(147 days)
Not Found
Yes
The "Intended Use / Indications for Use" section explicitly states that the software "uses machine learning to analyze non-contrast thoracic CT images".
No
The device is described as a post-processing software that evaluates calcified plaques and outputs metrics for informational purposes, aiding in risk assessment, but it does not diagnose or provide treatment.
Yes
The device evaluates calcified plaques in the coronary arteries to assess risk for coronary artery disease and outputs metrics like Agatston score, arterial age, and calcified lesion mass and volume. While it states it "does not diagnose coronary artery disease" and is "an aid only used to support a physician in the analysis of CT images," the act of evaluating risk and providing quantitative measures related to a medical condition falls under the umbrella of a diagnostic device, as it provides information used to aid in diagnosis or understanding a patient's condition.
Yes
The device is described as a "set of medical image post-processing computer algorithms" and a "Software and Medical Device (SaMD)". It reads in existing CT data and outputs reports and annotated images, without directly interfacing with hardware for data acquisition or patient interaction.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples from the human body. The description clearly states that the Imbio CAC Software analyzes non-contrast thoracic CT images. These are medical images, not biological samples like blood, urine, or tissue.
- The intended use is image post-processing. The software processes existing medical images to provide quantitative information about calcifications. It does not perform tests on biological specimens.
- The output is a report and annotated images. The results are presented as a summary report and overlaid images, which are typical outputs for medical image analysis software, not IVDs.
The device is described as a "Software and Medical Device (SaMD)" and is intended to be used as an "aid only used to support a physician in the analysis of CT images." This aligns with the definition of a medical device that processes imaging data, not an IVD.
No
The clearance letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
Imbio CAC Software is intended for use as a non-invasive post-processing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery disease. Imbio CAC Software uses machine learning to analyze non-contrast thoracic CT images and outputs a summary report containing Agatston score, arterial age, and calcified lesion mass and volume metrics of the calcification burden for the whole heart and individual coronary artery level. Additionally, Imbio CAC Software outputs annotated images previewing the segmentation of calcifications for informational purposes only. Imbio CAC Software is limited to the quantification of detected possible calcifications in adult patients ≥ 29 years of age. It does not diagnose coronary artery disease. The device output will be available to the users as part of the standard DICOM viewing workflow. The Imbio CAC Software results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CT images.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
The Imbio CAC Software is a set of medical image post-processing computer algorithms that together performs automated coronary artery calcification segmentation and reports a total Agatston score, calcified lesion mass and volume, and arterial age from thoracic computed tomography (CT) images. The Agatston score, calcified lesion mass and volume are reported both as a total and for each of the following individual coronary arteries: right coronary artery (RCA), left anterior descending (LAD), left circumflex (LCx). The Imbio CAC 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 CAC Software is a Software and Medical Device (SaMD) intended to provide annotated DICOM-formatted images and a PDF report that will be read most typically at a PACS workstation. Imbio CAC Software is an aid only used to support a physician in the analysis of CT images.
The Imbio CAC Software program reads in thoracic CT DICOM datasets, processes the data, then writes output DICOM files and summary reports to a specified directory. Imbio CAC Software outputs DICOMs of the original input DICOM CT images overlaid with color-codings representing the coronary artery calcification segmentations. Additionally, a summary PDF report is output.
Imbio CAC Software does not interface directly with any CT scanner or data collection equipment; instead the software imports data previously generated by such equipment and is integrated as part of the radiological workflow, reducing the risk of use errors.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Imbio CAC Software uses machine learning to analyze non-contrast thoracic CT images
Input Imaging Modality
non-contrast thoracic CT images
Anatomical Site
coronary arteries, whole heart, individual coronary artery level. Thoracic, Chest, Cardiac.
Indicated Patient Age Range
adult patients ≥ 29 years of age.
Intended User / Care Setting
Not Found
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
Non-clinical testing was conducted in the form of a retrospective, multi-center, standalone device performance assessment. 500 anonymized chest CT series meeting the input requirements for Imbio CAC Software were curated from a variety of sources including large publically available databases and private imaging data brokers. Exclusion criteria included:
- CTs from pediatric patients ( 0.859.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Cohen's kappa: 0.907 (95% CI 0.895, 0.920)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
June 13, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
Imbio, Inc. % Lauren Keith Director of Engineering 1015 Glenwood Avenue, Floor 4 MINNEAPOLIS MN 55405
Re: K230112
Trade/Device Name: CAC Software Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: May 9, 2023 Received: May 9, 2023
Dear Lauren Keith:
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
1
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 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.
