Cleerly ISCHEMIA
Device Facts
| Record ID | K231335 |
|---|---|
| Device Name | Cleerly ISCHEMIA |
| Applicant | Cleerly, Inc. |
| Product Code | QXZ · Cardiovascular |
| Decision Date | Sep 8, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2200 |
| Device Class | Class 2 |
| Attributes | AI/ML, Software as a Medical Device |
AI Performance
| Output | Algorithm | Acceptance | Observed | Dev DS | Dev Readers | Test DS | Test Readers |
|---|---|---|---|---|---|---|---|
| Coronary artery ischemia | — | — | Sensitivity: 76.2% (95% CI: 71.9%, 80.3%); Specificity: 85.2% (95% CI: 82.8%, 87.4%) | Derivation data set: 307 subjects from the CREDENCE trial. | — | CREDENCE trial validation data set (305 subjects) and additional US/OUS clinical studies (582 subjects total). | — |
Indications for Use
Cleerly ISCHEMIA analysis software is an automated machine learning-based decision support tool, indicated as a diagnostic aid for patients undergoing CT analysis using Cleerly Labs software. When utilized by an interpreting healthcare provider, this software tool provides information that may be useful in detecting likely ischemia associated with coronary artery disease. Patient management decisions should not be made solely on the results of the Cleerly ISCHEMIA analysis.
Device Story
Cleerly ISCHEMIA is an add-on software module for Cleerly Labs; it processes quantitative measures of atherosclerosis, stenosis, and vascular morphology derived from Coronary Computed Tomography Angiography (CCTA) images. The device uses a locked machine learning algorithm to determine the likely presence or absence of vessel-specific ischemia. It outputs a binary Cleerly ISCHEMIA Index (CII), where positive indicates likely ischemia (equivalent to invasive FFR ≤0.80) and negative indicates likely absence (equivalent to invasive FFR >0.80). The output is visualized in the Cleerly Labs interface by illuminating vessels red for positive CII. Used by healthcare providers in clinical settings to support functional evaluation of CAD. The device aids clinical decision-making by providing non-invasive functional information, potentially reducing the need for invasive procedures; patient management decisions must not rely solely on this output.
Clinical Evidence
Clinical validation used data from the prospective, multicenter CREDENCE trial (n=612) and additional US/OUS cohorts. Primary endpoint was diagnostic performance compared to invasive FFR (reference standard). Pooled analysis (N=582 subjects, 1521 vessel territories) showed 76.2% sensitivity (95% CI: 71.9%, 80.3%) and 85.2% specificity (95% CI: 82.8%, 87.4%) per-vessel territory. Per-patient territory analysis showed 86.6% sensitivity and 69.8% specificity.
Technological Characteristics
Add-on software module; SaMD; client-server architecture (Google Chrome application). Uses quantitative measures of atherosclerosis and vascular morphology from CCTA as input. Employs a locked machine learning algorithm for ischemia detection. Risk management per ISO 14971:2019. Cybersecurity controls integrated within Cleerly Labs platform.
Indications for Use
Indicated for clinically stable symptomatic patients with coronary artery disease (CAD) undergoing CT analysis using Cleerly Labs software to assist in detecting likely ischemia.
