(229 days)
No references device was used in this submission.
Yes
The document explicitly states that the device uses an "artificial intelligence algorithm" to perform its function.
No
This device is a software system that assesses the cardiothoracic ratio from X-ray images; it provides information for diagnosis but does not directly treat or prevent a disease or condition.
Yes
The device "automatically assesses the cardiothoracic ratio (CTR) of a chest X-ray image" and its output helps "physicians or other licensed practitioners" and is used in a clinical setting, which are characteristics of a diagnostic device. While its results are not for stand-alone clinical decision-making, it provides measurements and information crucial for diagnosis.
Yes
The device description explicitly states "The iCTR is a non-invasive software medical device designed to be installed on the computer with specific system requirements." It processes existing image data and does not include any hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The EFAI Intelligent Cardiothoracic Ratio Assessment System (iCTR) analyzes medical images (chest X-rays), not biological samples. It processes existing image data to provide a measurement (CTR).
- Intended Use: The intended use clearly states it's for assessing the cardiothoracic ratio from a chest X-ray image from the X-ray imager subject. This is image analysis, not in vitro testing.
- Device Description: The description reinforces that it's a "non-invasive software medical device" that analyzes "DICOM chest X-ray images."
The device falls under the category of medical image analysis software or radiological computer-assisted software, which are distinct from in vitro diagnostics.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
EFAI Intelligent Cardiothoracic Ratio Assessment System (or use by hospital and clinics to automatically assess the cardiothoracic ratio (CTR) of a chest X-ray image from the X-ray imager subject.
The iCTR is designed to measure the maximal transverse diameter of heart and maximal inner transverse diameter of thoracic cavity and calculate the CTR of a chest X-ray image in posterior (PA) chest view using an artificial intelligence algorithm.
Intended users of the software are aimed to the physicians or other licensed practitioners in the healthcare institutions, such as clinics, hospitals, healthcare facilities, residential care facilities and long-term care services.
The system is suitable for adults between 20 - 80 years of age.
Its results are not intended to be used on a stand-alone basis for clinical-decision making or otherwise preclude clinical assessment of cardiothoracic ratio (CTR) cases.
Product codes
QIH
Device Description
The iCTR is a non-invasive software medical device designed to be installed on the computer with specific system requirements. It is a radiological computer-assisted software system that automatically analyzes DICOM chest X-ray images in PA view and outputs the CTR through an artificial intelligence algorithm. The structure report includes a preview of the compressed chest X-ray image with the automatically-derived CTR result and annotation line, indicating the maximal transverse diameter of heart and maximal inner transverse diameter of thoracic cavity, and the trajectory of CTR records. The trajectory of CTR does not implement a predictive or prognostic feature.
Mentions image processing
Medical image management and processing system
Mentions AI, DNN, or ML
The iCTR is designed to measure the maximal transverse diameter of heart and maximal inner transverse diameter of thoracic cavity and calculate the CTR of a chest X-ray image in posterior (PA) chest view using an artificial intelligence algorithm.
Input Imaging Modality
Post-anterior (PA) view chest X-ray image
Chest X-ray in Digital Radiography (DR)
Anatomical Site
Heart, thoracic cavity
Indicated Patient Age Range
Adults between 20 - 80 years of age.
Adults of 20-80 years old
Intended User / Care Setting
Intended users of the software are aimed to the physicians or other licensed practitioners in the healthcare institutions, such as clinics, hospitals, healthcare facilities, residential care facilities and long-term care services.
Description of the training set, sample size, data source, and annotation protocol
Images and cases used for verification testing were carefully separated from training algorithms.
Description of the test set, sample size, data source, and annotation protocol
For clinical performance testing, we included at least a total of 840 eligible PA CXR images of adults (20 to 80 years old) patients from three participating sites (280 per site). We used accuracy to evaluate the agreement between EFAI iCTR-derived and physician derived CTR.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
EFAI iCTR Software verification and validation test results established that the device meets its design requirements and intended use. Specifically, software verification was conducted at unit, module, and system integration levels. Extensive algorithm development and software verification testing assessed the performance characteristics of the algorithm including EFAI iCTR accuracy, risk management, and overall functional performance.
