EchoGo Heart Failure

K222463 · Ultromics Limited · QUO · Nov 23, 2022 · Cardiovascular

Device Facts

• Record ID: K222463
• Device Name: EchoGo Heart Failure
• Applicant: Ultromics Limited
• Product Code: QUO · Cardiovascular
• Decision Date: Nov 23, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2200
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

EchoGo Heart Failure 1.0 is an automated machine learning-based decision support system, indicated as a diagnostic aid for patients undergoing routine functional cardiovascular assessment using echocardiography. When utilised by an interpreting clinician, this device provides information that may be useful in detecting heart failure with preserved ejection fraction (HFpEF). EchoGo Heart Failure 1.0 is indicated in adult populations over 25 years of age. Patient management decisions should not be made solely on the results of the EchoGo Heart Failure 1.0 analysis. EchoGo Heart Failure 1.0 takes as input an apical 4-chamber view of the heart that has been captured and assessed to have an ejection fraction ≥50%.

Device Story

Software-only device; processes DICOM echocardiogram files (apical 4-chamber view, EF ≥50%, no contrast, full cardiac cycle). Uses convolutional neural network (AI) to classify presence/absence of HFpEF. Operates on Ultromics or third-party infrastructure; fully automated; no user interface. Produces report for interpreting clinician. Used as adjunctive diagnostic aid in clinical pathways; results must be confirmed by other investigations. Benefits patient by providing automated decision support for HFpEF detection; assists clinicians in diagnostic decision-making.

Clinical Evidence

Retrospective case-control study (N=1,285; 639 controls, 646 cases) across 8 US sites. Sensitivity 87.8% (95% CI: 85.0-90.3%); specificity 82.0% (95% CI: 78.6-85.0%). p<0.001 for both. Repeatability 100%. Reproducibility: 86.7% positive agreement, 76.9% negative agreement. 7.3% non-diagnostic rate. Sub-group analysis for SGLT2i patients (n=105) showed 80.5% sensitivity and 87.3% specificity.

Technological Characteristics

Software-only SaMD. Input: DICOM echocardiogram (apical 4-chamber view). Processing: Convolutional neural network (AI). Connectivity: Networked/cloud-hosted. Standards: IEC 62304:2015, ISO 14971:2019, IEC 62366-1:2020, DICOM (NEMA PS 3.1-3.20). Software level of concern: Moderate.

Indications for Use

Indicated for adult patients >25 years undergoing routine functional cardiovascular assessment via echocardiography to aid in detecting heart failure with preserved ejection fraction (HFpEF). Requires apical 4-chamber view with ejection fraction ≥50%. Not for sole diagnostic use.

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

• T3 Platform Software (K213230)

Submission Summary (Full Text)

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November 23, 2022

Ultromics Limited Jaco Jacobs Chief Regulatory and Compliance Officer 4630 Kingsgate Cascade Way, Oxford Business Park Oxford, OX4 2SU United Kingdom

Re: K222463

Trade/Device Name: EchoGo Heart Failure Regulation Number: 21 CFR 870.2200 Regulation Name: Adjunctive Cardiovascular Status Indicator Regulatory Class: Class II Product Code: OUO Dated: October 24, 2022 Received: October 25, 2022

Dear Jaco Jacobs:

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

Sincerely,

# Stephen C. 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) K222463

Device Name EchoGo Heart Failure

### Indications for Use (Describe)

EchoGo Heart Failure 1.0 is an automated machine learning-based decision support system, indicated as a diagnostic aid for patients undergoing routine functional cardiovascular assessment using echocardiography. When utilised by an interpreting clinician, this device provides information that may be useful in detecting heart failure with preserved ejection fraction (HFpEF).

EchoGo Heart Failure 1.0 is indicated in adult populations over 25 years of age. Patient management decisions should not be made solely on the results of the EchoGo Heart Failure 1.0 analysis.

EchoGo Heart Failure 1.0 takes as input an apical 4-chamber view of the heart that has been captured and assessed to have an ejection fraction ≥50%.

| | Type of Use (Select one or both, as applicable) | |
|--|-------------------------------------------------|--|
| | | |

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for ULTROMICS. The logo consists of a circular graphic on the left and the word "ULTROMICS" in bold, dark blue letters on the right. The circular graphic is a gradient of blue and green, creating a swirling effect.

