(282 days)
Not Found
Yes
The summary explicitly mentions that the predicate device utilizes an "Artificial intelligence (AI) model developed using a convolutional neural network," indicating that the technology is relevant to the comparison and likely incorporated in the subject device or a similar approach is used.
No.
The device is used to estimate left ventricular end-diastolic pressure (LVEDP) to aid in the diagnosis of heart failure, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that the "measurement can aid in the diagnosis of heart failure." This directly indicates its role as a diagnostic tool.
No
The device description explicitly states that the Vivio System consists of an Arm Cuff system (BP cuff electronics, connection tubing), EKG patch, and a software application. It details the use of physical components like a blood pressure arm cuff, electrodes, a pneumatic pump, and an EKG Patch, which are integral to data collection. While it includes software, it is not solely software.
Based on the provided information, the Vivio® System is not an In Vitro Diagnostic (IVD).
Here's why:
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IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state; concerning a congenital abnormality; to determine the safety and compatibility of potential donations, including blood and tissue donations, with potential recipients; or to monitor therapeutic measures.
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Vivio System's Function: The Vivio System collects data non-invasively from the patient's body (brachial artery and chest) using an arm cuff and EKG patch. It does not examine specimens derived from the human body in vitro.
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Method of Measurement: The system estimates LVEDP based on physiological signals collected directly from the patient, not from analyzing a sample in a laboratory setting.
Therefore, the Vivio System falls under the category of a non-invasive diagnostic device rather than an In Vitro Diagnostic.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The Vivio® System is indicated to non-invasively estimate left ventricular end-diastolic pressure (LVEDP) is above or below 18mmHg. This measurement can aid in the diagnosis of heart failure when used by qualified healthcare professionals as an adjunct alongside other clinically relevant information. For use in adults only.
Product codes
OUO
Device Description
The Vivio System consists of an Arm Cuff system (BP cuff electronics, connection tubinq), EKG patch, and a software application that runs on an off-the-shelf computer tablet. Data is collected non-invasively at the brachial artery and via a single-lead EKG Patch. An off-the-shelf blood pressure arm cuff is attached to the patient's upper arm as if taking a blood pressure measurement. The Arm Cuff is attached to the blood pressure cuff with the quick connect end connected to the pneumatic pump within the Arm Cuff Electronics Enclosure. Two off-the-shelf electrodes are attached to the snap connections on the bottom of the EKG Patch and then connected on the left side of the patient's chest. Both the pneumatic pump attached to the Arm Cuff and EKG Patch are then powered on by pressing and releasing their respective power buttons. The Vivio App is opened on an off-the shelf computer tablet, and the on-screen prompts are followed to connect the Arm Cuff and the EKG Patch. The user is prompted to enter required patient and user data, initiating a patient recording session. Data from the recording session is processed by a proprietary algorithm and results reported on the computer tablet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
EchoGo uses a machine learning process to determine whether the echocardiographic images acquired are suggestive of heart failure.
Artificial intelligence (AI) model developed using a convolutional neural network
Input Imaging Modality
Waveform data from custom sensor technology
Anatomical Site
Brachial artery and chest (for EKG Patch)
Indicated Patient Age Range
Adults only.
Intended User / Care Setting
Qualified healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A prospective, multi-center clinical study enrolled 195 subjects scheduled for nonemergent left heart catheterization in a cardiac catheterization laboratory (Cath Lab Cohort) across 9 sites. A non-aged Healthy Cohort of 101 subjects were also enrolled at a single site. An additional Aged Healthy Cohort of 40 subjects were additionally enrolled at a single site. Statistical analysis was performed on a subset of validation data that had passed the completeness and quality requirements outlined in the data management plan and procedure.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Avicena conducted a prospective validation study to characterize the relationship of Avicena's non-invasive Vivio System for the estimation of elevated left ventricular end-diastolic pressure (LVEDP) as compared to gold-standard invasive LVEDP obtained via the Millar Mikro-Cath (Cath Lab Cohort) as well as reference-standard non-invasive echocardiographic indices (Aged Healthy Cohort). An additional nonaged healthy cohort was enrolled without the use of a reference comparator (Non-Aged Healthy Cohort).
A prospective, multi-center clinical study enrolled 195 subjects scheduled for nonemergent left heart catheterization in a cardiac catheterization laboratory (Cath Lab Cohort) across 9 sites. A non-aged Healthy Cohort of 101 subjects were also enrolled at a single site. An additional Aged Healthy Cohort of 40 subjects were additionally enrolled at a single site. Statistical analysis was performed on a subset of validation data that had passed the completeness and quality requirements outlined in the data management plan and procedure.
