Who is the manufacturer of ART-PLAN?

Therapanacea filed the 510(k) submission for ART-PLAN (K220813).

What is the FDA product code for ART-PLAN?

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

What is the regulatory pathway for ART-PLAN?

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

Does ART-PLAN use AI or machine learning?

Yes. ART-PLAN (K220813) 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 ART-PLAN?

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 ART-PLAN 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.

ART-PLAN

K220813 · Therapanacea · QKB · Jun 17, 2022 · Radiology

Device Facts

Record ID	K220813
Device Name	ART-PLAN
Applicant	Therapanacea
Product Code	QKB · Radiology
Decision Date	Jun 17, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K220813 · Jun 17, 2022	ART-PLAN	Therapanacea	Retrospective clinical patient image datasets (CT, MR, PET); Routine clinical cancer treatment records	Retrospective clinical data was used to train, validate, and test the performance of AI-based auto-segmentation and synthetic-CT generation algorithms. The data represents routine clinical practice across multiple centers and vendors.	AI-based contouring; Synthetic-CT generation; Retrospective clinical data; Algorithm training and validation

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
ART-Plan AI Model Training and Validation Cohort; Retrospective analysis of clinical patient data	Cancer patients undergoing radiotherapy; Sample Size: 8,736 patients (374,160 images); Number of Sites: Multiple centers (not specified)	Not applicable for this study	Dice Similarity Coefficient (DSC), Gamma passing criteria, qualitative clinical evaluation

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Automatic organ-at-risk and lymph node segmentation	Deep learning algorithm	Dice Similarity Coefficient (mean) >= 0.8 OR Dice Similarity Coefficient (mean) >= 0.54 OR Dice Similarity Coefficient (mean) >= mean (DSC inter-expert) + 5% OR qualitative evaluation A+B >= 85%	—	Training: 299,142 samples; Validation: 75,018 samples; Total: 374,160 samples (derived from 8,736 patients).	—	Clinical validation studies for various anatomies (Brain, Pelvis, Thorax) using retrospective clinical data.	>1 (clinical experts)
Synthetic CT generation	Deep learning algorithm	Median 2%/2mm gamma passing >= 95% OR median 3%/3mm gamma passing >= 99.0% OR mean dose deviation <= 2% in >= 88% of patients	—	Training: 299,142 samples; Validation: 75,018 samples; Total: 374,160 samples (derived from 8,736 patients).	—	Clinical performance evaluation comparing pseudo-CT to standard CT for pelvis and brain.	—

Indications for Use

ART-Plan is a software for multi-modal visualization, contouring and processing of 3D images of cancer patients for whom radiotherapy treatment has been prescribed. It allows the user to view, create and modify contours for the regions of interest. It also allows to generate automatically, and based on medical practices, the contours for the organs at risk and healthy lymph nodes and to register combinations of anatomical and functional images. Contours and images require verifications, potential modifications, and subsequently the validation of a trained user with professional qualifications in anatomy and radiotherapy before their export to a Treatment Planning System. ART-Plan offers the following visualization, contouring and manipulation tools to aid in the preparation of radiotherapy treatment: - Multi-modal visualization and rigid- and deformable registration of anatomical and functional images such as CT, MR, PET-CT, 4D-CT and CBCT - Display of fused and non-fused images to facilitate the comparison and delineation of image data by the user - Manual modification and semi-automatic generation of contours for the regions of interest - Automatic generation of contours for organs at risk and healthy lymph nodes, based on medical practices, on medical images such as CT and MR images. - Generation of pseudo-CT for supported anatomies The device is intended to be used in a radiation therapy clinical setting, by trained professionals only.

Device Story

ART-Plan is a software application for radiation therapy planning; it processes 3D multi-modal medical images (CT, PET-CT, CBCT, 4D-CT, MR). The device uses AI-based deep learning algorithms to automatically segment organs at risk and healthy lymph nodes, and to generate pseudo-CT images from MRI data. It also provides tools for rigid and deformable image registration, manual/semi-automatic contouring, and image fusion. Used in clinical settings by radiation oncologists, dosimetrists, and medical physicists; the software is accessed via web browser (cloud or server-based). Healthcare providers use the output to visualize anatomy, delineate regions of interest, and prepare data for export to treatment planning systems. By automating contouring and registration, the device aims to standardize workflows, reduce manual effort, and improve efficiency in radiotherapy treatment planning.

