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510(k) Data Aggregation
(108 days)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, leg and foot, due to strain from exercise or normal household and work activities
The Low-Frequency Therapy Instrument is a product that adopts modern electronic science and technology to produce low-frequency electrical pulse and transmit that through the skin to the underlying peripheral nerves by electrodes, in order to reach the therapeutic aim.
There are three models of Low-Frequency Therapy Instrument which are KTR-201, KTR-202, KTR-203. Their technical parameters are slightly different, but they share the basically same characteristics: 1) They are small, and exquisite; 2) they have different treatment modes which can satisfy various demands, thus can be used by a wider range of people; 3) LCD display with a big screen makes the operation easy and clear, and the contents displayed on LCD can guide the treatment.
The Low-Frequency Therapy Instrument is mainly composed of the host and electrode patches and it uses AAA batteries for power supply. To start therapy, first insert batteries, then paste the electrode patches onto treatment areas and press power button to turn the power on. The modes and intensity can be selected according to needs. The current status is displayed on LCD.
This FDA 510(k) submission describes the "Low-Frequency Therapy Instrument" (Models: KTR-201, KTR-202, KTR-203), a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief.
Here's an analysis of the acceptance criteria and supporting studies based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, the acceptance is implied by demonstrating substantial equivalence to a predicate device (Shenzhen OSTO Technology Company Limited's Health Expert Electronic Stimulator, Model AST-300C and AST-300D, K133929) and compliance with relevant voluntary standards.
The "Technological characteristics and substantial equivalence" table (pages 5-6) serves as the core comparison for "performance." Key metrics and their comparison to the predicate are:
| Parameter | Subject Device (K170205) | Primary Predicate (K133929) | Remark / Implied Acceptance |
|---|---|---|---|
| Indications for Use | Temporary pain relief for sore/aching muscles (shoulder, waist, back, arm, leg, foot) due to strain from exercise/normal activities. | Temporary pain relief for sore/aching muscles (shoulder, waist, back, back of the neck, arm, leg, foot) due to strain from exercise/normal activities by applying current to stimulate nerve. | Similar. The subject device's indications are slightly narrower (omitting "back of the neck"), but fundamentally the same therapeutic area and type of pain relief. Implied acceptance: performs a similar therapeutic function for similar conditions. |
| Regulation Number | 21 CFR 882.5890 | 21 CFR 882.5890 | Identical. Implied acceptance: operates under the same regulatory classification. |
| Product Code | NUH | NUH, NGX | Similar. NUH is shared, indicating the core function. Implied acceptance: fits the same product category. |
| Class | Class II | Class II | Identical. Implied acceptance: same regulatory class. |
| OTC/Rx | OTC | OTC | Identical. Implied acceptance: same intended availability. |
| Power Supply | KTR-201: DC 3V, 30 mA; KTR-202: DC 4.5V, 100 mA; KTR-203: DC 3V, 30mA | 100-240VAC, 50-60Hz, 0.1A | Different. Predicate is mains-powered. Remark states: "Predicate is powered by mains supply but does not affect safety and effectiveness of subject device." Implied acceptance: different power source does not compromise safety/effectiveness. |
| Output Modes | KTR-201: 10; KTR-202: 10; KTR-203: 5 | 25 | Identical. (This remark seems incorrect; the numbers are different for all subject models compared to the predicate's 25. It should likely state "Similar" or "Different but does not affect...") Implied acceptance: sufficient modes for therapy. |
| Output Channels | KTR-201: 1; KTR-202: 1; KTR-203: 2 | 2 | Similar. Remark states: "Does not affect safety and effectiveness of subject device." Implied acceptance: sufficient channels for therapy. |
| Timer Range | 15 mins | 25 mins | Different. Remark states: "Different but does not affect safety and effectiveness of subject device." Implied acceptance: sufficient timer for therapy sessions. |
| Waveform | Pulsed symmetric, biphasic, square wave | Pulse symmetric, biphasic, rectangular with interphase interval | Similar. Implied acceptance: provides therapeutically similar electrical stimulation. |
| Max Output Voltage | 44V@500ohm, 58V@2kohm, 63.5V@10kohm | 44V±10% @500ohm, 80V±10% @2kohm, 112V±10@10kohm | Similar. Implied acceptance: within acceptable therapeutic range. |
| Max Output Current | 88mA@500ohm, 29mA@2kohm, 6.35mA@10kohm | 88mA±10% @500ohm, 40mA±10% @2kohm, 11.2mA±10% @ 10kohm | Similar. Implied acceptance: within acceptable therapeutic range. |
| Net Charge (per pulse) | 0µC @500ohm | 0µC @500ohm | Identical. Important for safety to prevent DC component. Implied acceptance: safe. |
| Max Phase Charge | 11.7µC @500ohm | 12.78μC@500ohm | Similar. Implied acceptance: therapeutically comparable and safe. |
| Max Average Current (500ohm) | 7.4mA | 0.968mA | Different. Remark states: "Although the maximum average current is different, it is <10mA, which complies with the requirements of IEC 60601-2-10, so the difference does not affect safety and effectiveness of the subject device." Implied acceptance: safe and meeting standard. |
