(7 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study proving the CorVista® System meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The text does not explicitly state pre-defined acceptance criteria in a quantitative format (e.g., "Sensitivity >= X%"). Instead, it presents the device's performance results and implies that these results were deemed acceptable for substantial equivalence to the predicate device. The comparison to CCTA's "rule out performance" suggests a benchmark, but not a strict acceptance criterion.
| Performance Metric | Reported Device Performance (CorVista® System) | Implicit Acceptance Criteria (based on text) |
|---|---|---|
| Sensitivity | 88% | Comparable to rule out performance of coronary computed tomography angiography (CCTA) |
| Specificity | 51% | Comparable to rule out performance of coronary computed tomography angiography (CCTA) |
| AUC-ROC (Area Under the Receiver Operating Characteristic Curve) | 0.80 | Acceptable performance for aiding diagnosis and comparable to CCTA rule-out performance |
| Repeatability of CAD Score | Demonstrated acceptable results | "produces CAD score results that are both repeatable and repeatable" |
| Reproducibility of CAD Score | Demonstrated acceptable results | "produces CAD score results that are both repeatable and reproducible" |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: N = 1,816 subjects.
- Population A (CAD+ for Sensitivity Testing): Number not specified, but this population was evaluated for sensitivity.
- Population B (CAD- for Specificity Testing): Number not specified, but this population was evaluated for specificity.
- Data Provenance: Prospective, multicenter, non-randomized, repository study. The text does not explicitly state the country of origin, but given the FDA submission, it implicitly refers to data collected in the US.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
The text states that the ground truth for CAD was established via "invasive catheterization (ICA)" or "core-lab adjudicated CTA."
- Number of Experts: Not explicitly stated for ICA or CTA adjudication.
- Qualifications of Experts: It implies that medical professionals performed the ICA, and a core-lab performed the CTA adjudication. The specific qualifications (e.g., number of years of experience for radiologists or cardiologists performing these procedures/adjudications) are not detailed.
4. Adjudication Method for the Test Set
The adjudication method for the ground truth was:
- For ICA: Clinical outcome from invasive coronary angiography. This is a direct, invasive diagnostic procedure.
- For CTA: "Core-lab adjudicated CTA." This implies a standardized process by a specialized lab, likely involving multiple readers or a defined quality control process, but the specific multi-reader method (e.g., 2+1, 3+1) is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not explicitly stated to have been done for human readers with and without AI assistance to assess improvement. The study described focuses on the standalone performance of the CorVista System compared to established diagnostic methods (ICA/CTA). The device is intended to be an "aid in diagnosis" used "in conjunction with their clinical judgment," but the study design presented does not evaluate the human-AI interaction in a comparative effectiveness study setting.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance study was done. The described clinical testing focuses on the algorithm's performance in indicating the likelihood of significant CAD by comparing its predictions to objective ground truth (ICA/CTA results). The reported sensitivity, specificity, and AUC-ROC are measures of the algorithm's standalone performance.
7. The Type of Ground Truth Used
- Objective Clinical Data / Outcomes Data: The ground truth for the test set was established by:
- Invasive Coronary Angiography (ICA): This is considered a gold standard for diagnosing CAD.
- Core-lab Adjudicated Coronary Computed Tomography Angiography (CTA): This is another strong diagnostic imaging modality, with the "core-lab adjudicated" aspect indicating a high level of rigor in interpretation.
These methods directly determine the patient's actual CAD classification (CAD+ or CAD-).
8. The Sample Size for the Training Set
- The text states the ground truth for the "Model Training and Validation" was "Guideline-driven ground truth via invasive catheterization or core-lab adjudicated CTA." However, the specific sample size for the training set is not provided. The N=1,816 refers to the validation population (test set) used for performance testing.
9. How the Ground Truth for the Training Set Was Established
- The ground truth for model training (and validation) was established using "Guideline-driven ground truth via invasive catheterization or core-lab adjudicated CTA." This implies that the same rigorous, objective diagnostic methods used for the test set's ground truth were also used to label the data utilized during the training and internal validation phases of the algorithm development.
