
| Output Parameters (Key electrical characteristics - variations within acceptable limits) | Maximum Output Voltage, Maximum Output Current, Pulse Width, Max. Pulse Frequency, Net Charge, Maximum Phase Charge, Maximum Average Current, Maximum Current Density, Maximum Average Power Density to be comparable or safer than predicate. | Met/Compared: While some specific numerical values differ (e.g., Maximum Output Voltage and Current, Max. Pulse Frequency, Maximum Current Density, Maximum Average Power Density), the submission concludes these differences (and those attributable to different smallest surface area of electrodes) do not raise new safety or effectiveness issues. Net charge and pulse width are the same. |
| Patient Leakage Current | Normal Condition: ≤ 2μA; Single Fault Condition: < 10μA. | Met: Reported as 2μA (Normal Condition) and < 10μA (Single Fault Condition). |
| Average DC current through electrodes | < 0.01 μA when device is on but no pulses are applied. | Met: Reported as < 0.01 μA. |
| Electrode Pads | Electrode pads must be larger than 4cm². (Note: This is a design requirement rather than a performance criterion for the device itself). | Met: The application area of electrode pads must be larger than 4cm². The electrode pads are provided by GMDASZ Manufacturing Co., Ltd. with 510(k) cleared Number K092546. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "test set" in the context of clinical data for the device. The evaluation is based on engineering testing of a single device (or set of devices sufficient for engineering tests) to verify compliance with standards and comparison to the predicate device's specifications. It is a technical submission, not a clinical trial.
- Data Provenance: The data primarily comes from engineering and bench testing conducted by the manufacturer (Hong Qiangxing (Shen Zhen) Electronics Limited), likely performed in China (Shenzhen, Guangdong, China), where the manufacturer is located. This is a retrospective comparison to existing standards and predicate device specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this 510(k) submission. A 510(k) for an electrical stimulator device like this does not typically involve expert review for ground truth in a clinical sense. The "ground truth" here is compliance with established electrical safety and performance standards, as well as functional equivalence to a legally marketed predicate device. This is assessed through objective engineering tests.
4. Adjudication Method for the Test Set
This is not applicable. There is no "test set" requiring adjudication by experts in the context of this 510(k) submission. The evaluation is against objective engineering standards and a comparative analysis of technical specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices or other technologies where human interpretation or clinical effectiveness is a primary endpoint requiring comparison between different readers or technologies. For TENS/PMS devices seeking substantial equivalence, such studies are not usually required in a 510(k) submission; the focus is on safety and functional equivalence to the predicate.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This concept is not applicable to the "SM TENS & PMS" device. This is a direct electrical stimulation device; it does not involve algorithms that perform diagnostic or interpretative functions that would require a "standalone" performance evaluation in the way imaging AI algorithms do. Its performance is evaluated by its electrical output characteristics and safety.
7. The Type of Ground Truth Used
The "ground truth" in this context is compliance with recognized electrical safety and performance standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 62133, FCC 47 CFR Part 18) and technical specifications of the predicate device. There is no "pathology" or "outcomes data" ground truth as this is not a diagnostic or treatment outcome effectiveness study.
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning or AI that would require a "training set." The submission describes a hardware device not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth establishment for it.
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