Results of the EFAI iCTR were compared to evaluation by a panel of expert readers. That study met the pre-defined acceptance criteria and found that the observed accuracy estimates for the software were greater than 95% for identification of the imaging mode and the view.
The EFAI iCTR encompasses three quality control models and two annotation models. The quality control models are capable of filtering out non-chest X-ray images (Sensitivity 0.99, Accuracy 0.99), filtering out the non-PA view chest X-ray images(Sensitivity 0.99, Accuracy 0.97), and presenting with message for images with unclear boundary whose threshold is
§ 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
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Ever Fortune. AI Co., Ltd. Chen Ming-Fong Chairman Rm. D, 8F , NO. 573, Sec. 2, Taiwan Blvd., West Dist. TAICHUNG, 403020 TAIWAN
April 4, 2022
Re: K212624
Trade/Device Name: EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: March 9, 2022 Received: March 14, 2022
Dear Chen Ming-Fong:
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills Division 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
2
Indications for Use
510(k) Number (if known) K212624
Device Name
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
Indications for Use (Describe)
EFAI Intelligent Cardiothoracic Ratio Assessment System (or use by hospital and clinics to automatically assess the cardiothoracic ratio (CTR) of a chest X-ray image from the X-ray imager subject.
The iCTR is designed to measure the maximal transverse diameter of heart and maximal inner transverse diameter of thoracic cavity and calculate the CTR of a chest X-ray image in posterior (PA) chest view using an artificial intelligence algorithm.
Intended users of the software are aimed to the physicians or other licensed practitioners in the healthcare institutions, such as clinics, hospitals, healthcare facilities, residential care facilities and long-term care services.
The system is suitable for adults between 20 - 80 years of age.
Its results are not intended to be used on a stand-alone basis for clinical-decision making or otherwise preclude clinical assessment of cardiothoracic ratio (CTR) 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) | ☑ 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) |
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Image /page/3/Picture/0 description: The image displays the logo and name of the "EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System". The logo features a stylized teal-colored graphic with the text "EVER FORTUNE. AI" next to it. The text below the logo indicates that it is an intelligent system for assessing the cardiothoracic ratio.
510(k) Summary
K212624
The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:
I. Submitter
| Company: | EVER FORTUNE.AI Co., Ltd. |
|---|---|
| 8 F., No. 573, Sec. 2, Taiwan Blvd., | |
| West Dist., Taichung City 403020, Taiwan | |
| Phone: (886)-4-2322-6363 | |
| Fax: (886)-4-2322-9797 | |
| ra99@everfortuneai.com.tw | |
| Contact: | MING-FONG, CHEN (Chairman) |
| ra99@everfortuneai.com.tw | |
| Date Prepared: | March 09, 2022 |
II. Name of the Device
| Name of Device: | EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System |
|---|---|
| Common Name: | EFAI iCTR |
| Classification Name: | Medical image management and processing system |
| Review Panel: | Radiology |
| Regulation: | 21 CFR 892.2050 |
| Device Class: | Class II |
| Product Code: | QIH |
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III. Predicate Device
| Name | Manufacturer | 510(K)# |
|---|---|---|
| Imbio RV/LV Software | Imbio, LLC | K203256 |
The EFAI iCTR is equivalent to the Imbio RV/LV Software (K203256), manufactured by Imbio, LLC is provided as primary predicate device. The predicate has not been subject to a design-related recall. No references device was used in this submission.
IV. Device Description
The iCTR is a non-invasive software medical device designed to be installed on the computer with specific system requirements. It is a radiological computer-assisted software system that automatically analyzes DICOM chest X-ray images in PA view and outputs the CTR through an artificial intelligence algorithm. The structure report includes a preview of the compressed chest X-ray image with the automatically-derived CTR result and annotation line, indicating the maximal transverse diameter of heart and maximal inner transverse diameter of thoracic cavity, and the trajectory of CTR records. The trajectory of CTR does not implement a predictive or prognostic feature.