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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
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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 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
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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) |
|---|---|
| ------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------ |
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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 200Washington, DC 20012Phone: 919-619-7581Fax: 919-573-9105 |
|---|---|
| Primary Contact: | Gabrielle ZaeskaVice President, Regulatory Affairs & QualityCorVista Health, Inc.Email: gzaeska@corvista.comPhone: 612-267-5004Fax: 919-573-9105 |
| Alternate Contact: | Tom McDougalPrincipal Regulatory Affairs SpecialistCorVista Health, Inc.Email: tmcdougal@corvista.comPhone: 919-813-2724 ext 1058Fax: 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
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| 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.
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| Characteristic | Subject Device | Chosen Predicate Device withJustification | Comparison |
|---|---|---|---|
| Intended Use | The CorVista® System isintended to non-invasivelyanalyze physiological signalsusing machine learningtechniques to indicate thelikelihood of a cardiovasculardisease or condition | Viz HCM is intended to non-invasively analyze physiologicalsignals using machine learningtechniques to suggest thelikelihood of a cardiovasculardisease or condition | Same |
| Indications for Use | The CorVista® Systemanalyzes sensor-acquiredphysiological signals of patientspresenting with cardiovascularsymptoms (such as chest pain,dyspnea, fatigue) to indicate thelikelihood ofsignificant coronary arterydisease. The analysis ispresented for interpretation byhealthcare providers inconjunction with their clinicaljudgment, the patient's signs,symptoms, and clinical historyas an aid in diagnosis. | Viz HCM is intended to be used inparallel to the standard of care toanalyze recordings of 12-leadECG made on compatible ECGdevices. Viz HCM is capable ofanalyzing the ECG, detecting signsassociated with hypertrophiccardiomyopathy (HCM), andallowing the user to view the ECGand analysis results. Viz HCM isindicated for use on 12-lead ECGrecordings collected from patients18 years of age or older. Viz HCMis not intended for use on patientswith implanted pacemakers.Viz HCM is limited to analysis ofECG data and should not be usedin-lieu of full patient evaluation orrelied upon to make or confirmdiagnosis. Viz HCM identifiespatients for further HCM follow-up and does not replace the current | Different - This difference doesnot change the intended use of thedevice. The safety andeffectiveness of the CorVistaSystem in its intended usepopulation has been confirmedthrough testing.Any differences in the indicationsfor use do not affect the safety andeffectiveness of the CorVistaSystem and have been addressedthrough clinical and bench testingand supported by general andspecial controls. |
| Characteristic | Subject Device | Chosen Predicate Device withJustification | Comparison |
| Product Codes | (primary) QXX(21 CFR 870.2380)(subsequent product code)DQK(21 CFR 870.1425) | standard of care methods fordiagnosis of HCM. The results ofthe 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 thedisease state detected andhardware components. Thisdifference does not change theintended use of the device |
| Operation Mode | Spot-check | Viz HCM (DEN230003) | Same |
| Motion | Non-motion | Spot-checkHemoSphere AdvancedMonitoring Platform, HemoSphereClearSight Module (K201446) andWorkmate ClarisTM System v1.2(K210392)Both secondary predicates areintended for non-motion. | Same |
| Patient Population | Adult patients presenting withcardiovascular symptoms | Viz HCM (DEN230003)Adult patients | Different - This difference doesnot change the intended use of thedevice. The safety andeffectiveness of the CorVistaSystem in its intended usepopulation has been confirmedthrough testing |
| Characteristic | Subject Device | Chosen Predicate Device withJustification | Comparison |
| Environment of Use | Professional healthcareenvironment (i.e., localphysician offices, clinics andhospital settings) with cellularor 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-basedalgorithm | Viz HCM (DEN230003)Machine learning-based algorithm | Same |
