Lung Image Analysis

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Pulmonx Corporation % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114 ## Re: K212494 Trade/Device Name: Lung Image Analysis (LIA) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: August 6, 2021 Received: August 9, 2021 ## Dear Prithul Bom: 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). 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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 Submission Number (if known) #### K212494 Device Name Lung Image Analysis (LIA) #### Indications for Use (Describe) The Pulmonx LIA software provides CT values for pulmonary tissue which is essential for providing quantitative support for diagnosis and follow up examination. The LIA software can be used to support physician in the diagnosis and documentation of pulmonary tissue images (e.g. abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of sub-compartments (including lung structures), volumetric analysis, density evaluation, and reporting tools are provided. 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) #### 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}------------------------------------------------ K212494 # 510(K) SUMMARY This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92. ## Applicant Information: Pulmonx Corporation 700 Chesapeake Drive Redwood City, California 94063 ## Contact Person: Terry Solomon Email: tsolomon@pulmonx.com Phone: (650) 216-0195 ## Device Information: Trade Name: Regulation Name: Regulation Medical Specialty: Device Class: Product Code: Lung Image Analysis (LIA) Computed tomography x-ray system Radiology ll JAK ## Predicate Device: LungQ, K173821 The predicate device has not been subject to a design-related recall. No reference device is being used in this submission. ## Date Prepared: June 30, 2021 ## Device Description: The Lung Image Analysis (LIA) software is designed to aid in the interpretation of Computed Tomography (CT) scans of the thorax that may contain pulmonary abnormalities. Lung Image Analysis has both a graphical user interface and command-line software which can be run as a Windows application or from a command-line interpreter. The LIA software is to be used by trained professionals who are responsible for the correct and accurate use of medical images. In a typical clinical environment, the results provided by the software are used together with other clinical information by a medical professional. The software may be installed on an off-the-shelf PC computer system and is intended to be used with uncompressed digital images that are saved in DICOM format. {4}------------------------------------------------ ## Indications for Use: The LIA software provides CT values for pulmonary tissue which is essential for providing quantitative support for diagnosis and follow up examination. The LIA software can be used to support physician in the diagnosis and documentation of pulmonary tissue images (e.g. abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of subcompartments (including lung structures), volumetric analysis, density evaluations, fissure evaluation, and reporting tools are provided. # Summary of Technical Comparison: The LIA software is comparative to the predicate device, the Thirona LungQ Software (see Table 1). The software has the same intended use and similar technological characteristics, which do not raise any new questions of safety or effectiveness. | Item | LIA<br>Pulmonx<br>(Subject Device) | LungQ<br>Thirona<br>K173821<br>(Predicate Device) | Equivalence | |---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | JAK | JAK | Yes, identical. | | Regulation<br>Number | 21 CFR 892.1750 | 21 CFR 892.1750 | Yes, identical. | | Device<br>Classification | Class II | Class II | Yes, identical. | | Common Name | Software Accessory to a<br>Computed tomography x-ray<br>system | Software Accessory to a<br>Computed tomography x-ray<br>system | Yes, identical. | | Intended Use | The LIA software provides CT<br>values for pulmonary tissue<br>which is essential for providing<br>quantitative support for<br>diagnosis and follow up<br>examination. The LIA software<br>can be used to support<br>physician in the diagnosis and<br>documentation of pulmonary<br>tissue images (e.g.<br>abnormalities) from CT<br>thoracic datasets. Three-D<br>segmentation and isolation of<br>sub-compartments (including<br>lung structures), volumetric<br>analysis, density evaluations,<br>fissure evaluation, and<br>reporting tools are provided. | The Thirona LungQ software<br>provides CT values for<br>pulmonary tissue which is<br>essential for providing<br>quantitative support for<br>diagnosis and follow up<br>examination. The LungQ<br>software can be used to<br>support physician in the<br>diagnosis and documentation<br>of pulmonary tissue images<br>(e.g. abnormalities) from CT<br>thoracic datasets. Three-D<br>segmentation and isolation of<br>sub-compartments, volumetric<br>analysis, density evaluations,<br>fissure evaluation, and<br>reporting tools are provided. | Yes, identical. | | Modality | CT | CT | Yes, identical. | | Data Loading | DICOM | DICOM | Yes, identical. | | Application | Graphical User Interface and | Command-line interface | Yes, both devices provide | | Item | LIA<br>Pulmonx<br>(Subject Device) | LungQ<br>Thirona<br>K173821<br>(Predicate Device) | Equivalence | | | Command-line interface | | a command-line interface<br>while the subject device<br>also provides a GUI. The<br>addition of the GUI<br>provides a more user-<br>friendly interface. | | | Provides 3D segmentation | Provides 3D segmentation | Yes, identical. | | Segmentation | Provides segmentation of 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 | Provides segmentation of 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 | Yes, identical. | | | Provides Airways<br>Segmentation | Provides Airways<br>Segmentation | Yes, identical. | | | Software automatically<br>calculates segmentation (i.e.<br>lobe boundaries) and user can<br>manually edit lobe boundaries | Software automatically<br>calculates segmentation. | Yes, both devices<br>automatically calculate<br>segmentation.<br>The subject device also<br>allows the user to<br>manually edit<br>segmentation. Manually<br>editing segmentation was<br>included as a feature for<br>cases where the lobe<br>boundaries may be difficult<br>to automatically segment. | | Lung Volume<br>Analysis Support | Ability to measure volume 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 Lobe<br>Right Lower Lobe | Ability to measure volume 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 Lobe<br>Right Lower Lobe | Yes, identical. | | Volume Density<br>Analysis | Ability to measure volume at<br>multiple density ranges 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 Lobe | Ability to measure volume at<br>multiple density ranges 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 Lobe | Yes, identical. | | Item | LIA<br>Pulmonx<br>(Subject Device) | LungQ<br>Thirona<br>K173821<br>(Predicate Device) | Equivalence | | | Right Lower Lobe | Right Lower Lobe | | | | Allows the user to perform the<br>15th percentile density<br>analysis | Software provides the 15th<br>percentile density analysis | Yes, the output provides<br>histogram data that this<br>can be calculated from. | | Fissure Analysis | Ability to perform fissure<br>evaluations | Ability to perform fissure<br>evaluations | Yes, identical. | | Analyzed Data<br>Output | Provides data in .csv or .json<br>file | Provides a report | Yes, both devices provide<br>output to be used by<br>physicians. | ## Table 1: Substantial Equivalence between LIA and LungQ, the predicate device. {5}------------------------------------------------ {6}------------------------------------------------ # Performance Data: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Software verification and validation (V&V) were conducted to ensure that the LIA software met its intended use and software requirements. The V&V testing included subsystem integration testing, unit testing, module testing, and code reviews. The Lung Image Analysis software successfully passed the verification and validation. An equivalence study was conducted to compare data from 30 scans that were analyzed by both the predicate device, Thirona LungQ, and the subject device, Lung Image Analysis. Each device computed 120 fissure calculations, 180 lobar volumes, and 360 voxel density scores from 30 scans. Results from the two devices were similar, meeting the acceptance criteria. This shows that the Lung Image Analysis software is equivalent in performance to the predicate device. ## Summary: The LIA software has the same intended use as the predicate device. In addition, it has similar technological characteristics; performance data demonstrates that any differences in technological characteristics do not raise different questions of safety or effectiveness.