CorVista System with PH Add-On

K233666 · Analytics For Life, Inc. · SAT · Apr 5, 2024 · Cardiovascular

Device Facts

• Record ID: K233666
• Device Name: CorVista System with PH Add-On
• Applicant: Analytics For Life, Inc.
• Product Code: SAT · Cardiovascular
• Decision Date: Apr 5, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2380
• Device Class: Class 2
• Attributes: AI/ML

Intended Use

The CorVista® System analyzes sensor-acquired physiological signals of patients presenting with cardiovascular symptoms (such as chest pain, dyspnea, fatigue) to provide a binary output indicating the likelihood of elevated mean pulmonary arterial pressure (mPAP), an indicator of pulmonary hypertension. 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 for point-of-care use by healthcare providers. It consists of a base system (hardware, firmware, software) and disease-specific add-on modules. The PH Add-On module uses a machine-learned algorithm to analyze synchronously acquired cardiac electrical signals (via VCG) and hemodynamic signals (via PPG) from the patient's trunk and digits. The system transmits data to a secure web-based portal, generating a report that displays the likelihood of elevated mPAP. This output serves as an aid to clinical decision-making, intended to be used alongside the provider's clinical judgment, patient history, and physical signs to assist in diagnosing pulmonary hypertension.

Clinical Evidence

Prospective, multicenter, non-randomized study (N=386) of symptomatic subjects. Primary endpoint: diagnostic performance against invasive right heart catheterization (positive) and core-lab adjudicated TTE (negative). Results: 82% sensitivity, 92% specificity, >99% NPV, and 0.95 AUC-ROC. Secondary endpoint (mPAP > 21 mmHg threshold): 78% sensitivity, 0.93 AUC-ROC. Repeatability and reproducibility studies confirmed consistent PH score outputs.

Technological Characteristics

Modular system comprising a seven-channel lead set, PPG sensor, and tablet capture device. Operates via spot-check, non-motion acquisition. Connectivity via cellular or Wi-Fi to a cloud-based portal. Biocompatibility per ISO 10993-1. Electrical safety per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25, IEC 80601-2-61. Software utilizes a machine-learned detection algorithm.

Indications for Use

Indicated for adult patients presenting with cardiovascular symptoms (e.g., chest pain, dyspnea, fatigue) to aid in the diagnosis of pulmonary hypertension by indicating the likelihood of elevated mean pulmonary arterial pressure (mPAP).

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

• CorVista® System (K232686)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

Analytics for Life, Inc. Gabrielle Zaeska Vice President, Regulatory Affairs and Quality First Canadian Place 100 King Street West, Suite 5600 Toronto, ON M5X 1C9 Canada

#### Re: K233666

Trade/Device Name: CorVista System with PH Add-On Regulation Number: 21 CFR 870.2380 Regulation Name: Cardiovascular Machine Learning-Based Notification Software Regulatory Class: Class II Product Code: SAT Dated: November 15, 2023 Received: March 5, 2024

#### 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 (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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# for Robert T. Kazmierski -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

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Submission Number (if known)

K233666

Device Name

CorVista System with PH Add-On

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 provide a binary output indicating the likelihood of elevated mean pulmonary arterial pressure (mPAP), an indicator of pulmonary hypertension. 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)

## Analytics for Life, Inc. [510(k) Number - K233666]

This 510(k) Summary is in conformance with 21 CFR 807.92

| Submitter: | Analytics for Life, Inc.<br>First Canadian Place<br>100 King Street West, Suite 5600<br>Toronto, ON M5X 1C9<br>Canada<br>Phone: [phone] |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Gabrielle Zaeska<br>Vice President, Regulatory Affairs & Quality<br>Analytics for Life, Inc.<br>Email: [e-mail]<br>Phone: [phone] |
| Alternate Contact: | Tom McDougal<br>Principal Regulatory Affairs Specialist<br>Analytics for Life, Inc.<br>Email: [e-mail]<br>Phone: [phone] ext 1058 |
| Date Prepared: | 15 November 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: | SAT |

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#### Predicate Device:

| | Predicate |
|---------------------------|-----------------------------------------------------------|
| Trade / Device Name | CorVista® System |
| 510(k) Submitter / Holder | Analytics for Life, Inc. (formerly CorVista Health, Inc.) |
| 510(k) Number | K232686 |
| Regulation Number | 21 CFR 870.2380 |
| Classification Panel | Cardiovascular |
| Product Code | QXX |

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 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 Cor Vista 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 PH Add-On indicates the likelihood of elevated mean pulmonary arterial pressure (mPAP), an indicator of pulmonary hypertension. 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 CorVista® System analyzes sensor-acquired physiological signals of patients presenting with cardiovascular symptoms (such as chest pain, dyspnea, fatigue) to provide a binary output indicating the likelihood of elevated mean pulmonary arterial pressure (mPAP), an indicator of pulmonary hypertension. 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, CorVista System with CAD Add-On (K232686).

