Imbio RV/LV Software

K203256 · Imbio, LLC · QIH · Mar 9, 2021 · Radiology

Device Facts

• Record ID: K203256
• Device Name: Imbio RV/LV Software
• Applicant: Imbio, LLC
• Product Code: QIH · Radiology
• Decision Date: Mar 9, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• 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
Right Ventricle/Left Ventricle (RV/LV) diameter ratio	—	—	—	—	—	Reader Study-I (improvement of agreement among general radiologists) and Reader Study-II (accuracy of RV/LV diameter ratios compared to radiologist measurements).	>1 (general radiologist)

Indications for Use

The Imbio RV/LV Software device is designed to measure the maximal diameters of the right and left ventricles of the heart from a volumetric CTPA acquisition and report the ratio of those measurements. RV/LV analyzes cases using an artificial intelligence algorithm to identify the location and measurements of the ventricles. The RV/LV software provides the user with annotated images showing ventricular measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CTPA cases.

Device Story

Imbio RV/LV Software is a SaMD that processes volumetric CTPA image datasets to measure right and left ventricular diameters. It uses an AI algorithm to automatically segment and identify ventricular locations, calculating the RV/LV ratio. The software operates as a command-line executable, typically integrated into radiological workflows at PACS workstations. It outputs annotated DICOM images with color-coded caliper measurements and a summary PDF report. Physicians use these outputs as an aid to support clinical assessment of CTPA cases; results are not for stand-alone decision-making. The device benefits patients by providing automated, consistent measurements to assist in the evaluation of cardiac dimensions from existing CTPA scans.

Clinical Evidence

Clinical performance was evaluated via two reader studies using anonymized CTPA datasets. Reader Study-I demonstrated improved agreement among general radiologists when using the RV/LV output report. Reader Study-II demonstrated the accuracy of the software's RV/LV diameter ratios compared to radiologist measurements.

Technological Characteristics

SaMD; command-line executable; DICOM-compliant; automated segmentation and measurement algorithms; non-gated CTPA input; outputs DICOM secondary capture series and PDF reports. No hardware components; no biocompatibility requirements.

Indications for Use

Indicated for measuring maximal right and left ventricular diameters and their ratio from volumetric CTPA acquisitions to assist physicians in clinical assessment. No specific age or gender restrictions; intended for use by qualified medical professionals.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• ct42 Cardiac Computed Tomography Software (K111373)

Submission Summary (Full Text)

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March 9, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Imbio, LLC % Mr. William McLain Manager, RA/OA 1015 Glenwood Avenue, Floor 4 MINNEAPOLIS MN 55405

Re: K203256

Trade/Device Name: Imbio RV/LV Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: QIH Dated: February 4, 2021 Received: February 5, 2021

Dear Mr. McLain:

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 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)

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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 mediation-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

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration<br>Indications for Use | Form Approved: OMB No. 0910-01<br>Expiration Date: 06/30/2020<br>See PRA Statement below. |
|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | |
| K203256 | |
| Device Name | |

## Indications for Use (Describe)

The Imbio RV/LV Software device is designed to measure the maximal diameters of the right and left ventricles of the heart from a volumetric CTPA acquisition and report the ratio of those measurements. RV/LV analyzes cases using an artificial intelligence algorithm to identify the location and measurements of the ventricles. The RV/LV software provides the user with annotated images showing ventricular measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CTPA cases.

| Type of Use (Select one or both, as applicable) | <div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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#### I 510(k) Summary - K203256

#### I.1 Submission Owner and Correspondent

Imbio, LLC 1015 Glenwood Avenue Floor 4 Minneapolis, MN 55405 Contact: William McLain Phone: [phone] E-Mail: [e-mail]

Other submissions correspondents: Lauren Keith, Director of Engineering, and Hatice Akakin, Machine Learning Specialist

#### Date Summary Prepared I.2

February 1, 2021

#### Device Trade Name 1.3

RV /LV Software

#### 1.4 Device Common Name

Automated Radiological Image Processing Software

#### 1.5 Device Classification Name

Picture archiving and communications system. Classified as Class 2 at 21 CFR 892.2050, product code QIH.

## I.6 Legally Marketed Device To Which The Device Is Substantially Equivalent

The RV/LV Software is substantially equivalent to the ct42 Cardiac Computed Tomography Software cleared under K111373.

#### 1.7 Description of the Device

The Imbio CT RV/LV Software is a set of medical image post-processing computer algorithms that together perform automated image segmentation and diameter measurements on computed tomography pulmonary angiography (CTPA) images. The device then reports the ratio of those diameter measurements. The Imbio CT RV/LV Software is a single

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command-line executable program that may be run directly from the command-line or through scripting and thus the user interface is minimal.

