Vivio System

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October 4, 2019 Avicena, LLC % James West Principal Consultant West Device Innovations, LLC 23412 West 46th Street Shawnee, Kansas 66226 Re: K183710 Trade/Device Name: Vivio System Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: August 22, 2019 Received: August 27, 2019 Dear James West: 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). 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Sincerely, for Stephen Browning Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K183710 Device Name Vivio System Indications for Use (Describe) The Vivio System is indicated for low frequency (<200 Hz) or Bell Mode operation to acquire and transmit heart sound data to the tablet/UI (with Avicena App) for calculation of heart rate and display and playback of heart sounds (audio and visual). | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | <div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <input type="checkbox"/> Over The Counter Use (21 CFR 801 Subpart </div> | |X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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There are dots around the outside of the heart and some squiggly lines inside the oval. # Traditional 510(k) Summary for K183710 | Summary Date: | 02 Oct. 2019 | |----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applicant Name: | Avicena, LLC, 117 East Colorado Blvd. Suite 510 Pasadena CA<br>91105, Ph: 626.344.9665, Email: info@avicenaheart.com<br>Establishment Registration Number: FDA Registration is pending. | | Submission<br>Correspondent: | On behalf of Avicena LLC., the following consultant is assigned the<br>responsibility of submission correspondence:<br>Jim West, Principal Consultant at West Device Innovations, LLC<br>23412 West 46'th Street, Shawnee, KS 66226, Ph: 913.991.6288,<br>Email: jwest@westdeviceinnovations.com | | Trade Name: | Vivio System | | Common Name: | Digital Electronic Stethoscope | | Description: | The Vivio Unit is an electronic stethoscope containing a membrane,<br>placed on the skin over the carotid artery, that is displaced due to<br>vibrations produced by the arterial pulse waveform and heart<br>sounds associated with the aortic valve opening and closing. An<br>infrared light photo reflector transmits and detects light to/from the<br>membrane and outputs a current relative to the detected light (or<br>membrane movement). Sensor electronics inside the Vivio Unit<br>generate a current to operate the sensor, read the current produced<br>by the sensor and output a voltage relative to the current. Filter<br>electronics condition the sensor signal, process the data and<br>communicate the data to the tablet with the Avicena App. The Vivio<br>Unit is powered by an internal, rechargeable battery. | | Classification<br>Regulation, Class &<br>Product Code & Panel: | 21 CFR 870.1875(b)<br>Class II<br>Product Code: DQD<br>Panel: Cardiovascular | | Avicena | | K183710 | |----------------------------------|--|----------| | Vivio Device - 510(k) Submission | | Page 1/5 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "AVICENA" in all capital letters next to a logo. The logo is a drawing of a cell with some dots and lines inside and outside of it. The word "AVICENA" is in a simple, sans-serif font. ## Intended Use of Device | Product Requirements Document - Avicena Vivio Device | | |------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use: | The Vivio System is indicated for low frequency (<200 Hz) or Bell<br>Mode operation to acquire and transmit heart sound data to the<br>tablet/UI (with Avicena App) for calculation of heart rate and display<br>and playback of heart sounds (audio and visual). | | Intended Use: | The Vivio System is intended to be used as part of a physical<br>assessment of a patient by healthcare professionals for diagnostic<br>decision support. It may be used for the detection and amplification<br>of sounds from the heart and arteries with the use of selective<br>frequencies. It can be used on any person undergoing a physical<br>assessment. | | Intended User: | The Vivio System is intended to be used by Healthcare Providers. | | Intended Use<br>Environment: | The Vivio System is intended to be used in a clinical setting such as<br>a hospital, physician's office, or other patient care facility. | | Targeted Patient<br>Population: | It can be used on any person undergoing a physical assessment.. | | Contraindications: | Subjects with a hypersensitive response to even slight pressure<br>over the carotid pulse may faint when the carotid is palpated<br>(carotid sinus hypersensitivity). For this reason, the following are<br>contraindications for the use of the Vivio System:<br>• Patients with a history of carotid sinus hypersensitivity<br>(fainting in response to touching or positioning the neck)<br>• Patients with a known history of carotid artery stenosis<br>• Open skin lesions at the site of examination | | Predicate Device(s): | 510(k) Number: K083903<br>Manufacturer: 3M Company<br>Trade Name: 3M Littmann Electronic Stethoscope, Model 3200<br>Product Code: DQD<br>Classification: 870.1875 | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Reference Device(s): | 510(K) Number: K122129<br>Manufacturer: AtCor Medical | | Avicena | | | |----------------------------------|--|---------------------| | Vivio Device - 510(k) Submission | | K183710<br>Page 2/5 | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a logo with the word "AVICENA" in bold, sans-serif font. To the left of the word is a stylized graphic that resembles a cell or seed with an outer shell and inner components. The graphic is outlined in black and has a hand-drawn quality, with small dots and lines adding texture and detail. | Trade Name: SphygmoCor XCEL<br>Product Code: DSK: DXN<br>Classification: Computer, Blood-Pressure; System, Measurement,<br>Blood-Pressure, Non-Invasive | |---------------------------------------------------------------------------------------------------------------------------------------------------------| | | ## Comparison to Predicate The Vivio System combines the following features into one product that consists of a physical stethoscope for collection of heart sounds, and software in the form of an app on a tablet to record, playback and visualize the sounds recorded. The Vivio System, Model 1.0 under review and the predicate have similar indications for use. The devices are substantially equivalent. Table 1 below is a summary of the differences between the devices and a commentary regarding the reasons the differences do not introduce additional safety or efficacy concerns. The proposed device and the predicate device have the same/equivalent intended use, intended user, intended use environment and targeted patient population. The device under