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510(k) Data Aggregation
(550 days)
The Avologi Gel Primer is intended to be used with Luminice device to improve skin conductivity.
The Avologi Gel Primer is a clear, viscous and chloride-free formulation. The gel is to be applied to the area under an electrode to reduce the impedance of the contact interface between the electrode surface and the skin.
This document describes the Avologi Gel Primer (Model: Av25), an electroconductive gel intended for use with the Luminice device to improve skin conductivity. The submission demonstrates substantial equivalence to the predicate device, NuFACE Gel Primer (K161654), through performance testing.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Parameter) | Predicate Device (NuFACE Gel Primer - K161654) | Avologi Gel Primer (Av25) Performance | Comparison |
|---|---|---|---|
| Regulation Number | 21CFR 882.1275 | 21CFR 882.1275 | SE (Substantially Equivalent) |
| Regulation Name | Electroconductive Media | Electroconductive Media | SE |
| Regulatory Class | Class II | Class II | SE |
| Product Code | GYB | GYB | SE |
| Regulation Medical Specialty | Neurology | Neurology | SE |
| Intended Use | To be used with NuFACE microcurrent devices to improve skin conductivity. | To be used with Luminice device to improve skin conductivity. | SE |
| Use | Over-the-Counter cosmetic use | Over-the-Counter cosmetic use | SE |
| Environment of use | Home | Home | SE |
| Target population | Adults 18 years of age or older | Adults 18 years of age or older | SE |
| Where used | Topically on intact skin | Topically on intact skin | SE |
| Sterilization | Non-sterile | Non-sterile | SE |
| Color | Colorless | Colorless | SE |
| Appearance | Clear | Clear | SE |
| Odour | Odourless | Odourless | SE |
| Volume | 2 fl.oz. and 5 fl.oz. tube | 3.38 fl.oz. | Note 1 (Difference in packaging, does not affect performance) |
| Weight(g) | Not publicly available | 170 - 200 | Note 1 (Difference in packaging, does not affect performance) |
| Specific gravity | Not publicly available | 0.900 - 1.100 | SE |
| Viscosity(cps) | Not publicly available | 30000-80000 | Note 1 (Difference, does not affect performance) |
| pH | 6.0-7.0 | 5.0-7.0 | Note 1 (Difference, does not affect performance) |
| Biocompatibility | Complies with ISO 10993-5 and ISO 10993-10 | Complies with ISO 10993-5 and ISO 10993-10 (and ISO 10993-23) | SE |
| Chemical Safety | Non-OSHA PEL | Non-OSHA PEL | SE |
| Conductive material | Salt (Magnesium Sulfate) | Salt (Magnesium Sulfate) | SE |
| Impedance | Not publicly available | 154 Ω ± 10% | SE (Note 2 - acceptable based on performance study) |
| Shelf-life | Not publicly available | 3 years | Note 2 (acceptable based on real-time stability testing) |
| Conductivity (mS/cm) | 2-5 | 3.38 | Note 3 (similar to predicate, higher than some cleared devices, which is more conductive) |
| Microbiological growth (Total Aerobic Microbial Count) |
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(153 days)
To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities.
- Neck Pad is used in back of neck.
The subject device is intended to use on back of neck and it designed accord with human body cervical physiological curvature of streamlined ring design. It is a body-worn and home-use device. It uses low-frequency electronic therapy and designed to temporary relief of pain associated with sore and aching muscles in the back of neck. It only has one model: ST-304.
The trade name of the subject device is Transcutaneous electrical nerve stimulator.
The Transcutaneous electrical nerve stimulator (model: ST-304) consists of a main unit and Type C-USB charging cable. The main unit consists of shell, lithium battery (only 1pcs), neck electrodes pads (a pair of fixed neck electrodes pads), lower shell connector and control buttons and silicone pads. There are two fixed neck electrodes pads on the main unit. The material of neck electrodes pads is titanium material (Gr.2). There are only 1 pcs lithium battery in-build in main unit. The model of lithium battery is KRL 103040.