Regulatory Classification
Identification
The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
Special Controls
*Classification.* Class II (special controls). The special controls for this device are:(1) Software description, verification, and validation based on comprehensive hazard analysis must be provided, including: (i) Full characterization of technical parameters of the software, including any proprietary algorithm(s); (ii) Description of the expected impact of all applicable sensor acquisition hardware characteristics on performance and any associated hardware specifications; (iii) Specification of acceptable incoming sensor data quality control measures; and (iv) Mitigation of impact of user error or failure of any subsystem components (signal detection and analysis, data display, and storage) on accuracy of patient reports. (2) Scientific justification for the validity of the status indicator algorithm(s) must be provided. Verification of algorithm calculations and validation testing of the algorithm using a data set separate from the training data must demonstrate the validity of modeling. (3) Usability assessment must be provided to demonstrate that risk of misinterpretation of the status indicator is appropriately mitigated. (4) Clinical data must be provided in support of the intended use and include the following: (i) Output measure(s) must be compared to an acceptable reference method to demonstrate that the output measure(s) represent(s) the predictive measure(s) that the device provides in an accurate and reproducible manner; (ii) The data set must be representative of the intended use population for the device. Any selection criteria or limitations of the samples must be fully described and justified; (iii) Agreement of the measure(s) with the reference measure(s) must be assessed across the full measurement range; and (iv) Data must be provided within the clinical validation study or using equivalent datasets to demonstrate the consistency of the output and be representative of the range of data sources and data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment. (5) Labeling must include the following: (i) The type of sensor data used, including specification of compatible sensors for data acquisition; (ii) A description of what the device measures and outputs to the user; (iii) Warnings identifying sensor reading acquisition factors that may impact measurement results; (iv) Guidance for interpretation of the measurements, including warning(s) specifying adjunctive use of the measurements; (v) Key assumptions made in the calculation and determination of measurements; (vi) The measurement performance of the device for all presented parameters, with appropriate confidence intervals, and the supporting evidence for this performance; and (vii) A detailed description of the patients studied in the clinical validation ( *e.g.,* age, gender, race/ethnicity, clinical stability) as well as procedural details of the clinical study.
Predicate Devices
- EchoGo Heart Failure (K222463)
Reference Devices
Submission Summary (Full Text)
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September 8, 2023
Cleerly, Inc % John Smith Partner Hogan Lovells US LLP 555 13th St. NW Washington, District of Columbia 20004
Re: K231335
Trade/Device Name: Cleerly ISCHEMIA Regulation Number: 21 CFR 870.2200 Regulation Name: Adjunctive cardiovascular status indicator Regulatory Class: Class II Product Code: OXZ Dated: August 11, 2023 Received: August 11, 2023
Dear John Smith:
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,
# Robert T. Kazmierski -S
for
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
510(k) Number (if known)
K231335
Device Name
Cleerly ISCHEMIA
Indications for Use (Describe)
Cleerly ISCHEMIA analysis software is an automated machine learning-based decision support tool, indicated as a diagnostic aid for patients undergoing CT analysis using Cleerly Labs software. When utilized by an interpreting healthcare provider, this software tool provides information that may be useful in detecting likely ischemia associated with coronary artery disease. Patient management decisions should not be made solely on the results of the Cleerly ISCHEMIA analysis.
| Type of Use ( <i>Select one or both, as applicable</i> ) | |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| X Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="true" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) <input type="checkbox"/> |
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### 510(k) Summary
### Cleerly, Inc.'s Cleerly ISCHEMIA
#### 1. General Information
| Sponsor | Cleerly, Inc. |
|----------------|--------------------------------------------------------|
| Address | 110 16th Street<br>Suite 1400 #104<br>Denver, CO 80202 |
| Phone | 917-671-7746 |
| Contact Person | Candice Bautista-Biddle |
| Date Prepared | September 8, 2023 |
#### 2. Device Information
| Name of Device | Cleerly ISCHEMIA |
|---------------------|--------------------------------------------------------------|
| Classification Name | 21 CFR 870.2200 (Adjunctive Cardiovascular Status Indicator) |
| Regulatory Class | II |
| Product Code | QXZ |
#### 3. Predicate Device Information
| Name of Device | EchoGo Heart Failure (K222463) |
|---------------------|--------------------------------------------------------------|
| Classification Name | 21 CFR 870.2200 (Adjunctive Cardiovascular Status Indicator) |
| Regulatory Class | II |
| Product Code | QUO |
#### 4. Device Description
Cleerly ISCHEMIA is an add-on software module to Cleerly Labs (K202280, K190868) that determines the likely presence or absence of coronal vessel ischemia based on quantitative measures of atherosclerosis, stenosis, and significant vascular morphology from typically-acquired Coronary Computed Tomography Angiography images (CCTA). Cleerly ISCHEMIA, in conjunction with Cleerly Labs, outputs a Cleerly ISCHEMIA Index (CII), a binary indication of negative CII (likely absence of ischemia) or positive CII (likely presence of ischemia) with its threshold equivalent to invasive FFR >0.80 vs. ≤0.80, respectively, as identified in professional societal practice guidelines.
