(112 days)
The Nerivio is indicated for acute and/or preventive treatment of migraine with or without aura in patients 8 years of age or older. It is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura for acute treatment, or every other day for preventive treatment.
The Neriviolnfinity is indicated for acute and/or preventive treatment of migraine with or without aura in patients 8 years of age or older. It is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura for acute treatment, or every other day for preventive treatment.
The Nerivio and NerivioInfinity are wearable, battery-powered, Remote Electrical Neuromodulation (REN) devices that are controlled by a mobile application. The systems deliver low energy electrical pulses to the upper arm for 45 minutes per treatment, after which the device turns off automatically.
The devices are composed of:
- A pair of UltraStim® electrodes (K130987) covered with hydrogel and removable protective . film. In NerivioInfinity, the electrodes are embedded in a disposable, replaceable pad. In Nerivio, the electrodes are not disposable or replaceable,
- An electronic circuitry that includes microcontroller with firmware, LED indicator, a power button for activating the device, and Bluetooth radio for wireless connection to Android and iOS mobile platforms. The circuitry also includes a battery, which is rechargeable in NerivioInfinity and not rechargeable in Nerivio.
- An armband that is wrapped over the device to secure the device position on the user's arm is also included.
The devices are operated and controlled via mobile application software that is installed and run on the user's personal mobile device, such as a mobile phone or tablet. The device's hardware communicates with the mobile application through Bluetooth protocol. This mobile application software allows the user to control the stimulation intensity from 0 to 100% (representing intensity levels of 0-40mA), to start, pause or stop the stimulation program, and to view device status such as the device's connection state, stimulation, battery level (when connected to NerivioInfinity), remaining number of treatments (when connected to Nerivio), and user notifications.
The user is instructed to adjust the intensity to the strongest stimulation level just below the perceived pain level. Treatments with Nerivio and NerivioInfinity are intended to be self-administered by the user immediately after the onset of migraine headache or aura or every other day for migraine prevention.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:
The core of this submission is to expand the indicated age range of the Nerivio and NerivioInfinity devices to include children aged 8-11. Therefore, the acceptance criteria and study focus on demonstrating the safety and effectiveness of the device in this younger population, showing it is comparable to its performance in the previously cleared adolescent and adult populations.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is an age range expansion for an already cleared device, the "acceptance criteria" are implicitly demonstrating comparable safety and effectiveness in the new age group (8-11 years old) to the previously cleared age group (12 years and older). The performance metrics align with what would be expected for a migraine treatment device.
Implicit Acceptance Criteria (for the 8-11 age group) and Reported Device Performance:
| Acceptance Criteria (Implicit) | Reported Device Performance (6-11 years old*) |
|---|---|
| Safety: No new or increased safety concerns/adverse events. | No adverse events reported through customer service complaints and other product issue reports. |
| Acute Treatment Effectiveness: | |
| Consistent headache relief. | 72.2% of patients with available data (13/18) reported consistent headache relief. (Compared to prior adolescent data from K223169). |
| Consistent freedom from headache. | 36.0% of patients (9/25) reported consistent freedom from headache. (Compared to prior adolescent data from K223169). |
| Consistent functional disability relief. | 83.3% of patients with available data (15/18) reported consistent functional disability relief. (Compared to prior adolescent data from K223169). |
| Consistent functional disability freedom. | 38.9% of patients (7/18) reported consistent functional disability freedom. (Compared to prior adolescent data from K223169). |
| Consistent disappearance of nausea/vomiting. | 70.0% of patients (7/10) achieved consistent freedom from nausea/vomiting. (Compared to prior adolescent data from K223169). |
| Consistent disappearance of phonophobia. | 50.0% of patients (4/8) achieved consistent freedom from phonophobia. (Compared to prior adolescent data from K223169). |
| Consistent disappearance of photophobia. | 22.2% of patients (2/9) achieved consistent freedom from photophobia. (Compared to prior adolescent data from K223169). |
| Preventive Treatment Effectiveness: | Device use patterns over time are similar to effective use in the previously studied adolescent cohort. |
| Usability: Device can be safely and effectively used by the expanded age group. | Human Factors Testing: All critical tasks successfully performed with no use errors or close calls by 100% of child patients and their parents. All knowledge tasks successfully answered by 100% of participant parents. This validated that the devices can be used as intended by the expanded patient population (8-11 years old, with and without assistance of a parent). |
*Note: The study population included patients aged 6-11 years old. The device indication sought and granted in the 510(k) is for 8 years of age or older. The use of data from 6-7 year olds in the study would further support the safety and effectiveness for 8-11 year olds, as younger children might present more challenges in terms of compliance or adverse events.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The clinical investigation included n=293 patients aged 6-11 at their first use of Nerivio (for safety and overall usage patterns in the real world). For effectiveness endpoints (acute treatment), analyses were performed on a subset of patients who completed voluntary pre- and post-treatment surveys, with the number of patients varying for each specific outcome (e.g., 18 for headache relief, 25 for headache freedom, 18 for functional disability, 10 for nausea/vomiting, 8 for phonophobia, 9 for photophobia).
