(225 days)
The Ouell-FM is a transcutaneous electrical nerve stimulation (TENS) device indicated as an aid for reducing the symptoms of fibromyalgia in adults with high pain sensitivity. The Quell-FM may be used during sleep. The Quell-FM is labeled for use only with compatible NeuroMetrix electrodes.
Ouell-FM is a wearable, transcutaneous electrical nerve stimulator designed to stimulate sensory nerves in the upper-calf region. The device utilizes a microprocessor running embedded software and a custom high-voltage Application Specific Integrated Circuit (ASIC) to generate current regulated stimulating pulses with specific characteristics including pulse shape, amplitude, duration, pattern, and frequency. The device utilizes Bluetooth® low energy (BLE) to communicate with a mobile device that allows the user to start and stop therapy, control stimulation intensity, and modify certain operating characteristics. The device is powered by an embedded rechargeable lithium-ion polymer battery that is charged through a USB cable connected to an AC adapter.
The primary components of the device include the Quell-FM device, Band, Electrodes, and Quell-FM mobile app.
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A. Quell-FM Device
The Quell-FM device delivers electrical stimulation to the user through a disposable electrode placed on the user's body. The Quell-FM is labeled for use only with compatible NeuroMetrix electrodes (previously cleared in K140586), to which it connects through insulated female medical snap connectors embedded within its housing; no lead-wires are used. -
B. Band
A flexible band secures the Quell-FM device and the electrode to the user's leg using a hook and loop material. -
C. Electrodes
The Quell-FM device is labeled for use only with compatible NeuroMetrix electrodes (i.e., electrodes cleared under K140586). This use specification, in part, ensures the safe use of the device during sleep because NeuroMetrix electrodes have a known surface area that allows the device to quantitively determine relative skin contact area. Stimulation will be automatically stopped if device detects a decrease in skin-contact area which may lead to unsafe current density to be delivered as would occur during unattended use such as sleeping. -
D. Quell-FM Mobile App
Quell-FM is used with a mobile app, running on an iOS or Android mobile device, to which it communicates via Bluetooth. Using the mobile app, the user can start and stop the therapy, control stimulation intensity, and modify certain operating characteristics.
The provided document describes a clinical study to evaluate the effectiveness and safety of the Quell-FM device, a transcutaneous electrical nerve stimulator for fibromyalgia symptoms. Here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Quell-FM device are primarily demonstrated through its clinical effectiveness in reducing fibromyalgia symptoms and its safety profile. While explicit "acceptance criteria" in a pass/fail table format aren't directly provided for clinical endpoints (as would be typical for an AI/algorithm-based device), the successful grant of the De Novo request implies that the FDA found the following evidence acceptable for product classification. The "reported device performance" reflects the key findings from the clinical study.
| Acceptance Criteria (Implied from De Novo Grant) | Reported Device Performance (Clinical Study Results) |
|---|---|
| Safety: | |
| - Biocompatibility of patient-contacting components. | - Patient-contacting components (device enclosure, band, electrodes) were found to be biocompatible based on evaluations for cytotoxicity, irritation, and sensitization (per ISO 10993-1:2009), referencing prior clearances (K152954 and K140586). |
| - Electrical, thermal, and mechanical safety, and electromagnetic compatibility (EMC). | - Tested according to IEC 60601-1-2:2014, IEC 60601-1:2005+A1;C1:2014, IEC 60601-1-11:2015, and IEC 60601-2-10:2012. Results demonstrated the system meets specifications. |
| - Safe software operation and mitigation of software-related risks. | - Software considered "Moderate" level of concern. All elements of software documentation for this level were provided. Hazard analysis and V&V testing were performed with satisfactory results. |
| - Wireless coexistence testing. | - Wireless coexistence and communication security testing conducted per FDA guidance (August 14, 2013). Results demonstrated the system meets specifications. |
| - Lithium-ion battery safety. | - Tested in accordance with IEC 62133-2:2017. |
| - No serious adverse events; adverse events are minor and resolve with conservative measures. | - No serious adverse events reported. 9 of 12 reported adverse events (rash at site, numbness/tingling, muscle cramping) were definitely or possibly related to TENS use; all were minor and self-limited. Most common was mild rash. |
| Effectiveness: | |
| - Clinically meaningful reduction in fibromyalgia symptoms, particularly in the indicated population (adults with high pain sensitivity). | - Primary Endpoint (PGIC): Not statistically significant in the ITT population (p=0.279). |
- **However, in the higher pain sensitivity subgroup:** Mean PGIC score for active treatment (3.54) was significantly greater than sham (3.14), with a mean difference of 1.25 (95% CI [0.25, 2.24], p=0.015). This difference was considered clinically meaningful.
- Secondary Endpoints (ITT population): Active treatment showed significant improvement over sham in FIQR Total Score (p=0.015), BPI Interference (p=0.031), PDQ (p=0.027), and PDI (p=0.044).
- Secondary Endpoints (Higher Pain Sensitivity Subgroup): Active treatment showed significant improvement over sham in FIQR Total Score (p=0.031), FIQR Pain Item (p=0.003), BPI Severity (p=0.035), and PDQ (p=0.018).
- Responder Analyses: In the higher pain sensitivity subgroup, PGIC responder rate was 28% higher for active (57.8%) vs. sham (30.2%, p=0.025). FIQR responder rate was 30% higher for active (57.5%) vs. sham (28.1%, p=0.019). Pain intensity responder (>30% reduction) was 42% higher for active (59.5%) vs. sham (17.5%, p
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