(169 days)
VIDA PW2
No
The summary describes image processing and quantitative analysis of CT scans, but there is no mention of AI, ML, deep learning, or any related terms in the device description, intended use, or performance studies. The performance studies focus on equivalence to a predicate device and comparison to a manual reference standard, not on validating an AI/ML model.
No
The device is described as software that provides quantitative support for diagnosis and follow-up examination by segmenting and analyzing CT images of pulmonary tissue. It aids physicians in diagnosis and documentation but does not directly treat or prevent a disease or condition.
Yes
The software "provides quantitative support for diagnosis" and "can be used to support physician in the diagnosis and documentation of pulmonary tissues images".
Yes
The device is described as "standalone command-line software" and its function is to process CT scan data to provide quantitative analysis and reporting. There is no mention of accompanying hardware or hardware components being part of the device itself.
Based on the provided information, the Thirona LungQ software is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The LungQ software analyzes CT images of the thorax, which are generated from the patient's body but are not biological specimens like blood, urine, or tissue samples.
- The intended use focuses on analyzing medical images. The description clearly states the software provides CT values for pulmonary tissue and supports physicians in the diagnosis and documentation of pulmonary tissue images. This is consistent with medical imaging analysis software, not IVDs.
- The device description confirms it analyzes CT scans. It explicitly states the software is designed to aid in the interpretation of Computed Tomography (CT) scans.
Therefore, while the LungQ software is a medical device used to aid in diagnosis, it falls under the category of medical imaging analysis software rather than an In Vitro Diagnostic.
N/A
Intended Use / 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 evaluation, fissure evaluation, and reporting tools are provided.
Product codes
JAK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Thorax (pulmonary tissues)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Equivalence study:
Sample size: 250 CT scans
Data source: COPDGene study (http://www.copdgene.org)
Annotation protocol: Not explicitly stated, but the study compared outputs between VIDA PW2 (predicate device) and Thirona LungQ 1.1.0 for lung and lobar volumes and density scores (LAA-950HU, LAA-910HU, 15th percentile of density histogram). Equivalence criteria were defined for these measurements.
Fissure analysis study:
Sample size: 55 scans
Data source: Multicentre study conducted at five clinical study sites located in Germany, the Netherlands and Sweden (NCT01101958).
Annotation protocol: Voxel-wise fissure completeness was compared to a manual reference standard.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Equivalence study:
Study type: Equivalence study
Sample size: 250 CT scans from the COPDGene study.
Key results: The results showed that outputs from Thirona LungQ 1.1.0 are equivalent to the predicate device, VIDA PW2, based on predefined criteria for lung and lobar volumes and density scores (LAA-950HU, LAA-910HU, 15th percentile of density histogram).
Fissure analysis study:
Study type: Performance testing comparing a previously published version of fissure analysis to LungQ 1.1.0.
Sample size: 55 scans.
AUC: The area under the receiver operating characteristic curve (Az) was used as a performance measure.
Key results: 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
§ 892.1750 Computed tomography x-ray system.
(a)
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.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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: +31 (0)647142838 | |
| E-mail: evavanrikxoort@thirona.eu | |
| Date Prepared | June X, 2018 |
| Trade Name | LungQ |
| Common Use/Usual | |
| 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
Thirona
(Subject Device) | VIDA PW2
VIDA
Diagnostics
K083227
(Predicate Device) | Imbio CT
Lung Density
Analysis
Software
Imbio LLC
K141069
(Reference Device) |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Product Code | JAK | Identical | Identical |
| Regulation
Number | 21 CFR 892.1750 | Identical | Identical |
| Device
Classification | Class II | Identical | Identical |
| Common Name | Software Accessory to a
Computed tomography
x-ray system | Identical | Identical |
| Item | LungQ
Thirona
(Subject Device) | VIDA PW2
VIDA
Diagnostics
K083227
(Predicate
Device) | Imbio CT
Lung Density
Analysis
Software
Imbio LLC
K141069
(Reference
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
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. | Nearly Identical | Nearly Identical |
| Modality | CT | Identical | Identical |
| Data Loading | DICOM | Identical | Identical |
| Application | Command-line interface | Includes a
workstation | Identical |
| Segmentation | Provides 3D
segmentation | Identical | Identical |
| Item | LungQ
Thirona
(Subject Device) | VIDA PW2
VIDA
Diagnostics
K083227
(Predicate
Device) | Imbio CT
Lung Density
Analysis
Software
Imbio LLC
K141069
(Reference
Device) |
| | Provides Segmentation
of the:
• Left Lung
• Right Lung
• Left Upper Lobe
• Left Lower Lobe
• Right Upper
Lobe
• Right Middle
Lobe
• Right Lower
Lobe | Identical | Similar |
| | Provides Airways
Segmentation | Identical | Different |
| | User cannot manually
edit segmentation | User can manually
edit segmentation | Identical |
| Lung Volume
Analysis
Support | Ability to measure
volume for:
• Both Lungs
• Left Lung
• Right Lung
• Left Upper Lobe
• Left Lower Lobe
• Right Upper Lobe
• Right Middle Lob
• Right Lower Lobe | Identical | Similar |
| Item | LungQ
Thirona
(Subject Device) | VIDA PW2
VIDA
Diagnostics
K083227
(Predicate
Device) | Imbio CT
Lung Density
Analysis
Software
Imbio LLC
K141069
(Reference
Device) |
| Volume
Density
Analysis | Ability to measure
volume at multiple
density ranges for:
• Both Lungs
• Left Lung
• Right Lung
• Left Upper Lobe
• Left Lower Lobe
• Right Upper Lobe
• Right Middle Lob
• Right Lower Lobe | Identical | Similar |
| | Ability to measure the
15th percentile density
analysis | Identical | Different |
| | Does not perform low
density cluster analysis | Does perform low
density cluster
analysis | Identical |
| Fissure
Analysis | Ability to perform
fissure evaluations | Identical | Does not
perform fissure
evaluations |
| Analyzed Data
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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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 | |||
| smokers without airflow limitation | GOLD stage 0 | 112 | 44.80% |
| Subjects with COPD but with minimal | |||
| airflow limitations | GOLD stage 1 | 26 | 10.40% |
| Subjects with COPD and with moderate to | |||
| severe airflow limitations | GOLD stage 2-4 | 76 | 30.40% |
| Subjects with preserved ratio but impaired | |||
| 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