| Algorithm Calculationand Output | Likelihood of significant CADderived from calculated VCGand PPG features and patientdemographics. | Viz HCM (DEN230003)Presence of signs of HCM derivedfrom ECG signal. | Different – The output of theCorVista System provides userswith the likelihood of significantCAD for a given patient. Theprimary predicate indicates thepresence of signs of HCM. Thesesigns are equivalent in concept tothe calculated features that areused as the inputs to the CorVistamachine-learning process andresultant algorithm. Both devicesprocess signals to provideinformation to users oncardiovascular disease and as suchthe intended use is not impactedby this difference. The safety andeffectiveness of the CorVistaSystem has been confirmedthrough testing. |
| Characteristic | Subject Device | Chosen Predicate Device withJustification | Comparison |
| Ground Truth forModel Training andValidation | Guideline-driven ground truthvia invasive catheterization orcore-lab adjudicated CTA | Viz HCM (DEN230003)Cardiologist-adjudicated signs of adisease from ECG waveform | Different – The validation of thetwo devices differs in the level ofground truth that is used tovalidate performance. TheCorVista System has beenvalidated using the patient'sdisease state as ground truth, whilethe predicate device utilizes thepresence of signs that suggestdisease. This difference does notimpact the shared general intendeduse of providing information oncardiovascular status. The safetyand effectiveness of the CorVistaSystem has been confirmedthrough testing. |
| MeasuredPhysiologicalParameters | Synchronously acquired cardiacelectrical signals (acquired inorthogonal axes via VCG) andhemodynamic signals (acquiredvia photoplethysmography(PPG)) | HemoSphere AdvancedMonitoring Platform, HemoSphereClearSight Module (K201446) andWorkmate Claris™ System v1.2(K210392)K210392:Oximetry, heart rate, andadditional cardiovascularparameters (e.g., blood pressure,oxygen delivery, etc.)K201446:Electrocardiograph andintracardiac electrical signals | Same – The measuredphysiological parameters of theCorVista System are a subset ofthose measured by the secondarypredicate devices. The safety andeffectiveness of the CorVistaSystem has been confirmedthrough testing. |
| Characteristic | Subject Device | Chosen Predicate Device withJustification | Comparison |
| Data Displayed | Likelihood of significantCoronary Artery Disease(CAD) | Viz HCM (DEN230003)Notification Flag for patients whorequire further HCM follow-up | Different - Display of thelikelihood of disease is of superiordiagnostic value compared to anotification flag used in thepredicate device, therefore thesafety and effectiveness is non-inferior compared to the predicate.The clinical performance of theCorVista System for the intendeddisease and output has beenconfirmed through testing. |
| Application Site | Trunk & Digits | HemoSphere AdvancedMonitoring Platform, HemoSphereClearSight Module (K201446) andWorkmate Claris™ System v1.2(K210392)The secondary predicates haveapplication sites including theTrunk (K210392) and Digits(K201446). | Same – The CorVista Systemutilizes a subset of the applicationsites utilized by the secondarypredicate devices. |
| Data Output | Tablet easy-to-read display(LCD), Mobile App, and WebApp | Viz HCM (DEN230003)Mobile app | Different - This difference doesnot change the intended use of thedevice. The safety andeffectiveness of the CorVistaSystem has been confirmedthrough testing. |
| Characteristic | Subject Device | Chosen Predicate Device withJustification | Comparison |
| Hardware | Seven-Channel Lead Set,PPG Sensor,Capture Device (Tablet) | HemoSphere AdvancedMonitoring Platform, HemoSphereClearSight Module (K201446) andWorkmate ClarisTM System v1.2(K210392)The secondary predicates utilizelead sets, oximeter cables,computer systems, etc. | Different - This difference doesnot change the intended use of thedevice. The safety andeffectiveness of the CorVistaSystem has been confirmedthrough testing. |
| Software | CorVista Health ProprietaryAlgorithm,CorVista Health ProprietaryApplication | Viz HCM (DEN230003)Viz.ai Proprietary Algorithm,Viz.ai Proprietary Application | Different - This difference doesnot change the intended use of thedevice. The safety andeffectiveness of the CorVistaSystem has been confirmedthrough testing. |
| PhysicalDegree of ProtectionAgainst Electric Shock | Type CF – Applied Part | HemoSphere AdvancedMonitoring Platform, HemoSphereClearSight Module (K201446) andWorkmate ClarisTM System v1.2(K210392)Type BF and CF Applied Parts(K201446)Type CF - Applied Part(K210392) | Same - The degree of protectionagainst electrical shock is the sameas the secondary predicate devicesand is appropriate for the intendeduse environment. The safety andeffectiveness of the CorVistaSystem has been confirmedthrough testing. |
