Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. April 3, 2023 Avation Medical, Inc. Manish Vaishya Chief Technical Officer 1375 Perry Street Columbus, OH 43201 Re: K220454 Trade/Device Name: Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application Regulation Number: 21 CFR§ 876.5310 Regulation Name: Nonimplanted, peripheral electrical continence device Regulatory Class: II Product Code: NAM Dated: March 2, 2023 Received: March 3, 2023 Dear Manish Vaishya: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. 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See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Angel A. Soler-garcia -S for Jessica K. Nguyen, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220454 Device Name Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application ### Indications for Use (Describe) The Vivally® System is a wearable neuromodulation system to treat patients with the bladder conditions of urge urinary incontinence and urinary urgency. 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The company name is written in black, with the word "AVATION" on top and the word "MEDICAL" below it in a smaller font. ## 510 (k) Summary #### Submitter Information 1. | 510 (k) submitter | Avation Medical, Inc. | |-------------------|---------------------------------------------------| | Address | 1375 Perry St, Suite 13-150<br>Columbus, OH 43201 | | Contact Person | Manish Vaishya, PhD | |----------------|--------------------------------| | | Chief Technology Officer Phone | | | 614.591.4201 | | | Email : Manish@Aviation.com | Preparation date March 31, 2023 #### 2. Device Name | Trade Name of the Device | Vivally System Wearable, Non-Invasive Neuromodulation<br>System and Mobile Application | |---------------------------|----------------------------------------------------------------------------------------| | Common Name | Non-implanted peripheral nerve stimulator for incontinence | | Classification Name | Nonimplanted, Peripheral Electrical Continence Device | | Classification Regulation | 21 CFR 876.5310 | | Device Class | II | | Panel | Gastroenterology/Urology | | Product Code | NAM | #### Predicate and Reference Devices 3. | | Predicate | Reference | |-----------------------------|-----------------------------------------|--------------------------------| | 510(k) Number | K192731 | K132561 | | Trade Name of the<br>Device | ZIDA Wearable<br>Neuromodulation System | NURO Neuromodulation<br>System | #### Device Description 4. The Vivally System is a wearable, non-invasive, bladder control therapy with a mobile application to treat patients with the conditions of urge urinary incontinence and urinary urgency, without the need for surgery, implants, drugs, or needle-electrodes. {4}------------------------------------------------ The Vivally System utilizes neuromodulation to deliver electrical signals to the tibial nerve. The tibial nerve is a mixed (motor and sensory) peripheral nerve that feeds into the sacral plexus which contains the nerves that innervate the detrusor muscle surrounding the urinary bladder. The Vivally System also includes an analog input that measures the electromyogram (EMG) signal from the patient's foot via three additional EMG electrodes embedded on the Garment. The system operates in a combination of closed-loop using EMG as the physiological feedback, as well as in open-loop when the feedback signal is unreliable or unreadable. The main components of the Vivally System include a rechargeable-controller (Stimulator) powered by a rechargeable lithium-ion battery, an ankle worn Garment designed to be used on the left or right ankle, Gel Cushions and charging accessories. The Vivally System also includes a mobile application on the patient's personal device and a HIPAAcompliant cloud database. The Vivally Mobile Application allows the patient to start and manage a therapy session and provides access to condition support tools such as an electronic bladder diary to record symptoms, fluid intake and other factors impacting their condition and a record of therapy compliance. The HIPAA-compliant Vivally Cloud Database collects patient therapy statistics, therapy compliance and symptom tracking over time and can be accessed by the patient and physician as a tool to