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| Form Approved: OMB No. 0910-0120 |
|---|
| Expiration Date: 06/30/2020 |
| See PRA Statement below. |
| 510(k) Number (if known) | K230112 |
|---|---|
| -------------------------- | --------- |
| Device Name | CAC Software |
|---|---|
| ------------- | -------------- |
Imbio CAC Software is intended for use as a non-invasive post-processing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery disease. Imbio CAC Software uses machine learning to analyze non-contrast thoracic CT images and outputs a summary report containing Agatston score, arterial age, and calcified lesion mass and volume metrics of the calcification burden for the whole heart and individual coronary artery level. Additionally, Imbio CAC Software outputs annotated images previewing the segmentation of calcifications for informational purposes only. Imbio CAC Software is limited to the quantification of detected possible calcifications in adult patients ≥ 29 years of age. It does not diagnose coronary artery disease. The device output will be available to the users as part of the standard DICOM viewing workflow. The Imbio CAC Software results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CT images.
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
Indications for Use (Describe)
3
510(k) Summary
K230112
1.1 Submission Owner and Correspondent
- Imbio, Inc. 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 Kai Ludwig, Senior Imaging Scientist.
1.2 Date Summary Prepared
January 13, 2023
Device Trade Name 1.3
CAC Software
1.4 Device Common Name
Automated computer-assisted coronary artery calcification and reporting software
1.5 Device Classification Name
Computed tomography x-ray system. Classified as Class 2 at 21 CFR 892.1750, product code JAK.
1.6 Legally Marketed Device To Which The Device Is Substantially Equivalent
The CAC Software is substantially equivalent to the Zebra Medical Vision HealthCCSng cleared under K210085.
4
Description of the Device 1.7
The Imbio CAC Software is a set of medical image post-processing computer algorithms that together performs automated coronary artery calcification segmentation and reports a total Agatston score, calcified lesion mass and volume, and arterial age from thoracic computed tomography (CT) images. The Agatston score, calcified lesion mass and volume are reported both as a total and for each of the following individual coronary arteries: right coronary artery (RCA), left anterior descending (LAD), left circumflex (LCx). The Imbio CAC 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 CAC Software is a Software and Medical Device (SaMD) intended to provide annotated DICOM-formatted images and a PDF report that will be read most typically at a PACS workstation. Imbio CAC Software is an aid only used to support a physician in the analysis of CT images.
The Imbio CAC Software program reads in thoracic CT DICOM datasets, processes the data, then writes output DICOM files and summary reports to a specified directory. Imbio CAC Software outputs DICOMs of the original input DICOM CT images overlaid with color-codings representing the coronary artery calcification segmentations. Additionally, a summary PDF report is output.
Imbio CAC Software does not interface directly with any CT scanner or data collection equipment; instead the software imports data previously generated by such equipment and is integrated as part of the radiological workflow, reducing the risk of use errors.
1.8 Indication for Use
Imbio CAC Software is intended for use as a non-invasive post-processing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery disease. Imbio CAC Software uses machine learning to analyze non-contrast CT images and outputs a summary report containing Agatston score, arterial age, and calcified lesion mass and volume metrics of the calcification burden for the whole heart and individual coronary artery level. Additionally, Imbio CAC Software outputs annotated images previewing the segmentation of calcifications for informational purposes only. Imbio CAC Software is limited to the quantification of detected possible calcifications in adult patients > 29 years of age. It does not diagnose coronary artery disease. The device output will be available to the users as part of the standard DICOM viewing workflow. The Imbio CAC Software results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CT images.
1.9 Technological Characteristics
Table 1.1 compares the technological characteristics between the proposed CAC Software and the predicate Zebra Medical Vision HealthCCSng.