Clinical Evidence

Bench testing only. No clinical studies were conducted. Performance was validated using retrospective clinical data cohorts (374,160 samples from 8,736 patients). Metrics included Dice Similarity Coefficient (DSC) compared to AAPM thresholds (mean DSC >= 0.8) or inter-expert variability (mean DSC >= 0.54), and qualitative clinical evaluation (85% acceptance rate). Pseudo-CT generation was validated using gamma passing criteria (2%/2mm >= 95%; 3%/3mm >= 99%) and mean dose deviation (<= 2%).

Technological Characteristics

Software-based medical image management and processing system. Uses deep learning algorithms for automatic segmentation and synthetic CT generation. Supports DICOM 3.0. Connectivity via web-based platform (Chrome/Firefox). Deployment is server-based or cloud-based. No physical materials; software-only device.

Indications for Use

Indicated for cancer patients for whom radiation treatment has been planned. Intended for use by trained medical professionals including radiation oncologists, dosimetrists, and medical physicists. Supports display/visualization of 3D multi-modal medical image data (CT, PET-CT, CBCT, 4D-CT, MR).

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

ART-Plan v1.6.1 (K202700)

Reference Devices

Contour ProtégéAI (K210632)
MIM 4.1 (K071964)
MRCAT Pelvis (K182888)
MRCAT Brain (K193109)
Syngo.via RT Image Suite (K173635)