The primary efficacy objectives for the study were met; sensitivity of 80% (64-91), and specificity of 80% (73-86).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity of 80% (64-91)
Specificity of 80% (73-86)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2200 Adjunctive cardiovascular status indicator.
(a)
Identification. The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Software description, verification, and validation based on comprehensive hazard analysis must be provided, including:
(i) Full characterization of technical parameters of the software, including any proprietary algorithm(s);
(ii) Description of the expected impact of all applicable sensor acquisition hardware characteristics on performance and any associated hardware specifications;
(iii) Specification of acceptable incoming sensor data quality control measures; and
(iv) Mitigation of impact of user error or failure of any subsystem components (signal detection and analysis, data display, and storage) on accuracy of patient reports.
(2) Scientific justification for the validity of the status indicator algorithm(s) must be provided. Verification of algorithm calculations and validation testing of the algorithm using a data set separate from the training data must demonstrate the validity of modeling.
(3) Usability assessment must be provided to demonstrate that risk of misinterpretation of the status indicator is appropriately mitigated.
(4) Clinical data must be provided in support of the intended use and include the following:
(i) Output measure(s) must be compared to an acceptable reference method to demonstrate that the output measure(s) represent(s) the predictive measure(s) that the device provides in an accurate and reproducible manner;
(ii) The data set must be representative of the intended use population for the device. Any selection criteria or limitations of the samples must be fully described and justified;
(iii) Agreement of the measure(s) with the reference measure(s) must be assessed across the full measurement range; and
(iv) Data must be provided within the clinical validation study or using equivalent datasets to demonstrate the consistency of the output and be representative of the range of data sources and data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment.
(5) Labeling must include the following:
(i) The type of sensor data used, including specification of compatible sensors for data acquisition;
(ii) A description of what the device measures and outputs to the user;
(iii) Warnings identifying sensor reading acquisition factors that may impact measurement results;
(iv) Guidance for interpretation of the measurements, including warning(s) specifying adjunctive use of the measurements;
(v) Key assumptions made in the calculation and determination of measurements;
(vi) The measurement performance of the device for all presented parameters, with appropriate confidence intervals, and the supporting evidence for this performance; and
(vii) A detailed description of the patients studied in the clinical validation (
e.g., age, gender, race/ethnicity, clinical stability) as well as procedural details of the clinical study.
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October 6, 2023
Avicena, LLC % Lorry Weaver Principal Consultant Qserve Group, US 350 S. Main Street Suite 309 Doylestown, Pennsylvania 18901
Re: K223905
Trade/Device Name: Vivio® LVEDP System Regulation Number: 21 CFR 870.2200 Regulation Name: Adjunctive Cardiovascular Status Indicator Regulatory Class: Class II Product Code: OUO Dated: January 11, 2023 Received: January 13, 2023
Dear Lorry Weaver:
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 (the 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 available 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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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,
Stephen C. Browning -S
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices 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) K223905
Device Name Vivio® System
Indications for Use (Describe)
The Vivio® System is indicated to non-invasively estimate left ventricular end-diastolic pressure (LVEDP) is above or below 18mmHg. This measurement can aid in the diagnosis of heart failure when used by qualified healthcare professionals as an adjunct alongside other clinically relevant information. For use in adults only.