#### 5. Intended Use / Indications for Use
Cleerly ISCHEMIA analysis software is an automated machine learning-based decision support tool, indicated as a diagnostic aid for patients undergoing CT analysis using Cleerly Labs software. When utilized by an interpreting healthcare provider, this software tool provides information that may be useful in detecting likely ischemia associated with coronary artery disease. Patient management decisions should not be made solely on the results of the Cleerly ISCHEMIA analysis.
#### 6. Summary of Technological Characteristics
Cleerly ISCHEMIA is an add-on software module to Cleerly Labs that calculates vessel-specific likely ischemia presence based on quantitative measures of atherosclerosis, and vascular morphology from typically acquired CCTA.
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The Cleerly ISCHEMA data workflow begins after the Cleerly Labs outputs are approved for a study. A pre-processing module evaluates the eligibility of a study or vessels within the study for the Cleerly ISCHEMIA algorithm. The presence of certain identified anomalies can make an entire study ineligible, whereas the presence of a stent or exclusion in a vessel can make just that vessel ineligible. For all eligible vessels within a study, relevant Cleerly Labs outputs are aggregated from the default segment level to vessel level as the inputs to the Cleerly ISCHEMIA alqorithm to determine the likely presence of ischemia. The results will then be evaluated by a post-processing module, which ensures that vessels subtended to a likely ischemic vessel are also marked as likely ischemic. The Cleerly ISCHEMIA algorithm outputs a Cleerly ISCHEMIA Index (CII), a binary indication of likely ischemia presence vs absence for a given vessel, which is equivalent to invasive FFR ≤0.80 vs. >0.80, respectively. Invasive FFR is a widely accepted gold-standard for determining vessel-specific ischemia. The Cleerly ISCHEMIA algorithm is "locked," meaning it is not a continuous learning algorithm.
Cleerly ISCHEMIA Index (likely ischemia / not likely ischemia) is displayed visually by Cleerly Labs to show the likely presence or absence of ischemia within epicardial coronary artery vessels. Vessels with Cleerly ISCHEMIA Index indicating likely ischemia presence (positive CII) are illuminated red, while vessels with Cleerly ISCHEMA Index indicating likely ischemia absence (negative CII) are not illuminated. Cleerly ISCHEMIA analysis is intended to non-invasively support the functional evaluation of clinically stable symptomatic patients with coronary artery disease (CAD).
| Characteristic | Cleerly ISCHEMIA Device<br>(Subject device) | EchoGo Heart Failure (K222463) |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation | 21 CFR 870.2200 | 21 CFR 870.2200 |
| Generic Device Type | Adjunctive cardiovascular status<br>indicator | Adjunctive cardiovascular status<br>indicator |
| SaMD | Yes | Yes |
| Intended Use | Providing adjunctive information a<br>patient's cardiovascular condition<br>(diagnostic aid for ischemia<br>associated with coronary artery<br>disease) | Providing adjunctive information<br>on a patient's cardiovascular<br>condition (diagnostic aid for Heart<br>Failure with Preserved Ejection<br>Fraction (HFpEF)) |
| Indications for Use | Cleerly ISCHEMIA analysis<br>software is an automated<br>machine learning-based decision<br>support tool, indicated as a<br>diagnostic aid for patients<br>undergoing CT analysis using<br>Cleerly Labs software. When<br>utilized by an interpreting<br>healthcare provider, this software<br>tool provides information that may<br>be useful in detecting likely<br>ischemia associated with<br>coronary artery disease. Patient<br>management decisions should<br>not be made solely on the results<br>of the Cleerly ISCHEMIA<br>analysis. | EchoGo Heart Failure 1.0 is an<br>automated machine learning-<br>based decision support system,<br>indicated as a diagnostic aid for<br>patients undergoing routine<br>functional cardiovascular<br>assessment using<br>echocardiography. When utilised<br>by an interpreting clinician, this<br>device provides information that<br>may be useful in detecting heart<br>failure with preserved ejection<br>fraction (HFpEF). EchoGo Heart<br>Failure 1.0 is indicated in adult<br>populations over 25 years of age.<br>Patient management decisions<br>should not be made solely on the<br>results of the EchoGo Heart |
