ClariCT.AI

K183460 · Claripi, Inc. · LLZ · Jun 13, 2019 · Radiology

Device Facts

• Record ID: K183460
• Device Name: ClariCT.AI
• Applicant: Claripi, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jun 13, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

ClariCT.AI, is a software device intended for networking, communication, processing and enhancement of CT images in DICOM format regardless of the manufacturer of CT scanner or model.

Device Story

ClariCT.AI is a software-based image processing tool for CT DICOM images. It receives images from CT scanners, performs noise reduction and enhancement using pre-trained deep learning models, and transmits processed images to a PACS workstation. Used by radiologists and specialists in clinical settings to improve image quality, particularly for low-dose scans. The output allows clinicians to view enhanced images alongside original data, potentially aiding diagnostic confidence by reducing noise in low-dose acquisitions. The device operates on standard PC hardware with CUDA-supported graphics cards.

Clinical Evidence

No clinical studies performed. Bench testing included verification and validation using ACR CT Accreditation Phantom and clinical datasets (paired low/high dose, IR/FBP datasets, and diverse patient demographics/scan conditions). Testing confirmed compliance with ISO 14971 and NEMA-PS 3.1-3.20 standards.

Technological Characteristics

Software-based image processing; runs on Windows OS with PC hardware and CUDA-supported graphics cards. Uses pre-trained deep learning models for noise reduction. Interoperable via DICOM standard. No physical materials or energy sources.

Indications for Use

Indicated for radiologists and specialists requiring noise reduction and enhancement of CT images (head, chest, heart, abdomen), particularly for low-dose acquisitions or to improve image quality of Filtered Back Projection and Iterative Reconstruction images.

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

• Zia (K160852)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains 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 text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

June 13, 2019.

ClariPI Inc % Mr. Carl Alletto Consultant OTech Inc. 8317 Belew Drive MCKINNEY TX 75071

Re: K183460

Trade/Device Name: ClariCT.AI Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: May 3, 2019 Received: May 7, 2019

Dear Mr. Alletto:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

510(k) Number (if known) K183460

Device Name ClariCT.AI

Indications for Use (Describe)

ClariCT.AI, is a software device intended for networking, communication, processing and enhancement of CT images in DICOM format regardless of the manufacturer of CT scanner or model.

| 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 [e-mail]

"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, while the pi symbol is in a light blue color. Below the word "Clariπ" is the text "MEDICAL IMAGING SOLUTIONS" in a smaller, thinner font.

This 510(k) Summary is being submitted in accordance with the requirements of as required by K183460 section 807.92(c).

#### . SUBMITTER

ClariPl Inc. 3F, 70-15, Ihwajang-gil, Jongno-qu Seoul, Korea, Republic of [03088] Tel: [phone] Fax: [phone] Email: [e-mail]

Contact person: Ms. Hyun-Sook Park, CEO Date Prepared: May 3, 2019

# II. DEVICE

Name of Device: ClariCT.Al Common or Usual Name: Picture, archive and communications system Classification Name: System, Image Processing, Radiological (21 CFR 892.2050) Regulatory Class: II Product Code: LLZ

# III. PREDICATE DEVICE

This predicate has not been subject to a design-related recall.

The ClariCT.Al software device is substantially equivalent to K160852:

| Device Classification Name | system, image processing, radiological |
|-----------------------------|-------------------------------------------------------------------------------|
| 510(k) Number | K160852 |
| Device Name | Zia |
| Applicant | Zetta Medical Technologies, LLC.<br>1313 Ensell Road<br>Lake Zurich, IL 60047 |
| Regulation Number | 892.2050 |
| Classification Product Code | LLZ |
| Date Received | 03/28/2016 |
| Decision Date | 12/15/2016 |
| 510k Review Panel | Radiology |

# IV. DEVICE DESCRIPTION

ClariCT.Al software is intended for denoise processing and enhancement of CT DICOM images when higher image quality and/or lower dose acquisitions are desired. ClariCT.Al software can be used to reduce noises in CT images of the head, chest, heart, and abdomen, in particular in CT images with a lower radiation dose. ClariCT.Al may also improve the image quality of low-dose nondiagnostic Filtered Back Projection images as well as Iterative Reconstruction images.

