(154 days)
Not Found
Yes
The document explicitly states that the device uses a "deep-learning based software" and an "artificial intelligence algorithm" to perform its function.
No
The device is a diagnostic software that aids in assessing the CTR on X-ray scans; it does not provide therapy.
Yes
The device is described as "a deep-learning based software for use by hospitals and clinics for automated assessment of the CTR on chest X-ray (CXRs) scans," and its intended use is to "measure the ratio of the maximal transverse diameter of the heart (CD) and the maximal inner transverse diameter (TD) of the thoracic cavity and calculate the CTR value." These functions indicate it is used to analyze health data to provide information for diagnosis.
Yes
The device description explicitly states "The qXR-CTR is a non-invasive software medical device designed to be installed on the computer with specific system requirements." It processes existing image data and outputs results, without including or requiring any specific hardware components beyond a standard computer system.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes medical images: The qXR-CTR software analyzes chest X-ray images (DICOM files), which are medical images, not biological samples.
- The intended use is image analysis for measurement: The stated intended use is to "measure the ratio of the maximal transverse diameter of the heart (CD) and the maximal inner transverse diameter (TD) of the thoracic cavity and calculate the CTR value on posterior-anterior view chest view using an artificial intelligence algorithm." This is clearly focused on image analysis and measurement within the image.
Therefore, the qXR-CTR falls under the category of a medical device software that performs image analysis, rather than an In Vitro Diagnostic.
No
The input 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
qXR-CTR is a deep-learning based software for use by hospitals and clinics for automated assessment of the CTR on chest X-ray (CXRs) scans.
qXR-CTR is designed to measure the ratio of the maximal transverse diameter of the heart (CD) and the maximal inner transverse diameter (TD) of the thoracic cavity and calculate the CTR value on posterior-anterior view chest view using an artificial intelligence algorithm.
The intended users of this device are physicians or licensed practitioners in healthcare institutions, such as clinics, hospitals, residential care facilities, long-term care services, and healthcare facilities.
The system is suitable for adults > 22 years of age.
The device is used to aid the intended users and results are not intended to be used on a stand-alone basis for clinical decision making or otherwise preclude clinical assessment of CTR cases.
Product codes (comma separated list FDA assigned to the subject device)
QIH
Device Description
The qXR-CTR 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 cardiac diameter, thoracic diameter, and CTR through an artificial intelligence algorithm. The structured 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Chest X-ray in Digital Radiography (DR)
Anatomical Site
Heart, Thoracic Cavity
Indicated Patient Age Range
Adults ≥ 22 years of age.
Intended User / Care Setting
Physicians or licensed practitioners in healthcare institutions, such as clinics, hospitals, residential care facilities, long-term care services, and healthcare facilities.
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
The study included 435 scans with PA view from various parts of the US. The ground truth was established by 3 ABR thoracic radiologists with a minimum of 10 years of experience.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical studies were conducted on retrospectively collected chest X-rays to evaluate the performance of qXR-CTR for measuring the cardiac diameter and thoracic diameter.
The study included 435 scans with PA view from various parts of the US. The ground truth was established by 3 ABR thoracic radiologists with a minimum of 10 years of experience. The RMSE of the device in measuring the target structures exceeded the success criteria with RMSE for cardiac diameter being 7.55 (6.95, 8.34) mm and thoracic diameter being 5.43 (4.95, 6.11) mm.
Further, the mean absolute error along with standard deviation for both the cardiac and thoracic diameter was measured at 5.66 (5.0) mm and 4.04 (3.63) mm, respectively.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
RMSE:
Cardiac Diameter = 7.55 mm
Thoracic Diameter = 5.43 mm
Mean Absolute Error:
5.66 (5.0) mm (Cardiac Diameter)
4.04 (3.63) mm (Thoracic Diameter)
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
§ 892.2050 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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.
Qure.ai Technologies % Srinidhi Ragunathan Regulatory Clinical Affairs Manager Level 7, Commerz II, International Business Park Oberoi Garden City, Goregaon(E) Mumbai, Maharashtra 400063 INDIA
September 22, 2023
Re: K231149
Trade/Device Name: qXR-CTR Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH Dated: August 24, 2023 Received: August 24, 2023
Dear Srinidhi Ragunathan:
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
1
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 (OS) 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,
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231149
Device Name qXR-CTR
Indications for Use (Describe)
qXR-CTR is a deep-learning based software for use by hospitals and clinics for automated assessment of the CTR on chest X-ray (CXRs) scans.
qXR-CTR is designed to measure the ratio of the maximal transverse diameter of the heart (CD) and the maximal inner transverse diameter (TD) of the thoracic cavity and calculate the CTR value on posterior-anterior view chest view using an artificial intelligence algorithm.