V. Indications for Use
EFAI Intelligent Cardiothoracic Ratio Assessment System (or iCTR) is a software for use by hospital and clinics to automatically assess the cardiothoracic ratio (CTR) of a chest X-ray image from the X-ray imager subject. The iCTR is designed to measure the maximal transverse diameter of heart and maximal inner transverse diameter of thoracic cavity and calculate the CTR of a chest X-ray image in posterior (PA) chest view using an artificial intelligence algorithm.
Intended users of the software are aimed to the physicians or other licensed practitioners in the healthcare institutions, such as clinics, hospitals, healthcare facilities, residential care facilities and long-term care services. The system is suitable for adults between 20 - 80 years of age.
Its results are not intended to be used on a stand-alone basis for clinical-decision making or otherwise preclude clinical assessment of cardiothoracic ratio (CTR) cases.
VI. Comparison of Technical Characteristics with Predicate Device
The following table compares the EFAI iCTR to the predicate device with respect to intended use, indications for use, technological characteristics, device modalities and forms the determination of substantial equivalence. The comparison table shows that the subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.
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| Table - Comparison Table | ||||
|---|---|---|---|---|
| Feature | EFAI iCTR | |||
| (K212624) | Imbio RV/LV | |||
| Software | ||||
| (K203256) | Difference | |||
| Manufacturer | Ever Fortune.AI Co., | |||
| Ltd. | Imbio LLC | NA | ||
| Regulation Number | 21 CFR §890.2050 | 21 CFR §890.2050 | Same | |
| Regulatory Class | Class II | Class II | Same | |
| Product Code | OIH | OIH | Same | |
| Regulation | ||||
| Name | Medical image | |||
| management and | ||||
| processing system | Medical image | |||
| management and | ||||
| processing system | Same | |||
| Device Property | SaMD | SaMD | Same | |
| Intended Use / Indications For Use | ||||
| EFAI iCTR (K212624) | EFAI Intelligent Cardiothoracic Ratio Assessment System (or iCTR) is a software | |||
| for use by hospital and clinics to automatically assess the cardiothoracic ratio | ||||
| (CTR) of a chest X-ray image from the X-ray imager subject. The iCTR is | ||||
| designed to measure the maximal transverse diameter | ||||
| of heart and maximal inner transverse diameter of thoracic cavity and calculate | ||||
| the CTR of a chest X-ray image in posterior-anterior (PA) chest view using an | ||||
| artificial intelligence algorithm. | ||||
| Intended users of the software are aimed to the physicians or other licensed | ||||
| practitioners in the healthcare institutions, such as clinics, hospitals, healthcare | ||||
| facilities, residential care facilities and long-term care services. The system is | ||||
| suitable for adults between 20 - 80 years of age. | ||||
| Its results are not intended to be used on a stand-alone basis for clinical-decision | ||||
| making or otherwise preclude clinical assessment of cardiothoracic ratio (CTR) | ||||
| cases. | ||||
| Technical Characteristics | EFAI iCTR | |||
| (K212624) | Imbio RV/LV | |||
| Software | ||||
| (K203256) | Difference | |||
| Input | Post-anterior (PA) view | |||
| chest X-ray image | Non-gated, CT | |||
| Pulmonary | ||||
| angiography images | Yes, there is difference. | |||
| The proposed device used | ||||
| chest x-ray images in PA | ||||
| view as input to identify | ||||
| the maximal diameters of | ||||
| the maximal transverse | ||||
| diameter of heart and | ||||
| maximal inner transverse | ||||
| diameter of thoracic cavity. | ||||
| The primary device used | ||||
| CTPA images as input to | ||||
| identify the maximal | ||||
| diameters of the right and | ||||
| left ventricles of the heart. | ||||
| The verification report can | ||||
| verify the difference does | ||||
| not raise the impact of the | ||||
| safety and effectiveness. | ||||
| Both of the devices are in | ||||
| DICOM images as input. | ||||
| Output | Reports, DICOM | |||
| Secondary Capture | ||||
| series | Reports, DICOM | |||
| Secondary Capture | ||||
| series | Same | |||
| Report Structure | Report will be output in | |||
| the DICOM and JSON | ||||
| file format which is | ||||
| structured with | Report will be output | |||
| in DICOM file format | ||||
| which is structured | ||||
| with following | Similar. | |||
| The subject device is | ||||
| intended to output the | ||||
| maximal inner border | ||||
| diameter of thoracic cavity | ||||
| following information | ||||
| and function tool: |
- CTR
- adjustable
annotation line
(maximal inner
border diameter of
thoracic cavity and
maximal diameter
of heart) - the trajectory of
CTR (including
chest X-ray) | information and
function tool: - the RV/LV
Annotated Image
Series (the slices
with the maximum
ventricular
diameters, the
RV/LV Ratio, and
the individual
ventricular
measurements if
available.) - the RV/LV
Summary Report | and heart. The predicate
device is intended to output
the maximum ventricular
diameters.
