LungQ v3.0.0

{0}------------------------------------------------ Image /page/0/Picture/0 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 seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text. January 8, 2024 Thirona BV % Eva Rikxoort Official Correspondent Toernooiveld 300 Toernooiveld 300, 6525 EC NETHERLANDS Re: K232412 Trade/Device Name: LungO v3.0.0 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: August 10, 2023 Received: December 6, 2023 Dear Eva Rikxoort: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ 2 Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K232412 Device Name LungQ V3.0.0 #### Indications for Use (Describe) The Thirona LungQ software provides reproducible CT values for pulmonary tissue which is essential for providing quantitative support for diagnosis and follow up examination. The LungQ software can be used to support physician in the diagnosis and documentation of pulmonary tissues images (e.g. abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of sub-compartments, volumetric analysis, density evaluation, and reporting tools are provided. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| | <span style="text-decoration: underline;"></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;"></span> Over-The-Counter Use (21 CFR 801 Subpart C) | | <input checked="" type="checkbox"/> | <input type="checkbox"/> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ ### Section 05 #### Section 5 510(k) Summary ## 5.1 SUBMITTER Submitted by: Thirona BV Toernooiveld 300 6525 EC Nijmegen the Netherlands Contact Person: Eva van Rikxoort Telephone Number: +31 6 47 14 28 38 Email: evavanrikxoort@thirona.eu Date Prepared: 8th August 2023 ### 5.2 DEVICE | Trade Name | LungQ v3.0.0 | |-----------------------|----------------------------------| | Common Use/Usual Name | Computer Tomography X-ray system | | Product Code | JAK | | Classification | Class II, 21 CFR 892.1750 | | Device Panel | Radiology | #### 5.3 PREDICATE DEVICE | Predicate Device | LungQ V1.1.0 | |--------------------------|---------------------------| | Predicate Classification | Class II, 21 CFR 892.1750 | #### 5.4 REFERENCE DEVICE | Predicate Device | VIDA Vision | |--------------------------|---------------------------| | Predicate Classification | Class II, 21 CFR 892.1750 | {4}------------------------------------------------ ## 5.5 DEVICE DESCRIPTION The LungQ software is designed to aid in the interpretation of Computed Tomography (CT) scans of the thorax that may contain pulmonary abnormalities. LungQ is stand-alone command-line software which must be run from a command-line interpreter and does not have a graphical user interface. ## 5.6 INDICATION FOR USE The Thirona LungQ software provides reproducible CT values for pulmonary tissue which is essential for providing quantitative support for diagnosis and follow up examination. The LungQ software can be used to support physician in the diagnosis and documentation of pulmonary tissues images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of sub-compartments, volumetric analysis, density evaluations, fissure evaluation, and reporting tools are provided. ## 5.7 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS Table 5-1 below compares the Thirona LungQ software to the predicate device. | Item | LungQ v3.0.0<br>Thirona<br>(Subject Device) | LungQ v1.1.0<br>Thirona<br>(Predicate Device) | VIDA vision<br>VIDA Diagnostics, Inc<br>(Reference Device) | |---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|------------------------------------------------------------| | <b>510(k) Number</b> | NA | K173821 | K200990 | | Product Code | JAK | Same | Same | | Regulation Number | 21 CFR 892.1750 | Same | Same | | Device<br>Classification | Class II | Same | Same | | Common Name | Software Accessory to a<br>Computed tomography x-ray<br>system | Same | Same | | Intended Use | The Thirona LungQ software<br>provides reproducible CT<br>values for pulmonary tissue<br>which is essential for<br>providing quantitative<br>support for diagnosis and<br>follow up examination. The<br>LungQ software can be used<br>to support physician in the<br>diagnosis and<br>documentation of<br>pulmonary tissues images<br>(e.g., abnormalities) from CT<br>thoracic datasets. Three-D | Same | Equivalent | | | segmentation and isolation<br>of sub-compartments,<br>volumetric analysis, density<br>evaluations, fissure<br>evaluation, and reporting<br>tools are provided. | | | | Modality | CT | Same | Same | | Data Loading | DICOM | Same | Same | | Application | Command-line interface | Same | Equivalent | | OS | Linux | Equivalent | Equivalent | | Segmentation | Provides 3D segmentation | Same | Same | | | Provides Segmentation of<br>the:<br>• Left Lung<br>• Right Lung<br>• Left Upper Lobe<br>• Left Lower Lobe<br>• Right Upper Lobe<br>• Right Middle Lobe<br>• Right Lower Lobe<br>• Pulmonary<br>(sub)segments | Equivalent | Equivalent | | | Provides Airways<br>Segmentation | Same | Same | | | User cannot manually edit<br>segmentation | Same | Equivalent | | Lung Volume<br>Analysis Support | Ability to measure volume<br>for:<br>• Both Lungs<br>• Left Lung<br>• Right Lung<br>• Left Upper Lobe<br>• Left Lower Lobe<br>• Right Upper Lobe<br>• Right Middle Lob<br>• Right Lower Lobe<br>• Pulmonary<br>(sub)segments | Equivalent | Equivalent | | Volume Density<br>Analysis | Ability to measure volume at<br>multiple density ranges for:<br>• Both Lungs | Equivalent | Equivalent | | | Left Lung Right Lung Left Upper Lobe Left Lower Lobe Right Upper Lobe Right Middle Lob Right Lower Lobe Pulmonary (sub)segments Ability to measure the 15th percentile density analysis | Same | Same | | Fissure Analysis | Ability to perform fissure evaluations | Same | Same | | Analyzed Data Output | Provides a report | Same | Same | #### Table 5-1: Substantial Equivalence Comparison between Subject, Predicate and Reference Device {5}------------------------------------------------ {6}------------------------------------------------ ### 5.8 PERFORMANCE DATA The performance testing for LungQ consists of norm-compliance testing, design verification and validation testing. For norm-compliance and design verification, the testing was performed per subject device, while the validation, such as non-clinical validation and usability validation, were performed at system level representing a logical clinical workflow following the intended use. Performance testing data of the proposed devices demonstrate that the subject device is substantially equivalent to the predicate device, and that the design output meets the design input requirements. #### Compliance Testing Norm-compliance performance tests were performed on the proposed LungQ software according to the following FDA recognized consensus standards and FDA guidance documents (see Table 5-2 and Table 5-3), and were all passed. | Identification<br>Number | Edition /<br>Year | Title | Rec<br>Numbe<br>r | |----------------------------------|-------------------|----------------------------------------------------------------------------------------------------------|-------------------| | AAMI TIR57 | 2016 | Principles for medical device security—Risk management | 13-83 | | ANSI AAMI<br>IEC TIR 80002-<br>1 | 2009 | Medical device software - Part 1: Guidance on the<br>application of ISO 14971 to medical device software | 13-34 | | ANSI NEMA<br>HN 1 | 2019 | Manufacturer Disclosure Statement for Medical Device<br>Security | 13-123 | Table 5-2: Standards and Guidance documents {7}------------------------------------------------ | IEC 62304 | 1.1/2015 | Medical device software - Software life-cycle processes | 13-79 | |-----------------------|----------|-------------------------------------------------------------------------------------------------------------------------------|--------| | IEC 62366-1 | 1.1/2020 | Medical devices - Application of usability engineering to<br>medical devices | 5-129 | | IEC 82304-1 | 1.0/2016 | Health software - Part 1: General requirements for<br>product safety | 13-97 | | ISO 14971 | 3/2019 | Medical devices - Application of risk management to<br>medical devices | 5-125 | | ISO 15223-1 | 4/2021 | Medical devices — Symbols to be used with information<br>to be supplied by the manufacturer — Part 1: General<br>requirements | 5-117 | | ISO 20417 | 1/2021 | Medical devices — Information to be supplied by the<br>manufacturer | 5-135 | | ISO/IEC 21778 | 1/2017 | Information technology — The JSON data interchange<br>syntax | - | | ISO/IEC 27001 | 2/2013 | Information technology - Security techniques -<br>Information security management systems -<br>Requirements | - | | NEMA PS 3.1 -<br>3.20 | 2022d | Digital Imaging and Communications in Medicine<br>(DICOM) Set | 12-349 | #### Table 5-3: Guidance documents | Identification<br>Number | Year | Title | |--------------------------|------|---------------------------------------------------------------------------------------------------------------------------------------| | FDA-1997-D-0029 | 2002 | General Principles of Software Validation | | FDA-2011-D-0469 | 2016 | Applying Human Factors and Usability Engineering to Medical<br>Devices | | FDA-2011-D-0652 | 2014 | The 510(k) Program: Evaluating Substantial Equivalence in<br>Premarket Notifications [510(k)] | | FDA-2014-D-0456 | 2018 | Appropriate Use of Voluntary Consensus Standards in Premarket<br>Submissions for Medical Devices | | FDA-2015-D-4852 | 2017 | Design Considerations and Pre-market Submission<br>Recommendations for Interoperable Medical Devices | | FDA-2016-D-1853 | 2021 | Unique Device Identification System: Form and Content of the<br>Unique Device Identifier (UDI) | | FDA-2018-D-1329 | 2019 | Recommended Content and Format of Non-Clinical Bench<br>Performance Testing Information in Premarket Submissions | | FDA-2019-D-3598 | 2019 | Off-The-Shelf Software Use in Medical Devices | | FDA-2021-D-0775 | 2023 | Content of Premarket Submissions for Device Software Functions | | FDA-2021-D-1158 | 2022 | Cybersecurity in Medical Devices: Quality System Considerations and<br>Content of Premarket Submissions | | FDA-2023-D-1030 | 2023 | Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber<br>Devices and Related Systems Under Section 524B of the FD&C Act | {8}------------------------------------------------ #### Performance Testing Software Verification testing was conducted to ensure that the Lung Q software met its requirements. The verification testing included white box testing to verify implementation and system integration testing. The LungQ software successfully passed the verification testing. Software Validation was conducted to