The system enables the receipt of DICOM images from CT imaging devices (modalities), enables their denoise processing and enhancement, and transmission to a PACS workstation.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for "ClariPi MEDICAL IMAGING SOLUTIONS". The word "Clari" is in bold black font, and the "Pi" is a blue stylized version of the mathematical symbol pi. Below the logo is the text "MEDICAL IMAGING SOLUTIONS" in a smaller font size.

# V. INDICATIONS FOR USE

ClariCT.Al, is a software device intended for networking, communication, processing and enhancement of CT images in DICOM format regardless of the manufacturer of CT scanner or model.

# VI. SUBSTANTIAL EQUIVALENCE TABLE

The subject device (ClariCT.Al) is substantially equivalent to the predicate device (K160852, ZIA) which is also used for noise reduction and enhancement of CT images.

The following information compares the subject device to the predicate. The difference lies in noise reduction method where ClariCT.AI, the subject device uses pre-trained deep learning models whereas the predicate device uses reqularization process at flat regions with data fidelity constraints at edges. It has no effect on the safety or efficacy of the subject device and does not raise any potential safety risks, and the subject device is identical in performance to the legally marketed device.

| Item | Subject Device – ClariCT.AI | Predicate- ZIA<br>(K160852) |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | ClariCT.AI is intended for<br>networking, communication,<br>processing and enhancement<br>of CT images in DICOM<br>format. | ZIA image enhancement system is<br>an image processing software that<br>can be used for reducing noise in<br>CT images. Enhanced images will<br>be uploaded back to host/PACS<br>systems and exist in conjunction to<br>the original images. ZIA, is not<br>intended for mammography<br>applications. The device processing<br>is not effective for lesion, mass or<br>abnormalities of sizes less than 2.0<br>mm. |
| Intended User | Radiologists and Specialists | Radiologists and Specialists |
| Modality Support | CT | CT |
| Noise Reduction<br>Method | Noise reduction is performed<br>with the use of pre-trained<br>deep learning models. | Regularization process at flat<br>regions with data fidelity constraints<br>at edges. |
| Image Format and<br>communications | DICOM | DICOM |
| Components and<br>Hardware<br>requirement | Window Operating System,<br>PC Hardware, CUDA<br>supported graphics card or<br>equivalent. | Window Operating System,<br>PC Hardware, CUDA supported<br>graphics card or equivalent. |

### VII. PERFORMANCE DATA

Non-clinical performance testing has been performed on ClariCT.Al. (the subject device) and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:

- . ISO 14971Medical devices - Application of risk management to medical devices
- . NEMA-PS 3.1- PS 3.20 Digital Imaging and Communications in Medicine (DICOM)

{5}------------------------------------------------

# 510(k) Summary

Image /page/5/Picture/1 description: The image shows the logo for ClariPi Medical Imaging Solutions. The word "Clari" is in bold black font, followed by a blue pi symbol. Below the word "ClariPi" is the text "MEDICAL IMAGING SOLUTIONS" in a smaller, lighter font.

- . 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. ClariCT.Al has been validated using:
- The use of ACR CT Accreditation Phantom o
- A variety of clinical processed data: o
- " Paired datasets of low and high doses for the same patients
- IR & FBP datasets
- . Datasets for subgroup analysis of datasets with various genders, ages, body weights, races, and ethnicities
- . Datasets with varying scan conditions using scanners from different vendors for different organs

The test results in this 510(k), demonstrate that ClariCT.Al:

- complies with the aforementioned international and FDA-recognized consensus ● standards and
- . FDA guidance document, and
- . Meets the acceptance criteria and is adequate for its intended use.

Therefore, ClariCT.Al, is substantially equivalent to the currently marketed predicate device, in terms of safety and effectiveness.

### Clinical Testing:

ClariCT.Al does not require clinical studies to demonstrate substantial equivalence to the predicate device.

### VIII CONCLUSIONS

Verification and Validation activities required to establish the safety and effectiveness of ClarCT.Al, 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, application, and intended use. Test results with the phantom data and clinical processed dataset demonstrate that the subject device is as safe and effective and therefore substantially equivalent to the predicate device.