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510(k) Data Aggregation
(269 days)
Transcutaneous Electronic Nerve Stimulator is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
Transcutaneous Electronic Nerve Stimulator (Models: KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2491, KTR-2492, KTR-2493, KTR-2494) is a portable and battery powered multifunctional device, offering Transcutaneous Electronic Nerve Stimulator. They can give certain electrical pulse through electrode pads placed on the skin to help users to enjoy body stimulation.
For models: KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2301, KTR-2302, KTR-2342 have 3 operation modes:
For models: KTR-2491, KTR-2493, KTR-2493, KTR-2494 have 15 operation modes, 9 manual mode, and 6 automatic mode. They can be remotely controlled with an accessory remote control. And there is a LCD displays on remote control, which display mode and treatment time.
The electronic stimulator module has unified the operating elements of ON/OFF button. Intensity adjust button and Mode selection button.
The device is equipped with accessories of electrode pads, batteries and remote control (For KTR-249X series).
The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.
The provided text describes a 510(k) premarket notification for a Transcutaneous Electronic Nerve Stimulator (TENS) and does not contain information about acceptance criteria and a study proving the device meets those criteria, as typically understood in the context of diagnostic or prognostic AI/ML medical devices.
Instead, this document is a regulatory submission demonstrating substantial equivalence to previously cleared predicate devices. The "Test Summary" and "Comparison to predicate device" sections outline engineering tests and comparisons of technical specifications, rather than clinical performance studies against specific acceptance criteria for diagnostic accuracy.
Therefore, an output table as requested cannot be fully populated. However, I can extract the relevant information regarding the tests performed to support the "substantial equivalence" claim.
Here's a breakdown of what is available:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission for a TENS device, the "acceptance criteria" are related to industrial standards and engineering specifications rather than diagnostic performance metrics (e.g., sensitivity, specificity, AUC) typically seen with AI/ML devices. The reported "performance" is compliance with these standards and comparison of technical specifications to predicate devices.
| Acceptance Criterion (Standard/Parameter) | Reported Device Performance (Compliance/Value) |
|---|---|
| Electrical safety | Complies with IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10 |
| Electromagnetic compatibility (EMC) | Complies with IEC 60601-1-2 |
| Biocompatibility | Complies with ISO 10993-1, ISO 10993-5, ISO 10993-10 (for electrode pads) |
| Usability | Complies with IEC 62366-1 |
| Software verification and validation | Complies with FDA "Guidance for Pre-Market Submissions and for Software Contained in Medical Devices" |
| Waveform output specifications | Verified by waveform test report according to FDA guidance for TENS and Powered Muscle Stimulator |
| Patient Leakage Current (NC DC) | 0.5µA (Matches predicate) |
| Patient Leakage Current (SFC DC) | 0.6μΑ (Matches predicate) |
| Average DC current through electrodes (device on, no pulses) | < 0.01μΑ (Matches predicate) |
| Number of Output Channels | 1 channel (Matches primary predicate) |
| Number of Output Modes | 3-15 modes (Compared to 3-5 modes for predicates) |
| Output Intensity Level | 16 steps (Compared to 5, 15, 16 steps for predicates) |
| Synchronous or Alternating | Synchronous (Matches predicates where known) |
| Regulated Current or Voltage | Voltage Control (Matches predicates where known) |
| Software/Firmware/Microprocessor Control | Yes (Matches predicates) |
| Automatic Overload Trip | No (Matches predicates where known) |
| Automatic No-Load Trip | No (Matches predicates where known) |
| Automatic Shut Off | Yes (Matches predicates where known) |
| User Override Control | Yes (Matches predicates where known) |
| On/Off Status Indicator | Yes (Matches predicates where known) |
| Low Battery Indicator | No (Matches predicates where known) |
| Display Voltage/Current Level | Yes (Matches predicates where known) |
| Timer Range | 15 min (Compared to 10, 20, 25, 40 min range for predicates) |