ensure the software met the user needs (i.e. input requirements). This validation was based on user scenarios. The LungQ software successfully passed the software validation. Human factors (HF) engineering process was followed in accordance with the usability standard and FDA guidance. The restricted interface of LungQ with the third party end-user-interface is well controlled by the use of standard input and output formats. The usability is determined by the input requirements, which have been identified during risk management. The human factors validation test (summative usability evaluation) of LungQ was performed. #### Substantial equivalence Study A head-to-head performance testing was conducted between the subject and the predicate device. The aim of this study was to assess and compare the measurement of lung structure parameters, such as lung and lobar volumes, density scores (LAA-950HU and LAA-910HU), 15th percentile lung density (PD15), and fissure completeness between LungQ v3.0.0 (subject device) and LungQ v1.1.0 (primary predicate, K1738210). Firstly, both devices analyzed the lung and lobar volumes, density scores, PD15 and fissure completeness. Subsequently, Bland-Altman plots were used for the pairwise comparison of lung and lobar volumes, density scores, PD15 measurements between the two devices. Moreover, for comparison of the fissure completeness measurements between both devices, receiver operating characteristic (ROC) analysis was performed and the area under de ROC curve (Az value) was calculated. The tolerable variability for absolute and relative threshold values was defined as: - . Lung and lobar volume: Difference ≤ 10% - . Lung and lobar density measurements: - LAA-950HU: Agreements limits -1% to 1% - LAA-910HU: Agreement limits -10% and 10% o - 15™ Percentile: Agreement limits -10 HU to 10 HU O - Fissure completeness classification: Az value ≥ 0.95 The (sub)segmental volumes and density scores were not compared with the primary predicate but with segmentation which were corrected by human experts. The pairwise comparison between LungQ v3.0.0 and the experts was performed using Blant-Altman analysis of (sub)segmental volumes and density scores. The tolerable variability for absolute and relative values are 150mL and 5%, respectively. The results showed that for the lung and lobar volumes, density scores (LAA-950HU and LAA-910HU), and 15th percentile lung density (PD15), the difference between LungQ v3.0.0 (subject device) and {9}------------------------------------------------ the primary predicate were less than the threshold value. The area under the AUC curve (Az value) for the comparison of fissure completeness measurements between LungQ v3.0.0 (subject device) and the primary predicate was found to be 0.97, above the minimal threshold value. The mean difference (SD) between LungQ v3.0.0 and the reference of the human experts for the (sub)segmental volumes and density scores were less than the threshold value. The scans were taken with a wide variety of scanner brands and models used to obtain scans in the datasets used for the equivalence study testing are shown in Table 5-4. | Table 5-4: Imaging parameters equivalence study. | | | |--------------------------------------------------|--|--| |--------------------------------------------------|--|--| | Imaging parameters Equivalence study | | |--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Scanner manufacture | GE MEDICAL SYSTEMS; SIEMENS; Philips | | Scanner types | LightSpeed16; LightSpeed VCT; Sensation 64;<br>Definition; Sensation 16; Definition AS+;<br>SOMATOM Definition Flash; Brilliance 64;<br>LightSpeed Pro 16; Discovery CT750 HD;<br>SOMATOM Definition; LightSpeed Ultra<br>SOMATOM Definition AS; LightSpeed16 | The results showed that outputs from Thirona LungQ v3.0.0 are equivalent to the predicate device, LungQ v1.1.0. #### Conclusion on performance testing All compliance, verification and validation tests have been used to support substantial equivalence of the subject device and to demonstrate that the LungQ v3.0.0 device: - comply with the aforementioned international and FDA recognized consensus standards and FDA guidance documents; and - meet the acceptance criteria and are adequate for their intended use. Based on the information provided above, the LungQ v3.0.0 device is considered substantially equivalent to the predicate device in terms of safety and effectiveness. No clinical testing was required as substantial equivalence was demonstrated by the attributes of intended use, technological characteristics, and non-clinical testing. ### 5.9 CONCLUSIONS The proposed device, LungQ v3.0.0, is substantially equivalent to the above-mentioned predicate device, in terms of intended use, technological characteristics and, safety and effectiveness. Substantial equivalence was demonstrated by non-clinical performance tests provided in this 510(k) premarket notification. These tests demonstrate that the proposed device comply with the user needs specifications and product requirements, as well as the requirements specified in the international and Thirona {10}------------------------------------------------ FDA-recognized consensus standards, and are as safe and effective as the predicate device, and do not raise any new safety and/or effectiveness concerns.