Automated Ejection Fraction SaMD De Novo

The FDA completed its review of an Automated Ejection Fraction SaMD De Novo leading to a new Class II code, ‘QVD.’  The FDA notice follows including the special controls.

FDA Notice

Re: DEN220063

Trade/Device Name: Caption Interpretation Automated Ejection Fraction Software

Regulation Number: 21 CFR 892.2055

Regulation Name: Radiological machine learning-based quantitative imaging software with predetermined change control plan

Regulatory Class: Class II

Product Code: QVD

Dated: September 28, 2022

Received: September 28, 2022

The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your De Novo request for classification of the Caption Interpretation Automated Ejection Fraction Software, a prescription device under 21 CFR Part 801.109 with the following indications for use:

The Caption Interpretation Automated Ejection Fraction software is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM- compliant PACS system in order to provide automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation.

The Caption Interpretation Automated Ejection Fraction Software is indicated for use in adult patients.

FDA concludes that this device should be classified into Class II. This order, therefore, classifies the Caption Interpretation Automated Ejection Fraction Software, and substantially equivalent devices of this generic type, into Class II under the generic name radiological machine learning-based quantitative imaging software with predetermined change control plan.

FDA identifies this generic type of device as:

Radiological machine learning-based quantitative imaging software with predetermined change control plan. A radiological machine learning based quantitative imaging software with predetermined change control plan is a software-only device which employs machine learning algorithms on radiological images to provide quantitative imaging outputs. The device includes functions to support outputs such as view selection, segmentation and landmarking. The design specifications include planned modifications that may be made to the device consistent with an established predetermined change control plan.

After review of the information submitted in the De Novo request and provided interactively in response to interactive deficiencies, FDA has determined that, for the previously stated indications for use, the Caption Interpretation Automated Ejection Fraction Software can be classified in class II with the establishment of special controls for class II. FDA believes that class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type. The identified risks and mitigation measures associated with the device type are summarized in the following table:

Identified Risks to Health Mitigation MeasuresMitigation Measures
Inaccurate device output leading to patient receiving incomplete or suboptimal treatment/diagnosisDesign verification and validation activities identified in special control (1);

Certain labeling information identified in special control (4)

Implementation of modifications agreed in the authorized predetermined change control plan (PCCP) leads to algorithm producing inaccurate output, including:

  • Performance related to existing specifications at the time of clearance
  • Performance related to planned additional device capabilities and associated specifications

Special controls (2)-(3) and 4(vii);
Certain activities identified in special controls (1)

Misunderstanding of changes to the device input criteria, output performance, or other aspects of the design as changes are implemented under the PCCP, leading to misuse and incorrect treatment/diagnosis

Special controls (2)-(3);

Labeling information identified in special control (4)(vii)

Read the entire De Novo notification: DEN220063-Caption Ejection Fraction SW.

See our post discussing the Predetermined Change Control Plan (PCCP).

About the author

Brian is a biomedical software engineer - whatever that is! Started writing machine code for the Intel 8080 in 1983. Still enjoys designing and developing code. But probably enjoys his garden more now and watching plants grow ... and grandkids grow!

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