Imbio RV/LV Software is a Software and Medical Device (SaMD) intended to provide annotated images and a PDF report that will be read most typically at a PACS workstation. Imbio RV/LV Software is an aid only used to support a physician in the analysis of CTPA images.

The Imbio RV/LV Software program reads in DICOM CPTA image datasets, processes the data, then writes output DICOM files and summary reports to a specified directory. Imbio RV/LV Software outputs DICOMs of the original input DICOM CPTA images overlaid with color-codings representing the results of RV/LV computer caliper measurement. Additionally, a summary PDF report is output.

Imbio RV/LV Software does not interface directly with any CT scanner or data collection equipment; instead the software imports data files previously generated by such equipment and is integrated as part of the radiological work-flow, reducing the risk of use errors.

#### 1.8 Indications for Use

The Imbio RV/LV Software device is designed to measure the maximal diameters of the right and left ventricles of the heart from a volumetric CTPA acquisition and report the ratio of those measurements. RV/LV analyzes cases using an artificial intelligence algorithm to identify the location and measurements of the ventricles. The RV/LV software provides the user with annotated images showing ventricular measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CTPA cases.

#### 1.9 Technological Characteristics

Table 5 compares the technological characteristics between the proposed RV/LV Software and the predicate ct42 Cardiac Computed Tomography Software.

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| Feature | Proposed Device -<br>RV/LV Software | Predicate Device - ct42 Cardiac<br>Computed Tomography Software<br>(K111373) |
|---------------------------------|------------------------------------------------------|------------------------------------------------------------------------------|
| 510(k) # | TBD | K111373 |
| Device Class | 2 | 2 |
| Product Code | QIH | LLZ |
| Regulation<br>Name | Picture Archiving and<br>communications<br>systems | Picture Archiving and communications<br>systems |
| Regulation<br>Number | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Indication for<br>Use | Due to the length of<br>the statement, see<br>below. | Due to the length of the statement, see<br>below. |
| Input Data<br>Requirements | Non-gated, CT<br>Pulmonary<br>Angiography images | EKG-gated Cardiac CT images |
| DICOM<br>Compliant | Yes | Yes |
| LV<br>Segmentation | Yes | Yes |
| RV<br>Segmentation | Yes | Yes |
| Diameter<br>Measurements | Yes - Automated | Yes - Manual |
| Fully-automated<br>segmentation | Yes | No |
| Interface | Command-Line | Graphical user interface |
| Outputs | Reports, DICOM<br>Secondary Capture<br>series | Report, DICOM Secondary Capture<br>Series. |

Table 5: Technological Characteristics Comparison

Proposed RV/LV Software Indication for Use: The Imbio RV/LV Software device is designed to measure the maximal diameters of the right and left ventricles of the heart from a volumetric CTPA acquisition and report the ratio of those measurements. RV/LV analyzes cases using an artificial intelligence algorithm to identify the location and measurements of the ventricles. The RV/LV software provides the user with annotated images showing

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ventricular measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CTPA cases.

Predicate ct42 Cardiac Computed Tomography Software Indications for Use: ct42 is intended to be used for viewing, post-processing and quantitative evaluation of cardiovascular computed tomography (CT) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format. It enables:

- · Importing Cardiac CT Images in DICOM format
- · Supporting clinical diagnostics by qualitative analysis of the cardiac CT images using display functionality such as panning, windowing, zooming, navigation through series/slices and phases, 3D reconstruction of images including multi-planner reconstructions of the images.
- · Supporting clinical diagnostics by quantitative measurement of the heart and adjacent vessels in cardiac CT images
- · Supporting clinical diagnostics by quantitative measurements of calcified plaques in the coronary arteries (calcium scoring), specifically Agatston and volume and mass calcium scores

It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular CT images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. ct42 is a software application that can be used as a stand-alone product or in a networked environment.

The target population for the ct42 is not restricted, however the image acquisition by a cardiac CT scanner may limit the use of the device for certain sectors of the general public.

ct42 shall not be used to view or analyze images of any part of the body except the cardiac CT images acquired from a cardiovascular CT scanner.

#### I.10 Non-Clinical Testing

Non-clinical testing was conducted in the form of a software validation.

#### I.11 Biocompatibility

Biocompatibility testing is not applicable for the RV/LV Software.

#### I.12 Clinical Testing

Clinical performance testing was conducted in the form of a reader study. In order to assess the software's clinical performance, two different evaluations were carried out. The first test plan (Reader Study-I) demonstrated the improvement of the agreement among general radiologist with the assistance of the RVLV output report. The second test (Reader Study- II) will demonstrated the accuracy of RVLV diameter ratios compared to radiologist's measurement of the RVLV diameter ratio. Anonymized CTPA datasets were utilized in the reader study.

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# I. 510(K) SUMMARY - K203256

### I.13 Conclusions

The results of the comparison of design, intended use and technological characteristics demonstrate that the device is as safe and effective as the legally marketed predicate device.