#### 1 Submitter

| Company | Ultromics Limited<br>4630 Kingsgate Cascade Way, Oxford Business Park South, Oxford,<br>Oxfordshire, United Kingdom, OX4 2SU |
|---------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact | Dr. Jaco Jacobs |
| Date Prepared | 18th November 2022 |

#### 2 Subject Device

| Product Trade Name | EchoGo Heart Failure |
|--------------------|--------------------------------------------------------------|
| Model Number | 1.0 |
| 510(k) | K222463 |
| Manufacturer | Ultromics Limited |
| Medical Speciality | Cardiology |
| Regulation | 21 CFR 870.2200 – Adjunctive Cardiovascular Status Indicator |
| Product Code | QUO – Adjunctive Heart Failure Status Indicator |
| Regulatory Class | II |

EchoGo Heart Failure is the product trade name and 1.0 is the model number. For the avoidance of doubt, in this submission we combine the product trade name and model number and refer to the subject device as EchoGo Heart Failure 1.0.

#### 3 Predicate Device

| Predicate Device | T3 Platform Software |
|------------------|----------------------|
| 510(k) | K213230 |
| Manufacturer | Etiometry Inc. |

#### Device Description ব

EchoGo Heart Failure 1.0 is a software-only medical device manufactured by Ultromics Limited and granted breakthrough status by the FDA under Q212613.

EchoGo Heart Failure 1.0 takes as input a DICOM file containing an echocardiogram and reports a classification decision suggestive of the presence or absence of heart failure with preserved ejection fraction (HFpEF). The output of this device is based on an artificial intelligence (Al) model developed using a convolutional neural network that produces the classification result. The model takes as input a 2D echocardiogram in which an apical 4-chamber view of the heart has been captured and assessed to have an ejection fraction ≥50% (this would normally be computed using a medical device for the assessment of cardiac function of the left

Image /page/3/Picture/13 description: The image shows the text 'K222463' in a clear, sans-serif font. The text is presented in a vibrant blue color, which contrasts with the white background. The numbers and letters are evenly spaced and easily readable.

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ventricle, for example K213275). The echocardiogram should be acquired without contrast and contain at least one full cardiac cycle.

Independent training, validation and test datasets were used for training and performance assessment of the device. EchoGo Heart Failure 1.0 is fully automated and does not comprise a user interface.

EchoGo Heart Failure 1.0 produces a report containing the result of the classification, and this report is intended to be used by an interpreting clinician as an aid to diagnosis for HFpEF. The results are intended as an additional input to standard diagnostic pathways and should only be used by an interpreting clinician. The device is a diagnostic aid and thus according to common medical sense and the principles of differential diagnosis any diagnostic finding derived from usage of this product must be confirmed by additional diagnostic investigations, if in doubt. The ultimate diagnostic decision remains the responsibility of the interpreting clinician using patient presentation, medical history, and the results of available diagnostic tests, one of which may be EchoGo Heart Failure 1.0.

EchoGo Heart Failure 1.0 is a prescription only device.

## 5 Context

#### 5.1 Intended Use

Providing adjunctive information on a patient's cardiovascular condition (diagnostic aid for Heart Failure with Preserved Ejection Fraction (HFpEF)).

### 5.2 Intended User

The clinician interpreting the report produced by EchoGo Heart Failure 1.0 and making a diagnostic decision.

#### 5.3 Indications for Use

EchoGo Heart Failure 1.0 is an automated machine learning-based decision support system, indicated as a diagnostic aid for patients undergoing routine functional cardiovascular assessment using echocardiography. When utilised by an interpreting clinician, this device provides information that may be useful in detecting heart failure with preserved ejection fraction (HFpEF).

EchoGo Heart Failure 1.0 is indicated in adult populations over 25 years of age. Patient management decisions should not be made solely on the results of the EchoGo Heart Failure 1.0 analysis.

EchoGo Heart Failure 1.0 takes as input an apical 4-chamber view of the heart that has been captured and assessed to have an ejection fraction ≥50%.

## 5.4 Patient Population

Patients undergoing routine functional cardiovascular assessment using diagnostic echocardiography or those suspected of heart failure.

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## 6 Comparison of Intended Use

Both the subject and predicate devices are software-only devices as the subject device is an "automated machine learning based decision support system" and the predicate device "features the T3 Data Aggregation & Visualization software module version 5.0 and the T3 Risk Analytics Engine software module version 8.0″.