monitor and manage treatment. #### ર. Indications For Use The Vivally® System is a wearable neuromodulation system to treat patients with the bladder conditions of urge urinary incontinence and urinary urgency. | Device & Predicate<br>Device(s): | K220454 | K192731 (Predicate) | K132561(Reference) | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Vivally | ZIDA Wearable<br>Neuromodulation System | Nuro Neuromodulation<br>System | | Indications for Use | The Vivally® System is a<br>wearable neuromodulation<br>system to treat patients with<br>the bladder conditions of<br>urge urinary incontinence<br>and urinary urgency. | ZIDA Wearable<br>Neuromodulation System<br>is a neuromodulation<br>system that is intended to<br>treat patients with an<br>overactive bladder (OAB)<br>and associated symptoms<br>of urinary urgency, urinary<br>frequency, and urge<br>incontinence | The Nuro neuromodulation<br>system (stimulator model<br>Nuro 100) is intended to<br>treat patients with<br>overactive bladder (OAB)<br>and associated symptoms of<br>urinary urgency, urinary<br>frequency, and urge<br>incontinence. | | Prescription or OTC | Prescription | Prescription | Prescription | | Operating Principle | It is a non-invasive<br>wearable bladder control<br>therapy system utilizing<br>neuromodulation to treat<br>patients with bladder<br>conditions of the urge<br>urinary incontinence and<br>urinary urgency by<br>stimulating the tibial nerve. | It is a non-invasive<br>wearable device which<br>provides transcutaneous<br>electrical stimulation of<br>the posterior tibial nerve to<br>treat OAB. | It is designed as a<br>percutaneous tibial nerve<br>stimulation system (PTNS)<br>to deliver retrograde access<br>to the sacral nerve plexus<br>through percutaneous<br>electrical stimulation of the<br>posterior tibial nerve treat<br>overactive bladder (OAB)<br>and associated symptoms. | | | For closed loop operation<br>EMG electrodes are<br>embedded on the Garment | No EMG electrodes are<br>present | No EMG electrodes are<br>present | | Power source | Rechargeable Battery | 1x AAA Battery (non-<br>rechargeable) | Rechargeable Battery | #### Comparison of the Technological Characteristics with primary Predicateand Reference Devices 6. {5}------------------------------------------------ | | 240-mAh, 3.7V Li-Ion | | 130-mAh, 3.7V Li-Ion | |-------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------|---------------------------------------------| | Number of Output<br>Modes | 4 modes: Calibration,<br>therapy, test therapy, and<br>diary | 2 modes: Therapy and<br>testing | 2 modes: Calibration and<br>Therapy | | Therapy schedule | 30 minutes per session, 1x<br>or 3x per week or as<br>prescribed by clinician | 30 minutes per session, 1x<br>per week | 1x per week | | Therapy session<br>duration | 30 minutes | 30 minutes | 30 minutes | | Wireless<br>Technology | Bluetooth | Not present | Not present | | Electrode<br>dimension (each) | 22 X 50 mm<br>Estimated surface area of<br>996 mm² | 20 X 40 mm<br>Estimated surface area of<br>800 mm² | 34 gauge<br>Acupuncture needle<br>electrode | | Stimulation<br>Frequency | 20 Hz | 20 Hz | 20 Hz | | Pulse width | 40 – 600 us | 200 µs, fixed | 200 us | | Current amplitude | 20 mA fixed | 0-156 mA, adjustable | 0 - 9 mA pk-to-pk | | Electrode material | Silver ink coating | 80% nylon 20%<br>silver | Needle: stainless steel | As evidenced by the above table, both the subject and the predicate devices have similar intended use, but the subject and predicate devices have different technological characteristics. However, performance testing was conducted on the subject device, and it was established that the differences in technological characteristics between the subject and the predicate does not raise different questions of safety or effectiveness. ## 7. Non-Clinical Testing Below is a list of the tests that have been performed and successfully completed for the subject device per the below guidance and standards: - Biocompatibility testing according to ISO 10993-1:2018 Biological evaluation of medical O devices - Part 1: Evaluation and testing within a risk management process and FDA Guidance "Use of International Standard ISO 10993-1" (2016). - O Electrical Safety testing according to IEC 60601-1: 2020 - Medical electrical equipment -Basic