(125 days)
Not Found
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "analyzes cases using an artificial intelligence algorithm".
No
The device is intended for measurement and analysis of CTPA images to aid diagnosis, not to provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" states that the 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." Additionally, the "Intended User / Care Setting" mentions that the software is used by qualified medical professionals "for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process." These points indicate its role in providing data for diagnosis.
Yes
The device is explicitly described as "Imbio CT RV/LV Software" and "a set of medical image post-processing computer algorithms". It processes existing DICOM image data and outputs reports and annotated images, without including or requiring any specific hardware component for its function. It is also described as "Software and Medical Device (SaMD)".
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). This device analyzes images of the human body (CTPA scans).
- The intended use is to process and analyze medical images. This falls under the category of medical image processing software, not IVD.
- The device description explicitly states it processes DICOM image datasets. This confirms it works with imaging data, not biological samples.
Therefore, while it is a medical device that aids in diagnosis, it does not meet the definition of an In Vitro Diagnostic.
No
The text explicitly states "Control Plan Authorized (PCCP) and relevant text: Not Found", indicating no mention of PCCP authorization.
Intended Use / 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.
Product codes
QIH
Device Description
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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
volumetric CTPA acquisition (Computed Tomography Pulmonary Angiography images)
Anatomical Site
heart (right and left ventricles)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician (specifically, qualified medical professionals, experienced in examining and evaluating cardiovascular CT images, as per predicate device description used for comparison) at a PACS workstation.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Anonymized CTPA datasets were utilized in the reader study.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Improvement of the agreement among general radiologist, Accuracy of RVLV diameter ratios compared to radiologist's measurement of the RVLV diameter ratio.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
0
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)
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
Food and Drug Administration
Indications for Use | Form Approved: OMB No. 0910-01
Expiration Date: 06/30/2020
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) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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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: 717-656-9656 E-Mail: billmclain@imbio.com
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
4
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.
5
| Feature | Proposed Device -
RV/LV Software | Predicate Device - ct42 Cardiac
Computed Tomography Software
(K111373) |
|---------------------------------|------------------------------------------------------|------------------------------------------------------------------------------|
| 510(k) # | TBD | K111373 |
| Device Class | 2 | 2 |
| Product Code | QIH | LLZ |
| Regulation
Name | Picture Archiving and
communications
systems | Picture Archiving and communications
systems |
| Regulation
Number | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Indication for
Use | Due to the length of
the statement, see
below. | Due to the length of the statement, see
below. |
| Input Data
Requirements | Non-gated, CT
Pulmonary
Angiography images | EKG-gated Cardiac CT images |
| DICOM
Compliant | Yes | Yes |
| LV
Segmentation | Yes | Yes |
| RV
Segmentation | Yes | Yes |
| Diameter
Measurements | Yes - Automated | Yes - Manual |
| Fully-automated
segmentation | Yes | No |
| Interface | Command-Line | Graphical user interface |
| Outputs | Reports, DICOM
Secondary Capture
series | Report, DICOM Secondary Capture
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
6
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.
7
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.