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 logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format. TheraPanacea % Edwin Lindsay QA/RA consultant Pépinière Cochin Paris Santé, 29 rue du Faubourg Saint-Jacques Paris. 75014 FRANCE Re: K220813 Trade/Device Name: ART-Plan Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management and Processing System Regulatory Class: Class II Product Code: QKB Dated: March 16, 2022 Received: March 21, 2022 Dear Edwin Lindsay: 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 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, Julie Sullivan, Ph.D. Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure for {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K220813 Device Name ART-Plan #### Indications for Use (Describe) ART-Plan is indicated for cancer patients for whom radiation treatment has been planned. It is intended to be used by tramed medical professionals including, but not limited to, radiation oncologists, dosimetrists, and medical physicists. ART-Plan is a software application intended to display and visualize 3D multi-modal medical image data. The user may import, define, display, transform and store DICOM3.0 compliant datasets (including regions of interest structures). These images, contours and objects can subsequently be exported/distributed within the system, across computer networks and/or to radiation treatment planning systems. Supported modalities include CT. PET-CT. CBCT, 4D-CT and MR images. ART-Plan supports Al-based contouring on CT and MR images and offers semi-automatic and manual tools for segmentation. To help the user assess changes in image data and to obtain combined multi-modal image information, ART-Plan allows the registration of anatomical and functional images and display of fused and non-fused images to facilitate the comparison of patient image data by the user. With ART-Plan, users are also able to generate, visualize, evaluate and modify pseudo-CT from MRI images. 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) | #### 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}------------------------------------------------ ### 510(k) Summary This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92. #### Submitter's Name: TheraPanacea #### Submitter's Address: Pépinière Paris Santé Cochin 29 rue du Faubourg Saint-Jacques 75014 Paris France Telephone: +33 9 62 52 78 19 #### Establishment Registration Number: 3019834893 #### Contact Person: Edwin Lindsay Telephone +44 (0) 7917134922 #### Date Prepared: 16 Mar 2022 #### Below summaries the Device Classification Information regarding the TheraPanacea ART-Plan: #### Primary Product Code: | Regulation Number | Device | Device Class | Product Code | Classification Panel | |----------------------|------------------------------------------------------|-----------------|-----------------|-------------------------| | 892.2050 | Medical image management and processing system | Class II | QKB | Radiology | #### Device Trade Name: ART-Plan Device Common Name: ART-Plan #### Intended Use: Page 1 of 28 {4}------------------------------------------------ ART-Plan is a software for multi-modal visualization, contouring and processing of 3D images of cancer patients for whom radiotherapy treatment has been prescribed. It allows the user to view, create and modify contours for the regions of interest. It also allows to generate automatically, and based on medical practices, the contours for the organs at risk and healthy lymph nodes and to register combinations of anatomical and functional images. Contours and images require verifications, potential modifications, and subsequently the validation of a trained user with professional qualifications in anatomy and radiotherapy before their export to a Treatment Planning System. ART-Plan offers the following visualization, contouring and manipulation tools to aid in the preparation of radiotherapy treatment: - Multi-modal visualization and rigid- and deformable registration of anatomical and O functional images such as CT, MR, PET-CT, 4D-CT and CBCT - O Display of fused and non-fused images to facilitate the comparison and delineation of image data by the user - O Manual modification and semi-automatic generation of contours for the regions of interest - Automatic generation of contours for organs at risk and healthy lymph nodes, based 0 on medical practices, on medical images such as CT and MR images. - Generation of pseudo-CT for supported anatomies 0 The device is intended to be used in a radiation therapy clinical setting, by trained professionals only. #### Indications for Use: ART-Plan is indicated for cancer patients for whom radiation treatment has been planned. It is intended to be used by trained medical professionals including, but not limited to, radiologists, radiation oncologists, dosimetrists, and medical physicists. ART-Plan is a software application intended to display and visualize 3D multi-modal medical image data. The user may import, define, display, transform and store DICOM3.0 compliant datasets (including regions of interest structures). These images, contours and objects can subsequently be exported/distributed within the system, across computer networks and/or to radiation treatment planning systems. Supported modalities include CT, PET-CT, CBCT, 4D-CT and MR images. ART-Plan supports Al-based contouring on CT and MR images and offers semi-automatic and manual tools for seqmentation. To help the user assess changes in image data and to obtain combined multi-modal image information, ART-Plan allows the registration of anatomical and functional images and display of fused and non-fused images to facilitate the comparison of patient image data by the user. With ART-Plan, users are also able to generate, visualize, evaluate and modify pseudo-CT from MRI images. {5}------------------------------------------------ #### Summary of Substantial Equivalence: The following predicate devices have been that the ART-Plan can claim equivalence with and these are detailed below #### General Comparison | | General Information | | | | | | | | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Property | Proposed Device ART-Plan v1.10.0 | Primary Predicate ART-Plan v1.6.1 | Reference device Contour ProtégéAl | Reference device MIM 4.1 | Reference device MRCAT Pelvis | Reference device MRCAT Brain | Reference device Syngo.via RT Image Suite | Comment | | Common Name | Radiological image processing software for radiation therapy | Radiological