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).

The Vivio System is intended to be used as part of a physical assessment of a patient by healthcare professionals for diagnostic decision support. It may be used for the detection and amplification of sounds from the heart and arteries with the use of selective frequencies. It can be used on any person undergoing a physical assessment.

Device Description

The Vivio Unit is an electronic stethoscope containing a membrane, placed on the skin over the carotid artery, that is displaced due to vibrations produced by the arterial pulse waveform and heart sounds associated with the aortic valve opening and closing. An infrared light photo reflector transmits and detects light to/from the membrane and outputs a current relative to the detected light (or membrane movement). Sensor electronics inside the Vivio Unit generate a current to operate the sensor, read the current produced by the sensor and output a voltage relative to the current. Filter electronics condition the sensor signal, process the data and communicate the data to the tablet with the Avicena App. The Vivio Unit is powered by an internal, rechargeable battery.

AI/ML Overview

The provided text describes a 510(k) submission for the Avicena Vivio System, a digital electronic stethoscope. While it outlines the device's intended use, comparison to a predicate device, and compliance with various standards, it does not contain specific acceptance criteria or a study proving the device meets acceptance criteria related to its diagnostic accuracy or clinical performance.

The document explicitly states: "This submission does not include animal or clinical performance testing."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets them from the provided text, as such information is not present. The submission focuses on substantial equivalence based on technical characteristics, safety, and non-clinical bench testing.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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). 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. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. 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,

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

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Indications for Use

510(k) Number (if known) K183710

Device Name Vivio System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over The Counter Use (21 CFR 801 Subpart

|X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the word "AVICENA" in all caps, with a logo to the left of the word. The logo is a stylized drawing of a heart with an oval inside. 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 CA91105, Ph: 626.344.9665, Email: info@avicenaheart.comEstablishment Registration Number: FDA Registration is pending.
SubmissionCorrespondent:	On behalf of Avicena LLC., the following consultant is assigned theresponsibility of submission correspondence:Jim West, Principal Consultant at West Device Innovations, LLC23412 West 46'th Street, Shawnee, KS 66226, Ph: 913.991.6288,Email: jwest@westdeviceinnovations.com
Trade Name:	Vivio System
Common Name:	Digital Electronic Stethoscope
Description:	The Vivio Unit is an electronic stethoscope containing a membrane,placed on the skin over the carotid artery, that is displaced due tovibrations produced by the arterial pulse waveform and heartsounds associated with the aortic valve opening and closing. Aninfrared light photo reflector transmits and detects light to/from themembrane and outputs a current relative to the detected light (ormembrane movement). Sensor electronics inside the Vivio Unitgenerate a current to operate the sensor, read the current producedby the sensor and output a voltage relative to the current. Filterelectronics condition the sensor signal, process the data andcommunicate the data to the tablet with the Avicena App. The VivioUnit is powered by an internal, rechargeable battery.
ClassificationRegulation, Class &Product Code & Panel:	21 CFR 870.1875(b)Class IIProduct Code: DQDPanel: Cardiovascular

Avicena		K183710
Vivio Device - 510(k) Submission		Page 1/5

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Intended Use of Device

Product Requirements Document - Avicena Vivio Device
Indications for Use:	The Vivio System is indicated for low frequency (<200 Hz) or BellMode operation to acquire and transmit heart sound data to thetablet/UI (with Avicena App) for calculation of heart rate and displayand playback of heart sounds (audio and visual).
Intended Use:	The Vivio System is intended to be used as part of a physicalassessment of a patient by healthcare professionals for diagnosticdecision support. It may be used for the detection and amplificationof sounds from the heart and arteries with the use of selectivefrequencies. It can be used on any person undergoing a physicalassessment.
Intended User:	The Vivio System is intended to be used by Healthcare Providers.
Intended UseEnvironment:	The Vivio System is intended to be used in a clinical setting such asa hospital, physician's office, or other patient care facility.
Targeted PatientPopulation:	It can be used on any person undergoing a physical assessment..
Contraindications:	Subjects with a hypersensitive response to even slight pressureover the carotid pulse may faint when the carotid is palpated(carotid sinus hypersensitivity). For this reason, the following arecontraindications for the use of the Vivio System:• Patients with a history of carotid sinus hypersensitivity(fainting in response to touching or positioning the neck)• Patients with a known history of carotid artery stenosis• Open skin lesions at the site of examination

Predicate Device(s):	510(k) Number: K083903Manufacturer: 3M CompanyTrade Name: 3M Littmann Electronic Stethoscope, Model 3200Product Code: DQDClassification: 870.1875
Reference Device(s):	510(K) Number: K122129Manufacturer: AtCor Medical

Avicena
Vivio Device - 510(k) Submission		K183710Page 2/5

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Trade Name: SphygmoCor XCELProduct Code: DSK: DXNClassification: Computer, Blood-Pressure; System, Measurement,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		K183710Page 3/5

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Avicena Vivio Device Traditional 510(k) Summary

SECTION 001




	Vivio System(Subject Device)(K183710)	3M Model 3200 withZargis StethAssist(Predicate Device)(K083903)	Comments on Efficacy/Safety
Information
Signal Export	No export functionality.	Can export .wav and .zsafiles and print a report.	The Vivio System does not allowfor long term storage, and assuch has no mechanism to exportdata. This has no impact onsafety or efficacy.
Arterial PulseWaveform	Displays on tablet.	No.	Used as an assessment toindicate adequate systemapplication/placement and isnot presented for clinicalinterpretation.
Design
Replaceablediaphragm	No, the system isself-contained and notmodifiable by theusers.	Yes, the diaphragm canbe replaced	It is not possible for a user tomodify the Vivio Device. Whilethis is a difference between thepredicate, it offers no risk tosafety or efficacy.
Labeling
No latexindication	No	Yes	Our product has no latex in itspackaging or construction, but wehave not added this declarationto our labels.
Arterial PulseWaveform	Yes	No	The following is included in theInstructions for Use: The arterialpulse waveform is used as anassessment to indicate adequatesystem application/placementand is not presented for clinicalinterpretation.
Category APEquipment	No	Yes	The Vivio System has not beentested for flammable anestheticmixture with air. It is not intendedfor use in a surgical environment.
Electric shockwarning	Usage is not allowedwhen device isplugged into wallpower. The Vivio	To reduce the riskassociated with anelectrical shock do notuse the stethoscope on	Since the Vivio Unit does nothave a removable diaphragm,there is not an equivalentwarning. The device additionally

Avicena		K183710
Vivio Device - 510(k) Submission		Page 4/5

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Avicena Vivio Device Traditional 510(k) Summary

device will not pair withthe tablet whenplugged into mainspower.	patients without thestethoscope's diaphragmcover in place.	will not function while connectedto mains power as an additionalsafety measure.
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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	K183710Page 5/5

Regulation Number and Section

§ 870.1875 Stethoscope.

(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.