(90 days)
Quell is intended for use as a transcutaneous electrical nerve stimulation device for temporary relief of pain associated with sore and aching muscles in the lower extremities due to strain from exercise or normal household and work activities.
Quell is intended for use as a transcutaneous electrical nerve stimulation device for the symptomatic relief and management of chronic intractable pain.
The device may be used during sleep. The device is labeled for use only with compatible NeuroMetrix electrodes.
Quell is a single output-mode transcutaneous electrical nerve stimulator for symptomatic relief and management of chronic intractable pain that is sold without a prescription. - The device utilizes a microprocessor running embedded software to control a high-voltage circuit that generates currentregulated stimulating pulses with specific technical characteristics including pulse shape, amplitude, duration, pattern, and frequency. The device is powered by an embedded rechargeable Lithium-Ion battery that is charged through a USB cable connected to an AC adapter.
The device delivers electrical stimulation to the user through a disposable electrode placed on the user's body. The device is labeled for use only with compatible NeuroMetrix electrodes (e.g., K140586). to which it connects through insulated female medical snap connectors embedded within its housing; no lead-wires are used.
The user interface consists of a push button and a linear 6 LED array consisting of 5 white LEDs and 1 amber LED. The LED array indicates stimulation status, battery charging, and error conditions.
A Quell user may initiate therapy, increase stimulation intensity and decrease stimulation intensity through a wireless control mechanism that is collectively referred to as the "virtual button." The virtual button is available through the Quell mobile app and is intended for use in the same environments as the Quell device.
The provided text is a 510(k) premarket notification letter and summary for the Quell device, a Transcutaneous Electrical Nerve Stimulator (TENS). It describes the device, its intended use, and compares it to a predicate device (NeuroMetrix ASCEND).
Based on the document, here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results in the format requested. Instead, it details that Quell was found substantially equivalent to the predicate device, ASCEND (K140333), based on similar indications for use, technological characteristics, and compliance with various standards.
The acceptance criteria implicitly relate to meeting the performance and safety requirements of the predicate device and relevant industry standards.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Similar Indications for Use | Identical indications for use as ASCEND (K140333) for temporary relief of pain associated with sore and aching muscles in lower extremities and symptomatic relief/management of chronic intractable pain. |
| Similar Technological Characteristics (Basic Unit) | One stimulation channel, single output mode, user-controlled intensity, fixed therapy session timer, LED indicators, battery powered. Specific parameters like power source, leakage current, and output modes are within acceptable limits or identical to the predicate. |
| Similar Technological Characteristics (Output Specifications) | Biphasic, rectangular waveform. Maximum output voltage and current are identical to the predicate. Frequency is random with an 80 Hz mean (range 60-100 Hz), identical to the predicate. Net charge is nominally 0 µC. Differences in phase duration, maximum phase charge, maximum current density, maximum average current, and maximum average power density are acknowledged but deemed acceptable as they are within the range of other 510(k) cleared TENS devices and do not raise new safety/effectiveness questions. |
| New Features Do Not Raise New Safety/Effectiveness Questions | Features like On-skin Timer, Auto-restart Timer, Stimulation Lock, Sleep Settings, Sleep Tracking, Virtual Button, and Mobile App are justified as either convenience features or low-risk functions, with validation testing confirming safety and effectiveness where applicable (e.g., Virtual Button, Mobile App). Sleep tracking is explicitly stated as not for diagnosis or treatment of sleep disorders. |
| Compliance with Voluntary Standards | Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62304, IEC 60601-1-11, and 21 CFR 898 (for Electromagnetic Compatibility). |
| Sufficient Performance & Safety Data | Verification, validation, and performance data from non-clinical testing demonstrate substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "NeuroMetrix determined that bench and non-clinical testing were sufficient to demonstrate that Quell is as safe and effective as the predicate ASCEND device."
- Sample Size for Test Set: Not applicable or not specified in terms of human subjects. The testing was primarily non-clinical (bench testing), focusing on electrical, mechanical, and software aspects.
- Data Provenance: The data provenance is from non-clinical verification and validation testing conducted by NeuroMetrix, Inc. The document does not mention any human clinical trials for this 510(k) submission, nor does it refer to country of origin for human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
As the evaluation was based on non-clinical testing and comparison to a predicate device, the concept of "ground truth" established by clinical experts for a test set (e.g., image interpretation) does not directly apply in this context. The "ground truth" here is adherence to engineering specifications, safety standards, and the performance characteristics of the predicate device. The experts involved would be the engineers, quality assurance personnel, and regulatory affairs specialists at NeuroMetrix. Their specific qualifications are not detailed in this document.
4. Adjudication Method for the Test Set
Not applicable, as this was not a clinical study involving subjective interpretation requiring adjudication among experts. The "adjudication" was effectively through the established engineering and regulatory compliance processes of the manufacturer and subsequent FDA review.
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 device is a Transcutaneous Electrical Nerve Stimulator (TENS), not an AI-powered diagnostic imaging tool. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is outside the scope of this device and documentation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a physical TENS unit. While it includes "embedded software" and a "mobile app" with "virtual button" functionality, it is not an algorithm that performs a diagnostic task independently. The "standalone" performance here refers to the device's electrical, mechanical, and software function as a physical unit without a human directly manipulating its physical buttons (though human interaction via the app is an extension of control).
The document notes:
- "Verification testing of Quell included electrical, mechanical and software tests to show that the device meets its target specifications over a range of operating and storage conditions."
- "Validation and performance testing demonstrates that the device meets as reflected in the functional specification."
- The "virtual button functionality was validated in system testing, and in a validation protocol designed to confirm that the virtual button is safe and effective..."
- "Those features of the mobile app that relate to the control and function of the Quell device were validated in system testing."
These statements confirm that the device's functional integrity, including its software and wireless control, was tested comprehensively in what can be considered standalone performance tests in an engineering context.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for this submission is primarily based on:
- Engineering Specifications: The device's electrical, mechanical, and software characteristics meeting predefined targets.
- Regulatory Standards: Compliance with relevant IEC standards (IEC 60601-1, 60601-1-2, 60601-1-6, 62304, 60601-1-11), and 21 CFR 898.
- Predicate Device Equivalence: The performance and safety characteristics being substantially equivalent to the legally marketed predicate device (NeuroMetrix ASCEND K140333).
- Risk Assessment: Demonstration that new features do not introduce new questions of safety or effectiveness.
8. The Sample Size for the Training Set
Not applicable. This document describes a 510(k) submission for a physical medical device, not a machine learning model that requires a distinct training set in the typical sense. The "training" for the device would be its design and manufacturing processes adhering to specifications.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there isn't a "training set" in the context of machine learning. The "ground truth" for the device's design and manufacturing is established by engineering principles, regulatory requirements, and historical data from similar devices (especially the predicate).
§ 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).