LungQ Software

K173821 · Thirona Corporation · JAK · Jun 5, 2018 · Radiology

Device Facts

• Record ID: K173821
• Device Name: LungQ Software
• Applicant: Thirona Corporation
• Product Code: JAK · Radiology
• Decision Date: Jun 5, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Thirona LungQ software provides CT values for pulmonary tissue which is essential for providing quantitative support for diagnosis and follow up examination. The Lung Q 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, fissure evaluation, and reporting tools are provided.

Device Story

LungQ is a standalone command-line software tool for processing thoracic CT scans. It ingests DICOM-formatted CT datasets to perform automated 3D segmentation of lungs, lobes, and airways. The software calculates volumetric measurements and density evaluations, including low attenuation areas (LAA-950HU, LAA-910HU) and 15th percentile density histograms, as well as fissure analysis. Operated by clinicians, the software provides quantitative reports to support the diagnosis and documentation of pulmonary abnormalities. By automating complex volumetric and density measurements, the device assists physicians in clinical decision-making for pulmonary disease management and follow-up.

Clinical Evidence

Equivalence study compared 250 CT scans from the COPDGene cohort analyzed by both LungQ and the predicate VIDA PW2. Metrics included lung/lobar volumes and density scores (LAA-950HU, LAA-910HU, 15th percentile). Results showed agreement within pre-defined limits (e.g., volume difference ≤10%). Fissure analysis performance was validated against a manual reference standard using 55 scans; LungQ 1.1.0 achieved an average Az of 0.95, significantly outperforming a previous version (Az 0.76, p<0.001).

Technological Characteristics

Standalone command-line software; processes DICOM CT thoracic datasets. Features 3D segmentation of lungs, lobes, and airways; volumetric and density quantification; fissure evaluation. Utilizes filtered back projection reconstruction. No graphical user interface. Software version 1.1.0.

Indications for Use

Indicated for use by physicians to provide quantitative support for diagnosis and follow-up examination of pulmonary tissue abnormalities using CT thoracic datasets. Applicable to patients undergoing CT scans for pulmonary assessment.

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

• VIDA PW2 (K083227)

Reference Devices

• Imbio CT Lung Density Analysis Software (K141069)

Submission Summary (Full Text)

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June 5th , 2018

Thirona Corporation % Jean-Paul Charbonnier Managing Director Toernooiveld 300 6525 EC Nijmegen THE NETHERLANDS

Re: K173821

Trade/Device Name: LungQ Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: May 31, 2018 Received: June 1, 2018

Dear Jean-Paul Charbonnier:

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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jeff Bargar

for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known)

K173821

Device Name LungQ

Indications for Use (Describe)

The Thirona LungQ software provides CT values for pulmonary tissue which is essential for providing quantitative support for diagnosis and follow up examination. The Lung Q 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, fissure 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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| Submitter | Thirona Corporation |
|--------------------------|-----------------------------------------|
| Contact Person | Eva van Rikxoort |
| | Managing Director |
| | Thirona BV |
| | Toernooiveld 300 |
| | 6525 EC Nijmegen |
| | the Netherlands |
| | Phone: [phone] |
| | E-mail: [e-mail] |
| Date Prepared | June X, 2018 |
| Trade Name | LungQ |
| Common Use/Usual<br>Name | Computer Tomography X-ray system |
| Product Code | JAK |
| Classification | Class II, 21 CFR 892.1750 |
| Device Panel | Radiology |
| Predicate Device | VIDA PW2 |
| Predicate Classification | Class II, 21 CFR 892.1750 |
| Reference Device | Imbio CT Lung Density Analysis Software |
| Reference Classification | Class II, 21 CFR 892.1750 |

Section 2.0 510(k) Summary

### 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 standalone command-line software which must be run from a command-line interpreter and does not have a graphical user interface.

### Indications for Use

The Thirona LungQ software provides 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.