The neck electrodes pads (a pair of fixed neck electrodes pads) are a kind of Titanium material, and the detail content as following description and as the classify of ASTM F67 2017 it is under Gr2.
The Transcutaneous electrical nerve stimulator (model: ST-304) power supply is 3.7V DC using built-in lithium battery(1200mAh). The built-in lithium battery can be recharged. But the power adapter (Input: 100-240V~, 50/60Hz,0.7A, Output: 5V== 1000mA) is not the parts of the subject device so it shall be supplied by the user. There are two fixed neck electrodes pads on the main unit. The material of neck electrodes pads is Titanium material (Gr.2).
The Transcutaneous electrical nerve stimulator (model: ST-304) totally has 3 modes. The stimulation has 2 modes for stimulating and 15 output Intensity Levels for each mode, so the device can give certain electrical pulse through the neck electrodes pads on the intact skin of back neck to help users to temporary relief of pain. The heating only has 1 mode for heating and it can also provide a constant temperature of 32℃ to 38℃ to provide a warming sensation. The stimulation function and heating function can be used separately or simultaneously. The neck electrodes pads provide users with back of neck stimulation and heat to warm and comfort the muscles of the back of neck.
The main unit provides access to adjust the intensity up or down and adjust stimulating mode, put ON/OFF the main unit and heating function.
The Intensity level of electrical stimulation and heating function are easily controlled by the end user using manual, push-button controls. The push-button controls are consisted of four button which are Switch on/off button/mode switch button, heating button, Intensity increase button and Intensity decrease button.
The default stimulation time is 10 minutes, and the user cannot adjust but could turn off the device during working condition.
Transcutaneous electrical nerve stimulator (model: ST-304) has 2 types stimulation modes: Mode 1, Mode 2.
Before use the device to wipe the Electro Therapy Conductive Gel on the Neck Electrode Pads. But the Electro Therapy Conductive Gel is not the part of subject device so it shall be supplied by the user.
Principle of operation:
The Transcutaneous electrical nerve stimulator (model: ST-304) sends low-voltage electrical pulses to specific nerves via two fixed neck electrodes pads applied on the intact skin of back of neck and powered by rechargeable lithium battery. The purpose is to temporarily relieve pain. By adjusting the output voltage and frequency to produce the low-voltage electrical pulses and achieve the effect of electrotherapy. Voltage regulation is realized by the Boost Converter circuit, which controls the voltage amplitude by modifying the PWM control circuit. After that, the voltage is released to the electrode through the analog circuit, and the time change of the output voltage is controlled by modifying the PWM frequency to achieve the specific electrotherapy effect.
The provided text is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study.
Therefore, the document does not contain the information requested regarding:
- Acceptance criteria in the context of a clinical study or specific performance metrics for the device's intended use.
- A study that proves the device meets acceptance criteria. No clinical performance study is described.
- Sample size for test sets or training sets.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth for the training set was established.
Instead, the document details non-clinical testing performed to demonstrate that the device is as safe and effective as its predicate devices, based on compliance with recognized consensus standards.
However, I can extract information related to the device's technical specifications and how they compare to predicate devices, which implicitly serves as the "acceptance criteria" and "device performance" for the substantial equivalence claim.
1. Table of Acceptance Criteria (Implicit for Substantial Equivalence) and Reported Device Performance:
The "acceptance criteria" for this 510(k) submission are implicitly defined by the technical specifications of the predicate devices. The "reported device performance" refers to the subject device's technical specifications. The discussion of differences (D1-D17) explains why these differences do not raise new questions of safety or effectiveness.