consideration uses for a predicate device, the 3M Littmann Model 3200 Electronic Stethoscope (cleared under 510(k) K083903) used in conjunction with the Zargis StethAssist phonocardiogram software. Additionally a reference device is included, the AtCor Medical SphygmoCor XCEL (cleared under 510(k) K122129). It should be noted that phonocardiograms are 510(k) exempt devices per 870.2390. Essentially, the use of the Littmann Model 3200 with StethAssist software is related to heart sounds, heart sound waveforms, and heart rate visualization, and SphygmoCor for arterial pulse waveform visualization which can be used by the clinician as an assessment to indicate adequate system application/placement and is not presented for clinical interpretation. The Vivio product differs from the predicate in the areas of: - signal export capability ● - replaceable diaphragm ● - latex indication label - category AP Equipment classification labeling - sharp edges caution statement - electric warning labeling ● - visualization of the arterial pulse waveform for assessing adequate device placement ● While the differences listed affect the design and form of the product they do not introduce any safety, performance or efficacy concerns. | Avicena | | | |----------------------------------|--|---------------------| | Vivio Device - 510(k) Submission | | K183710<br>Page 3/5 | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "AVICENA" in a simple, sans-serif font. To the left of the word is a stylized graphic that appears to be a heart shape with some internal markings. The graphic is drawn with a rough, hand-drawn quality, giving it a slightly imperfect and organic feel. # Avicena Vivio Device Traditional 510(k) Summary SECTION 001 | | | | | Table 1 Differences between Vivio System and Predicate Efficacy/Safety Concerns | |----------------------------|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | | | | | | | | | | | | | | Vivio System<br>(Subject Device)<br>(K183710) | 3M Model 3200 with<br>Zargis StethAssist<br>(Predicate Device)<br>(K083903) | Comments on Efficacy/Safety | | | Information | | | | | | Signal Export | No export functionality. | Can export .wav and .zsa<br>files and print a report. | The Vivio System does not allow<br>for long term storage, and as<br>such has no mechanism to export<br>data. This has no impact on<br>safety or efficacy. | | | Arterial Pulse<br>Waveform | Displays on tablet. | No. | Used as an assessment to<br>indicate adequate system<br>application/placement and is<br>not presented for clinical<br>interpretation. | | | Design | | | | | | Replaceable<br>diaphragm | No, the system is<br>self-contained and not<br>modifiable by the<br>users. | Yes, the diaphragm can<br>be replaced | It is not possible for a user to<br>modify the Vivio Device. While<br>this is a difference between the<br>predicate, it offers no risk to<br>safety or efficacy. | | | Labeling | | | | | | No latex<br>indication | No | Yes | Our product has no latex in its<br>packaging or construction, but we<br>have not added this declaration<br>to our labels. | | | Arterial Pulse<br>Waveform | Yes | No | The following is included in the<br>Instructions for Use: The arterial<br>pulse waveform is used as an<br>assessment to indicate adequate<br>system application/placement<br>and is not presented for clinical<br>interpretation. | | | Category AP<br>Equipment | No | Yes | The Vivio System has not been<br>tested for flammable anesthetic<br>mixture with air. It is not intended<br>for use in a surgical environment. | | | Electric shock<br>warning | Usage is not allowed<br>when device is<br>plugged into wall<br>power. The Vivio | To reduce the risk<br>associated with an<br>electrical shock do not<br>use the stethoscope on | Since the Vivio Unit does not<br>have a removable diaphragm,<br>there is not an equivalent<br>warning. The device additionally | | | Avicena | | K183710 | |----------------------------------|--|----------| | Vivio Device - 510(k) Submission | | Page 4/5 | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Avicena. The logo consists of a stylized heart shape with an oval inside, containing some text. To the right of the heart shape is the word "AVICENA" in all capital letters. ## Avicena Vivio Device Traditional 510(k) Summary | device will not pair with<br>the tablet when<br>plugged into mains<br>power. | patients without the<br>stethoscope's diaphragm<br>cover in place. | will not function while connected<br>to mains power as an additional<br>safety measure. | |------------------------------------------------------------------------------|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------| |------------------------------------------------------------------------------|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------| #### Summary of Clinical and Non-Clinical Testing This submission does not include animal or clinical performance testing. This submission includes data from bench testing to evaluate the performance of the Avicena Vivio System - Electronic Stethoscope. Testing involved performance and bench testing as well as user and usability testing. Although there are no specific performance standards for this device, the device was tested for compliance with voluntary standards as outlined in the following table. Testing to the following standards was conducted per the standards requirements: - CFR 21CFR820: Part 820 QUALITY SYSTEM REGULATION, ● - IEC 62304:2006 + A1:2015 Medical device software Software life cycle processes, ● - ISO 14971:2012 Medical devices Application of risk management to medical devices, ● - ASTM D4169-16 Performance Testing of Shipping Containers and Systems, ● - . AAMI ES 60601-1:2005 + A1:2012 + A2:2010 +C1:2009 - Medical electrical equipment -Part 1: General requirements for basic safety and essential performance - . IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility - Requirements and tests - ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and ● testing within a risk management process and U.S. Food and Drug Administration (FDA) Guidance Document for the Use of ISO 10993-1 (issued 06/16/2016) - . IEC 60601-2-27: 2011/(R)2016 Medical electrical equipment - Part 2-27 Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment ## Conclusions Avicena believes the proposed Vivio System and its predicate the 3M Littmann Model 3200 Electronic Stethoscope are substantially equivalent in their intended users, intended use environment and indications for use. They share similar design and technology output characteristics as well as recording the same biological functions. The differences that exist between the devices do not affect the relative safety and/or effectiveness. | Avicena | | |----------------------------------|---------------------| | Vivio Device - 510(k) Submission | K183710<br>Page 5/5 |