| Characteristic | Subject Device | Chosen Predicate Device withJustification | Comparison |
| Functional and SafetyTesting | IEC 60601-1 | HemoSphere AdvancedMonitoring Platform, HemoSphereClearSight Module (K201446) andWorkmate Claris™ System v1.2(K210392) | Different - This difference doesnot change the intended use of thedevice. All devices completedFunctional and Safety testingpursuant to their design andintended use. The safety andeffectiveness of the CorVistaSystem has been confirmedthrough testing. |
| IEC 60601-1-2 | |||
| IEC 60601-2-25 | |||
| IEC 80601-2-61 | |||
| IEC 60259 | |||
| IEC 62133 | K201446:IEC 60601-1IEC 60601-1-2IEC 60601-1-6IEC 60601-1-8IEC 60601-2-34IEC 60601-2-57IEC 60601-2-49IEC 80601-2-49Wireless Co-existenceK210392:IEC 60601-1IEC 60601-1-2 | ||
| AIM 7351731 | |||
| ANSI IEEE C63.27 | |||
| FCC 47CFR Part 15 Subpart C | |||
| Biocompatibility | ISO 10993 | HemoSphere AdvancedMonitoring Platform, HemoSphereClearSight Module (K201446) andWorkmate Claris™ System v1.2(K210392) | Different - This difference doesnot change the intended use of thedevice. All devices completedbiocompatibility testing pursuantto their level of patient contact.The safety and effectiveness of theCorVista System has beenconfirmed through testing. |
| Surface contact | |||
| Skin | |||
| Limited duration (<24 hours) | |||
| K201446: ISO 10993 (viapredicates)K210392: Connected devicescompleted biocompatibility | |||
Table 1. Detailed Comparison of the Subject and Predicate Device
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CorVista® System CorVista Health, Inc.
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Traditional 510(k) Request Summary of 510(k)
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Traditional 510(k) Request Summary of 510(k)
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Traditional 510(k) Request Summary of 510(k)
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CorVista® System CorVista Health, Inc.
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Summary of Non-Clinical Testing
As part of the product development process and risk assessment, a series of non-clinical verification/validation testing and supplemental studies were conducted on both the hardware and software features of the CorVista System to ensure the device operates as intended. As summarized below, all the studies demonstrated acceptable performance to the protocols tested.
- . Software Verification and Validation: The CorVista Base System and CAD Add-On Module underwent verification and validation testing to demonstrate the software operates and performs according to written and pre-approved specifications. Results of the CorVista Base System and CAD Add-On Module verification and validation testing demonstrate acceptance criteria were met.
- Performance Bench Testing: A series of standard bench testing has been performed on ● the CorVista Base System including battery lifecycle, signal quality, wireless coexistence, label integrity, and other functional verification. All studies demonstrated acceptance criteria were met.
- Electrical & EMC Safety Testing: Electrical and EMC safety testing has been performed on the CorVista Base System. All studies demonstrated acceptance criteria were met. All elements of the CorVista System were determined to meet acceptable performance to the following standards:
- IEC 60601-1 O
- IEC 60601-1-2 O
- IEC 60601-2-25 O
- IEC 80601-2-61 O
- IEC 60259 O
- IEC 62133 O
- O EC53:2013
- AIM 7351731 O
- ANSI IEEE C63.27 O
- FCC 47CFR Part 15 Subpart C о
- Biocompatibility: CorVista Health conducted biocompatibility testing in accordance with ● FDA's Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and ISO 10993-1:2018. The following biocompatibility testing was successfully completed on the CorVista Capture™ device's patient contacting materials:
- Cytotoxicity MEM Elution Testing per ISO 10993-5:2009, Biological O Evaluation of Medical Devices-Part 5: Tests for In Vitro Cytotoxicitv
- Maximization Testing for Delayed-Type Hypersensitivity in Hartley Guinea Pigs o per ISO 10993-10:2010, Biological Evaluation of Medical Devices – Tests for Irritation and Skin Sensitization
- Intracutaneous (Intradermal) Reactivity Testing in New Zealand White Rabbits o per ISO 10993-10:2010, Biological Evaluation of Medical Devices – Tests for Irritation and Skin Sensitization
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- . Human Factors / Usability: CorVista Health conducted Human Factors / Usability testing in accordance with FDA's Guidance "Applying Human Factors and Usability Engineering to Medical Devices." Human Factors / Usability Testing was conducted in two different studies to cover the CorVista System and CAD Add-On Module.