Both devices are indicated as adjunctive devices that provide information that may be useful for healthcare professionals in forming a diagnostic decision. The subject device is a "diagnostic aid for patients undergoing routine functional cardiovascular assessment" and the predicate device is intended to be used "to utilize this information to aid in clinical decisions".

Both devices are intended to provide information on the cardiovascular state of patients. The subject device "provides information that may be useful in detecting heart failure with preserved ejection fraction (HFpEF)", whereas the predicate device "presents partial quantitative information about the patient's cardiovascular condition".

Both the subject and predicate devices are adjunctive devices and patient management decisions should not be made solely on device recommendations. Specifically, for the subject device "Patient management decisions should not be made solely on the results of the EchoGo Heart Failure 1.0 analysis"; the predicate states that "The primary data should be reviewed as part of standard patient evaluations and no decisions should be solely based on the indices".

Both the subject and predicate devices have indications for adult populations. The subject device "EchoGo Heart Failure 1.0 is indicated in adult populations over 25 years of age" and the predicate is indicated for use on "adult, paediatric, and neonatal patients".

For purposes of substantial equivalence, the term intended use means the general purpose of the device or its function and encompasses the indications for use. The term indications for use describes the disease the device is intended to serve as a diagnostic aid including a description of the patient population for which the device is intended. Both devices are intended as adjunctive aids for cardiovascular states or conditions and both devices can be used on adult populations. It follows that both devices have intended use of providing adjunctive information on the cardiovascular condition of a patient.

Any minor differences between the intended use and/or indications for use do not raise any new concerns with regards to safety and effectiveness. The regulation product code of the predicate device, PPW, under the associated regulation includes special controls that were applied to the subject device. The general controls and special controls of the predicate device are sufficient to ensure the substantial equivalence of the subject device and adequately control any differences.

#### 7 Comparison of Technological Characteristics

A full comparison of the technological characteristics of the subject and predicate devices follows.

The following technological differences exist between the subject and predicate devices:

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- . The subject device takes as input a DICOM file containing an echocardiogram and the predicate device uses as input numeric physiological information from medical devices to which it is connected. Both devices therefore receive as input data that is the output of another medical device.
- The output of the subject device is based on an artificial intelligence (AI) model developed using a . convolutional neural network that produces a classification result. The output of the predicate device is derived from mathematical manipulations of physiologic data and measurements received from connected devices.
- . The subject device reports a classification as suggestive or not suggestive of the presence of heart failure with preserved ejection fraction (HFpEF), while the predicate device calculates indices that provides information on the respiratory or cardiovascular status of patients (IVCO2 and ACD, HLA and IDO2, respectively). Both devices are adjunctive cardiovascular status indicators.
- The predicate device outputs or displays amalgamated information from connected devices not output by ● the subject device, for example:
- Airway flow, volume, and pressure .
- . Arterial blood pressure (invasive and non-invasive, systolic, diastolic, and mean)
- Bi-spectral index (BIS, signal quality index, suppression ratio) .
- . Cardiac Index
- Cardiac output ●
- Central venous pressure .
- Cerebral perfusion pressure ●
- End-tidal CO2 ●
- Heart rate ●
- Heart rate variability ●
- Intracranial pressure ●
- Left atrium pressure ●
- Oxygen saturation (intravascular, regional, SpO2) ●
- Premature ventricular counted beats ●
- Pulmonary artery pressure (systolic, diastolic, and mean) .
- Pulse pressure variation ●
- Pulse Rate ●
- Respiratory rate ●
- Right atrium pressure ●
- Temperature (rectal, oesophageal, tympanic, blood, core, nasopharyngeal, skin) ●
- Umbilical arterial pressure (systolic, diastolic, and mean) .

The following table summarises technological characteristics.

