(25 days)
Not Found
Yes
The document explicitly states that "Noise reduction is performed with the use of pre-trained deep learning models," which is a form of machine learning.
No
The device is a software for image processing and enhancement of CT images. It does not directly treat or diagnose a disease state.
No
The device is described as software for processing and enhancing CT images rather than making a diagnosis. Its purpose is to improve image quality for diagnostic interpretation by a healthcare professional.
Yes
The device is explicitly described as "ClariCT.AI is a software device" and its function is solely processing and enhancing CT images. The description of adding a module to integrate with an AI Marketplace system further reinforces its software nature, as it's being hosted and integrated into existing IT infrastructure. There is no mention of accompanying hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that ClariCT.AI is for "networking, communication, processing and enhancement of CT images". This is focused on image manipulation and improvement, not on analyzing biological samples or providing diagnostic information directly from a biological specimen.
- Device Description: The description reinforces this by stating its purpose is to "denoise processing and enhancement of CT DICOM images". It aims to improve the quality of the image itself, which is then interpreted by a radiologist.
- Lack of Biological Sample Analysis: There is no mention of the device interacting with or analyzing any biological samples (blood, urine, tissue, etc.). IVD devices are specifically designed to perform tests on such samples to provide diagnostic information.
In summary, ClariCT.AI is a software device that processes and enhances medical images (CT scans) to aid in diagnosis, but it does not perform in vitro diagnostic testing on biological specimens.
No
The provided text explicitly states "Control Plan Authorized (PCCP) and relevant text Not Found," indicating no mention of PCCP authorization.
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 (comma separated list FDA assigned to the subject device)
LLZ
Device Description
ClariCT.AI 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, 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 predicate device is a software application to denoise on CT images, integrated with the clinical environment through DICOM communication on-premise, and runs under the Microsoft Windows platform.
The subject device, ClariCT.Al, added a new module (named Al Marketplace Integration module) to the original cleared device (K183460) to enable installation on the Al Marketplace system. The module integrates the Denoising Processor of the original device into the Al Marketplace system. So ClariCT.Al can be hosted through a third-party Al marketplace that integrates centrally with PACS and seamlessly integrates into the existing IT and modality infrastructure.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT
Anatomical Site
head, chest, 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
Not Found
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 14971 Medical 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.
- · Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document Issued on: October 2, 2014.
- · 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 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 devices, in terms of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
July 27, 2021
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 USA Inc. 1645 Park Creek Ct. ROCHESTER HILLS MI 48309
Re: K212074
Trade/Device Name: ClariCT.AI Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: July 1, 2021 Received: July 2, 2021
Dear Harry 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 mav, 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 avare 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 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-reporting
1
combination-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
2
Indications for Use
510(k) Number (if known) K212074
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/0 description: The image shows the logo for "ClariPi", an AI medical imaging solutions company. The word "Clari" is in bold black font, while the "Pi" symbol is in blue. Below the company name, the words "AI MEDICAL IMAGING SOLUTIONS" are written in a smaller, non-bold font.
510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of as required by section 807.92(c).
. SUBMITTER
ClariPi Inc. 3F, 70-15, Ihwajang-gil, Jongno-gu Seoul, Republic of Korea [03088] Tel: +82-2-741-3014 Fax: +82-2-743-3014 Email: claripi@claripi.com
Contact person: Ms. Hyun-Sook Park, CEO Date Prepared: July 01, 2021
II. DEVICE
Name of Device: ClariCT.Al Common or Usual Name: Picture, archive and communications system Classification Name: Medical Image Management and Processing System (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, addressed in this premarket notification, is substantially equivalent to the following commercially available software:
| Device Classification Name | Medical Image Management and Processing System |
|---|---|
| 510(k) Number | K183460 |
| Device Name | ClariCT.Al |
| Applicant | ClariPi Inc. |
| 3F, 70-15, Ihwajang-gil, Jongno-gu | |
| Seoul, Korea, Republic of [03088] | |
| Regulation Number | 892.2050 |
| Classification Product Code | LLZ |
| Date Received | 12/13/2018 |
| Decision Date | 06/13/2019 |
| 510k Review Panel | Radiology |
IV. DEVICE DESCRIPTION
ClariCT.AI 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, and abdomen, in particular in CT images with a lower radiation dose. ClariCT.Al may also
4
Image /page/4/Picture/0 description: The image shows the logo for "Clariπ AI MEDICAL IMAGING SOLUTIONS". The word "Clari" is in bold black font, while the pi symbol is in blue. Below the word "Clariπ" is the text "AI MEDICAL IMAGING SOLUTIONS" in a smaller, thinner font.
510(k) Summary
improve the image quality of low-dose nondiagnostic Filtered Back Projection images as well as Iterative Reconstruction images.
The predicate device is a software application to denoise on CT images, integrated with the clinical environment through DICOM communication on-premise, and runs under the Microsoft Windows platform.
The subject device, ClariCT.Al, added a new module (named Al Marketplace Integration module) to the original cleared device (K183460) to enable installation on the Al Marketplace system. The module integrates the Denoising Processor of the original device into the Al Marketplace system. So ClariCT.Al can be hosted through a third-party Al marketplace that integrates centrally with PACS and seamlessly integrates into the existing IT and modality infrastructure.
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 following information compares the subject device to the predicate. The difference is that the subject device can be integrated into the Al Marketplace system that distributes Docker images in a virtual machine running in a Linux environment. 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 Device
ClariCT.AI (K183460) |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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. |
| 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. | Noise reduction is performed with the
use of pre-trained deep learning
models. |
| Image
Format | DICOM | DICOM |
| Components
And
Hardware
Requirement | Window Operating System,
PC Hardware, CUDA supported
graphics card or equivalent. | Window or Linux Operating System.
PC Hardware supported graphics
card or equivalent. |
5
510(k) Summary
Image /page/5/Picture/1 description: The image shows the logo for ClariPi, a company that provides AI medical imaging solutions. The logo consists of the word "Clari" in black font, followed by a blue pi symbol. Below the word "ClariPi" is the text "AI MEDICAL IMAGING SOLUTIONS" in a smaller black font. The logo is simple and modern, and it conveys the company's focus on artificial intelligence and medical imaging.
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 14971 Medical 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.
- · Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document Issued on: October 2, 2014.
- · 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 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 devices, in terms of safety and effectiveness.
Clinical Testing:
ClariCT.Al does not require clinical studies to demonstrate substantial equivalence to the predicate devices.
VIII CONCLUSIONS
Verification and Validation activities required to establish the safety and effectiveness of ClariCT.Al were performed. Testing involved system-level tests, performance tests, and safety tests from risk analysis. These tests demonstrated the subject device meets predefined functionality requirements.
The subject device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. Test results with the substantial datasets demonstrate that the subject device is as safe and effective as the predicate devices. Therefore, the subject device is substantially equivalent to the predicate devices.