(24 days)
No reference device is being used in this submission.
No
The summary describes standard image processing techniques (segmentation, volumetric analysis, density evaluation) and does not mention AI/ML terms or provide details about training/test sets typically associated with such technologies.
No
The device is described as software that provides quantitative support for diagnosis and follow-up examination of pulmonary tissue, aids in the interpretation of CT scans, and provides tools for volumetric analysis and density evaluation. It does not exert any direct therapeutic action on the patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software "can be used to support physician in the diagnosis and documentation of pulmonary tissue images".
Yes
The device description explicitly states it is "software" and is intended to be installed on an "off-the-shelf PC computer system" and used with digital images. There is no mention of proprietary hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Pulmonx LIA software analyzes medical images (CT scans) of the thorax. It processes existing image data to provide quantitative information about pulmonary tissue.
- No Sample Analysis: The device does not interact with or analyze biological samples taken from a patient. Its input is image data, not biological material.
The device is a medical image analysis software intended to aid physicians in interpreting CT scans for diagnosis and follow-up. This falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for 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.
Product codes
JAK
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Pulmonary tissue / thoracic datasets / lung structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference device is being used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
September 2, 2021
Image /page/0/Picture/1 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 logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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)
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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
Pulmonx
(Subject Device) | LungQ
Thirona
K173821
(Predicate Device) | Equivalence |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | JAK | JAK | Yes, identical. |
| Regulation
Number | 21 CFR 892.1750 | 21 CFR 892.1750 | Yes, identical. |
| Device
Classification | Class II | Class II | Yes, identical. |
| Common Name | Software Accessory to a
Computed tomography x-ray
system | Software Accessory to a
Computed tomography x-ray
system | Yes, identical. |
| Intended 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
sub-compartments (including
lung structures), volumetric
analysis, density evaluations,
fissure evaluation, and
reporting tools are provided. | 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 tissue 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. | 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
Pulmonx
(Subject Device) | LungQ
Thirona
K173821
(Predicate Device) | Equivalence |
| | Command-line interface | | a command-line interface
while the subject device
also provides a GUI. The
addition of the GUI
provides a more user-
friendly interface. |
| | Provides 3D segmentation | Provides 3D segmentation | Yes, identical. |
| Segmentation | Provides segmentation of the:
Left Lung
Right Lung
Left Upper Lobe
Left Lower Lobe
Right Upper Lobe
Right Middle Lobe
Right Lower Lobe | Provides segmentation of the:
Left Lung
Right Lung
Left Upper Lobe
Left Lower Lobe
Right Upper Lobe
Right Middle Lobe
Right Lower Lobe | Yes, identical. |
| | Provides Airways
Segmentation | Provides Airways
Segmentation | Yes, identical. |
| | Software automatically
calculates segmentation (i.e.
lobe boundaries) and user can
manually edit lobe boundaries | Software automatically
calculates segmentation. | Yes, both devices
automatically calculate
segmentation.
The subject device also
allows the user to
manually edit
segmentation. Manually
editing segmentation was
included as a feature for
cases where the lobe
boundaries may be difficult
to automatically segment. |
| 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 Lobe
Right Lower Lobe | Ability to measure volume for:
Both Lungs
Left Lung
Right Lung
Left Upper Lobe
Left Lower Lobe
Right Upper Lobe
Right Middle Lobe
Right Lower Lobe | Yes, identical. |
| 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 Lobe | 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 Lobe | Yes, identical. |
| Item | LIA
Pulmonx
(Subject Device) | LungQ
Thirona
K173821
(Predicate Device) | Equivalence |
| | Right Lower Lobe | Right Lower Lobe | |
| | Allows the user to perform the
15th percentile density
analysis | Software provides the 15th
percentile density analysis | Yes, the output provides
histogram data that this
can be calculated from. |
| Fissure Analysis | Ability to perform fissure
evaluations | Ability to perform fissure
evaluations | Yes, identical. |
| Analyzed Data
Output | Provides data in .csv or .json
file | Provides a report | Yes, both devices provide
output to be used by
physicians. |
Table 1: Substantial Equivalence between LIA and LungQ, the predicate device.
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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.