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510(k) Data Aggregation
(90 days)
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Transcutaneous Electrical Nerve Stimulator is a portable and DC 3.7V battery powered multifunction device that adopts modern electronic science and technology to delivers electric pulses generated to the electrodes. It has two functions: Transcutaneous electrical nerve stimulation(TENS) and Electrical muscle stimulation (EMS).
The device has 20 operation programs. It includes operating elements of Power ON/OFF button, intensity decrease button, Menu selection button, and A/B channel selection button.
The display screen can show battery power, program, mode, keylock status, intensity level, treatment time and output channel. The device is equipped with accessories of electrode cables, and one Type-C cable. The electrode cables are used to connect the pads to the device; the Type-C cable is used to connect the charger and the built-in lithium battery.
In additional, according to different simulation-needed bodies, users can choose the three types of electrode pad based on their own situation. The electrode pads are manufactured by ShenZhen Technology Co., Ltd with 510(k) cleared Number K171381.
The provided document is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device. This type of filing does not contain detailed clinical study data or acceptance criteria in the format typically used for AI/ML device evaluations. Instead, it demonstrates substantial equivalence to predicate devices primarily through non-clinical performance and a comparison of technical specifications.
Therefore, I cannot extract information related to acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these are not typically included or required in a non-clinical 510(k) submission for a TENS device.
However, I can extract the available information regarding the device's technical specifications and how its performance is compared to predicate devices, focusing on the "Substantial Equivalence Comparison" tables.
Here's a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define "acceptance criteria" for clinical performance. Instead, it compares the subject device's technical specifications to those of predicate devices to establish substantial equivalence. The "reported device performance" refers to the subject device's specifications and its compliance with relevant international standards.
Here's a table summarizing key technical specifications and their comparison to predicate devices, drawing from the "Substantial Equivalence Comparison" tables. "Acceptance Criteria" here are implicitly defined by the ranges and characteristics observed in the predicate devices and compliance with relevant standards.
| Element of Comparison | Acceptance Criteria (Implied by Predicate Range/Compliance) | Reported Device Performance (Subject Device K6106) | Comparison Result |
|---|---|---|---|
| General | |||
| Product Code | NUH, NGX, NYN, GZJ, IPF, IRT (covered by predicates) | NUH, NGX | Same (within the scope of predicate product codes) |
| Regulation Number | 21 CFR 882.5890, 21 CFR 890.5850 | 21 CFR 882.5890, 21 CFR 890.5850 | Same |
| Prescription/OTC | OTC | OTC | Same |
| Intended Use | Temporary relief of pain (TENS); Muscle performance improvement (EMS) covering specific body parts | Identical to primary predicate for TENS and EMS indications | Same |
| Power Supply | Internal/rechargeable batteries (e.g., 3x1.5V AAA, 3.7V lithium) | Internal battery: 3.7Vd.c. 300mAh | Same (within typical battery specifications for such devices) |
| Method of Line Current Isolation | Type BF/Battery supply/Voltage transformer isolation | Type BF | Same (Type BF is a recognized isolation type) |
| Patient Leakage Current | <10 µA (Normal), <50 µA (Single Fault) (Based on predicate/standard limits) | <1 µA (Normal), <1 µA (Single Fault) | Same (Meets or exceeds predicate/standard safety levels) |
| Number of Output Modes | 1 to 50 modes (Across predicate devices) | TENS: 10, EMS: 10 (Total 20) | Similar (Subject device's 20 modes are within the range observed in predicates, and comply with IEC 60601-2-10 and AAMI/ANSI ES60601-1, per Note 2) |
| Number of Output Channels | 1, 2, or 4 channels | 4 | Same (within predicate range) |
| Software/Firmware/Microprocessor Control | Yes (Standard for these devices) | Software | Same |
| Automatic Shut-off | Yes | Yes | Same |
| Timer Range | 10-540 minutes (Across predicates) | 10-60 minutes | Similar (Subject device's range is included within predicate's ranges and is user-adjustable based on need, per Note 1) |
