Broncholab

K191550 · Fluidda, Inc. · JAK · Mar 4, 2020 · Radiology

Device Facts

• Record ID: K191550
• Device Name: Broncholab
• Applicant: Fluidda, Inc.
• Product Code: JAK · Radiology
• Decision Date: Mar 4, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Broncholab provides physicians with reproducible CT values for providing quantitative support for diagnosis and follow-up examination. Broncholab can be used to support physicians in the diagnosis and documentation of pulmonary tissues images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of subcompartments, volumetric analysis, density evaluations, low density cluster analysis, fissure evaluation and reporting tools are combined with a dedicated workflow.

Device Story

Broncholab is a SaMD that processes inspiratory chest CT scans (DICOM 3.0) to provide quantitative pulmonary analysis. Users upload scans via a web portal; the system performs automated 3D segmentation and isolation of lung lobes and airways. It calculates lung/lobar volumes, airway volumes, density scores (including LAA-950HU and 15th percentile density), blood vessel density, and fissure integrity. The device generates a PDF report for the physician. It is intended for use by physicians to support diagnosis and therapy effectiveness assessment. The system includes manual and automated quality checks before report generation. It operates on standard hardware via a web browser.

Clinical Evidence

No clinical performance testing data provided. Bench testing included a head-to-head comparison with the predicate device using diverse CT datasets (GE, Philips, Siemens scanners). Metrics included Bland-Altman plots for lobe volume, emphysema, blood vessel density, PD15, and airway volume, and ICC (0.75; 95% CI: 0.54, 0.87) for fissure integrity. Mean differences for relative values were <5% and absolute values were within thresholds.

Technological Characteristics

SaMD; operates on standard PC hardware via web browser. Inputs: DICOM 3.0 CT scans. Processing: 3D segmentation based on local geometry and Hounsfield Unit (HU) thresholds. Outputs: Volumetric and density-based quantitative metrics. Connectivity: Web-based portal for data upload and report delivery. Software: Automated image processing pipeline with manual/automated QC.

Indications for Use

Indicated for physicians to support diagnosis and follow-up examination of pulmonary tissue abnormalities using CT thoracic datasets.

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 Pulmonary Workstation 2 (PW2) (K083227)

Submission Summary (Full Text)

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March 4, 2020

Fluidda Inc. c/o Anjali Nair Regulatory Affairs Specialist 750 N. San Vicente Blvd. Suite 800 West WEST HOLLYWOOD CA 90069

Re: K191550

Trade/Device Name: Broncholab Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: January 28, 2020 Received: January 29, 2020

Dear Anjali Nair:

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 medical devices and radiation-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,

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

510(k) Number (if known) K191550

Device Name Broncholab

Indications for Use (Describe)

Broncholab provides physicians with reproducible CT values for providing quantitative support for diagnosis and follow-up examination. Broncholab can be used to support physicians in the diagnosis and documentation of pulmonary tissues images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of subcompartments, volumetric analysis, density evaluations, low density cluster analysis, fissure evaluation and reporting tools are combined with a dedicated workflow.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# Section 5 - 510(k) Summary

| Submitter | Fluidda Inc. |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Submission Number | K191550 |
| Address | 750 N San Vicente Blvd Ste. 800 West, West Hollywood, CA<br>90069, USA |
| Contact Person | Anjali Nair<br>Regulatory Affairs Specialist at Fluidda Inc.<br>Tel: [phone]<br>Email: [e-mail] |
| Date Prepared | January 28, 2020 |
| Trade Name | Broncholab |
| Common Name | Quantitative CT analysis system |
| Classification Name | Computed Tomography X-Ray System |
| Regulation Number | 21 CFR 892.1750 |
| Classification | Class II |
| Product Code | JAK |
| Panel | Radiology |
| Legally marketed Primary Predicate Device | Vida Pulmonary Workstation 2 (PW2), Vida Diagnostics<br>(K083227) |
| Predicate Regulation Number | 21 CFR 892.1750 |
| Predicate Classification & Product Code | Class II; Product Code- JAK<br>The predicate device has not been subject to a design-related<br>recall. |

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## Device Description

Broncholab is a SaMD (Software as Medical Device) which provides quantitative CT values that are intended to support the physician in the diagnosis and documentation of pulmonary tissues images (abnormalities) from CT scans. The CT scan images are transformed into 3D models of the patient-specific lungs using several image processing steps. Broncholab can be used to assess the effectiveness of therapy based on CT scan data. It is used along with the following accessories:

- Web Portal: Enables the uploading of CT scans and patient data
- Client Report: Enables the conversion of the output of Broncholab (CT values) into a desired digital format (PDF Report) and transfers this Report to the physician via email.