The table below provides a detailed comparison of the CorVista System (with PH Add-On) to the predicate device.

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| Characteristic | Subject Device | Predicate Device | Comparison |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The CorVista® System is<br>intended to non-invasively<br>analyze physiological signals<br>using machine learning<br>techniques to indicate the<br>likelihood of a cardiovascular<br>disease or condition | The CorVista® System is intended<br>to non-invasively analyze<br>physiological signals using<br>machine learning techniques to<br>indicate the likelihood of a<br>cardiovascular disease or<br>condition | Same |
| Indications for Use | The CorVista® System analyzes<br>sensor-acquired physiological<br>signals of patients presenting with<br>cardiovascular symptoms (such as<br>chest pain, dyspnea, fatigue) to<br>provide a binary output indicating<br>the likelihood of elevated mean<br>pulmonary arterial pressure<br>(mPAP), an indicator of<br>pulmonary hypertension. The<br>analysis is presented for<br>interpretation by healthcare<br>providers in conjunction with<br>their clinical judgment, the<br>patient's signs, symptoms, and<br>clinical history as an aid in<br>diagnosis. | The CorVista® System analyzes<br>sensor-acquired physiological<br>signals of patients presenting with<br>cardiovascular symptoms (such as<br>chest pain, dyspnea, fatigue) to<br>indicate the likelihood of<br>significant coronary artery disease.<br>The analysis is presented for<br>interpretation by healthcare<br>providers in conjunction with their<br>clinical judgment, the patient's<br>signs, symptoms, and clinical<br>history as an aid in diagnosis. | Different - This difference in<br>specific disease state indicated<br>does not change the intended use<br>of the device. Any differences in<br>the indications for use do not<br>affect the safety and<br>effectiveness of the CorVista<br>System with PH Add-On and<br>have been addressed through<br>clinical and bench testing and<br>supported by general and special<br>controls. |
| Product Codes | (primary) SAT<br>(21 CFR 870.2380) | (primary) QXX<br>(21 CFR 870.2380) | Different – primary product<br>codes reflect the disease state<br>detected. This difference does<br>not change the intended use of<br>the device. |
| Operation Mode | Spot-check | Spot-check | Same |
| Characteristic | Subject Device | Predicate Device | Comparison |
| Motion | Non-motion | Non-motion | Same |
| Patient Population | Adult patients presenting with<br>cardiovascular symptoms | Adult patients presenting with<br>cardiovascular symptoms | Same |
| Environment of Use | Professional healthcare<br>environment (i.e., local physician<br>offices, clinics and hospital<br>settings) with cellular or Wifi | Professional healthcare<br>environment (i.e., local physician<br>offices, clinics and hospital<br>settings) with cellular or Wifi | Same |
| Prescription vs. Off-<br>the-Shelf | Prescription | Prescription | Same |
| Technological Characteristics | | | |
| Algorithm | Machine learning-based<br>algorithm | Machine learning-based algorithm | Same |
| Algorithm Calculation<br>and Output | Likelihood of elevated mPAP<br>derived from calculated VCG and<br>PPG features and patient<br>demographics. | Likelihood of significant CAD<br>derived from calculated VCG and<br>PPG features and patient<br>demographics. | Similar – both algorithms<br>calculate and output the<br>likelihood of a cardiovascular<br>disease state derived from<br>calculated VCG and PPG features<br>and patient demographics. |
| Ground Truth for<br>Model Training and<br>Validation | Guideline-driven ground truth via<br>invasive catheterization or core-<br>lab adjudicated TTE | Guideline-driven ground truth via<br>invasive catheterization or core-<br>lab adjudicated CTA | Same- The validation of the two<br>devices both use invasive<br>catheterization to determine<br>ground truth positive reference<br>subjects, and core-lab<br>adjudicated non-invasive<br>imaging modalities to determine<br>reference negative subjects.<br>The safety and effectiveness of<br>the CorVista System with PH<br>Add-On has been confirmed<br>through validation testing. |
| Characteristic | Subject Device | Predicate Device | Comparison |
| Measured Physiological<br>Parameters | Synchronously acquired cardiac<br>electrical signals (acquired in<br>orthogonal axes via VCG) and<br>hemodynamic signals (acquired<br>via photoplethysmography<br>(PPG)) | Synchronously acquired cardiac<br>electrical signals (acquired in<br>orthogonal axes via VCG) and<br>hemodynamic signals (acquired<br>via photoplethysmography (PPG)) | Same, both CorVista System<br>devices use identical acquisition<br>hardware. |
| Data Displayed | PH report indicating the<br>likelihood of elevated mPAP | CAD report, indicating the<br>likelihood of Coronary Artery<br>Disease (CAD) | Different - This difference does<br>not change the intended use of<br>the device. The safety and<br>effectiveness of the CorVista<br>System has been confirmed<br>through testing. |
| Application Site | Trunk & Digits | Trunk & Digits | Same |
| Data Output | Tablet easy-to-read display<br>(LCD), Mobile App, and Web<br>App | Tablet easy-to-read display<br>(LCD), Mobile App, and Web<br>App | Same |