Table 1. Substantial Equivalence Comparison Between Subject and Predicate Device
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| Characteristic | Cleerly ISCHEMIA Device<br>(Subject device) | EchoGo Heart Failure (K222463) |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Failure 1.0 analysis. EchoGo<br>Heart Failure 1.0 takes as input<br>an apical 4-chamber view of the<br>heart that has been captured and<br>assessed to have an ejection |
| | | fraction $≥50%$ . |
| Anatomical Site | Cardiovascular | Cardiovascular |
| Users | Healthcare provider | Interpreting clinician |
| Machine Learning-<br>Based Algorithm | Yes | Yes |
| Operating Platform | Client-Server Google Chrome<br>Application. | Hosted on Ultromics' platform or<br>on third party infrastructure. |
| Risk Management | In accordance with ISO<br>14971:2019 | In accordance with ISO<br>14971:2019 |
| Usability | Usability assessment determined<br>there were no critical tasks<br>associated with the use of the<br>device. | Complies with IEC 62366-1:2020<br>and general use of FDA guidance<br>documents on usability<br>engineering. Formative and<br>summative evaluations conducted<br>with accredited cardiac<br>physiologists (N=2) and<br>cardiologists (N=5). |
| Pre-clinical | No animal studies were | No animal studies were |
| Performance Testing | conducted. | conducted. |
| Bench Performance<br>Testing | Technical validation. | Technical validation, numerical<br>stability, and regression testing. |
| Clinical Performing<br>Testing | Validated on a US/OUS cohort<br>population, comprising 23<br>independent clinical sites<br>representative of the intended<br>use population. | Validated on a US cohort<br>population, comprising 8<br>independent clinical sites<br>representative of the intended<br>use population. |
#### 7. Performance Data
### Non-clinical Testing
Risk assessment, performance, and cybersecurity of Cleerly ISCHEMIA have been evaluated and verified in accordance with software pre-defined specifications and applicable performance standards through software verification testing. Verification testing confirmed that the software requirements fulfilled the pre-defined acceptance criteria.
The nonclinical verification test results established that the device meets its design requirements and intended use. During the development, potential hazards were evaluated and controlled through risk management activities. The performance testing demonstrates that the device meets all its specifications.
### Clinical Testing
Clinical validation testing was done to validate the diagnostic performance of Cleerly ISCHEMIA for non-invasive determination of the functional significance of CAD, as referenced to direct invasive
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measurement of FFR as the reference standard. The Cleerly ISCHEMIA validation study used data from the CREDENCE Trial (Computed TomogRaphic Evaluation of Atherosclerotic DEtermiNants of Myocardial IsChEmia), a prospective, multicenter trial of 612 stable subjects with suspected, but unconfirmed, CAD who were referred for non-emergent clinically indicated ICA based upon MPI and/or CCTA. CREDENCE enrollees were recruited across 17 centers between 2014 and 2017. Eligibility criteria included referral to non-emergent ICA. All index tests were interpreted blindly by core laboratories. The study population comprised 612 patients with stable symptoms and without a prior diagnosis of CAD referred for non-emergent ICA. Patients were recruited across 23 centers. Trial participants were assigned to 2 subsets with the first half of enrollees at each site assigned to the derivation (n = 307) and the second half to the validation (n = 305) data set.
The primary endpoint analysis is provided in Table 2 below.
