(182 days)
Not Found
Yes
The text explicitly mentions the use of "pre-trained deep learning models" for image processing.
No
The device is a software for image processing and enhancement of CT images, not for therapy.
No
Explanation: The device is described as software for processing and enhancing CT images, specifically for denoising and improving image quality. Its stated intended use is for "networking, communication, processing and enhancement of CT images" for display to a radiologist. While it aids in providing better images for diagnosis, it does not itself perform a diagnostic function or provide a diagnosis.
Yes
The device description explicitly states "ClariCT.Al software is intended for denoise processing and enhancement of CT DICOM images" and "The system enables the receipt of DICOM images... enables their denoise processing and enhancement, and transmission to a PACS workstation." This indicates the device's function is solely based on processing digital image data, without mention of any accompanying hardware components required for its operation beyond standard computing infrastructure.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that ClariCT.AI processes and enhances CT images, which are generated from within the body, not from a specimen taken from the body.
- The device description focuses on image processing and enhancement. This is a characteristic of medical imaging software, not IVD devices.
- The input is CT images. IVDs typically analyze biological samples like blood, urine, tissue, etc.
Therefore, ClariCT.AI is a medical imaging software device, not an IVD.
No
The input clearly states "Control Plan Authorized (PCCP) and relevant text: Not Found", indicating no PCCP information.
Intended Use / Indications for 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.
Product codes
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT
Anatomical Site
head, chest, heart, and abdomen
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiologists and Specialists
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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)
- . 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.
ClariCT.Al does not require clinical studies to demonstrate substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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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)
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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: +82-2-741-3014 Fax: +82-2-743-3014 Email: claripi@claripi.com
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. |
| 1313 Ensell Road | |
| 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
(K160852) |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | ClariCT.AI is intended for
networking, communication,
processing and enhancement
of CT images in DICOM
format. | ZIA image enhancement system is
an image processing software that
can be used for reducing noise in
CT images. Enhanced images will
be uploaded back to host/PACS
systems and exist in conjunction to
the original images. ZIA, is not
intended for mammography
applications. The device processing
is not effective for lesion, mass or
abnormalities of sizes less than 2.0
mm. |
| Intended User | Radiologists and Specialists | Radiologists and Specialists |
| Modality Support | CT | CT |
| Noise Reduction
Method | Noise reduction is performed
with the use of pre-trained
deep learning models. | Regularization process at flat
regions with data fidelity constraints
at edges. |
| Image Format and
communications | DICOM | DICOM |
| Components and
Hardware
requirement | Window Operating System,
PC Hardware, CUDA
supported graphics card or
equivalent. | Window Operating System,
PC Hardware, CUDA supported
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)
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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.