Inspiratory CT scan images uploaded by the users are converted into quantitative CT values using a combination of software tools. Quality checks (both manual and automated) are implemented to assure the quality of the final data. The outputs are provided as absolute values and as a percentage of the total airway volume/ lobar volume depending on the parameter. The device can be used on a computer with a web browser installed and consists of two accessories:

- An online portal to upload the CT scans
- · An accessory that enables the creation of the Report

#### The CT values include:

- 1. Lung and Lobar Volume is the volume of the 3D model of each lung lobe.
- 2. Airway Volume is defined as the region from the trachea until the segmental bronchi.
- 3. Lung Density Scores/ Volumes is defined as all the intrapulmonary voxels with Hounsfield Units between -1024 and -950 using the inspiratory scans:
- · Low attenuation areas below -950 HU (LAA-950HU)
- · 15th percentile of density histogram : Percentile density (PD) can also be used to express Emphysema.
- · Blood vessel density : Blood vessel density can be determined through segmentation and 3-D reconstruction of the blood vessels. The segmentation is based on local geometry features and HU thresholds and is performed on the inspiratory CT scan.
- 4. Fissure Analysis (fissure integrity) is the percentage of the fissure. Lung fissures are a doublefold of visceral pleura that either completely or incompletely separates the lungs into lung lobes.

CT scan images must be DICOM 3.0 compliant.

### Indications for Use Statement

Broncholab provides physicians with reproducible CT values for providing quantitative support for diagnosis and follow-up examination. Broncholab can be used to support physicians in the diagnosis and documentation of pulmonary tissues images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of subcompartments, volumetric analysis, density cluster analysis, fissure evaluation and reporting tools are combined with a dedicated workflow.

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## Summary of Technological Comparisons