The intended users of this device are physicians or licensed practitioners in healthcare institutions, such as clinics, hospitals, residential care facilities, long-term care services, and healthcare facilities.
The system is suitable for adults > 22 years of age.
The device is used to aid the intended users and results are not intended to be used on a stand-alone basis for clinical decision making or otherwise preclude clinical assessment of 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) |
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510(k) SUMMARY
Qure.ai's qXR-CTR
1 SUBMITTER
Qure.ai Technologies Level 7, Commerz II, International Business Park Oberoi Garden City, Goregaon (E), Mumbai 400 063 Phone: +91-9768123013 Primary Contact Person: Srinidhi Ragunathan Secondary contact person: Bunty Kundnani
Date Prepared: August 23, 2023
2 DEVICE
| Name of Device: | qXR-CTR |
|---|---|
| Common or Usual Name: | Automated radiological image processing software |
| Classification Name: | Medical image management and processing system |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | QIH |
3 PREDICATE DEVICE
| Name of Device: | EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System |
|---|---|
| Manufacturer: | Ever Fortune.Al Co., Ltd. |
| 510(k) Number: | K212624 |
4
4 INTENDED USE / INDICATIONS FOR USE:
qXR-CTR is a deep-learning based software for use by hospitals and clinics for automated assessment of the CTR on chest X-ray (CXRs) scans.
qXR-CTR is designed to measure the ratio of the maximal transverse diameter of the heart (CD) and the maximal inner transverse diameter (TD) of the thoracic cavity and calculate the CTR value on posterior-anterior view chest view using an artificial intelligence algorithm.
The intended users of this device are physicians or licensed practitioners in healthcare institutions, such as clinics, hospitals, residential care facilities, long-term care services, and healthcare facilities.
The system is suitable for adults ≥ 22 years of age.
The device is used to aid the intended users and results are not intended to be used on a stand-alone basis for clinical decision making or otherwise preclude clinical assessment of CTR cases.
ഗ DEVICE DESCRIPTION
The qXR-CTR 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 cardiac diameter, thoracic diameter, and CTR through an artificial intelligence algorithm. The structured 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.
ട COMPARISON OF THE PREDICATE DEVICE
qXR-CTR is technologically similar to the predicate device, EFIA iCTR Assessment in regard to intended use and technological characteristics. Both are medical image management and processing system intended to read chest X-rays to measure target structures (cardiac and thoracic diameter). The algorithms function similarly and there are no notable technological differences between the subject and predicate devices.
In terms of establishing substantial equivalence, the subject and predicate device have the same intended use, as an image processing tool that measures anatomical structures and produces caselevel output. The indications for use proposed for the subject device are similar those of the predicate device.
| Predicate Device | Subject Device | |
|---|---|---|
| Device Name | EFAI Intelligent Cardiothoracic | |
| Ratio (iCTR) Assessment | ||
| System | qXR-CTR | |
| 510(k) Number | K212624 | NA |
| Regulation | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Regulation Description | radiological computer- | |
| assisted software | radiological computer-assisted | |
| software |
| Table 1 Comparison between gXR-CTR and the Predicate Device | ||
|---|---|---|
| Predicate Device | Subject Device | |
| Product Code | QIH | QIH |
| Device type | Quantifying software | Quantifying software |
| Manufacturer | Ever Fortune.Al Co., Ltd. | Qure.ai Technologies |
| Intended use / | ||
| Indications for Use | EFAI Intelligent Cardiothoracic | |
| Ratio Assessment System (or | ||
| iCTR) is a software for use by | ||
| hospitals 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. | qXR-CTR is a deep-learning based | |
| software for use by hospitals and | ||
| clinics for automated assessment of | ||
| the CTR on chest X-ray (CXRs) scans. |
qXR-CTR is designed to measure the
ratio of the maximal transverse
diameter of the heart (CD) and the
maximal inner transverse diameter
(TD) of the thoracic cavity and
calculate the CTR value on posterior-
anterior view chest view using an
artificial intelligence algorithm.
The intended users of this device are
physicians or licensed practitioners in
healthcare institutions, such as clinics,
hospitals, residential care facilities,
long-term care services, and
healthcare facilities.
The system is suitable for adults ≥ 22
years of age.
