Who is the manufacturer of CorVista® System?

Corvista Health, Inc. filed the 510(k) submission for CorVista® System (K232686).

What is the FDA product code for CorVista® System?

QXX. It is classified under 21 CFR 870.2380 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for CorVista® System?

510(k) clearance (submission type: Traditional).

Does CorVista® System use AI or machine learning?

Yes. CorVista® System (K232686) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like CorVista® System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like CorVista® System get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

CorVista® System

K232686 · Corvista Health, Inc. · QXX · Sep 8, 2023 · Cardiovascular

Device Facts

Record ID	K232686
Device Name	CorVista® System
Applicant	Corvista Health, Inc.
Product Code	QXX · Cardiovascular
Decision Date	Sep 8, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2380
Device Class	Class 2
Attributes	AI/ML

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Significant Coronary Artery Disease	—	—	88% sensitivity, 51% specificity, 0.80 AUC-ROC	—	—	Prospective, multicenter, nonrandomized, repository study (N=1,816).	—

Indications for Use

The CorVista® System analyzes sensor-acquired physiological signals of patients presenting with cardiovascular symptoms (such as chest pain, dyspnea, fatigue) to indicate the likelihood of significant coronary artery disease. The analysis is presented for interpretation by healthcare providers in conjunction with their clinical judgment, the patient's signs, symptoms, and clinical history as an aid in diagnosis.

Device Story

CorVista System is a non-invasive, modular diagnostic platform; acquires physiological signals via 7-channel VCG (cardiac electrical) and PPG (hemodynamic) sensors; processes data through a machine-learning detection algorithm to output a likelihood score for significant coronary artery disease (CAD). Used in professional healthcare settings (clinics, hospitals) by clinicians; output displayed on tablet, mobile, or web portal. Assists healthcare providers in clinical decision-making by providing diagnostic aid for symptomatic patients; intended to be used alongside clinical judgment, patient history, and physical signs. Benefits include non-invasive assessment of CAD likelihood, potentially streamlining diagnostic pathways.

Clinical Evidence

Prospective, multicenter, nonrandomized study (N=1,816) of symptomatic patients. Ground truth established via invasive coronary angiography (ICA) or Computed Tomography Angiography (CTA). Performance metrics: 88% sensitivity, 51% specificity, 0.80 AUC-ROC. Repeatability and reproducibility confirmed via IDENTIFY study (multiple signals collected by same/different coordinators).

Technological Characteristics

Modular system: CorVista Base System (hardware/firmware/software) + CAD Add-On Module. Sensors: 7-channel VCG lead set, PPG sensor. Connectivity: Cellular/WiFi to web-based portal. Standards: IEC 60601-1, 60601-1-2, 60601-2-25, 80601-2-61, 60259, 62133, AIM 7351731, ANSI IEEE C63.27, FCC Part 15. Biocompatibility: ISO 10993-1, 10993-5, 10993-10. Algorithm: Machine learning-based detection.

Indications for Use

Indicated for adult patients presenting with cardiovascular symptoms (e.g., chest pain, dyspnea, fatigue) to aid in the diagnosis of significant coronary artery disease (CAD).

Regulatory Classification

Identification

Viz HCM is a cardiovascular machine learning-based notification software intended to be used in parallel to the standard of care to analyze 12-lead ECG recordings from patients 18 years of age or older. It detects signs associated with hypertrophic cardiomyopathy (HCM) and allows the user to view the ECG and analysis results. It is not intended for use on patients with implanted pacemakers, does not replace standard diagnostic methods, and is not intended to rule out HCM or be used in lieu of a full patient evaluation.