| 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 C) |
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Section 5: 510(k) Summary - [21 CFR 807.92]
| 807.92(a)(1), (2), (3) | |
|---|---|
| Date Prepared: | July 20, 2023 |
| Submitter's Name: | Avicena, LLC |
| 117 E. Colorado Blvd., Suite 510 | |
| Pasadena, CA 91105 | |
| +1 (626) 956-3606 | |
| Official Correspondent: | Lorry Weaver, Principal Consultant |
| Qserve Group US | |
| +1 (916) 220-1137 | |
| lorry.weaver@qservegroup.com | |
| Device Trade Name: | Vivio® System |
| Common Name: | Adjunctive cardiovascular status indicator for left ventricular |
| end diastolic pressure (LVEDP) | |
| Review Panel: | Office of Cardiovascular Devices (OHT2) |
| Classification Name: | Adjunctive cardiovascular status indicator |
| Regulation No.: | 870.2200 |
| Classification Code: | QUO |
| Predicate Device: | EchoGo Heart Failure: 510(k) Number K222463 |
| Classification Code: QUO | |
| Regulation: 870.2200 |
Device Description 807.92(a)(4):
The Vivio System consists of an Arm Cuff system (BP cuff electronics, connection tubinq), EKG patch, and a software application that runs on an off-the-shelf computer tablet. Data is collected non-invasively at the brachial artery and via a single-lead EKG Patch. An off-the-shelf blood pressure arm cuff is attached to the patient's upper arm as if taking a blood pressure measurement. The Arm Cuff is attached to the blood pressure cuff with the quick connect end connected to the pneumatic pump within the Arm Cuff Electronics Enclosure. Two off-the-shelf electrodes are attached to the snap connections on the bottom of the EKG Patch and then connected on the left side of the patient's chest. Both the pneumatic pump attached to the Arm Cuff and EKG Patch are then powered on by pressing and releasing their respective power buttons. The Vivio App is opened on an off-the shelf computer tablet, and the on-screen prompts are followed to connect the Arm Cuff and the EKG Patch. The user is prompted to enter required patient and user data, initiating a patient recording session. Data from the recording session is processed by a proprietary algorithm and results reported on the computer tablet.
The Vivio System Is designed for use by qualified healthcare professionals.
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Indications for Use /Intended Use 807.92(a)(5)]:
The Vivio® System is indicated to non-invasively estimate left ventricular end-diastolic pressure (LVEDP) is above or below 18mmHq. This measurement can aid in the diagnosis of heart failure when used by qualified healthcare professionals as an adjunct alongside other clinically relevant information. For use in adults only.
Technological Characteristics 807.92(a)(6):
The Vivio® System ("Vivio") and EchoGo Heart Failure ("EchoGo") have similar technological characteristics both within regulation 870.2200 and product code QUO. The devices are prescription devices based on sensor technology or image data to provide information to an interpreting clinician in detecting heart failure. Each device is intended for adjunctive use with other physical vital sign parameters and patient information and neither device is intended to independently direct therapy.
The technical method described for product code QUO is aligned with both devices which analyze patient data (such as echocardiographic images) and provide an output that indicates likelihood of the presence of heart failure. The Vivio and EchoGo each meet this technical method definition. Vivio analyzes patient waveform data from custom sensor technology placed on the arm and chest of a patient. Vivio analyzes the acquired data to output an estimate of LVEDP to aid a clinician in the process of arriving at a diagnosis of heart failure. EchoGo analyzes patient echocardiographic data and informs the clinician that the acquired data is suggestive of heart failure with preserved ejection. Vivio and EchoGo each interpret non-invasive data to provide a binary outcome in which the status indicator can be represented as normal or abnormal; LVEDP above or below 18 mmHg for the Vivio and the echocardiogram provided as suggestive of heart failure or not suggestive of heart failure for the EchoGo.
Vivio and EchoGo do have some differences that do not raise new issues of safety or efficacy. The method by which the two devices acquire their non-invasive patient data is different. The EchoGo uses echocardiographic images acquired by ultrasound. The Vivio uses pulse and ECG waveform information acquired using custom hardware. This difference in how the patient data is acquired does not present new or different issues related to safety or effectiveness as both devices provide a heart failure status that is adjunct to other clinical parameters. Additionally, the algorithm approach between Vivio and EchoGo is different. EchoGo uses a machine learning process to determine whether the echocardiographic images acquired are suggestive of heart failure. Vivio uses a fixed parameter model to determine whether LVEDP is greater than 18 mmHg.
A summary of similarities and differences are summarized below.
Similar features:
- Adiunctive use alongside clinically relevant information ●
- Qualitative result interpret non-invasive data to provide a binary outcome ●
- . Non-invasive sensor technology
- Aid in diagnosis of heart failure ●
- Use by qualified healthcare professionals ●
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Differing features:
| EchoGo | Vivio System |
|---|---|
| Artificial intelligence (AI) model | |
| developed using a convolutional | |
| neural network | Algorithm uses a fixed parameter |
| model to predict status indicator | |
| Echocardiographic data images from | |
| ultrasound DICOM files | Waveform data from custom sensor |
| technology |
Summary of Non-Clinical Test - Performance and Safety Testing 807.92(b)(1):
Special Controls defined in 870.2200 have been met as provided in the 510(k) submission.
The Vivio System was evaluated and found to meet standards and requirements for biocompatibility, electrical, electromagnetic, and packaging.
Biocompatibility
Biocompatibility testing was conducted on the body contacting materials according to ISO 10993-1 5th edition 2018-08 for transient exposure (