image processing software for radiation therapy | Radiological Image Processing Software For Radiation Therapy | System, image processing, radiological | System, Planning, Radiation Therapy Treatment | System, Planning, Radiation Therapy Treatment | System, Planning, Radiation Therapy Treatment | N/A | | Device Manufacturer | TheraPanacea | TheraPanacea | MIM Software, Inc | MIMvista Corp (now MIM Software Inc) | Philips Medical Systems | Philips Medical Systems | Siemens Medical Solutions USA, Inc. | N/A | | 510k | N/A | K202700 | K210632 | K071964 | K182888 | K193109 | K173635 | N/A | | Device Classification | II | II | II | II | II | II | II | N/A | | Primary Product Code | QKB | QKB | QKB | LLZ | MUJ | MUJ | MUJ | The primary product code is QKB "Radiological Image Processing Software For Radiation Therapy" as the software uses Al algorithms and is intended for radiation therapy, just like the primary predicate device | | Secondary Product Code | LLZ, MUJ | LLZ | - | - | - | - | LLZ | As secondary product code: LLZ (System, Image Processing, Radiological) was included as the software is used in | | | | | | | | | | image processing and some predicates use it as primary or secondary product code: MUJ (System, Planning, Radiation Therapy Treatment) was includes as it is a software used in the planning of radiotherapy treatment and some of the reference devices use it as their primary code | | Target Population | Any patient type for whom relevant modality scan image data is available | Any patient type for whom relevant modality scan data is available | Not stated | Not stated | Any patient with soft tissue cancers in the pelvic region for whom radiotherapy treatment has been planned | Any patient with primary and metastatic brain tumor for whom radiotherapy treatment has been planned | Not stated | The proposed device has identical target populations to the primary and reference devices. | | Environment | Hospital | Hospital | Hospital | Hospital | Hospital | Hospital | Hospital | The proposed device and predicates have identical target environments | | Intended Use/ Indication for Use | Intended Use ART-Plan is a software for multi-modal visualization, contouring and processing of 3D images of cancer patients for whom radiotherapy treatment has been prescribed. It allows the user to view, create and modify contours for the regions of interest. It also allows to generate automatically, and based on medical | Intended Use ART-Plan is a software designed to assist the contouring process of the target anatomical regions on 3D-images of cancer patients for whom radiotherapy treatment has been planned. The SmartFuse module allows the user to register combinations of anatomical and | Intended Use Contour ProtégéAl is an accessory to MIM software used for the contouring of anatomical structures in imaging data using machine-learnin g-based algorithms automatically. Appropriate | Intended Use MIM 4.1 (SEASTAR) software is intended for trained medical professionals including, but not limited to, radiologists, oncologists, physicians, medical technologists, dosimetrists and physicists. | Intended Use: MRCAT imaging is intended to provide the operator with information of tissue properties for radiation attenuation estimation purposes in photon external beam radiotherapy | Intended Use: MRCAT imaging is intended to provide the operator with information of tissue properties for radiation attenuation estimation purposes in photon external beam radiotherapy | Intended use: Not available in the summary Indication for use: syngo.via RT Image Suite is a 3D and 4D image visualization, multimodality manipulation and contouring tool that helps the | The intended use and indications for use of the proposed device, ART-Plan v1.10.0 and the primary predicate ART-Plan v1.6.1 are similar as they are both intended for medical image registration and segmentation in the context of radiotherapy treatment planning: they allow multi-modal and mono-modal rigid | | practices, the contours | functional images and | image | MIM 4.1 (SEASTAR) is a medical image and information management system that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, as well as create, display and print reports from those images. The medical modalities of these medical imaging systems include, but are not limited to, CT, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. | treatment planning. | treatment planning. | preparation and response assessment of treatments such as, but not limited to those performed with radiation (for example, Brachytherapy, Particle Therapy, External Beam Radiation Therapy). It provides tools to efficiently view existing contours, create, edit, modify, copy contours of regions of the body, such as but not limited to, skin outline, targets and organs-at-risk. It also provides functionalities to create and modify simple treatment plans. Contours, images and treatment plans can subsequently be exported to a Treatment Planning System. The software combines following digital | deformable registration for the same modalities of images (CT, MR, PET they allow automatic segmentation of organs-at-risk and lymph nodes on injected and non-injected CT images using deep learning algorithms they allow the import, manipulation, visualisation, generation and the export of DICOM images The intended for the proposed device has been adapted to provide a more specific description of the proposed device but does not represent a new intended use, except for the additional claims for the proposed device as compared to the primary predicate as: - it includes an improved version of the existing automatic segmentation tool as compared to the one of ART-Plan v1.6.1. - it allows automatic segmentation on more anatomies and organ-at-risk | | | for the organs at risk | display them with | visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAI. Contour ProtégéAI is not intended to detect or contour lesions. | MIM 4.1 (SEASTAR) provides the user with the means to display, register and fuse medical images from multiple modalities. Additionally, it evaluates cardiac left ventricular function and perfusion, including left ventricular | Indications for Use: | Indications for use: | | | | | and healthy lymph | fused and non-fused | | | | | | | | | nodes and to register | displays to facilitate | | | | | | | | | combinations of | the comparison and | | | | | | | | | anatomical and | delineation of image | | | | |…

ART-PLAN

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