Who is the manufacturer of ClariPulmo?

Claripi, Inc. filed the 510(k) submission for ClariPulmo (K203783).

What is the FDA product code for ClariPulmo?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for ClariPulmo?

510(k) clearance (submission type: Traditional).

Does ClariPulmo use AI or machine learning?

Yes. ClariPulmo (K203783) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like ClariPulmo?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like ClariPulmo get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

ClariPulmo

K203783 · Claripi, Inc. · LLZ · Apr 6, 2022 · Radiology

Device Facts

Record ID	K203783
Device Name	ClariPulmo
Applicant	Claripi, Inc.
Product Code	LLZ · Radiology
Decision Date	Apr 6, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
High Attenuation Area (HAA) quantification	—	—	PCC: 0.980 – 0.983	—	—	Manual vs threshold-based segmentations including patients with pneumonia and COVID-19	>1 (expert radiologist)
Low Attenuation Area (LAA) quantification	—	—	PCC: 0.99	—	—	Manual vs threshold-based segmentations including healthy and diseased patients	>1 (expert radiologist)
Lung segmentation	Deep learning model	—	PCC: 0.977-0.992; DICE: 0.98-0.99	—	—	One internal and two external datasets	>1 (expert radiologist)

Indications for Use

ClariPulmo is a non-invasive image analysis software for use with CT images which is intended to support the quantification of lung CT images. The software is designed to support the physician in the diagnosis and documentation of pulmonary tissue images (e.g., abnormalities) from the CT thoracic datasets. (The software is not intended for the diagnosis of pneumonia or COVID-19). The software provides automation of the lungs and quantification of low-attenuation areas within the segmented lungs by using predefined Hounsfield unit thresholds. The software displays by color the segmented lungs and analysis results. ClariPulmo provides optional denoising and kernel normalization functions for improved quantification of lung CT images in cases when CT images were taken at low-dose conditions or with sharp reconstruction kernels.

Device Story

ClariPulmo is a standalone software application for lung CT image analysis. It takes thoracic CT datasets as input. The device uses a pre-trained deep learning model for automatic lung segmentation. It quantifies low-attenuation areas (LAA) and high-attenuation areas (HAA) using predefined Hounsfield unit thresholds. Optional U-Net based algorithms perform kernel normalization (sharp to smooth kernel) and denoising (low-dose to enhanced quality) to improve quantification. The software displays segmented lungs and analysis results via color overlays, tables, and charts. It is used by physicians in clinical settings to support diagnosis and documentation of pulmonary tissue abnormalities. The output assists clinicians in quantifying lung tissue density, which can aid in assessing lung conditions. It does not perform automated diagnosis of pneumonia or COVID-19.

Clinical Evidence

No clinical data. Non-clinical performance testing included bench testing of HAA/LAA analysis and AI-based segmentation/denoising/normalization. HAA analysis showed PCC 0.980–0.983; LAA analysis showed PCC 0.99. AI-based lung segmentation demonstrated PCC 0.977–0.992 and DICE coefficients 0.98–0.99 across various subgroups (normal/LAA/HAA, scanner types, kernels, low-dose).

Technological Characteristics

Standalone software for CT image processing. Uses deep learning (U-Net architecture) for segmentation, denoising, and kernel normalization. Operates on thoracic CT datasets. Complies with DICOM (NEMA-PS 3.1-3.20) and ISO 14971 risk management standards.

Indications for Use

Indicated for adult patients receiving lung CT to support quantification of lung CT images, including segmentation and analysis of low-attenuation and high-attenuation areas. Not indicated for diagnosis of pneumonia or COVID-19.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

THORACIC VCAR (K103480)

Reference Devices

Imbio CT Lung Density Analysis Software (K141069)
VIDA vision (formerly VIDA Pulmonary Workstation 2 (PW2)) (K200990)
ClariCT.AI (K183460)

Submission Summary (Full Text)