| | Subject Device | Predicate Device | | |
|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Proprietary Name | Broncholab | Vida Pulmonary Workstation 2 (PW2) | SUBSTANTIAL<br>EQUIVALENCE (SE)<br>COMPARISON | |
| Manufacturer | Fluidda, Inc. | Vida Diagnostics | | |
| 510(k) | K191550 | K083227 | | |
| Labeling | | | | |
| | Regulation | 21 CFR 892.1750 | 21 CFR 892.1750 | Same |
| | Product code | JAK | JAK | Same |
| Classification | Class. Name | Computed Tomography X- Ray<br>System | Computed Tomography X- Ray System | Same |
| Indications for Use Statement | | Broncholab provides physicians<br>with reproducible CT values for<br>pulmonary tissue for providing<br>quantitative support for diagnosis<br>and follow-up examination. | The Vida Pulmonary Workstation 2 (PW2)<br>software provides reproducible CT values for<br>pulmonary tissue which is essential for<br>providing quantitative support for diagnosis<br>and follow up examinations. | Same |
| | | Broncholab can be used to support<br>physicians in the diagnosis and<br>documentation of pulmonary<br>tissues images (e.g.,<br>abnormalities) from CT thoracic<br>datasets. | The PW2 can be used to support the<br>physician in the diagnosis and documentation<br>of pulmonary tissue images (e.g.,<br>abnormalities) from CT thoracic datasets. | Same |
| | | Three-D segmentation and<br>isolation of subcompartments,<br>volumetric analysis, density<br>evaluations, low density cluster<br>analysis, fissure evaluation and<br>reporting tools are combined with<br>a dedicated workflow. | Three-D segmentation and isolation of sub-<br>compartments, volumetric analysis, density<br>evaluations, low density cluster analysis and<br>reporting tools are combined with a<br>dedicated workflow. | Same |
| Intended User Population | | Physician | Physician | Same |
| Patients population | | Broncholab can be used to support<br>physicians in the diagnosis and<br>documentation of pulmonary<br>tissues images (e.g.,<br>abnormalities) from CT thoracic<br>datasets. | The PW2 can be used to support the<br>physician in the diagnosis and documentation<br>of pulmonary tissue images (e.g.,<br>abnormalities) from CT thoracic datasets. | Same |
| | | Subject Device | Predicate Device | |
| | Device Proprietary Name | Broncholab | Vida Pulmonary Workstation 2 (PW2) | SUBSTANTIAL<br>EQUIVALENCE (SE)<br>COMPARISON |
| Manufacturer | | Fluidda, Inc. | Vida Diagnostics | |
| | 510(k) | K191550 | K083227 | |
| | | Technical (IT) Considerations | | |
| | Modality | CT | CT | Same |
| | Data Loading | DICOM | DICOM | Same |
| | Application | Graphical User Interface (GUI) | Workstation | Equivalent<br>Using the GUI does not<br>affect the processing of<br>scans. It only provides a<br>means to transfer the<br>input and receive the<br>output (Report). These<br>differences do not raise<br>different questions<br>regarding the safety and<br>effectiveness of the<br>subject device. |
| | Automation of process | Automation of tasks within the<br>workflow of the FRI<br>Quantification Software | Fully automated analysis of an<br>inspiratory chest CT scan | Equivalent |
| | Software device that<br>operates on industry<br>standard hardware | Yes | Yes | Same |
| | CT Scan<br>Protocol<br>Requirements | Equivalent | Equivalent | Equivalent |
| | Input | Chest CT Scans | Chest CT Scans | Same |
| | Output | 1.<br>Lung and lobar volume<br>2.<br>Airway volume<br>3.<br>Lung and lobar density scores<br>4.<br>Fissure analysis | 1. Lung and lobar volume<br>2. Lung and lobar density scores<br>3. Fissure analysis | Like the predicate, the subject<br>device provides:<br>1. Lung and lobar<br>volume<br>2. Lung and lobar<br>density scores<br>3. Fissure analysis<br>Performance testing to<br>demonstrate accuracy and<br>effectiveness of the airway<br>volume and blood vessel<br>density parameter, along with<br>all other outputs has been<br>performed and the results are<br>placed in Section 18 -<br>Performance Testing - Bench |
| | Analyzed Data Output | Provides a Report | Provides a report | Same |
| | Subject Device | Predicate Device | | |
| Device Proprietary Name | Broncholab | Vida Pulmonary Workstation 2 (PW2) | SUBSTANTIAL | |
| Manufacturer | Fluidda, Inc. | Vida Diagnostics | EQUIVALENCE (SE)<br>COMPARISON | |
| 510(k) | K191550 | K083227 | | |
| | | Tasks performed by Device | | |
| Segmentation | Provides Three-D Segmentation | Provides Three-D Segmentation | Same | |
| | Provides Segmentation of: | Provides Segmentation of: | Same | |
| | · Left Lung | · Left Lung | | |
| | · Right Lung | · Right Lung | | |
| | · Left Upper Lobe (LUL) | · Left Upper Lobe (LUL) | | |
| | · Left Lower Lobe (LLL) | · Left Lower Lobe (LLL) | | |
| | · Right Upper Lobe (RUL) | · Right Upper Lobe (RUL) | | |
| | · Right Middle Lobe (RML) | · Right Middle Lobe (RML) | | |
| | · Right Lower Lobe (RLL) | · Right Lower Lobe (RLL) | | |
| | Provides Airway Segmentation | Provides Airway Segmentation | Same | |
| | Intended user cannot manually<br>edit segmentation. | Intended user can manually edit<br>segmentation | These differences do not<br>raise different questions<br>regarding the safety and<br>effectiveness of the<br>subject device. | |
| Volumetric Analysis | Ability to measure volume for: | Ability to measure volume for: | Same | |
| | · Both Lungs<br>· Left Lung<br>· Right Lung<br>· Left Upper Lobe (LUL)<br>· Left Lower Lobe (LLL)<br>· Right Upper Lobe (RUL)<br>· Right Middle Lobe (RML)<br>· Right Lower Lobe (RLL) | · Both Lungs<br>· Left Lung<br>· Right Lung<br>· Left Upper Lobe (LUL)<br>· Left Lower Lobe (LLL)<br>· Right Upper Lobe (RUL)<br>· Right Middle Lobe (RML)<br>· Right Lower Lobe (RLL) | | |
| Density 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 (LUL)<br>· Left Lower Lobe (LLL)<br>· Right Upper Lobe (RUL)<br>· Right Middle Lobe (RML)<br>· Right Lower Lobe (RLL) | Ability to measure<br>volume at multiple<br>density ranges for:<br>· Both Lungs<br>· Left Lung<br>· Right Lung<br>· Left Upper Lobe (LUL)<br>· Left Lower Lobe (LLL)<br>· Right Upper Lobe (RUL)<br>· Right Middle Lobe (RML)<br>· Right Lower Lobe (RLL) | Same | |
| | Ability to measure 15th percentile<br>density. blood vessel density and | Ability to measure 15th percentile density,<br>blood vessel density and perform fissure | Same | |
| | perform fissure evaluations | evaluations | | |
| Detects Airway<br>Morphology | Yes | Yes | Same | |
| Steps in the use of the device | | | | |
| Quality check of CT<br>Scans | Quality Checks on CT Scans | Integrated scan quality check | Equivalent<br>Both the subject and<br>predicate devices conduct<br>quality checks on incoming<br>data although exact<br>wording is different. | |
| Analysis | Automation of tasks in the<br>workflow of the FRI Quantification<br>Software.…