| Characteristic | Predicate Device Standard (Implicit Acceptance Criteria) | Subject Device Performance (Transcutaneous Electrical Nerve Stimulator, model ST-304) |
|---|---|---|
| Safety and EMC Standards Compliance | Compliance with ANSI AAMI ES60601-1, ANSI AAMI IEC 60601-1-2, ANSI AAMI HA 60601-1-11, IEC 60601-2-10, IEC 62304. ISO 10993-5, ISO 10993-10, ISO 10993-1. | Compliant. The subject device has demonstrated compliance with all listed safety and EMC standards through testing. (Sections 7, D1, D2, D4, D8, D11, D12, D13, D14, D15, D16, D17) |
| Intended Use & Indications for Use | Temporary relief of pain associated with sore and aching muscles in the back of neck. | Same. "To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities. - Neck electrodes Pads is used in back of neck." (Section 5, Table row "Intended Use & Indications for Use") |
| Power Source - Main Unit | 3.7Vdc, lithium battery (2200mAh for Predicate 1, 500mAh for Predicate 2). | 3.7Vdc, 1200mAh Rechargeable lithium battery. Different capacity (D1). |
| Patient Leakage Current (Normal Condition) | AC: 23.3 µA (Predicate 1), 54.5 µA (Predicate 2); DC: ≤ 1 µA (Predicate 1), 0.5 µA (Predicate 2). | Different, but compliant. Electrical safety demonstrated by passing ANSI AAMI ES60601-1 and IEC 60601-2-10 tests. (D2) |
| Output Intensity Level - Stimulating | Predicate 1: 50; Predicate 2: 50. | 15 levels. (D3) |
| Heating Temperature | Predicate 1: 30-40°C; Predicate 2: NA. | 32-38°C. Within the range of Predicate 1. (D3, D4) |
| Timer Range | 5-30 minutes. | 10 minutes. Covered by the range of predicate devices. (D5) |
| Maximum Output Voltage | Mode 1: 44V @ 500 Ω, 80V @ 2 kΩ, 112V @ 10 kΩ. Mode 2 (Predicate equivalent): Similar to Mode 1. | Mode 1: 44V @ 500 Ω, 80V @ 2 kΩ, 112V @ 10 kΩ. Mode 2: 42V @ 500 Ω, 78V @ 2 kΩ, 105V @ 10 kΩ. Small difference for Mode 2 but deemed safe and effective. (D9) |
| Maximum Output Current | Mode 1: 88mA @ 500 Ω, 40mA @ 2 kΩ, 11.2mA @ 10 kΩ. Mode 2 (Predicate equivalent): Similar to Mode 1. | Mode 1: 88mA @ 500 Ω, 40mA @ 2 kΩ, 11.2mA @ 10 KΩ. Mode 2: 84mA @ 500 Ω, 39mA @ 2 KΩ, 10.5mA @ 10 KΩ. Small difference for Mode 2 but deemed safe and effective. (D10) |
| Maximum Phase Charge (μC) | Predicate 1: 10.56 µC @ 500Ω; Predicate 2: 12.78 µC @ 500Ω. | Mode 1: 10.3µC @ 500Ω. Mode 2: 9.6µC @ 500Ω. Small differences acceptable and deemed safe and effective. (D11) |
| Maximum Current Density (mA/cm² r.m.s.) @ 500Ω | Predicate 1: 0.0326 mA/cm²; Predicate 2: 0.235 mA/cm². | Mode 1: 2.2mA/cm². Mode 2: 2.2mA/cm². Difference noted but deemed safe and effective. (D12) |
| Maximum Average Power Density (mW/cm²) @ 500Ω | Predicate 1: 0.0000266mW/cm²; Predicate 2: 1.38 mW/cm². | Mode 1: 0.36mW/cm². Mode 2: 0.32mW/cm². Difference noted (between predicates) but less than 0.25 Watts/cm² and deemed safe and effective. (D13) |
Since this is a 510(k) submission, the device's acceptance is based on demonstrating "substantial equivalence" to predicate devices, primarily through non-clinical testing and comparison of technical characteristics, not through clinical trials demonstrating specific performance criteria against a disease outcome.
Summary of Missing Information (as per your request, not present in the document):
- Sample size for the test set and the data provenance: Not applicable, as no clinical test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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 not an AI/imaging diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical ground truth is established for efficacy.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical testing for electrical safety, EMC, biocompatibility, and software verification, as listed in Section 7. This testing demonstrates that despite minor technical differences, the device is as safe and effective as the predicate devices for its intended use.
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