- . Shelf Life / Cleaning Validation: CorVista Health conducted studies to support the shelf life and cleaning of the CorVista System.
- o A cleaning validation study of the CorVista System was conducted utilizing FDA's Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," AAMI TIR 12: 2020, AAMI TIR 30: 2011, ASTM F3208-20, and ASTM F3293-18. Based on the results of this validation, the CorVista Base System can be cleaned effectively following the Instructions for Use.
- An accelerated aging study was conducted in accordance with ASTM F1980 to o simulate a 2-year shelf life. Test results demonstrated that the device is safe and effective for use throughout a 2-year use life.
Summary of Clinical Testing
The performance of the CorVista® System to indicate the likelihood of significant coronary artery disease (CAD) was evaluated through subgroups enrolled in a prospective, multicenter, nonrandomized, repository study. The study was designed to collect and store acquired physiological signals paired with subject meta-data, including clinical outcomes data from subjects within the intended use population. The study included IRB approved clinical protocols with informed consent for each patient. All subjects were consecutively and prospectively enrolled and met the established inclusion/exclusion criteria.
Male and female study subjects (N=1,816) were enrolled into two groups based on their reference standard (invasive coronary angiography (ICA) and Computed Tomography Angiography (CTA)). These subjects were divided into populations A and B for Sensitivity and Specificity testing:
- Population A (found to be positive for significant CAD+): Used for Sensitivity Testing.
- Population B (subjects determined to be negative for significant CAD-): Used for . Specificity Testing.
Sensor-acquired physiological signals were collected from the subjects using the CorVista Capture™ device based on the scheduling of their diagnostic imaging procedure. To assess device performance in the intended use population, the actual CAD classification (CAD+ or CAD-) of each subject (as determined by their reference procedure) was compared to the algorithm prediction results derived from the CorVista System with CAD Add-On Module.
The validation population (A and B) used for performance testing included symptomatic subjects with a range of cardiovascular symptoms and risks factors which prompted the use of ICA and CTA for CAD evaluation. The diagnostic performance of the CorVista System in this broad
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population was demonstrated to be 88% sensitivity and 51% specificity, with a 0.80 AUC-ROC. These results are comparable to the rule out performance of coronary computed tomography angiography (CCTA). The CorVista System is designed to be used in conjunction with the healthcare provider's clinical judgment, the patient's signs, symotoms, and clinical history as an aid in diagnosis. Please refer to the Instructions for Use for further information.
CVH further conducted an evaluation of repeatability and reproducibility of the CAD Add-On output (i.e., CAD Score) using subjects prospectively enrolled in the IDENTIFY study. For repeatability, subjects had 5 signals collected by the same study coordinator according to the Instructions for Use. For reproducibility, subjects had 3 signals collected, with each signal being collected by a different study coordinator. The resulting statistics demonstrate that the CorVista System produces CAD score results that are both repeatable and reproducible.
Substantial Equivalence Conclusion
The CorVista System has an identical intended use to the legally marketed predicate device (DEN230003). Differences between the CorVista System and the predicate device (DEN230003) do not raise new questions of safety or effectiveness. Based on the clinical testing, non-clinical performance and safety testing of the Cor Vista System, the Cor Vista System is substantially equivalent to the legally marketed predicate device (DEN230003).
N/A