safety and essential performance - Electromagnetic Compatibility testing according to IEC 60601-1-2: 2020 General O requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests - IEC 60601-2-10:2016 Particular requirements for the basic safety and essential o performance of nerve and muscle stimulators - 0 IEC 60601-1-10 Ed 1.2 :2020 General Requirements for Basic Safety And Essential Performance - Collateral Standard: Requirements For The Development Of Physiologic Closed-Loop Controllers - o IEC 62366-1 Ed 1.1: 2020 Medical devices Part 1:Application of Usability Engineering to Medical Devices - o Software Verification and Validation Testing according to FDA's Guidance for {6}------------------------------------------------ the Content of Premarket Submissions for Software Contained in Medical Devices" Additionally, performance bench data was submitted for device performance and durability of the subject device. This data included: - o Stimulation performance and closed-loop functionality tests. - o Testing for Medical Devices Home Use, including environmental, operating, shock and vibration. - o System and component durability and cycle testing. - o Use case testing for comfort, safety and tolerability. - o Cybersecurity testing All predetermined acceptance criteria were met. #### Clinical Study Summary 8. To confirm the safety, effectiveness of the subject device. Avation Medical conducted a prospective, multi-center study which evaluated the safety and effectiveness of the Vivally System for thirty minutes per session one to three times per week for 12 weeks , and then once every other week in the long-term follow up. After 12 weeks, subjects who met additional inclusion/exclusion criteria, such as completion of the 12 weeks of study with a minimum compliance of 90% for diary entries were able to continue in the long-term follow-up (24 months) portion of the study to assess the sustainability of therapeutic effect provided by the subject device. However, only 12 month follow-up data were submitted to support this 510(k). Nine centers within the United States screened and enrolled subjects that met the inclusion and exclusion criteria. 96 subjects, confirmed to suffer from one or more symptoms of OAB as measured by a baseline 3-day bladder diary, and who met the other inclusion criteria, were enrolled into the study. 88.5% subjects in the study were female. 80.2% study subjects were white and 10.4% were black. Mean age of the subjects was 60.8 years. Objective confirmation of the activation of the subject's tibial nerve (via EMG signal feedback) was achieved, and a personalized therapeutic range was set for each subject by their physician. Therapy sessions were performed by the subject at-home for 30 minutes per session, one to three times per week for 12 weeks, and twice per month during the long-term follow up portion. 96 subjects were enrolled and included in the Intent-to-Treat (ITT) population, 94 were deemed evaluable and 73 were deemed per protocol (PP). 47 subjects continued in the long-term follow-up phase of the study and completed the 6 month follow-up, followed by 39 for 12 months follow-up. Baseline Symptoms - Daily average events per day: {7}------------------------------------------------ | | ITT (N=96) | | PP (N=73) | | |-----------------------------------------|------------------------------------------------|----------------------------------------------------------------------------------------|------------------------------------------------|-------------------------------------------------------------------------------------| | OAB Symptom | Number of Subjects<br>Reporting Symptom<br>(%) | Average Daily of<br>Symptom Events at<br>Baseline<br>(Mean ± SD;<br>Median [Min, Max]) | Number of Subjects<br>Reporting Symptom<br>(%) | Average Daily<br>Symptom Events at<br>Baseline<br>(Mean ± SD;<br>Median [Min, Max]) | | UUI<br>(Urinary Incontinence<br>events) | 76 (79.1%) | 4.82 ± 4.13<br>3.67 [0.33, 16.0] | 58 (79.5%) | 4.92 ± 4.13<br>3.83 [0.33, 15.67] | | Urges<br>(Urinary urgency<br>events) | 74 (77.1%) | 6.94 ± 5.85<br>6.0 [0.33, 28.0] | 54 (74.0%) | 6.99 ± 6.06<br>6.67 [0.33, 28.0] | | Voids (Voiding<br>frequency) | 89 (92.7%) | 13.34 ± 4.13<br>12.0 [8.67, 38.33] | 73 (100%) | 13.28 ± 3.13<br>12.0 [10.0, 