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### Summary of Technical Comparisons

The table below compares the Thirona LungQ software to both the predicate and reference devices.

| Item | LungQ<br>Thirona<br>(Subject Device) | VIDA PW2<br>VIDA<br>Diagnostics<br>K083227<br>(Predicate Device) | Imbio CT<br>Lung Density<br>Analysis<br>Software<br>Imbio LLC<br>K141069<br>(Reference Device) |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Product Code | JAK | Identical | Identical |
| Regulation<br>Number | 21 CFR 892.1750 | Identical | Identical |
| Device<br>Classification | Class II | Identical | Identical |
| Common Name | Software Accessory to a<br>Computed tomography<br>x-ray system | Identical | Identical |
| Item | LungQ<br>Thirona<br>(Subject Device) | VIDA PW2<br>VIDA<br>Diagnostics<br>K083227<br>(Predicate<br>Device) | Imbio CT<br>Lung Density<br>Analysis<br>Software<br>Imbio LLC<br>K141069<br>(Reference<br>Device) |
| Intended Use | The Thirona LungQ<br>software provides CT<br>values for pulmonary<br>tissue which is essential<br>for providing<br>quantitative support for<br>diagnosis and follow up<br>examination. The<br>LungQ software can be<br>used to support<br>physician in the<br>diagnosis and<br>documentation of<br>pulmonary tissues<br>images (e.g.,<br>abnormalities) from CT<br>thoracic datasets. Three-<br>D segmentation and<br>isolation of sub-<br>compartments,<br>volumetric analysis,<br>density evaluations,<br>fissure evaluation, and<br>reporting tools are<br>provided. | Nearly Identical | Nearly Identical |
| Modality | CT | Identical | Identical |
| Data Loading | DICOM | Identical | Identical |
| Application | Command-line interface | Includes a<br>workstation | Identical |
| Segmentation | Provides 3D<br>segmentation | Identical | Identical |
| Item | LungQ<br>Thirona<br>(Subject Device) | VIDA PW2<br>VIDA<br>Diagnostics<br>K083227<br>(Predicate<br>Device) | Imbio CT<br>Lung Density<br>Analysis<br>Software<br>Imbio LLC<br>K141069<br>(Reference<br>Device) |
| | Provides Segmentation<br>of the:<br>• Left Lung<br>• Right Lung<br>• Left Upper Lobe<br>• Left Lower Lobe<br>• Right Upper<br>Lobe<br>• Right Middle<br>Lobe<br>• Right Lower<br>Lobe | Identical | Similar |
| | Provides Airways<br>Segmentation | Identical | Different |
| | User cannot manually<br>edit segmentation | User can manually<br>edit segmentation | Identical |
| Lung Volume<br>Analysis<br>Support | Ability to measure<br>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 Lob<br>• Right Lower Lobe | Identical | Similar |
| Item | LungQ<br>Thirona<br>(Subject Device) | VIDA PW2<br>VIDA<br>Diagnostics<br>K083227<br>(Predicate<br>Device) | Imbio CT<br>Lung Density<br>Analysis<br>Software<br>Imbio LLC<br>K141069<br>(Reference<br>Device) |
| Volume<br>Density<br>Analysis | Ability to measure<br>volume at multiple<br>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 Lob<br>• Right Lower Lobe | Identical | Similar |
| | Ability to measure the<br>15th percentile density<br>analysis | Identical | Different |
| | Does not perform low<br>density cluster analysis | Does perform low<br>density cluster<br>analysis | Identical |
| Fissure<br>Analysis | Ability to perform<br>fissure evaluations | Identical | Does not<br>perform fissure<br>evaluations |
| Analyzed Data<br>Output | Provides a report | Identical | Identical |

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#### Non-Clinical 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 implantation and system integration testing. The LungQ software successful passed the verification testing.

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### thi

Software Validation was conducted to ensure the software met the user needs (i.e. input requirements). This validation was based on user scenarios. The LungO software successfully passed the software validation.