Special Controls

In combination with the general controls of the FD&C Act, cardiovascular machine learningbased notification software is subject to the following special controls:

Predicate Devices

Viz HCM (DEN230003)

Reference Devices

HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module (K201446)
Workmate Claris™ System v1.2 (K210392)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. September 8, 2023 CorVista Health, Inc. Gabrielle Zaeska Vice President Regulatory Affairs 7144 13th Place NW. Suite 2200 Washington, District of Columbia 20012 Re: K232686 Trade/Device Name: CorVista® System Regulation Number: 21 CFR 870.2380 Regulation Name: Cardiovascular machine learning-based notification software Regulatory Class: Class II Product Code: QXX, DQK Dated: September 1, 2023 Received: September 1, 2023 Dear Gabrielle Zaeska: 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 {1}------------------------------------------------ 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 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 (QS) 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 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 G. 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K232686 Device Name CorVista® System #### Indications for Use (Describe) The CorVista® System analyzes sensor-acquired physiological signals of patients presenting with cardiovascular symptoms (such as chest pain, dyspnea, fatigue) to indicate the likelihood of significant coronary artery disease. The analysis is presented for interpretation by healthcare providers in conjunction with their clinical judgment, the patient's signs, symptoms, and clinical history as an aid in diagnosis. 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) | |-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------| |-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------| #### 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}------------------------------------------------ ## Summary of 510(k) ## CorVista Health, Inc. [510(k) Number - K232686] This 510(k) Summary is in conformance with 21 CFR 807.92 | Submitter: | CorVista Health, Inc. (“CorVista Health”) 7144 13th Place NW, Suite 200 Washington, DC 20012 Phone: 919-619-7581 Fax: 919-573-9105 | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Primary Contact: | Gabrielle Zaeska Vice President, Regulatory Affairs & Quality CorVista Health, Inc. Email: gzaeska@corvista.com Phone: 612-267-5004 Fax: 919-573-9105 | | Alternate Contact: | Tom McDougal Principal Regulatory Affairs Specialist CorVista Health, Inc. Email: tmcdougal@corvista.com Phone: 919-813-2724 ext 1058 Fax: 919-573-9105 | | Date Prepared: | 1 September 2023 | | Trade Name: | CorVista® System | | Common Name: | Cardiovascular machine learning-based notification software | | Classification: | Class II | | Regulation Number: | 21 CFR 870.2380 | | Classification Panel: | Cardiovascular | | Product Code: | QXX | Subsequent Product Code: DQK {4}------------------------------------------------ | | Predicate | |---------------------------|-----------------| | Trade / Device Name | Viz HCM | | 510(k) Submitter / Holder | Viz.ai, Inc. | | 510(k) Number | DEN230003 | | Regulation Number | 21 CFR 870.2380 | | Classification Panel | Cardiovascular | | Product Code | OXO | The predicate device has not been subject to a design-related recall. #### Device Description The CorVista® System is a non-invasive medical device system comprised of several hardware and software components that are designed to work together to allow a physician to evaluate the patient for the presence of cardiac disease, or cardiac disease indicators, using a static detection algorithm. The CorVista System has a modular design, where disease-specific "Add-On Modules" will integrate with a single platform, the CorVista Base System, to realize its intended use. The CorVista Base System is a combination of hardware, firmware, and software components with the functionality to acquire, transmit, store, and analyze data, and to generate a report for display in a secure web-based portal. The architecture of the CorVista Base system allows for integration with indication-specific "Add-Ons" which perform data analysis using a machine learned detection algorithm to indicate the likelihood of specific diseases at point of care. The CAD Add-On indicates the likelihood of significant Coronary Artery Disease (CAD). The analysis is presented for interpretation by healthcare providers in conjunction with their clinical judgment, the patient's signs, symptoms, and clinical history as an aid in diagnosis. #### Indications for Use The Cor Vista® System analyzes sensor-acquired physiological signals of patients presenting with cardiovascular symptoms (such as chest pain, dyspnea, fatigue) to indicate the likelihood of significant coronary artery disease. The analysis is presented for interpretation by healthcare providers in conjunction