## Table 1. Detailed Comparison of the Subject and Predicate Device

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| Characteristic | Subject Device | Predicate Device | Comparison | | |
|----------------|-------------------------------------------------------------------|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|------|
| Hardware | Seven-Channel Lead Set,<br>PPG Sensor,<br>Capture Device (Tablet) | Seven-Channel Lead Set,<br>PPG Sensor,<br>Capture Device (Tablet) | Same, both CorVista System<br>devices use identical hardware. | | |
| | Software | Analytics for Life, Inc.<br>Proprietary Algorithm and<br>Application | CorVista System with CAD Add-<br>On (K232686)<br>Analytics for Life, Inc. Proprietary<br>Algorithm and Application | Same | |
| | | Physical<br>Degree of Protection<br>Against Electric Shock | Type CF – Applied Part | CorVista System with CAD Add-<br>On (K232686)<br>Type CF – Applied Part | Same |

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| Characteristic | Subject Device | Predicate Device | Comparison |
|-----------------------|------------------------------|------------------------------|------------|
| Functional and Safety | IEC 60601-1 | IEC 60601-1 | Same |
| Testing | IEC 60601-1-2 | IEC 60601-1-2 | |
| | IEC 60601-2-25 | IEC 60601-2-25 | |
| | IEC 80601-2-61 | IEC 80601-2-61 | |
| | IEC 60259 | IEC 60259 | |
| | IEC 62133 | IEC 62133 | |
| | AIM 7351731 | AIM 7351731 | |
| | ANSI IEEE C63.27 | ANSI IEEE C63.27 | |
| | FCC 47CFR Part 15 Subpart C | FCC 47CFR Part 15 Subpart C | |
| Biocompatibility | ISO 10993 | ISO 10993 | Same |
| | Surface contact | Surface contact | |
| | Skin | Skin | |
| | Limited duration (<24 hours) | Limited duration (<24 hours) | |

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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 PH 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 PH 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, packaging 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:
- о IEC 60601-1
- 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 о
- ANSI IEEE C63.27 O
- FCC 47CFR Part 15 Subpart C o
- 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 Cytotoxicity
- 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 Add-On Modules.
- . Shelf Life / Cleaning Validation: CorVista Health conducted studies to support the shelf life and cleaning of the CorVista System.
- 0 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 elevated mean pulmonary arterial pressure (mPAP) was evaluated through subgroups enrolled in a prospective, multicenter, non-randomized, repository study. The study was designed to collect and store acquired physiological signals paired with subject meta-data, including clinical outcomes data from symptomatic 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=386) were enrolled into two groups based on their reference standard (invasive right heart catheterization (RHC) and core lab adjudicated Transthoracic echocardiogram (TTE)). These subjects were divided into populations A and B for Sensitivity and Specificity testing:

- Population A (elevated mPAP population): Used for Sensitivity Testing. ●
- Population B (non-elevated mPAP population): 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 known clinical outcome (elevated mPAP, defined as ≥ 25mmHg), or non-elevated mPAP (as determined by core lab adjudication of TTE) of each subject was compared to the algorithm prediction results derived from the Cor Vista System with PH 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 RHC and

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TTE for evaluation of their symptoms. The diagnostic performance of the CorVista System in this broad population was demonstrated to be 82% sensitivity and 92% specificity, NPV of >99%, with a 0.95 AUC-ROC. The CorVista System is designed to be used in conjunction with the healthcare provider's clinical judgment, the patient's signs, symptoms, and clinical history as an aid in diagnosis. Please refer to the Instructions for Use for further information.

The performance of the CorVista System was additionally evaluated at a secondary endpoint using a positive population defined using the threshold of mPAP > 21 mmHg. Results of this performance evaluation demonstrated that the PH algorithm at this disease threshold has an AUC-ROC of 0.93, and a sensitivity of 0.78, which passed the pre-specified secondary endpoint.

A4L further conducted an evaluation of repeatability and reproducibility of the PH Add-On output (i.e., PH Score) using subjects prospectively enrolled in the IDENTIFY studies. For repeatability, subjects had 5 signals collected by the same study coording 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 PH 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 (K232686). Differences between the CorVista System and the predicate device (K232686) do not raise new questions of safety or effectiveness. Based on the clinical testing, non-clinical performance and safety testing of the CorVista System with PH Add-On, the CorVista System is substantially equivalent to the legally marketed predicate device (K232686).