The device is used to aid the intended
users and results are not intended to
be used on a stand-alone basis for
clinical decision making or otherwise
preclude clinical assessment of CTR
cases. |
| Algorithm for
measurement of target
structures | AI Algorithm | AI Algorithm |
| Modality | Chest X-ray in Digital
Radiography (DR) | Chest X-ray in Digital Radiography (DR) |
| Input | Post-anterior (PA) view chest
X-ray image | Post-anterior (PA) view chest X-ray
image |
| Input format | DICOM | DICOM |
| Output Format | Reports, DICOM Secondary
Capture series | Pdf report is generated, DICOM
Secondary capture is returned to the
PACS |
| Report Structure | Report will be output in the
DICOM and JSON file format | Report will be output in the DICOM
and JSON file format which is
structured with following information |
| | Predicate Device | Subject Device |
| | | |
| | following information and
function tool: 1) CTR 2)
adjustable annotation line
(maximal inner border
diameter of thoracic cavity
and maximal diameter of
heart) 3) the trajectory of CTR
(including chest X-ray) | and function tool: 1) CTR 2) annotation
line (maximal inner border diameter of
thoracic cavity and maximal diameter
of heart) |
| Intended User | Physicians or other licensed
practitioners in the healthcare
institutions | Physicians or other licensed
practitioners in the healthcare
institutions |
| Target Population | 20-80 years | ≥ 22 years |
| Modality | Chest X-ray in Digital
Radiography | Chest X-ray in Digital Radiography |
| Intended Use
Environment | Healthcare institutions
(Clinics, hospitals, healthcare
facilities, residential care
facilities and long-term care
services) | Healthcare institutions (Clinics,
hospitals, healthcare facilities,
residential care facilities and long-term
care services) |
| Software device that | Yes | Yes |
| operates on off the shelf | | |
| hardware | | |
| Software devices uses | Yes | Yes |
| software algorithms for
image | | |
| Diameter Measurement | Yes | Yes |
| Storage | Saved in JSON and DICOM file
format text for DICOM and
DICOM file format | The text report is generated with the CXR
scan on a Structured Report (SR) format for
PACS-based mode. For the Web-based
mode, the user can download a PDF
version of the report with the same
information |
| Software Requirement | Ubuntu 18.04 (Web browser:
chrome 88.0.4324.182 or
above) | Ubuntu 20.04+ |
| Performance metrics of the predicate device and qXR-CTR | | |
| Performance level | RMSE: | RMSE: |
| | Cardiac Diameter = 8.81 mm
Thoracic Diameter = 14.4 mm | Cardiac Diameter = 7.55 mm
Thoracic Diameter = 5.43 mm |
| | Mean Absolute Error:
NR | Mean Absolute Error:
5.66 (5.0) mm |
| Measurement | Root Mean Squared Error (95%
CI) in mm | Mean Absolute Error (SD) in mm |
| Cardiac Diameter | 7.55 (6.96, 8.38) | 5.66 (5.0) |
| Thoracic Diameter | 5.43 (4.94, 6.09) | 4.04 (3.63) |
| CTR | 0.03 (0.02, 0.03) | 0.02 (0.02) |
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6
SOFTWARE TESTING 7
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device has a Moderate level of concern.
7
8 PERFORMANCE TESTING - CLINICAL
The performance of qXR-CTR was validated by clinical tests. All the safety parameters of the device were verified in accordance with the software specifications and applicable performance standards and met the acceptance criteria(passed), demonstrating that the software fulfills all its requirement specifications.
Clinical studies were conducted on retrospectively collected chest X-rays to evaluate the performance of qXR-CTR for measuring the cardiac diameter and thoracic diameter.
The study included 435 scans with PA view from various parts of the US. The ground truth was established by 3 ABR thoracic radiologists with a minimum of 10 years of experience. The RMSE of the device in measuring the target structures exceeded the success criteria with RMSE for cardiac diameter being 7.55 (6.95, 8.34) mm and thoracic diameter being 5.43 (4.95, 6.11) mm. The predicate EFAI iCTR Assessment's performance was cardiac diameter RMSE: 8.81 mm and thoracic diameter: 14.4 mm.
Further, the mean absolute error along with standard deviation for both the cardiac and thoracic diameter was measured at 5.66 (5.0) mm and 4.04 (3.63) mm, respectively.
Table 2 Overall Results of Accuracy Testing of qXR-CTR
ರಿ CONCLUSION
The comparison in Table 1 and the software and performance testing presented above demonstrate that the qXR-CTR device is substantially equivalent to the predicate device. The qXR-CTR is a software only device, similar to the predicate (EFAI iCTR Assessment) and has no new risks related to safety and effectiveness. The qXR-CTR has the same intended users and similar indications, technological characteristics, and principles of operation as the predicate devices operate in parallel to the standard of care workflow. The performance testing demonstrates that the qXR-CTR performs as intended and is therefore substantially equivalent to the predicate. Software and Clinical testing support that the device performs in accordance with the device requirements.