{0}------------------------------------------------ April 6, 2022 Image /page/0/Picture/1 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that. ClariPi Inc. % Harry Park President ClariPi Detroit Office 1645 Park Creek Ct. Rochester Hills DETROIT MI 48309 Re: K203783 Trade/Device Name: ClariPulmo Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: March 31, 2022 Received: March 31, 2022 Dear Mr. Park: 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 {1}------------------------------------------------ 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) 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 (OS) 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, Laurel Burk, Ph.D Assistant Director Diagnostic X-ray Systems Team 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 510(k) Number (if known) K203783 Device Name ClariPulmo Indications for Use (Describe) ClariPulmo is a non-invasive image analysis software for use with CT images which is intended to support the quantification of lung CT images. The software is designed to support the physician in the diagnosis and documentation of pulmonary tissue images (e.g., abnormalities) from the CT thoracic datasets. (The software is not intended for the diagnosis of preumonia or COVID-19). The software provides automation of the lungs and quantification of low-attenuation areas within the segmented lungs by using predefined Hounsfield unit thresholds. The software displays by color the segmented lungs and analysis results. ClariPulmo provides optional denoising and kernel normalization functions for improved quantification of lung CT images in cases when CT images were taken at low-dose conditions or with sharp reconstruction kernels. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for "Clariπ Medical Imaging Solutions". The word "Clari" is in bold black font, followed by a blue pi symbol. Below the word "Clariπ" is the text "MEDICAL IMAGING SOLUTIONS" in a smaller, thinner font. The logo is simple and professional, and it is likely used to represent a company that provides medical imaging solutions. This 510(k) Summary is being submitted in accordance with the requirements of as required by section 807.92(c). - SUBMITTER . ClariPi Inc. 2F~4F, 11, Ihwajang-1 gil, Jongno-gu Seoul, Republic of Korea [03088] Tel: +82-2-741-3014 Fax: +82-2-743-3014 Email: claripi@claripi.com Contact person: Mr. Harry Park, ClariPi USA Date Prepared: April 6, 2022 - II. DEVICE Device Name: ClariPulmo Common or Usual Name: Radiological Image Processing Software Regulation Name: "Medical Image Management and Processing System" Regulation Number: 21 CFR 892.2050 Regulatory Class: II K-Number: K203783 Product Code: LLZ ### III. PREDICATE DEVICE The following table shows the predicate devices of the proposed ClariPulmo: | Device Classification Name | System, Image processing, Radiological (Predicate device) | | | |--------------------------------|------------------------------------------------------------------------|--|--| | 510(k) Number | K103480 | | | | Device Name | THORACIC VCAR | | | | Applicant | GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW Waukesha, WI 53188, USA | | | | Regulation Number | 892.2050 | | | | Classification Product Code | LLZ | | | | Date Received | 11/26/2010 | | | | Decision Date | 03/07/2011 | | | | 510k Review Panel | Radiology | | | The proposed ClariPulmo and its predicate devices. THORACIC VCAR (K103480) is substantially equivalent regarding its intended use, clinical indications, and principle of operation. Further to the predicate device, ClariPi has identified the following currently marketed devices as reference devices of proposed ClariPulmo: {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for ClariPi Medical Imaging Solutions. The word "Clari" is written in bold, black letters. To the right of "Clari" is a blue symbol that resembles the mathematical symbol pi. Below the word "Clari" is the phrase "MEDICAL IMAGING SOLUTIONS" in smaller, black letters. | Device Classification Name | System, X-Ray, Tomography, Computed (Reference Device) | System, X-Ray, Tomography, Computed (Reference Device) | System, Image processing, Radiological (Reference Device) | |------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| | 510(k) Number | K141069 | K200990 | K183460 | | Device Name | Imbio CT Lung Density Analysis Software | VIDA vision (formerly VIDA Pulmonary Workstation 2 (PW2)) | ClariCT.AI | | Applicant | IMBIO LLC 227 COLFAX AVE NSUITE 144 Minneapolis, MN 5 5405 USA | VIDA Diagnostics, Inc. 500 Crosspark Rd. W250 BioVentures Center Coralville, IA 52241 USA | ClariPi Inc. 3F, 70-15, Ihwajang-gil, Jongno-gu, Seoul, Republic of Korea 03088 | | Regulation Number | 892.1750 | 892.1750 | 892.2050 | | Classification Product Code | JAK | JAK | LLZ | | Date Received | 04/24/2014 | 04/15/2020 | 12/13/2018 | | Decision Date | 09/17/2014 | 08/07/2020 | 06/13/2019 | | Decision | Substantially