Table 1.1: Technological Characteristics Comparison with Predicate Device
| Indications for Use | Due to the length of the
statement, see below. | Due to the length of the
statement, see below. | Different but does not
introduce questions of
safety and effectiveness. |
| --------------------- | --------------------------------------------------- | --------------------------------------------------- | ------------------------------------------------------------------------------- |
|---|
5
| Characteristic | Proposed Device CAC Software | Predicate Device Zebra Medical Vision HealthCCSng | Comparison |
|---|---|---|---|
| Regulatory | |||
| FDA Clearance | TBD | K210085 (9/9/2021) | |
| Product Code | JAK | JAK | Same |
| Class | II | II | Same |
| Regulation | 21 CFR 892.1750 | 21 CFR 892.1750 | Same |
| Software | Device is software only | Device is software only | Same |
| Level of Concern | Moderate | Moderate | Same |
| General | |||
| Modality | CT | CT | Same |
| Anatomical Site | Thoracic, Chest, Cardiac | Thoracic, Chest, Cardiac | Same |
| Support Input CT Scan | Low and standard dose. Cardiac-gated and non-cardiac-gated. Up to 3mm slice thickness. | Low and standard dose. Non-cardiac-gated. Up to 3mm slice thickness. | Different - Predicate is not labeled for use in cardiac-gated scans. |
| Image Format | DICOM | DICOM | Same |
| Use Environment | Hospitals and Clinics including Inpatient and outpatient, and lung cancer screening programs. | Hospitals and Clinics including Inpatient and outpatient, and lung cancer screening programs. | Same |
| Quantification | |||
| Calcium Detection | Automatic | Automatic | Same |
| Default Threshold | 130 (HU) | 130 (HU) | Same |
| Calcium Reporting | CAC score and reference 5 category CAC risk | 3 category CAC risk | Different - Predicate does not report CAC score and combines lower risk categories. |
| Display and Outputs | |||
| Outputs | DICOM Report and CAC annotated DICOM images. | DICOM Report and CAC annotated DICOM images. | Same |
| Alteration of original image | No | No | Same |
| Image Viewing | Images viewed on existing viewing workstation. | Images viewed on existing viewing workstation. | Same |
| Characteristic | Proposed Device | ||
| CAC Software | Predicate Device | ||
| Zebra Medical Vision | |||
| HealthCCSng | Comparison | ||
| Communication with Patient | Does not communicate | ||
| with patients. | Does not communicate | ||
| with patients. | Same |
6
7
Proposed Device CAC Software Indication for Use: Imbio CAC Software is intended for use as a non-invasive post-processing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery disease. Imbio CAC Software uses machine learning to analyze non-contrast thoracic CT images and outputs a summary report containing Agatston score, arterial age, and calcified lesion mass and volume metrics of the calcification burden for the whole heart and individual coronary artery level. Additionally, Imbio CAC Software outputs annotated images previewing the segmentation of calcifications for informational purposes only. Imbio CAC Software is limited to the quantification of detected possible calcifications in adult patients ≥ 29 years of age. It does not diagnose coronary artery disease. The device output will be available to the users as part of the standard DICOM viewing workflow. The Imbio CAC Software results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CT images.
Predicate Device Zebra Medical Vision HealthCCSng Indications for Use: HealthCCSng device is intended for use as a non-invasive post-processing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery disease. The software generates an estimated coronary artery calcium detection category. The HealthCCSng device analyzes existing non-cardiac-gated CT studies that include the heart of adult patients above the age of 30. The device generates a three-category output representing the estimated quantity of calcium detected together with the preview axial images of the detected calcium meant for informational purposes only. The device output will be available to the radiologist as part of their standard workflow. The HealthCCSng results are not intended to be used on a stand-alone basis for risk attribution, clinical decision-making or otherwise preclude clinical assessment of CT studies.
1.10 Clinical Study
Non-clinical testing was conducted in the form of a retrospective, multi-center, standalone device performance assessment. 500 anonymized chest CT series meeting the input requirements for Imbio CAC Software were curated from a variety of sources including large publically available databases and private imaging data brokers. Exclusion criteria included:
- · CTs from pediatric patients ( 0.859.
1.11 Biocompatibility
Biocompatibility testing is not applicable for the CAC Software.
Conclusions 1.12
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.