with their clinical judgment, the patient's signs, symptoms, and clinical history as an aid in diagnosis. ### Substantial Equivalence The CorVista System is substantially equivalent to its predicate device, Viz HCM (DEN230003). The table below provides a detailed comparison of the CorVista System to the predicate device. {5}------------------------------------------------ | Characteristic | Subject Device | Chosen Predicate Device with Justification | Comparison | |------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The CorVista® System is intended to non-invasively analyze physiological signals using machine learning techniques to indicate the likelihood of a cardiovascular disease or condition | Viz HCM is intended to non- invasively analyze physiological signals using machine learning techniques to suggest the likelihood of a cardiovascular disease or condition | Same | | Indications for Use | The CorVista® System analyzes sensor-acquired physiological signals of patients presenting with cardiovascular symptoms (such as chest pain, dyspnea, fatigue) to indicate the likelihood of significant coronary artery disease. The analysis is presented for interpretation by healthcare providers in conjunction with their clinical judgment, the patient's signs, symptoms, and clinical history as an aid in diagnosis. | Viz HCM is intended to be used in parallel to the standard of care to analyze recordings of 12-lead ECG made on compatible ECG devices. Viz HCM is capable of analyzing the ECG, detecting signs associated with hypertrophic cardiomyopathy (HCM), and allowing the user to view the ECG and analysis results. Viz HCM is indicated for use on 12-lead ECG recordings collected from patients 18 years of age or older. Viz HCM is not intended for use on patients with implanted pacemakers. Viz HCM is limited to analysis of ECG data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis. Viz HCM identifies patients for further HCM follow- up and does not replace the current | Different - This difference does not change the intended use of the device. The safety and effectiveness of the CorVista System in its intended use population has been confirmed through testing. Any differences in the indications for use do not affect the safety and effectiveness of the CorVista System and have been addressed through clinical and bench testing and supported by general and special controls. | | Characteristic | Subject Device | Chosen Predicate Device with Justification | Comparison | | Product Codes | (primary) QXX (21 CFR 870.2380) (subsequent product code) DQK (21 CFR 870.1425) | standard of care methods for diagnosis of HCM. The results of the device are not intended to rule- out HCM follow-up. (primary predicate) QXO (21 CFR 870.2380) (reference predicates) DQK (21 CFR 870.1425) | Different – codes reflect the disease state detected and hardware components. This difference does not change the intended use of the device | | Operation Mode | Spot-check | Viz HCM (DEN230003) | Same | | Motion | Non-motion | Spot-check HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module (K201446) and Workmate ClarisTM System v1.2 (K210392) Both secondary predicates are intended for non-motion. | Same | | Patient Population | Adult patients presenting with cardiovascular symptoms | Viz HCM (DEN230003) Adult patients | Different - This difference does not change the intended use of the device. The safety and effectiveness of the CorVista System in its intended use population has been confirmed through testing | | Characteristic | Subject Device | Chosen Predicate Device with Justification | Comparison | | Environment of Use | Professional healthcare environment (i.e., local physician offices, clinics and hospital settings) with cellular or Wifi | Viz HCM (DEN230003) Hospital and pre-hospital settings | Same | | Prescription vs. Off- the-Shelf | Prescription | Viz HCM (DEN230003) Prescription | Same | | Technological Characteristics | | | | | Algorithm | Machine learning-based algorithm | Viz HCM (DEN230003) Machine learning-based algorithm | Same | | Algorithm Calculation and Output | Likelihood of significant CAD derived from calculated VCG and PPG features and patient demographics. | Viz HCM (DEN230003) Presence of signs of HCM derived from ECG signal. | Different – The output of the CorVista System provides users with the likelihood of significant CAD for a given patient. The primary predicate indicates the presence of signs of HCM. These signs are equivalent in concept to the calculated features that are used as the inputs to the CorVista machine-learning process and resultant algorithm. Both devices process signals to provide information to users on cardiovascular disease and as such the intended use is not impacted by this difference. The safety and effectiveness of the CorVista System has been confirmed through testing. | | Characteristic | Subject Device | Chosen Predicate Device with Justification | Comparison | | Ground Truth for Model Training and Validation | Guideline-driven ground truth via invasive catheterization or core-lab adjudicated CTA | Viz HCM (DEN230003) Cardiologist-adjudicated signs of a disease from ECG waveform | Different – The validation of the two devices differs in the level of ground truth that is used to validate performance. The CorVista System has been validated using the patient's disease state as ground truth, while the predicate device utilizes the presence of signs that suggest disease. This difference does not impact the shared general intended use of providing information on cardiovascular status. The safety and effectiveness of the CorVista System has been confirmed through testing. | | Measured Physiological Parameters | Synchronously acquired cardiac electrical signals (acquired in orthogonal axes via VCG) and hemodynamic signals (acquired via photoplethysmography (PPG)) | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module (K201446) and Workmate Claris™ System v1.2 (K210392) K210392: Oximetry, heart rate, and additional cardiovascular parameters (e.g., blood pressure, oxygen delivery, etc.) K201446: Electrocardiograph and intracardiac electrical signals | Same – The measured physiological parameters of the CorVista System are a subset of those measured by the secondary predicate devices. The safety and effectiveness of the CorVista System has been confirmed through testing. | | Characteristic | Subject Device | Chosen Predicate Device with Justification | Comparison | | Data Displayed | Likelihood of significant Coronary Artery Disease (CAD) | Viz HCM (DEN230003) Notification Flag for patients who require further HCM follow-up | Different - Display of the likelihood of disease is of superior diagnostic value compared to a notification flag used in the predicate device, therefore the safety and effectiveness is non- inferior compared to the predicate. The clinical performance of the CorVista System for the intended disease and output has been confirmed through testing. | | Application Site | Trunk & Digits | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module (K201446) and Workmate Claris™ System v1.2 (K210392) The secondary predicates have application sites including the Trunk (K210392) and Digits (K201446). | Same – The CorVista System utilizes a subset of the application sites utilized by the secondary predicate devices. | | Data Output | Tablet easy-to-read display (LCD), Mobile App, and Web App | Viz HCM (DEN230003) Mobile app | Different - This difference does not change the intended use of the device. The safety and effectiveness of the CorVista System has been confirmed through testing. | | Characteristic | Subject Device | Chosen Predicate Device with Justification | Comparison | | Hardware | Seven-Channel Lead Set, PPG Sensor, Capture Device (Tablet) | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module (K201446) and Workmate ClarisTM System v1.2 (K210392) The secondary predicates utilize lead sets, oximeter cables, computer systems, etc. | Different - This difference does not change the intended use of the device. The safety and effectiveness of the CorVista System has been confirmed through testing. | | Software | CorVista Health Proprietary Algorithm, CorVista Health Proprietary Application | Viz HCM (DEN230003) Viz.ai Proprietary Algorithm, Viz.ai Proprietary Application | Different - This difference does not change the intended use of the device. The safety and effectiveness of the CorVista System has been confirmed through testing. | | Physical Degree of Protection Against Electric Shock | Type CF – Applied Part | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module (K201446) and Workmate ClarisTM System v1.2 (K210392) Type BF and CF Applied Parts (K201446) Type CF - Applied Part (K210392) | Same - The degree of protection against electrical shock is the same as the secondary predicate devices and is appropriate for the intended use environment. The safety and effectiveness of the CorVista System has been confirmed through testing. | | Characteristic | Subject Device | Chosen Predicate Device with Justification | Comparison | | Functional and Safety Testing | IEC 60601-1 | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module (K201446) and Workmate Claris™ System v1.2 (K210392) | Different - This difference does not change the intended use of the device. All devices completed Functional and Safety testing pursuant to their design and intended use. The safety and effectiveness of the CorVista System has been confirmed through testing. | | | IEC 60601-1-2 | | | | | IEC 60601-2-25 | | | | | IEC 80601-2-61 | | | | | IEC 60259 | | | | | IEC 62133 | K201446: IEC 60601-1 IEC 60601-1-2 IEC 60601-1-6 IEC 60601-1-8 IEC 60601-2-34 IEC 60601-2-57 IEC 60601-2-49 IEC 80601-2-49 Wireless Co-existence K210392: IEC 60601-1 IEC 60601-1-2 | | | | AIM 7351731 | | | | | ANSI IEEE C63.27 | |…

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