- Data Provenance: The study consisted of a retrospective analysis of prospectively-collected real-world data for children in the United States. The data was collected between May 2020 to October 2023.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study does not involve expert readers establishing ground truth in the traditional sense (e.g., for image interpretation). The "ground truth" for effectiveness is patient-reported outcomes of migraine symptoms, consistent with how efficacy trials for migraine treatments are typically conducted. Safety data is collected via customer service reports, which are also patient-reported or initiated.
4. Adjudication Method for the Test Set
Not applicable in this context. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where multiple expert readers interpret subjective data (like medical images) and their disagreements need to be resolved to establish ground truth. This study relies on patient-reported outcomes for effectiveness and adverse event reporting for safety.
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 standalone therapeutic device for migraine treatment, not an AI-assisted diagnostic tool that would involve human "readers" interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is a device that directly treats a condition; it's not an AI algorithm that provides a diagnosis or analysis. Therefore, a "standalone algorithm performance" evaluation is not relevant in the same way it would be for an AI diagnostic device. The device's performance is its direct therapeutic effect, not its output as an algorithm.
7. The Type of Ground Truth Used
The ground truth for effectiveness was patient-reported outcomes (PROs) on migraine symptoms (headache pain, functional disability, nausea/vomiting, phonophobia, photophobia) via voluntary pre- and post-treatment surveys. For safety, the ground truth was based on reported adverse events through customer service complaints and other product issue reports.
8. The Sample Size for the Training Set
Not applicable. This is not a study validating an AI model that requires a distinct training set. The clinical investigation is a real-world study assessing the device's performance in a new age group. The "knowledge" or "training" for the device itself comes from its prior development and existing clinical data which supported its previous clearances for older populations.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the context of an AI/ML model for this specific submission. The established efficacy and safety data from prior clinical trials in adolescents and adults (e.g., K223169 and K232152) serve as the benchmark against which the performance in the 8-11 age group is compared for equivalence.
§ 882.5899 Trunk and limb electrical stimulator to treat headache.
(a)
Identification. A trunk and limb electrical stimulator to treat headache is a device intended to treat headache through the application of electrical stimulation anywhere on the body of the patient apart from the patient's head or neck through electrodes placed on the skin. The stimulation may be provided transcutaneously or percutaneously.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. This testing must include:
(i) Characterization of the electrical stimulation, including the following: Waveforms; output modes; maximum output voltage and maximum output current (at 500Ω, 2kΩ, and 10kΩ loads); pulse duration; frequency; net charge per pulse; and maximum phase charge, maximum current density, maximum average current, and maximum average power density (at 500Ω);
(ii) Characterization of the impedance monitoring system; and
(iii) Characterization of the electrode performance including the electrical performance, adhesive integrity, shelf-life, reusability, and current distribution of the electrode surface area.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance testing must demonstrate electromagnetic compatibility and electrical, mechanical, and thermal safety in the intended use environment.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Labeling must include the following:
(i) Instructions for use, including the typical sensations experienced during treatment;
(ii) A detailed summary of the electrical stimulation output, and the device technical parameters, including any wireless specifications;
(iii) A shelf life for the electrodes and reuse information; and
(iv) Instructions on care and cleaning of the device.