28.0] | ### Effectiveness Outcome: Effectiveness results were measured using responder rate, where a responder is a subject with an improvement of 50% or greater over baseline symptoms for UUI and urinary urgency events, and 30% improvement over baseline for voiding events. The responder rates at 12 weeks, 6 months and 12 months are listed in the table below- | Treatment<br>duration | Effectiveness Metric | UUI (Incontinence<br>Events, ≥ 50%<br>improvement) | Urges (Urgency<br>Events, ≥ 50%<br>improvement) | Voiding<br>Frequency<br>(Voiding Events,<br>≥ 30%<br>improvement) | |-----------------------|--------------------------------------------------------------|----------------------------------------------------|-------------------------------------------------|-------------------------------------------------------------------| | 12 Weeks<br>(N = 94) | # with symptoms at baseline (Y) | 76 | 74 | 89 | | | # of responders (X) | 47 | 41 | 31 | | | Responder Rate (X/Y)*100% | 61.8% | 55.4 % | 34.8 % | | | Symptom Event Reduction<br>(Mean ± SD;<br>Median [Min, Max]) | 1.91 ± 3.10<br>1.33 [-8.67, 11.67] | 3.10 ± 3.85<br>2.33 [-3.0, 23.0] | 2.92 ± 2.53<br>3.0 [-3.67, 10.33] | | 6 months<br>(N = 47) | # with symptoms at baseline (Y) | 43 | 36 | 44 | | | # of responders (X) | 27 | 25 | 15 | | | Responder Rate (X/Y)*100% | 62.8 % | 69.4 % | 34.1 % | | | Symptom Event Reduction<br>(Mean ± SD;<br>Median [Min, Max]) | 2.13 ± 3.03<br>1.67 [-9.0, 10.0] | 3.97 ± 5.22<br>2.17 [-4.0, 23.0] | 2.67 ± 2.50<br>2.50 [-4.67, 7.0] | | 12 months<br>(N = 39) | # with symptoms at baseline (Y) | 35 | 29 | 36 | | | # of responders (X) | 22 | 20 | 10 | | | Responder Rate (X/Y)*100% | 62.9 % | 69.0 % | 27.8 % | | | Symptom Event Reduction<br>(Mean ± SD;<br>Median [Min, Max]) | 1.29 ± 3.85<br>1.67 [-10.67, 10.33] | 2.84 ± 4.87<br>1.33 [-5.0, 21.0] | 1.85 ± 2.80<br>2.33 [-6.33, 5.33] | # Responder Rates and Daily Average Symptom Event Reduction Safety Outcome: {8}------------------------------------------------ The sponsor reported a total of 77 adverse events throughout the first 12 weeks of the study among which 61 were mild. The sponsor reported 12 device/procedure related adverse events which were all mild or moderate. No device-or procedure related severe adverse events were reported. The device or procedure related adverse events were foot pain (02), foot contusion (01), frequent urination (03), skin irritation (01), mild thermal burn (01) and urinary incontinence (01). One subject exited the study due to frequent urination. All the other adverse events were resolved either by reducing the stimulation parameters or replacing the device components (e.g., gel cushion replacement resolved the adverse event related to mild thermal burn). In the long-term follow up to 12 months, 12 additional adverse events were recorded, all listed as mild (10) to moderate (2) and only one noted as possibly related to the device. That adverse event was recorded as prominent varicose veins. No treatment was needed for the adverse event. # Quality of Life (QOL): 5 QOL (OAB-q, I-QoL, IIQ-7, PGIC, and OHG) assessments were conducted as part of the clinical study. Outcomes for all QOL domains exceeded the threshold validated for the minimal clinically important difference confirming that the Vivally System has a positive impact on Quality of Life. ### Assessment of Clinical Data: The statistical analysis of the clinical data was not pre-specified and post-hoc in nature. Therefore, all the clinical data presented in this summary are descriptive. The clinical data submitted in this 510(k) demonstrate the subject device provides a clinically meaningful improvement in UUI and urinary urgency symptoms. While the lack of pre-specified statistical analyses increases the uncertainty around the clinical data, considering the favorable safety profile of the device, the non-invasive nature of the treatment, the potential for the device to increase accessibility of the treatment, and the percent of responders for UUI and urinary urgency, the benefits of the device in treating the specific symptoms of UUI and urinary urgency outweigh the risks. #### 9. Conclusions Based on the information presented in this submission, it can be concluded that the subject device is substantially equivalent to the predicate.