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 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.
1. Airway Volume is defined as the region from the trachea until the segmental bronchi.
1. 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.
1. 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.

AI/ML Overview

Here's a breakdown of the requested information regarding the acceptance criteria and study for the Broncholab device:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document provides performance results in relation to a predicate device (Vida PW2) for most metrics, and against expert segmentations for airway volume. The acceptance criteria for the comparison against the predicate are implicitly defined by similar performance to the predicate or being below specified thresholds. For airway volume, explicit thresholds are provided.

Metric	Acceptance Criteria	Reported Device Performance
Lobe Volume (Relative values)	Mean difference (range) between Broncholab and predicate device less than 5%	Mean difference (range) between Broncholab and predicate device was less than 5%
Lobe Volume (Absolute values)	Mean difference (range) between Broncholab and predicate device less than 150mL	Mean difference (range) between Broncholab and predicate device was less than 150mL
Emphysema (Relative values)	Mean difference (range) between Broncholab and predicate device less than 5%	Mean difference (range) between Broncholab and predicate device was less than 5%
Emphysema (Absolute values)	Mean difference (range) between Broncholab and predicate device less than 150mL	Mean difference (range) between Broncholab and predicate device was less than 150mL
Blood Vessel Density (Relative values)	Mean difference (range) between Broncholab and predicate device less than 5%	Mean difference (range) between Broncholab and predicate device was less than 5%
Blood Vessel Density (Absolute values)	Mean difference (range) between Broncholab and predicate device less than 150mL	Mean difference (range) between Broncholab and predicate device was less than 150mL
15th Percentile Lung Density (PD15)	Mean difference (range) between Broncholab and predicate device less than 1 HU	Mean difference (range) between Broncholab and predicate device was less than 1 HU
Fissure Integrity	Intraclass Correlation Coefficient (ICC) of 0.75 or higher (implicitly, based on reported value)	ICC estimate (95% CI) for comparison of fissure integrity was 0.75 (0.54, 0.87)
Airway Volume (Relative values)	Mean difference (range) between Broncholab and physicians less than 5%	Mean difference (range) between Broncholab and physicians was less than 5%
Airway Volume (Absolute values)	Mean difference (range) between Broncholab and physicians less than 150mL	Mean difference (range) between Broncholab and physicians was less than 150mL

The document mentions "The tolerable variability for absolute and relative values are 150mL and 5%, respectively." This statement applies to the absolute and relative values across the various metrics where applicable.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample size (number of cases/patients) used for the comparison study. It refers to "datasets used for the performance testing."

Data Provenance: The CT scans used were taken from a "wide variety of scanner brands and models" including GE Healthcare, Philips, and Siemens. The specific country of origin or whether the data was retrospective or prospective is not explicitly stated in the provided text.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: 3 physicians
Qualifications of Experts: The document refers to them simply as "three physicians." No specific subspecialty (e.g., radiologist) or years of experience are provided.

4. Adjudication Method for the Test Set

For airway volume, the ground truth was established by "taking the mean airway volume obtained from three physicians' segmentation." This implies a form of consensus or averaging method after individual expert input, but not a formal adjudication method like 2+1 or 3+1 for discordance resolution.

For other metrics compared against the predicate device, the ground truth for the test set is implicitly the output of the predicate device itself, rather than expert consensus on individual features.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The provided text describes a head-to-head performance testing against a predicate device and against expert segmentations for airway volume. It does not describe a multi-reader, multi-case (MRMC) comparative effectiveness study to assess the improvement of human readers with AI assistance versus without. Therefore, there is no effect size reported for human readers improving with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes. The study described is a standalone performance evaluation of the Broncholab algorithm. It compares the algorithm's output directly against the predicate device's output and against expert segmentations (for airway volume) without the involvement of a human-in-the-loop interacting with the Broncholab device during the performance assessment phase.

7. The Type of Ground Truth Used

For Lobe Volume, Emphysema, Blood Vessel Density, PD15, and Fissure Integrity: The ground truth was effectively the output of the predicate device (Vida Pulmonary Workstation 2 (PW2)). The study aims to show substantial equivalence to this legally marketed device.
For Airway Volume: The ground truth was expert consensus (mean of three physicians' segmentations).

