(598 days)
Pro-Sport™ is indicated for:
- . symptomatic relief and management of chronic, intractable pain
- adjunctive treatment in the management of post-surgical and post-traumatic pain .
The candidate Pro-Sport Avazzia device is a micro-current transcutaneous electro-stimulation device. It is an easy-to-use, handheld, AA battery-operated portable device for use in the home or clinic.
The device is a portable, battery operated microcurrent electrical stimulation device that applies charge and power to the tissue through electrodes where maximum power delivered to the load is controlled and limited, and an automatic shut off is implemented.
The user can passively place the electrodes where indicated and apply stimulation for a period of time.
The user controls the output by selecting the preset mode and power setting. The device's controls and visual indicators are located on the upper side of the case and on the upper cover.
The Pro-Sport™ device incorporates a more sophisticated digital liquid crystal display user interface to help the user select the mode and see parameters like the power level, time, and other information and has one mode that allows practitioners to set up their own therapy signals.
The provided document is a 510(k) summary for the Avazzia Pro-Sport™ device, which is a microcurrent transcutaneous electro-stimulation device. The purpose of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics, and does not raise new questions of safety or effectiveness.
This submission focuses on comparing the new device, Avazzia Pro-Sport™, to its predicate devices (Body-Stim™, Biomodulator™, Best-RSI™, Best-Pro 1™, Model BEST -- AV1™, K062641). The acceptance criteria for such a device are primarily based on demonstrating substantial equivalence to the predicate, rather than meeting specific performance metrics from a clinical study for a novel device.
Here's an analysis based on the provided text, addressing your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for K123099 are essentially the characteristics of the predicate device, as the goal is to show substantial equivalence. The document doesn't provide specific quantitative performance metrics like sensitivity/specificity for a diagnostic device, but rather technical specifications and shared indications for use.
| Parameter | Acceptance Criteria (Predicate) | Reported Device Performance (Avazzia Pro-Sport™) | Conclusion (Meets/Does Not Meet) |
|---|---|---|---|
| Labeling Claims/Indication | TENS: symptomatic relief & management of chronic, intractable pain; adjunctive treatment in post-surgical & post-traumatic pain | TENS: symptomatic relief & management of chronic, intractable pain; adjunctive treatment in post-surgical & post-traumatic pain | Meets |
| Device Name/Model | Best-Pro 1, Best-RSI, Biomodulator, Body-Stim | Avazzia Pro Sport™ | Not applicable (new model name) |
| Manufacturer | Avazzia, Inc. | Avazzia, Inc. | Meets |
| Power Source | 2 - 1.5 V AA batteries | 2 - 1.5 V AA batteries | Meets |
| Number of Output Modes | 4 preset modes | 24 (including 14 preset and AVA user programmable) | Exceeds (Enhanced feature) |
| Low Battery Indication | Yes | Yes | Meets |
| Timer Range | 60 minutes | 60 minutes | Meets |
| Compliance with Voluntary Standards | Yes | Yes (IEC 60601-1, IEC 60601-1-2) | Meets |
| Compliance with 21 CFR 898 | Yes | Yes | Meets |
| Weight | 7oz | 7oz | Meets |
| Dimensions | 2.6" X 1.35" X 4.7" | 2.6" X 1.35" X 4.7" | Meets |
| Housing Materials | Handheld ABS plastic housing with Polypac plastic nameplate and onboard electrodes | Handheld ABS plastic housing with Polypac plastic nameplate and onboard electrodes | Meets |
| User Interface Display | LEDs | LCD (digital display) | Differs (Enhanced feature) |
| Design Material | PCBs inside plastic case housing | PCBs inside plastic case housing | Meets |
| Energy Type | Electro-stimulation | Electro-stimulation | Meets |
| Pulse Duration | 0.1 - 1.15 mS | 0.1 - 1.15 mS | Meets |
| Pulse Frequency | 0.5 to 2500 Hz | 0.5 to 2500 Hz | Meets |
| Output Voltage | 20 - 650 V | 20 - 650 V | Meets |
| Current Amplitude TENS | 0 - 90mA | 0 - 90mA | Meets |
| Timeout | 60 minutes | 60 minutes | Meets |
| Waveform | Pulsed, damped, asymmetric biphasic sinusoidal | Pulsed, damped, asymmetric biphasic sinusoidal | Meets |
The "study" that proves the device meets the acceptance criteria is primarily the comparison to the predicate device and verification and validation tests (e.g., safety and EMC compliance), as stated in the "Conclusions" section: "Verification and validation tests as well as certificates and test reports contained in this submission demonstrate that the submitted models are substantially equivalent to the safety and effectiveness as that of the cleared devices." The document explicitly states that the new device has the same technological characteristics as the predicate for all listed electrical parameters. The differences are in the user interface (LCD vs. LED, more modes, user-programmable mode), which the submission argues "do not pose new questions regarding safety and effectiveness."
2. Sample size used for the test set and the data provenance
This document does not describe a clinical study with a "test set" of patients or data in the way one might for a diagnostic or therapeutic AI device. The "test set" here refers to the device itself and its components undergoing engineering and electrical safety testing. The submission confirms "Verification and validation tests" were performed, but does not provide details on the sample size for these tests (e.g., how many devices were tested, how many cycles of operation).
The data provenance is internal testing performed by Avazzia, Inc. There is no mention of external data or country of origin for such data. This appears to be a prospective set of engineering tests conducted on the new device model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study requiring expert clinical ground truth. The "ground truth" for electrical and mechanical specifications is established by engineering standards and functional requirements.
4. Adjudication method for the test set
Not applicable. No expert adjudication process is described as this is an engineering compliance summary, not a clinical study.
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 not an AI or imaging device, and no MRMC study involving human readers is mentioned or relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system. It is a physical electro-stimulation device. Its performance is evaluated based on its electrical output characteristics and user interface functionality, not algorithmic performance.
7. The type of ground truth used
The ground truth used for this submission is:
- Predicate Device Specifications: The established, cleared specifications and performance of the previous (predicate) TENS devices.
- Voluntary Standards: International Electro-technical Commission (IEC) standards for medical electrical equipment (IEC 60601-1 for safety and IEC 60601-1-2 for EMC).
- Regulatory Requirements: 21 CFR 898 for device compliance.
- Engineering Specifications: Internal design requirements for the device's electrical output (pulse duration, frequency, voltage, current, waveform) and physical characteristics (weight, dimensions, materials).
8. The sample size for the training set
Not applicable. There is no machine learning or AI component to this device, therefore no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).