(142 days)
Not Found
Yes
The document explicitly mentions "machine learned detection algorithm," "machine learning techniques," and "Machine learning-based algorithm" in the device description and mentions section.
No
The device is described as an aid in diagnosis, not a device for treatment or therapy.
Yes.
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device provides a binary output "as an aid in diagnosis" of pulmonary hypertension. The "Device Description" also mentions that the system is designed to "allow a physician to evaluate the patient for the presence of cardiac disease indicators."
No
The device description explicitly states that the CorVista® System is comprised of "several hardware and software components" and mentions a "CorVista Capture™ device" used for collecting physiological signals.
Based on the provided information, the CorVista® System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. This typically includes blood, urine, tissue, or other bodily fluids.
- The CorVista® System analyzes physiological signals acquired from sensors placed on the patient's body. The description mentions "sensor-acquired physiological signals" and "non-invasive medical device system comprised of several hardware and software components." This indicates external measurement of bodily functions, not analysis of a sample taken from the body.
The device's function is to analyze these external physiological signals to provide an indication of the likelihood of elevated mean pulmonary arterial pressure. This is a form of non-invasive diagnostic aid, but it does not fit the definition of an In Vitro Diagnostic.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
SAT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Cardiovascular Machine Learning-Based Notification Software
machine learning techniques
machine learned detection algorithm
Machine learning-based algorithm
Input Imaging Modality
Not Found
Anatomical Site
Trunk & Digits
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Professional healthcare environment (i.e., local physician offices, clinics and hospital settings) with cellular or Wifi
Description of the training set, sample size, data source, and annotation protocol
Guideline-driven ground truth via invasive catheterization or core-lab adjudicated TTE
Description of the test set, sample size, data source, and annotation protocol
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 TTE for evaluation of their symptoms.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
82% sensitivity and 92% specificity, NPV of >99%, with a 0.95 AUC-ROC.
AUC-ROC of 0.93, and a sensitivity of 0.78 (for mPAP > 21 mmHg threshold).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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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3
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.
First Canadian Place
100 King Street West, Suite 5600
Toronto, ON M5X 1C9
Canada
Phone: 919-728-5012 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Gabrielle Zaeska
Vice President, Regulatory Affairs & Quality
Analytics for Life, Inc.
Email: gzaeska@analytics4life.com
Phone: 612-267-5004 |
| Alternate Contact: | Tom McDougal
Principal Regulatory Affairs Specialist
Analytics for Life, Inc.
Email: tmcdougal@analytics4life.com
Phone: 919-813-2724 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.
5
| Characteristic | Subject Device | Predicate Device | 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 | 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 | 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 | |||
| 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. | 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. | Different - This difference in | ||
| specific disease state indicated | |||
| does not change the intended use | |||
| of the device. Any differences in | |||
| the indications for use do not | |||
| affect the safety and | |||
| effectiveness of the CorVista | |||
| System with PH Add-On and | |||
| have been addressed through | |||
| clinical and bench testing and | |||
| supported by general and special | |||
| controls. | |||
| Product Codes | (primary) SAT | ||
| (21 CFR 870.2380) | (primary) QXX | ||
| (21 CFR 870.2380) | Different – primary product | ||
| codes reflect the disease state | |||
| detected. This difference does | |||
| not change the intended use of | |||
| 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 | ||
| cardiovascular symptoms | Adult patients presenting with | ||
| cardiovascular symptoms | Same | ||
| Environment of Use | Professional healthcare | ||
| environment (i.e., local physician | |||
| offices, clinics and hospital | |||
| settings) with cellular or Wifi | Professional healthcare | ||
| environment (i.e., local physician | |||
| offices, clinics and hospital | |||
| settings) with cellular or Wifi | Same | ||
| Prescription vs. Off- | |||
| the-Shelf | Prescription | Prescription | Same |
| Technological Characteristics | |||
| Algorithm | Machine learning-based | ||
| algorithm | Machine learning-based algorithm | Same | |
| Algorithm Calculation | |||
| and Output | Likelihood of elevated mPAP | ||
| derived from calculated VCG and | |||
| PPG features and patient | |||
| demographics. | Likelihood of significant CAD | ||
| derived from calculated VCG and | |||
| PPG features and patient | |||
| demographics. | Similar – both algorithms | ||
| calculate and output the | |||
| likelihood of a cardiovascular | |||
| disease state derived from | |||
| calculated VCG and PPG features | |||
| and patient demographics. | |||
| Ground Truth for | |||
| Model Training and | |||
| Validation | Guideline-driven ground truth via | ||
| invasive catheterization or core- | |||
| lab adjudicated TTE | Guideline-driven ground truth via | ||
| invasive catheterization or core- | |||
| lab adjudicated CTA | Same- The validation of the two | ||
| devices both use invasive | |||
| catheterization to determine | |||
| ground truth positive reference | |||
| subjects, and core-lab | |||
| adjudicated non-invasive | |||
| imaging modalities to determine | |||
| reference negative subjects. | |||
| The safety and effectiveness of | |||
| the CorVista System with PH | |||
| Add-On has been confirmed | |||
| through validation testing. | |||
| Characteristic | Subject Device | Predicate Device | Comparison |
| Measured Physiological | |||
| Parameters | Synchronously acquired cardiac | ||
| electrical signals (acquired in | |||
| orthogonal axes via VCG) and | |||
| hemodynamic signals (acquired | |||
| via photoplethysmography | |||
| (PPG)) | Synchronously acquired cardiac | ||
| electrical signals (acquired in | |||
| orthogonal axes via VCG) and | |||
| hemodynamic signals (acquired | |||
| via photoplethysmography (PPG)) | Same, both CorVista System | ||
| devices use identical acquisition | |||
| hardware. | |||
| Data Displayed | PH report indicating the | ||
| likelihood of elevated mPAP | CAD report, indicating the | ||
| likelihood of Coronary Artery | |||
| Disease (CAD) | 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. | |||
| Application Site | Trunk & Digits | Trunk & Digits | Same |
| Data Output | Tablet easy-to-read display | ||
| (LCD), Mobile App, and Web | |||
| App | Tablet easy-to-read display | ||
| (LCD), Mobile App, and Web | |||
| App | Same |
Table 1. Detailed Comparison of the Subject and Predicate Device
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7
8
| Characteristic | Subject Device | Predicate Device | Comparison | ||
|---|---|---|---|---|---|
| Hardware | Seven-Channel Lead Set, | ||||
| PPG Sensor, | |||||
| Capture Device (Tablet) | Seven-Channel Lead Set, | ||||
| PPG Sensor, | |||||
| Capture Device (Tablet) | Same, both CorVista System | ||||
| devices use identical hardware. | |||||
| Software | Analytics for Life, Inc. | ||||
| Proprietary Algorithm and | |||||
| Application | CorVista System with CAD Add- | ||||
| On (K232686) | |||||
| Analytics for Life, Inc. Proprietary | |||||
| Algorithm and Application | Same | ||||
| Physical | |||||
| Degree of Protection | |||||
| Against Electric Shock | Type CF – Applied Part | CorVista System with CAD Add- | |||
| On (K232686) | |||||
| Type CF – Applied Part | Same |
9
| 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 (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).