Lung Image Analysis

K212494 · Pulmonx Corporation · JAK · Sep 2, 2021 · Radiology

Device Facts

• Record ID: K212494
• Device Name: Lung Image Analysis
• Applicant: Pulmonx Corporation
• Product Code: JAK · Radiology
• Decision Date: Sep 2, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

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.

Device Story

LIA software processes uncompressed DICOM CT thoracic datasets; performs 3D segmentation of lung structures (left/right lungs, lobes) and airways; calculates volumetric analysis, density evaluations, and fissure evaluations. Operates on off-the-shelf PC via GUI or command-line interface. Used by trained medical professionals in clinical environments to support diagnosis and documentation of pulmonary abnormalities. Output provided as .csv or .json files for physician review alongside other clinical information. Benefits include quantitative support for diagnosis and follow-up of pulmonary tissue conditions.

Clinical Evidence

Bench testing only. Equivalence study compared LIA and LungQ using 30 CT scans. Metrics included 120 fissure calculations, 180 lobar volumes, and 360 voxel density scores. Results showed similarity between devices, meeting all acceptance criteria. Software V&V included unit, module, subsystem integration testing, and code reviews.

Technological Characteristics

Software-based image analysis tool for CT thoracic datasets. Compatible with off-the-shelf PC hardware. Inputs: DICOM format images. Outputs: .csv or .json files. Features: 3D segmentation, volumetric analysis, density evaluation, fissure evaluation, GUI, and command-line interface. No specific hardware or energy source requirements; standalone software application.

Indications for Use

Indicated for use by trained professionals to support diagnosis and documentation of pulmonary tissue images (e.g., abnormalities) from CT thoracic datasets, providing quantitative support for diagnosis and follow-up examination.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• LungQ (K173821)

Submission Summary (Full Text)

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September 2, 2021

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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). 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

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

, for

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

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# 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)

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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: [e-mail] Phone: [phone]

## 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.

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## 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.

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# Performance Data:

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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.