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size used for the training set of the Broncholab algorithm. It focuses solely on the performance testing.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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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Section 5 - 510(k) Summary

Submitter	Fluidda Inc.
Submission Number	K191550
Address	750 N San Vicente Blvd Ste. 800 West, West Hollywood, CA90069, USA
Contact Person	Anjali NairRegulatory Affairs Specialist at Fluidda Inc.Tel: +91 9324857705Email: anjali.nair@fluidda.com
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(K083227)
Predicate Regulation Number	21 CFR 892.1750
Predicate Classification & Product Code	Class II; Product Code- JAKThe predicate device has not been subject to a design-relatedrecall.

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Device Description

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.
1. Airway Volume is defined as the region from the trachea until the segmental bronchi.
1. 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.
1. 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)	SUBSTANTIALEQUIVALENCE (SE)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- RaySystem	Computed Tomography X- Ray System	Same
Indications for Use Statement		Broncholab provides physicianswith reproducible CT values forpulmonary tissue for providingquantitative support for diagnosisand follow-up examination.	The Vida Pulmonary Workstation 2 (PW2)software provides reproducible CT values forpulmonary tissue which is essential forproviding quantitative support for diagnosisand follow up examinations.	Same
		Broncholab can be used to supportphysicians in the diagnosis anddocumentation of pulmonarytissues images (e.g.,abnormalities) from CT thoracicdatasets.	The PW2 can be used to support thephysician in the diagnosis and documentationof pulmonary tissue images (e.g.,abnormalities) from CT thoracic datasets.	Same
		Three-D segmentation andisolation of subcompartments,volumetric analysis, densityevaluations, low density clusteranalysis, fissure evaluation andreporting tools are combined witha dedicated workflow.	Three-D segmentation and isolation of sub-compartments, volumetric analysis, densityevaluations, low density cluster analysis andreporting tools are combined with adedicated workflow.	Same
Intended User Population		Physician	Physician	Same
Patients population		Broncholab can be used to supportphysicians in the diagnosis anddocumentation of pulmonarytissues images (e.g.,abnormalities) from CT thoracicdatasets.	The PW2 can be used to support thephysician in the diagnosis and documentationof pulmonary tissue images (e.g.,abnormalities) from CT thoracic datasets.	Same
		Subject Device	Predicate Device
	Device Proprietary Name	Broncholab	Vida Pulmonary Workstation 2 (PW2)	SUBSTANTIALEQUIVALENCE (SE)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	EquivalentUsing the GUI does notaffect the processing ofscans. It only provides ameans to transfer theinput and receive theoutput (Report). Thesedifferences do not raisedifferent questionsregarding the safety andeffectiveness of thesubject device.
	Automation of process	Automation of tasks within theworkflow of the FRIQuantification Software	Fully automated analysis of aninspiratory chest CT scan	Equivalent
	Software device thatoperates on industrystandard hardware	Yes	Yes	Same
	CT ScanProtocolRequirements	Equivalent	Equivalent	Equivalent
	Input	Chest CT Scans	Chest CT Scans	Same
	Output	1.Lung and lobar volume2.Airway volume3.Lung and lobar density scores4.Fissure analysis	1. Lung and lobar volume2. Lung and lobar density scores3. Fissure analysis	Like the predicate, the subjectdevice provides:1. Lung and lobarvolume2. Lung and lobardensity scores3. Fissure analysisPerformance testing todemonstrate accuracy andeffectiveness of the airwayvolume and blood vesseldensity parameter, along withall other outputs has beenperformed and the results areplaced in Section 18 -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)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 manuallyedit segmentation.	Intended user can manually editsegmentation	These differences do notraise different questionsregarding the safety andeffectiveness of thesubject device.
Volumetric Analysis	Ability to measure volume for:	Ability to measure volume for:	Same
	· Both Lungs· Left Lung· Right Lung· Left Upper Lobe (LUL)· Left Lower Lobe (LLL)· Right Upper Lobe (RUL)· Right Middle Lobe (RML)· Right Lower Lobe (RLL)	· Both Lungs· Left Lung· Right Lung· Left Upper Lobe (LUL)· Left Lower Lobe (LLL)· Right Upper Lobe (RUL)· Right Middle Lobe (RML)· Right Lower Lobe (RLL)
Density analysis	Ability to measurevolume at multipledensity ranges for:· Both Lungs· Left Lung· Right Lung· Left Upper Lobe (LUL)· Left Lower Lobe (LLL)· Right Upper Lobe (RUL)· Right Middle Lobe (RML)· Right Lower Lobe (RLL)	Ability to measurevolume at multipledensity ranges for:· Both Lungs· Left Lung· Right Lung· Left Upper Lobe (LUL)· Left Lower Lobe (LLL)· Right Upper Lobe (RUL)· Right Middle Lobe (RML)· Right Lower Lobe (RLL)	Same
	Ability to measure 15th percentiledensity. blood vessel density and	Ability to measure 15th percentile density,blood vessel density and perform fissure	Same
	perform fissure evaluations	evaluations
Detects AirwayMorphology	Yes	Yes	Same
Steps in the use of the device
Quality check of CTScans	Quality Checks on CT Scans	Integrated scan quality check	EquivalentBoth the subject andpredicate devices conductquality checks on incomingdata although exactwording is different.
Analysis	Automation of tasks in theworkflow of the FRI QuantificationSoftware.	Fully automated quantification	EquivalentIn the case of both thedevices, image processingsteps that can be donemanually are doneautomatically in order tosave time. Any differencesdo not raise differentquestions regarding thesafety and effectiveness ofthe subject device.
Review of output	The Report is QC verified beforeit is emailed to the physician.	Automated quality check of the Report	EquivalentIn the case of both thesubject and the predicatedevices, the final output isreviewed before it is madeavailable to the intendeduser.
Delivery of results:the results aredelivered back to theintended user	Yes	Yes	Same
Other Areas of Comparison
Energy used and/ordelivered to patient	No	No	Same
Materials	N/A	N/A	Same