| Max Current Density | 0.15mA/cm²@500ohm | 0.235mA/cm²@500ohm | Different. Remark states: "Current density is <2mA/cm² which complies with the requirements of IEC 60601-2-10, so the difference does not affect safety and effectiveness of the subject device." Implied acceptance: safe and meeting standard. |
| Max Power Density | 0.56mW/cm²@500ohm | 1.38mW/cm²@500ohm | Different. Remark states: "Power density is <0.25W/cm² and does not affect safety and effectiveness of the subject device." (Note: The provided predicate value is 1.38mW/cm², which is 0.00138W/cm², significantly less than 0.25W/cm². The remark aligns with this.) Implied acceptance: safe and meeting standard. |
| Pulse Frequency | 1-200Hz | 77.3Hz | Similar. Implied acceptance: provides flexible yet therapeutically relevant frequencies. |
| Pulse Duration | 50-220us | 120us | Similar. Implied acceptance: provides flexible yet therapeutically relevant pulse durations. |
The primary "acceptance criteria" here are substantial equivalence to the predicate device and compliance with recognized IEC standards. The study aims to demonstrate that its electrical characteristics and safety parameters are comparable or fall within accepted safety limits defined by these standards, despite some differences from the predicate.
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical tests only. There is no mention of a clinical test set involving human subjects for performance or efficacy evaluation. The "data provenance" therefore refers to the origin of engineering and safety test results, rather than clinical data.
- Sample Size: Not applicable as no clinical test set is described. The relevant "samples" would be the units of the device models (KTR-201, KTR-202, KTR-203) used for engineering and electrical testing. The exact number of units tested is not specified but is typically a small number for such compliance testing.
- Data Provenance: The tests are non-clinical (engineering, electrical, software, biocompatibility). These tests were conducted by the manufacturer (Shenzhen Kentro Medical Electronics Co., Ltd) or accredited labs. The nationality is implied to be China, where the manufacturer is located. All tests are inherently prospective as they are conducted specifically to support this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. As no clinical test set is described, there is no "ground truth" established by medical experts for performance or efficacy. The "ground truth" in this context would be the specifications and requirements of the relevant IEC standards (e.g., IEC60601-1, IEC60601-2-10) and FDA guidance, against which the device's electrical outputs were measured. Compliance is determined by whether the measured parameters fall within the limits set by these standards.
4. Adjudication Method for the Test Set
Not applicable. Since there's no clinical data or human assessment of primary endpoints, no expert adjudication method (like 2+1, 3+1) is described or needed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is a type of clinical study involving multiple readers (e.g., radiologists) evaluating multiple cases (e.g., medical images) to compare the diagnostic performance of different methods or devices. This is not applicable to a TENS device, which provides direct therapeutic electrical stimulation, not diagnostic information. The submission focuses on substantial equivalence based on technical specifications and safety standards, not comparative clinical effectiveness.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device itself is a standalone therapeutic device; it is not an algorithm that requires human input to interpret its output in the same way an AI-powered diagnostic tool would. Its "standalone performance" is implicitly demonstrated through the non-clinical tests (electrical output, safety, software validation) showing it meets its design specifications and relevant standards. The device is intended for over-the-counter (OTC) use by consumers without professional human-in-the-loop operation, reflecting its standalone nature.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance is:
- Engineering/Performance Specifications: The device's own design specifications for output parameters (voltage, current, frequency, pulse duration, waveform).
- Voluntary Consensus Standards: The requirements and limits defined by international standards such as IEC 60601-1 (general safety), IEC 60601-1-11 (home healthcare environment), IEC 60601-2-10 (nerve and muscle stimulators), and IEC 60601-1-2 (EMC). For biocompatibility, ISO 10993-5 and ISO 10993-10 for the electrode patches.
- Predicate Device Characteristics: The established safety and effectiveness profile of the legally marketed predicate device (K133929), used as a benchmark for substantial equivalence.
There is no pathology or outcomes data from a clinical trial presented as ground truth.
8. The Sample Size for the Training Set
Not applicable. This device is an electrical stimulation device, not an AI/machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is used for this type of device.
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