Equivalent (SE) | Substantially Equivalent (SE) | Substantially Equivalent (SE) | | Regulation Medical Specialty | Radiology | Radiology | Radiology | The Imbio CT Lung Density Analysis Software (K141069), VIDA|vision (formerly VIDA Pulmonary Workstation 2 (PW2)) (K200990) and ClariCT.Al (K183460) are reference devices for additional technologies and support the addition application functionalities and enhanced capabilities. ## IV. DEVICE DESCRIPTION ClariPulmo is a standalone software application analyzing lung CT images that can be used to support the physician in the quantification of lung CT image when examining pulmonary tissues. ClariPulmo provides two main and optional functions: - LAA Analysis provides quantitative measurement of pulmonary tissue image with low . attenuation areas (LAA). LAA are measured by counting those voxels with low attenuation values under the user-predefined thresholds within the segmented lungs. This feature supports the physician in quantifying lung tissue image with low attenuation area. - HAA Analysis provides quantitative measurement of pulmonary tissue image with high attenuation areas (HAA). HAA are measured by counting those voxels with high attenuation {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for ClariPi Medical Imaging Solutions. The word "Clari" is in black, followed by a blue pi symbol. Below the word "Clari" is the text "MEDICAL IMAGING SOLUTIONS" in a smaller font size. values using the user-predefined thresholds within the seamented lungs. This feature supports the physician in quantifying lung tissue image with high attenuation area. - Lungs are automatically segmented using a pre-trained deep learning model. - The optional Kernel Normalization function provides an image-to-image translation from a sharp kernel image to a smooth kernel image for improved quantification of lung CT images. The Kernel Normalization algorithm was constructed based on the U-Net architecture. - The optional Denoising function provides an image-to-image translation from a noisy lowdose image to a noise-reduced enhanced quality image of LDCT for improved quantification of lung LDCT images. The Denoising algorithm was constructed based on the U-Net architecture. The ClariPulmo software provides summary reports for measurement results that contains color overlay images for the lungs tissues as well as table and charts displaying analysis results. ## V. INDICATIONS FOR USE ClariPulmo is a non-invasive image analysis software for use with CT images which is intended to support the quantification of lung CT images. The software is designed to support the physician in the diagnosis and documentation of pulmonary tissue images (e.g., abnormalities) from the CT thoracic datasets. (The software is not intended for the diagnosis of pneumonia or COVID-19). The software provides automated segmentation of the lungs and quantification of low-attenuation and high-attenuation areas within the segmented lungs by using predefined Hounsfield unit thresholds. The software displays by color the segmented lungs and analysis results. ClariPulmo provides optional denoising and kernel normalization functions for improved quantification of lung CT images in cases when CT images were taken at low-dose conditions or with sharp reconstruction kernels. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for ClariPi Medical Imaging Solutions. The logo features the word "Clari" in bold, black letters, followed by a stylized blue pi symbol. Below the word "ClariPi" is the text "MEDICAL IMAGING SOLUTIONS" in a smaller, sans-serif font. # vi. INTENDED POPULATION The device is intended for adult patients receiving lung CT. ## VII. SUBSTANTIAL EQUIVALENCE TABLE | Feature | ClariPulmo (Subject Device) | Thoracic VCAR K103480 (Predicate Device) | Imbio CT Lung Density Analysis Software K141069 (Reference Device) | VIDA vision (formerly VIDA Pulmonary Workstation 2 (PW2)) K200990 (Reference Device) | ClariCT.AI K183460 (Reference Device) | |---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------| | Algorithm | Deep learning | unknown | Image post- processing algorithm | Self-contained image analysis | Deep learning | | Modality | CT | CT | CT | CT | CT | | Type of scan | Thoracic CT | Thoracic CT | Thoracic CT | Thoracic CT | Head, heart, chest and abdomen CT | | DICOM standard | Yes | Yes | Yes | Yes | Yes | | Automatic segmentation of both the left and right lungs and airways | Yes | Yes | Yes | Yes | Not relevant | | Lung volume analysis support: Both, Left, and Right Lungs | Yes | Yes | Yes | Yes | Not relevant | | Low attenuation analysis | Yes Lung density result quantificati on with HU density range, volume measurem ent, lung density index and Perc15 measurem ent | Yes Lung density result quantificati on with HU density range, volume measurem ent | Yes Lung density result quantification with HU density range, volume measurement , lung density index and PercX (where "X" corresponds to the desired percentile) calculated in the Inspiration Assessment | Yes Lung density result quantification with HU density range, volume measurement, lung density index and Perc15 measurement | Not relevant | {7}------------------------------------------------ Image /page/7/Picture/1 description: The image is a logo for a company called "ClariPi MEDICAL IMAGING SOLUTIONS". The word "Clari" is in black, and the "Pi" is in blue. Underneath the word "ClariPi" is the phrase "MEDICAL IMAGING SOLUTIONS". | High attenuation analysis | | | | | | |------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|---------|--------------| | | Yes Lung density result quantificati on with HU density range and volume measurem ent based on selected HU ranges set by user | Yes Lung density result quantificati on with HU density range and volume measurem ent based on selected HU ranges set by user | Not supported | unknown | Not relevant | | Adjustable density thresholds for refining and optimizing HU range | Yes | Yes | Not supported | Yes | Not relevant | | Viewer displays lung density in color according to Hounsfield Unit (HU) range. | Yes | Yes | Yes | Yes | Not relevant | | Viewer displays density graph/histogram of the classified lung voxels' relative frequencies | Yes | Unknown | Yes | Yes | Not relevant | | Report includes overlay of density quantification results and density graph histogram | Yes | Unknown | Yes | Yes | Not relevant | | Low-dose CT support | Yes | Not supported | Yes | Yes | Yes | ## VIII. PERFORMANCE TESTING Non-clinical performance testing has been performed on ClariPulmo (the subject device) to support the safety and effectiveness of the features including the HAA and LAA analysis, Al-based lung seqmentation, Al-based kernel normalization and denoising. The HAA analysis showed excellent agreement (PCC: 0.980 – 0.983) with expert-established seqmentations of user-defined high attenuation areas. The test dataset used for manual vs threshold-based segmentations included patients with pneumonia and COVID-19. The LAA analysis showed excellent agreement (PCC: 0.99) with expert-established segmentations of user-defined low attenuation areas. The test dataset used for manual vs threshold-based segmentations included both health and diseased patients. The Al-based lung segmentation demonstrated excellent agreements with that by expert radiologist's imageJ based segmentation for one internal and two external datasets showing PCC of 0.977-0.992 and DICE coefficients of 0.98~0.99 with statistical significance across normal/LAA/HAA patients, CT scanner, reconstructed kernel and low-dose subgroups . The submitted performance testing data demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document: - ISO 14971 Medical devices Application of risk management to medical devices. ● {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for "Clariπ MEDICAL IMAGING SOLUTIONS". The word "Clari" is in black, and the pi symbol is in blue. Below the word "Clariπ" is the text "MEDICAL IMAGING SOLUTIONS" in a smaller font. - NEMA-PS 3.1- PS 3.20 Digital Imaging and Communications in Medicine (DICOM). ● - Guidance for the Content of Premarket Submissions for Software Contained in Medical ● Devices issued May 11, 2005. - Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices issued September 6, 2017. - . The subject device, was tested in accordance with the internal Verification and Validation processes of ClariPi Inc. Verification and Validation tests have been performed to address intended use, the technological characteristics claims, requirement specifications, and the risk management results. The test results in this 510(k), demonstrate that ClariPulmo: - complies with the aforementional and FDA-recognized consensus standards and . - . FDA quidance document, and - . meets the acceptance criteria and is adequate for its intended use. Therefore, ClariPulmo, is substantially equivalent to the currently marketed predicate device, in terms of safety and effectiveness. #### Clinical Testing: ClariPulmo does not require clinical studies to demonstrate substantial equivalence to the predicate device. ### IX. CONCLUSIONS Verification and Validation activities required to establish the safety and effectiveness of ClariPulmo were performed. Testing involved system level tests, performance tests, and safety testing from risk analysis. Testing performed, demonstrated the subject device meets pre-defined functionality requirements. The subject device and predicate device are substantially equivalent in the areas of technical characteristics, general function, and intended use does not raise any new potential risks and is equivalent in performance to existing legally marketed devices. Nonclinical tests demonstrate that the subject device is as safe and therefore substantially equivalent to the predicate device.

ClariPulmo

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