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Non-Clinical Performance Testing

Verification testing was conducted against predetermined acceptance criteria to show that the subject device performs the functions that are equivalent to the predicate device. Broncholab successfully passed verification testing. Design validation was performed in simulated use settings. The results support substantial equivalence of the subject device to the predicate device and demonstrate that it is safe and effective for its intended use.

The following quality assurance measures were applied during software development:

Software Development Life Cycle
· Software Risk Assessment
Software Configuration Management and Version Control
· Software issue tracking and resolution

A head-to-head performance testing was conducted between the subject and the predicate device.

The aim of this study was to assess and compare the measurement of lung structure parameters at inspiration, such as lobe volume, emphysema, blood vessel density, 15th percentile lung density (PD15) and fissure integrity, between the Broncholab device and the VIDA device, i.e. primary predicate (K083227). Firstly, both devices analyzed the lobe volume, emphysema, blood vessel density, PD15 and fissure integrity, Bland-Altman plots were used for the pairwise comparison of the lobe volume, emphysema, blood vessel density and PD15 measurements between the two devices. Moreover, for the comparison of the fissure integrity measurements between both devices, the Intraclass Correlation Coefficient (ICC) with 95% confidence interval (CI) was calculated. The airway volumes are not compared with the primary predicate but with segmentations which were corrected by three physicians. The pairwise comparison between Broncholab and the physicians was performed using Bland-Altman plots of airway volume.

The tolerable variability for absolute and relative values are 150mL and 5%, respectively.

The results showed that for the lobe volume, emphysema and blood vessel density measurements expressed in relative values, the mean differences (range) between Broncholab and the primary predicate were all less than 5%. When expressed in absolute values, the mean differences (range) between Broncholab and the primary predicate were less than the threshold absolute value. The mean difference (range) between Broncholab and the primary predicate for the PD15 measurements was less than 1 HU. The ICC estimate (95% Cl) for comparison of the fissure integrity measurements between Broncholab and the primary predicate was found to be 0.75 (0.54, 0.87). The mean difference (range) between Broncholab and the physicians for the airway volume measurements expressed in relative values was less than 5%. Expressed in absolute values the mean difference (range) was less than the absolute threshold value. Ground truth was established by taking the mean airway volume obtained from three physicians' segmentation.

The scans were take with a wide variety of scanner brands and models used to obtain scans in the datasets used for the performance testing are:

Imaging parameters	Equivalence study
Scanner manufacture	GE Healthcare; Philips; Siemens
Scanner types	LightSpeed VCT; LightSpeed Pro 16; LightSpeed 16; Revolution CT;Revolution EVO; iCT 256; Emotion 16; SOMATOM Definition AS; SOMATOM Force; SOMATOM Definition Flash; Brilliance 64; Definition; Definition AS+;Discovery CT750 HD; Sensation 64

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Clinical Performance Data

No clinical performance testing data is provided with this submission.

Conclusion

Based on the intended use and technological characteristics comparison, non-clinical tests described, it can be concluded that taken individually as well as in sum, the subject device (Broncholab) is as safe, as effective, and performs as well as the predicate device (Vida PW2) and is thus substantially equivalent to it.

Regulation Number and Section

§ 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.