An equivalence study comparing 250 CT scans from the COPDGene study (http://www.copdgene.org) analyzed by the predicate device, VIDA PW2, and the same 250 CT scans analyzed by Thirona LungQ. LungQ 1.1.0 was run allowing for interaction with the LungQ results in the Image Analysis Service as described in the Service Manual. The scans were randomly selected from the entire COPDGene cohort, leading to a population of subjects with and without COPD and with different stages of COPD. The distribution of subjects with respect to their disease state is provided below.

| Category | Disease state | # of subjects | % of data set |
|---------------------------------------------------------------------------|------------------|---------------|---------------|
| Control subjects: current or former<br>smokers without airflow limitation | GOLD stage 0 | 112 | 44.80% |
| Subjects with COPD but with minimal<br>airflow limitations | GOLD stage 1 | 26 | 10.40% |
| Subjects with COPD and with moderate to<br>severe airflow limitations | GOLD stage 2-4 | 76 | 30.40% |
| Subjects with preserved ratio but impaired<br>spirometry | GOLD stage PRISm | 33 | 13.20% |
| Control subjects: non-smokers | None | 3 | 1.20% |

The 250 scans were taken with a wide variety of scanners. The imaging parameters of the 250 scans are provided below.

The outputs between VIDA PW2 and Thirona LungQ 1.1.0 were compared. The following measurements were analyzed for equivalence:

- Lung and lobar volumes ●
- Lung and lobar density scores: .
- o Low attenuation areas below -950 HU (LAA-950HU)
- o Low attenuation areas below -910 HU (LAA-910HU)
- o 15th percentile of density histogram (perc15)

Equivalence was determined using the following criteria:

- Lung and lobar volume: Difference ≤ 10% ●
- . Lung and lobar density measurements:
- o LAA-950HU: Agreements limits -1% to 1%
- o LAA-910HU: Agreement limits -10% and 10%
- o 15th Percentile: Agreement limits -10 HU to 10 HU

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The results showed that outputs from Thirona LungQ 1.1.0 are equivalent to the predicate device, VIDA PW2.

Additional performance testing of Thirona LungQ fissure analysis was conducted to compare a previously published version to LungQ 1.1.0. This study was performed on a set of 55 scans taken from a multicentre study conducted at five clinical study sites located in Germany, the Netherlands and Sweden (NCT01101958). The 55 scans were taken with a wide variety of scanners. The imaging parameters of the 55 scans are provided below.

Voxel-wise fissure completeness was compared to a manual reference standard in order to evaluate the performance of the two algorithms. The area under the receiver operating characteristic curve (Az) was used as a performance measure. A statistically higher Az value was set as the criteria to prove that LungQ 1.1.0 outperforms the previously published version.

For each individual scan. the Az value for LungO 1.1.0 was higher compared to the previously published version. The average Az of LungQ 1.1.0 was 0.95, compared to a statistically significantly lower average Az value of 0.76 for the previously published version (tested with a paired-sample t-test, p<0.001). This study showed that the fissure analysis of LungQ 1.1.0 significantly outperforms the previously published version.

| Imaging parameters | Equivalence study | Fissure analysis |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| # of scans | 250 | 55 |
| Voxel spacing | 0.50 - 0.97 mm | 0.44 - 0.81 mm |
| Slice thickness | 0.625 - 0.9 mm | 0.6 - 1.5 mm |
| Slice spacing | 0.45 - 0.625 mm | 0.45 - 1.2 mm |
| Peak Kilovoltage | 120 pKv | 120 - 130 pKv |
| Scanner manufacture | GE MEDICAL SYSTEMS; SIEMENS;<br>Philips | SIEMENS; Philips |
| Scanner types | LightSpeed16; LightSpeed VCT;<br>Sensation 64; Definition; Sensation 16;<br>Definition AS+; SOMATOM Definition<br>Flash; Brilliance 64; LightSpeed Pro 16;<br>Discovery CT750 HD; SOMATOM<br>Definition | Mx8000 IDT 16; iCT<br>128; Volume Zoom;<br>Emotion 16; Sensation<br>64; Definition;<br>SOMATOM Definition; |
| Reconstruction algorithms | Filtered back projection | Filtered back projection |
| Reconstruction kernels | STANDARD; B35f; B | B40f; B50s; B60f; B60s;<br>B80f |
| milliampere second | 200 mAs | NA |

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#### Conclusions

Based on the comparison of intended use and key technological characteristics, Thirona believes that the Subject Device (LungQ) is substantially equivalent to the Predicate Device.