| Compliance with Voluntary Standards | IEC 60601-1, -1-2, -1-11, -2-10, ISO 10993, AAMI/ANSI ES60601-1 (Covered by predicates) | IEC 60601-1, -1-2, -1-11, -2-10 | Same (Subject device complies with relevant safety and performance standards for TENS/EMS devices) |
| Electrical Output Parameters | |||
| Waveform | Biphasic/Square/Symmetrical biphasic/Pulsed, symmetric, biphasic | Biphasic | Same (Falls within the common waveforms of predicate devices, per Note 3) |
| Maximum Output Voltage at 500 Ω | 50-68V (Observed in predicates) | 68V | Similar (Within predicate ranges and complies with standards, per Note 3) |
| Maximum Output Current at 500 Ω | 104-200mA (Observed in predicates) | 136mA | Similar (Within predicate ranges and complies with standards, per Note 3) |
| Frequency (Hz) | 1-500 Hz (Observed in predicates) | 2-80 Hz | Similar (Within predicate ranges and complies with standards, per Note 4) |
| Pulse Duration (μs) | 50-500µS (Observed in predicates) | 120-400μS | Similar (Within predicate ranges and complies with standards, per Note 4) |
| Maximum Phase Charge at 500 Ω | 17-78 μC (Observed in predicates) | 65.82 μC | Similar (Within predicate ranges and complies with standards, per Note 5) |
| Maximum Current Density at 500 Ω | 0.08-1.86 mA/cm² (Observed in predicates) | 1.001 mA/cm² | Similar (Within predicate ranges and complies with standards, per Note 5) |
| Max. Average Current at 500 Ω | 1.88-24.33 mA (Observed in predicates) | 24.33 mA | Similar (Within predicate ranges and complies with standards, per Note 5) |
| Maximum Average Power Density W/cm² at 500 Ω | Max < 0.25 W/cm² (per FDA guidance) | 0.0122 W/cm² | Similar (Meets the FDA guidance requirement and falls within predicate ranges, per Note 5) |
| Average DC current through electrodes when device is on but no pulses are being applied (µA) | 0 or < 0.01μA (Observed in predicates) | 0 | Same |
Regarding the study that proves the device meets (these implicit) acceptance criteria:
The document relies on non-clinical performance testing to demonstrate that the subject device (K6106) meets the safety and effectiveness requirements, primarily by showing compliance with recognized international standards and substantial equivalence to legally marketed predicate devices.
The studies referenced are:
- Compliance with International Standards for Medical Electrical Equipment:
- IEC 60601-1:2005+A1:2012+A2:2020 (General Requirements for Safety)
- IEC 60601-2-10:2012+A1:2016 (Particular requirements for nerve and muscle stimulators)
- IEC 60601-1-2:2014+A1:2020 (Electromagnetic compatibility)
- IEC 60601-1-11:2015 (Requirements for medical electrical systems used in the home healthcare environment)
- Software Validation: FDA software validation guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on: January 11, 2002". (Though no specific study details are provided, compliance with this guidance is stated).
- Guidance for Product-Specific Requirements: "Guidance Document for Powered Muscle Stimulator 510(k)s Document issued on: June 9, 1999."
The general conclusion is that "The electrical safety, EMC, biocompatibility, software verification, and output specifications information provided is sufficient to demonstrate substantial equivalence to the Transcutaneous Electrical Nerve Stimulator, model: K6106 is nearly identical to the predicate devices, differences in their characteristics do not raise new questions regarding safety and effectiveness with identical indications for use and essentially identical technological characteristics..." (Page 7).
Non-Applicable Sections for this document type:
- Sample sized used for the test set and the data provenance: Not applicable. This is a non-clinical submission. No clinical test set data is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert ground truth is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication is described.
- 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 a TENS/EMS device, not an AI/ML diagnostic or image analysis device that would typically involve human readers or AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a non-clinical TENS/EMS device submission. Ground truth for safety and performance is based on compliance with electrical, mechanical, and biological standards.
- The sample size for the training set: Not applicable. This device does not use a "training set" in the context of AI/ML.
- How the ground truth for the training set was established: Not applicable.
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