qXR-BT

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Qure.ai Technologies % Bunty Kundnani Head of Regulatory Affairs Level 7, Commerz II, International Business Park Oberoi Garden City, Goregaon (E) Mumbai, Maharashtra 400063 INDIA Re: K212690 Trade/Device Name: qXR-BT Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH Dated: November 22, 2021 Received: November 24, 2021 Dear Bunty Kundnani: 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 and Part 809); 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, 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K212690 Device Name qXR-BT ### Indications for Use (Describe) The qXR-BT device is intended to generate a secondary digital chest X-ray image that facilitates confirmation of the position of a breathing tube and an anatomical landmark on adult chest X-rays. This device is intended for use by licensed physicians who are trained in the evaluation of breathing tube placement on chest X-rays. The qXR-BT image provides adjunctive information and is not a substitute for the original PA/AP image. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------|--| | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | | | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | | ## 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 PRAStaff(@fda.hhs.gov "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." {3}------------------------------------------------ # 510(k) SUMMARY Qure.ai's qXR-BT #### 1 SUBMITTER Qure.ai Technologies Level 7, Commerz II, International Business Park Oberoi Garden City, Goregaon (E), Mumbai 400 063 Phone: +91-9768123013 Contact Person: Bunty Kundnani Date Prepared: November 22, 2021 #### 2 DEVICE | Name of Device: | qXR-BT | |-----------------------|--------------------------------------------------| | 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 | #### PREDICATE DEVICE 3 | Name of Device: | ClearRead+Confirm Image Processing System | |-----------------|-------------------------------------------| | Manufacturer: | Riverain Technologies LLC | | 510(k) Number: | K123526 | #### 4 INTENDED USE / INDICATIONS FOR USE: The qXR-BT device is intended to generate a secondary digital chest X-ray image that facilitates confirmation of the position of a breathing tube and an anatomical landmark on adult chest Xrays. This device is intended for use by licensed physicians who are trained in the evaluation of breathing tube placement on chest X-rays. The qXR-BT image provides adjunctive information and is not a substitute for the original PA/AP image. {4}------------------------------------------------ #### ട DEVICE DESCRIPTION qXR-BT is a standalone image analysis software used during the review of digital chest radiographic images, intended to facilitate determining the position of the breathing tube relative to the carina. Standard of care medical imaging workflows are well established, and include pre-existing software components such as a PACS, DICOM viewer and imaging worklist; qXR-BT is designed to integrate with these components. X-rays are sent to qXR-BT by means of transmission functions within the user's PACS system. Upon completion of processing, the qXR-BT device returns results to the user's PACS or other userspecified radiology software system or database. The input to the qXR-BT device is a chest X-ray (AP and PA, referred to as frontal) in digital imaging and communications in medicine (DICOM) format. The qXR-BT device produces PDF and DICOM format outputs that enable users to view the position of a breathing tube and an anatomical landmark (carina). The PDF format output contains preview images that show segmented structures outlined with a textual report describing the structures detected. The text report is restricted to the presence or absence of the breathing tubes and the carina as detected by the software device. The DICOM format output consists of a single complete additional DICOM series for each input scan. This DICOM output contains labeled overlays indicating the location and extent of the segmentable structures, suitable for viewing in the PACS or radiology viewer. The qXR-BT analysis module consists of a set of pre-trained convolutional neural networks (CNNs), that form the core processing component shown in Figure 1. This core processing component is coupled with a pre-processing module to prepare input DICOMs for processing by the CNNs and a post-processing module to convert the output into visual and tabular format for users. Image /page/4/Figure/8 description: This image shows a flowchart of the qXR-BT Analysis process. The process starts with chest x-ray scans in DICOM format, followed by pre-processing, core processing, and post-processing. The output of the post-processing step is then used to generate a secondary image with markers and labels in DICOM format, as well as a report with a preview image and table in PDF format. The title of the flowchart is "qXR-BT Analysis". ## Figure 1: Schematic showing the design of qXR-BT device #### б COMPARISON WITH PREDICATE DEVICE Like the potential predicate devices, qXR-BT facilitates the confirmation of placement of a medically inserted tube on chest X-rays. In terms of establishing substantial equivalence, the subject and predicate device have the same intended use, as an image processing tool that generates a secondary digital radiographic image to facilitate the confirmation of the position of {5}------------------------------------------------ medically inserted tube. The indications for use proposed for the subject device are similar to those of the predicate device, with the primary difference being