| Endpoint | Result | Lower 95% Confidence Limit |
|-----------------------------------|--------------------|----------------------------|
| Sensitivity, per-vessel territory | 75.9%<br>(167/220) | 70.7% |
| Specificity, per-vessel territory | 83.4%<br>(521/625) | 80.2% |
# Table 2. Primary Endpoint Results
In addition to the CREDENCE data, device performance was supported by additional studies performed both in the US and outside of the US (OUS). Cumulative results of the CREDENCE data with these other data sources are provided in Tables 3 and 4 as follows:
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| | Pooled US<br>(N=149 subjects, 285<br>vessel territories) | | Pooled OUS<br>(N=433 subjects, 1236<br>vessel territories) | | Pooled US + Pooled OUS<br>(N=582 subjects, 1521<br>vessel territories) | |
|-------------|----------------------------------------------------------|-----------------|------------------------------------------------------------|-----------------|------------------------------------------------------------------------|-----------------|
| | Estimate | 95% CI | Estimate | 95% CI | Estimate | 95% CI |
| Sensitivity | 79.5%<br>(58/73) | 70.7%,<br>87.8% | 75.5%<br>(259/343) | 70.6%,<br>80.2% | 76.2%<br>(317/416) | 71.9%,<br>80.3% |
| Specificity | 82.5%<br>(175/212) | 76.5%,<br>88.1% | 85.8%<br>(766/893) | 83.3%,<br>88.1% | 85.2%<br>(941/1105) | 82.8%,<br>87.4% |
| PPV | 61.1%<br>(58/95) | 51.1%,<br>70.9% | 67.1%<br>(259/386) | 61.8%,<br>72.0% | 65.9%<br>(317/481) | 61.2%,<br>70.3% |
| NPV | 92.1%<br>(175/190) | 88.1%,<br>95.6% | 90.1%<br>(766/850) | 87.9%,<br>92.3% | 90.5%<br>(941/1040) | 88.5%,<br>92.3% |
| LR+ | 4.54 | - | 6.78 | - | 5.15 | - |
| LR- | 0.25 | - | 0.36 | - | 0.28 | - |
Table 3. Pooled Per-Vessel Territory Diagnostic Performance Estimates by US, Outside US (OUS), and Combined US and OUS Patient Cohorts, Along with 95% Confidence Intervals (CI)
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# Table 4. Per patient territory diagnostic performance estimates by region and in aggregated with 95% Cl.
| | Pooled US<br>(N=149 subjects) | | Pooled OUS<br>(N=433 subjects) | | Pooled US + Pooled OUS<br>(N=582 subjects) | |
|-------------|-------------------------------|-----------------|--------------------------------|-----------------|--------------------------------------------|-----------------|
| | Estimate | 95% CI | Estimate | 95% CI | Estimate | 95% CI |
| Sensitivity | 87.5%<br>(56/64) | 77.0%,<br>93.8% | 86.4%<br>(190/220) | 81.2%,<br>90.3% | 86.6%<br>(246/284) | 82.1%,<br>90.1% |
| Specificity | 75.3%<br>(64/85) | 65.1%,<br>83.3% | 67.6%<br>(144/213) | 61.1%,<br>73.5% | 69.8%<br>(208/298) | 64.4%,<br>74.7% |
| PPV | 72.7%<br>(56/77) | 61.8%,<br>81.5% | 73.4%<br>(190/259) | 67.7%,<br>78.4% | 73.2%<br>(246/336) | 68.2%,<br>77.7% |
| NPV | 88.9%<br>(64/72) | 79.3%,<br>94.5% | 82.8%<br>(144/174) | 76.4%,<br>87.7% | 84.6%<br>(208/246) | 79.5%,<br>88.6% |
| LR+ | 3.54 | - | 2.67 | - | 2.87 | - |
| LR- | 0.17 | - | 0.20 | - | 0.19 | - |
Cumulatively, these data demonstrate acceptable clinical performance.
#### 8. Cybersecurity
As an add-on module to Cleerly Labs, controls over Cybersecurity risks for Cleerly ISCHEMIA are enacted within Cleerly Labs. Cleerly Labs has implemented security features for device and data protection. Cybersecurity requirements, risk analysis, and mitigation was addressed in accordance with FDA guidance, "Content of Premarket Submission for Management of Cybersecurity in Medical Devices."
#### 9. Conclusions
Cleerly ISCHEMIA is as safe and effective as the predicate EchoGo Heart Failure device (K222463). Cleerly ISCHEMIA has a similar intended use and indications for use, as well as similar technological characteristics and principles of operation as its predicate device. The minor differences between the indications do not alter the intended use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between Cleerly ISCHEMA and its predicate device raise no new issues of safety or effectiveness. Cleerly ISCHEMIA is as safe and effective as the predicate EchoGo Heart Failure (K222463). Thus, Cleerly ISCHEMIA is substantially equivalent.