| Maximum Output Voltage (@500Ω, 2KΩ, 10KΩ) | 43.6V±10% @ 500Ω, 59V±10% @ 2KΩ, 66.5V±10% @ 10KΩ (Compared to similar ranges for predicates. Note 2 states similar maximum peak voltage) |
| Maximum Output Current (@500Ω, 2KΩ, 10KΩ) | 87.2mA±10% @ 500Ω, 29.5mA±10% @ 2KΩ, 6.65mA±10% @ 10KΩ (Compared to similar ranges for predicates. Note 2 states similar maximum peak voltage) |
| Pulse Duration | 120µs (Compared to 65-224µs range for predicates) |
| Pulse Frequency | 20-100Hz (Compared to 1-110Hz range for predicates) |
| Net Charge (per pulse) | 0µC @ 500Ω, Balanced waveform (Matches predicates where known) |
| Maximum Phase Charge | 12.66µC @ 500Ω (Compared to 7.67-33.07µC range for predicates) |
| Maximum Current Density (mA/cm², r.m.s.) (@500Ω) | 0.058 mA/cm² (Compared to 0.154-0.437 mA/cm² for predicates) |
| Maximum Average Power Density (@500Ω) | 0.037 mW/cm² (Compared to 0.0008-1.2 mW/cm² for predicates) |
| Operating Environment | Temperature: +5°C-+40°C, Humidity: 0%-80%RH, Atmospheric pressure: 860hPa-1060hPa (Matches predicates where known) |
| Storage Environment | Temperature: 0°C-+55°C, Humidity: 0-93%RH, Atmospheric pressure: 500hPa-1060hPa (Matches predicates where known) |
| Housing Materials and Construction | Main unit: ABS plastic (Matches predicates) |
| Waveform | Pulsed, symmetric, biphasic (Differs from one predicate, but matches others) |
| Shape | Rectangular, with interphase interval (Differs from one predicate, but matches others) |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical "test set" and therefore does not specify a sample size or data provenance in the context of clinical performance evaluation (e.g., diagnostic accuracy). The testing described is primarily engineering bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in the context of expert consensus for AI/ML performance is not discussed for this device. The evaluations were based on compliance with engineering standards.
4. Adjudication method for the test set
Not applicable. There was no clinical "test set" requiring adjudication.
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 is a TENS device, not an AI/ML diagnostic or prognostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a TENS device, not an AI/ML algorithm. Its performance is inherent in its electrical output and user interface, which are assessed through engineering and usability tests.
7. The type of ground truth used
For the engineering tests (electrical safety, EMC, biocompatibility, usability, software verification, waveform output), the "ground truth" is defined by the requirements and specifications within the referenced international standards (IEC 60601 series, ISO 10993 series, IEC 62366-1) and FDA guidance documents. Compliance is assessed against these established technical benchmarks.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
Summary of the study that proves the device meets the acceptance criteria (based on available information):
The device's safety and performance were evaluated through a series of lab bench tests to demonstrate compliance with recognized international standards and FDA guidance for TENS devices. These tests included:
- Electrical safety tests: Performed according to IEC 60601-1, IEC 60601-1-11, and IEC 60601-2-10 standards.
- Electromagnetic compatibility (EMC) tests: Performed according to IEC 60601-1-2 standard.
- Biocompatibility tests: Performed according to ISO 10993-1, ISO 10993-5, and ISO 10993-10 standards for the electrode pads.
- Usability tests: Performed according to IEC 62366-1 standard.
- Software verification and validation tests: Performed according to FDA "Guidance for Pre-Market Submissions and for Software Contained in Medical Devices."
- Waveform test report: Conducted to verify the output specifications of the device according to relevant FDA guidance documents for TENS and Powered Muscle Stimulators.
The document asserts that these tests, along with a detailed comparison of technological characteristics, features, specifications, materials, mode of operation, and intended use against three legally marketed predicate devices, demonstrate that the subject device is Substantially Equivalent (SE) to the primary predicate device. The differences noted (e.g., in number of output modes, maximum output voltage/current, pulse duration, pulse frequency) were concluded not to raise new issues of safety or effectiveness, as they either fell within acceptable ranges or aligned with existing requirements.
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