(277 days)
No
The summary describes a standard electronic stethoscope that acquires and transmits heart sound data for display and playback. There is no mention of AI, ML, or any advanced algorithms for interpretation or analysis beyond basic heart rate calculation. The performance studies focus on bench testing and compliance with voluntary standards, not on the performance of an AI/ML model.
No.
The device is intended for diagnostic decision support as part of a physical assessment, not for therapy. It facilitates the detection and amplification of heart and artery sounds.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Vivio System is intended to be used as part of a physical assessment of a patient by healthcare professionals for diagnostic decision support."
No
The device description clearly outlines hardware components including a membrane, infrared light photo reflector, sensor electronics, filter electronics, and an internal rechargeable battery, in addition to the software (Avicena App).
Based on the provided information, the Vivio System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Vivio System Function: The Vivio System is an electronic stethoscope that acquires and transmits heart sound data from the surface of the skin over the carotid artery. It does not analyze samples taken from the body.
- Intended Use: The intended use is for physical assessment and diagnostic decision support by listening to and visualizing heart sounds. This is a non-invasive method.
Therefore, the Vivio System falls under the category of a medical device used for physical examination and data acquisition, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Vivio System is indicated for low frequency (
§ 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.
0
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
1
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
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 ( 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 CA |
| 91105, Ph: 626.344.9665, Email: info@avicenaheart.com | |
| Establishment Registration Number: FDA Registration is pending. | |
| Submission | |
| Correspondent: | On behalf of Avicena LLC., the following consultant is assigned the |
| responsibility of submission correspondence: | |
| Jim West, Principal Consultant at West Device Innovations, LLC | |
| 23412 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 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. | |
| Classification | |
| Regulation, Class & | |
| Product Code & Panel: | 21 CFR 870.1875(b) |
| Class II | |
| Product Code: DQD | |
| 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 ( |