| Characteristic | Subject Device<br>EchoGo Heart Failure 1.0 | Predicate Device<br>T3 Platform Software |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation | 21 CFR 870.2200 | 21 CFR 870.2200 |
| Generic Device<br>Type | Adjunctive cardiovascular status<br>indicator | Adjunctive cardiovascular status<br>indicator |
| Characteristic | Subject Device | Predicate Device |
| | EchoGo Heart Failure 1.0 | T3 Platform Software |
| SaMD | Yes | Yes |
| Intended Use | Providing adjunctive information on a<br>patient's cardiovascular condition<br>(diagnostic aid for Heart Failure with<br>Preserved Ejection Fraction (HFpEF)). | Providing adjunctive information on a<br>patient's cardiovascular and respiratory<br>condition. |
| Indications for Use | EchoGo Heart Failure 1.0 is an<br>automated machine learning-based<br>decision support system, indicated as a<br>diagnostic aid for patients undergoing<br>routine functional cardiovascular<br>assessment using echocardiography.<br>When utilised by an interpreting<br>clinician, this device provides<br>information that may be useful in<br>detecting heart failure with preserved<br>ejection fraction (HFpEF).<br>EchoGo Heart Failure 1.0 is indicated in<br>adult populations over 25 years of age.<br>Patient management decisions should<br>not be made solely on the results of the<br>EchoGo Heart Failure 1.0 analysis.<br>EchoGo Heart Failure 1.0 takes as input<br>an apical 4-chamber view of the heart<br>that has been captured and assessed to<br>have an ejection fraction ≥50%. | The T3 Data Aggregation & Visualization<br>software module is intended for the<br>recording and display of multiple<br>physiological parameters of the adult,<br>paediatric, and neonatal patients from<br>supported bedside devices. The<br>software module is not intended for<br>alarm notification or waveform display,<br>nor is it intended to control any of the<br>independent bedside devices to which it<br>is connected. The software module is<br>intended to be used by healthcare<br>professionals for the following purposes:<br>• To remotely consult regarding a<br>patient's status, and<br>• To remotely review other standard<br>or critical near real-time patient data<br>in order to utilize this information to<br>aid in clinical decisions and deliver<br>patient care in a timely manner.<br>The T3 Data Aggregation & Visualization<br>software module can display numeric<br>physiologic data captured by other<br>medical devices:<br>• Airway flow, volume, and pressure<br>• Arterial blood pressure (invasive and<br>non-invasive, systolic, diastolic, and<br>mean)<br>• Bi-spectral index (BIS, signal quality<br>index, suppression ratio)<br>• Cardiac Index • Cardiac output<br>• Central venous pressure<br>• Cerebral perfusion pressure<br>• End-tidal CO2<br>• Heart rate<br>• Heart rate variability |
| Characteristic | Subject Device | Predicate Device |
| | EchoGo Heart Failure 1.0 | T3 Platform Software |
| | | • Intracranial pressure<br>• Left atrium pressure<br>• Oxygen saturation (intravascular,<br>regional, SpO2)<br>• Premature ventricular counted beats<br>• Pulmonary artery pressure<br>(systolic, diastolic, and mean)<br>• Pulse pressure variation<br>• Pulse Rate<br>• Respiratory rate<br>• Right atrium pressure<br>• Temperature (rectal, oesophageal,<br>tympanic, blood, core,<br>nasopharyngeal, skin)<br>• Umbilical arterial pressure (systolic, diastolic, and mean)<br>The T3 Data Aggregation & Visualization<br>software module can display laboratory<br>measurements including arterial and<br>venous blood gases, complete blood<br>count, and lactic acid. T3 Data<br>Aggregation & Visualization software<br>module can display information<br>captured by the T3 Risk Analytics Engine<br>software module.<br>The T3 Risk Analytics Engine software<br>module calculates four indices: the IDO2<br>Index for inadequate delivery of oxygen,<br>the IVCO2 Index for inadequate<br>ventilation of carbon dioxide, the ACD<br>Index for acidaemia, and the HLA Index<br>for hyperlactatemia.<br>The IDO2 Index is indicated for use by<br>health care professionals with post-<br>surgical patients 0 to 12 years of age and<br>weighing 2 kg or more under intensive<br>care. The IDO2 Index is derived by<br>mathematical manipulations of the<br>physiologic data and laboratory<br>measurements received by the T3 Data<br>Aggregation & Visualization software<br>module. When the IDO2 Index is |
| Characteristic | Subject Device | Predicate Device |
| | EchoGo Heart Failure 1.0 | T3 Platform Software |
| | | increasing, it means that there is an |
| | | increasing risk of inadequate oxygen |
| | | delivery and attention should be |
| | | brought to the patient. |
| | | The IDO2 Index presents partial |
| | | quantitative information about the |
| | | patient's cardiovascular condition, and |
| | | no therapy or drugs can be administered |
| | | based solely on the interpretation |
| | | statements. The IVCO2 Index is indicated |
| | | for use by health care professionals with |
| | | invasively ventilated patients 0 to 12 |
| | | years of age and weighing 2 kg or more |
| |…