The report structure both
can demonstrate the
annotation line and subject
image in DICOM format. | |
| Intended Users | Physicians or other
licensed practitioners in
the healthcare
institutions | Thoracic Radiologists,
General Radiologists,
Pulmonologists,
Cardiologists, imaging
technologists under the
supervision of a
physician, or
researchers | Yes, there is difference.
The proposed device is
intended to provide the
trained clinicians to use
but no limited in the doctor
specialists. The predicate
device is intended to
provide the radiologists
and cardiologist and
imaging technologists to
use. The difference does
not raise no impact of the
safety and effectiveness. | |
| Target Population | Adults of 20-80 years old | No restrictions | Yes, there is a difference.
Proposed device only
intended use for the patient
in the adults of 20-80 years
old. The validation report
can verify the difference
does raise no impact of the
safety and effectiveness. | |
| Imaging Modality | Chest X-ray in Digital
Radiography (DR) | Computed
Tomography
Pulmonary
Angiography (CTPA)
images | Yes, there is a difference.
Despite two compared
devices is present with the
different imaging modality.
The verification &
validation result has shown
no impact raise in the
safety and effectiveness. | |
| Intended Use
Environment | Healthcare institutions
(Clinics, hospitals,
healthcare facilities,
residential care facilities
and long-term care
services) | No restrictions | Yes, there is a difference.
The usability report can
verify the different
environment does not raise
the impact of safety and
effectiveness. | |
| Software device that
operates on off-the-shelf
hardware | Yes | Yes | Same | |
| Software devices uses
software algorithms for
image | Yes | Yes | Same | |
| Diameter Measurement | Yes - Automated | Yes - Automated | Same | |
| Storage | Saved in JSON and
DICOM file format text
for DICOM and
DICOM file format | Saved in PDF and
DICOM compatible
format | They have same DICOM
format storage. The
storage of subject device in
JSON format has been
validated through the
system test. There is no
impact on safety or
effectiveness of the subject
device. | |
The Imbio RV/LV Software device is designed to measure the maximal diameters Imbio RV/LV Software (K203256) 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
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| EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System |
|---|
VII. Performance Data – Clinical Testing
EFAI iCTR Software was developed and tested in accordance with EFAI's Design Control processes and has been subjected to extensive safety and performance testing. EFAI iCTR Software verification and validation test results established that the device meets its design requirements and intended use. Specifically, software verification was conducted at unit, module, and system integration levels. Extensive algorithm development and software verification testing assessed the performance characteristics of the algorithm including EFAI iCTR accuracy, risk management, and overall functional performance. Images and cases used for verification testing were carefully separated from training algorithms.
Results of the EFAI iCTR were compared to evaluation by a panel of expert readers. That study met the pre-defined acceptance criteria and found that the observed accuracy estimates for the software were greater than 95% for identification of the imaging mode and the view.
The EFAI iCTR encompasses three quality control models and two annotation models. The quality control models are capable of filtering out non-chest X-ray images (Sensitivity 0.99, Accuracy 0.99), filtering out the non-PA view chest X-ray images(Sensitivity 0.99, Accuracy 0.97), and presenting with message for images with unclear boundary whose threshold is