that the predicate device is intended to facilitate the confirmation of multiple types of lines, tubes, and wires, while the subject device is intended to facilitate the confirmation of only one type of tube, viz. breathing tubes. | | Predicate Device<br>ClearRead+Confirm<br>(K123526) | Subject Device<br>qXR-BT | |-------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | ClearRead+Confirm | qXR-BT | | 510(k) Number | K123526 | K212690 | | Regulation | 21 CFR 892.2050 | 21 CFR 892.2050 | | Regulation Description | Medical image management<br>and processing system<br><br>Formerly: Picture archiving<br>and communications system | Medical image management and<br>processing system | | Product Code | LLZ | QIH | | Device type | Radiological Image<br>Processing System | Automated Radiological Image<br>Processing Software | | Manufacturer | Riverain Technologies | Qure.ai Technologies | | Intended use / Indications<br>for Use | ClearRead+Confirm is<br>intended to generate an<br>enhanced, secondary digital<br>radiographic image of the<br>chest to facilitate<br>confirmation of line/tubes.<br>The enhanced AP or PA<br>image of the chest provides<br>improved visibility of lines<br>and tubes. The ClearRead<br>+Confirm image provides<br>adjunctive information and<br>is not a substitute for the<br>original PA/AP image. This<br>device is intended to be used<br>by trained professionals,<br>such as physicians,<br>radiologists, and technicians,<br>on patients with lines and<br>tubes and is not intended to<br>be used on pediatric<br>patients. | The qXR-BT device is intended to<br>generate a secondary digital chest X-<br>ray image that facilitates<br>confirmation of the position of a<br>breathing tube and an anatomical<br>landmark on adult chest X-rays. This<br>device is intended for use by licensed<br>physicians who are trained in the<br>evaluation of breathing tube<br>placement on chest X-rays. The qXR-<br>BT image provides adjunctive<br>information and is not a substitute<br>for the original PA/AP image. | | Modality | Digital chest radiograph | Digital chest radiograph | | Input format | DICOM | DICOM | | | Predicate Device<br>ClearRead+Confirm<br>(K123526) | Subject Device<br>qXR-BT | | Output Format | Secondary digital chest X-ray<br>image | Secondary digital chest X-ray image<br>and other Multiple electronic reports<br>with localization information of<br>segmented structures | | Intended User | Physicians, radiologists and<br>technicians | Physicians and radiologists | | Hardware | No additional hardware;<br>standalone software device<br>that integrates with PACS<br>through DICOM protocols | qXR-BT is standalone software<br>deployed on-premise or on the<br>cloud, that integrates with PACS or<br>other hardware or software imaging<br>platforms, including digital<br>radiographic processing systems<br>through DICOM protocols | | Comparison of Differences between qXR-BT and the predicate device | | | | Types of lines and tubes | Various medically inserted<br>tubes, lines, tubes and wires | Medically inserted breathing tubes<br>(tracheal tubes) only | | Internal algorithms used<br>for image processing and<br>the mechanism by which<br>the output is displayed to<br>the clinician | ClearRead+Confirm uses a<br>bone suppression<br>mechanism with overall<br>image enhancements to<br>improve the visibility of lines<br>and tubes and provides no<br>boxes or markings to the<br>user. | qXR-BT uses pre-trained<br>convolutional neural networks to<br>process the images, and the device<br>highlights the tip of the tube and the<br>carina using markings on the<br>secondary image. | Table 1: Comparison between qXR-BT and the Predicate Device {6}------------------------------------------------ #### 7 TESTING ### Software 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. ## Performance Testing Qure.ai performed standalone performance testing to test the accuracy of qXR-BT's analysis. The number of Chest X-ray images used for this performance testing was 162. Table 2 shows localization accuracy for the 2 target structures – carina and tip of breathing tube and the accuracy of distance measurement between these 2 structures. The ground truth was based on manual annotation of three radiologists from United States. For the target structures, the {7}------------------------------------------------ standalone performance exceeded the preset acceptance criteria. The table below shows a summary of the results of performance testing. | Target<br>Structure<br>(Number of<br>scans) | Metric | Mean<br>(Standard<br>Deviation) | Median (10th -<br>90th percentile) | Mean (95% CI) | Success Criteria | |---------------------------------------------------------------------|----------------------|---------------------------------|------------------------------------|-----------------------|--------------------------------| | Carina (162) | Absolute<br>Distance | 2.15 (1.25) | 1.86 (0.63 -<br>4.05) | 2.15 (1.96 -<br>2.35) | Upper bound of<br>95% CI ≤ 3mm | | Tip of<br>Breathing<br>Tube (162) | Absolute<br>Distance | 1.97 (1.09) | 1.8 (0.7 - 3.64) | 1.97 (1.80 –<br>2.13) | Upper bound of<br>95% CI ≤ 3mm | | Distance<br>between tip<br>of breathing<br>tube and<br>carina (162) | Absolute<br>Error | 1.98 (1.41) | 1.64 (0.27 -<br>4.12) | 1.98 (1.76 –<br>2.20) | Upper bound of<br>95% CI ≤ 6mm | ## Table 2: Overall Results of Accuracy Testing in mm Cl = confidence interval qXR-BT also passed software validation and system verification checks. #### 8 CONCLUSION The comparison in Table 2 and the software and performance testing presented above demonstrate that the qXR-BT device is substantially equivalent to the predicate device.