Who is the manufacturer of ART-Plan+ (v.3.0.0)?

Therapanacea Sas filed the 510(k) submission for ART-Plan+ (v.3.0.0) (K242822).

What is the FDA product code for ART-Plan+ (v.3.0.0)?

MUJ. It is classified under 21 CFR 892.5050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for ART-Plan+ (v.3.0.0)?

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

Does ART-Plan+ (v.3.0.0) use AI or machine learning?

Yes. ART-Plan+ (v.3.0.0) (K242822) 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+ (v.3.0.0)?

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+ (v.3.0.0) 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+ (v.3.0.0)

Q: What are the predicate devices for ART-Plan+ (v.3.0.0)?

Radiation Planning Assistant (RPA) (K222728).

K242822 · Therapanacea Sas · MUJ · Feb 25, 2025 · Radiology

Device Facts

Record ID	K242822
Device Name	ART-Plan+ (v.3.0.0)
Applicant	Therapanacea Sas
Product Code	MUJ · Radiology
Decision Date	Feb 25, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.5050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

ART-Plan+'s indicated target population is cancer patients for whom radiotherapy treatment has been prescribed. In this population, any patient for whom relevant modality imaging data is available. ART-Plan+'s includes several modules: - SmartPlan which allows automatic generation of radiotherapy treatment plan that the users import into their own Treatment Planning System (TPS) for the dose calculation, review and approval. This module is available for supported prescriptions for prostate only. - Annotate which allows automatic generation of contours for organs at risk, lymph nodes and tumors, based on medical practices, on medical images such as CT and MR images ART-Plan+ is not intended to be used for patients less than 18 years of age. The indicated users are trained medical professionals including, but not limited to, radiotherapists, radiation oncologists, medical physicists, dosimetrists and medical professionals involved in the radiation therapy process. The indicated use environments include, but are not limited to, hospitals, clinics and any health facility offering radiation therapy.

Device Story

ART-Plan+ is a software platform for radiotherapy planning; inputs include 3D medical images (CT, MR). It utilizes deep-learning algorithms to perform automatic segmentation of organs at risk, lymph nodes, and tumors; it also generates automatic radiotherapy treatment plans for prostate cases. Used in hospitals and clinics by radiation oncologists, medical physicists, and dosimetrists. The software integrates into existing radiotherapy workflows; users import generated contours and plans into their own Treatment Planning System (TPS) for final dose calculation, review, and approval. By automating time-consuming contouring and planning tasks, the device aims to improve efficiency and consistency in the radiation therapy process, ultimately benefiting patients through standardized, high-quality treatment planning.

Clinical Evidence

Bench testing only. Validation included non-regression testing (n=24), qualitative evaluation (n=18), and quantitative evaluation (n=24) of OAR autosegmentation. Brain metastasis (n=51) and glioblastoma (n=43) segmentation were validated against expert contours using DSC, sensitivity, precision, and false-positive metrics. Treatment plan generation (n=20) was validated via quantitative DVH goal comparison (≤5% difference) and qualitative expert review (≥93% clinical acceptability). All tests met pre-defined acceptance criteria.

Technological Characteristics

Software-based radiotherapy planning platform. Utilizes deep-learning algorithms for image segmentation and treatment planning. Compatible with CT and MR imaging modalities. Operates as a standalone software application integrated into clinical workflows. No hardware components. Connectivity via standard clinical network/TPS integration.

Indications for Use

Indicated for cancer patients (≥18 years) prescribed radiotherapy where relevant modality imaging data is available. Used for automatic contouring of organs at risk, lymph nodes, and tumors, and automatic generation of radiotherapy treatment plans (prostate only).

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

Radiation Planning Assistant (RPA) (K222728)

Reference Devices

VBrain (K213628)
ART-Plan (K234068)

Related Devices

K220813 — ART-PLAN · Therapanacea · Jun 17, 2022
K253091 — ART-Plan+ (v3.1.0) · Therapanacea Sas · Dec 23, 2025
K232479 — ART-Plan · Therapanacea · Dec 22, 2023
K230023 — ART-Plan · Therapanacea Sas · Apr 19, 2023
K212915 — MVision AI Segmentation · MVision AI · May 3, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ February 25, 2025 Image /page/0/Picture/1 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Therapanacea SAS Bhairavi Ajachandra Compliance Director 7 bis boulevard Bourdon Paris, 75004 France Re: K242822 Trade/Device Name: ART-Plan+ (v.3.0.0) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: MUJ, OKB, LLZ Dated: September 18, 2024 Received: September 18, 2024 Dear Bhairavi Ajachandra: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory {2}------------------------------------------------ assistance/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, Locan Weidner Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team 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 {3}------------------------------------------------ ### Indications for Use Submission Number (if known) #### K242822 Device Name ART-Plan+ (v.3.0.0) Indications for Use (Describe) ART-Plan+'s indicated target population is cancer patients for whom radiotherapy treatment has been prescribed. In this population, any patient for whom relevant modality imaging data is available. ART-Plan+'s includes several modules: - SmartPlan which allows automatic generation of radiotherapy treatment plan that the users import into their own Treatment Planning System (TPS) for the dose calculation, review and approval. This module is available for supported prescriptions for prostate only. - Annotate which allows automatic generation of contours for organs at risk, lymph nodes and tumors, based on medical practices, on medical images such as CT and MR images ART-Plan+ is not intended to be used for patients less than 18 years of age. The indicated users are trained medical professionals including, but not limited to, radiotherapists, radiation oncologists, medical physicists, dosimetrists and medical professionals involved in the radiation therapy process. The indicated use environments include, but are not limited to, hospitals, clinics and any health facility offering radiation therapy. 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." {4}------------------------------------------------ # K242822 ### 510(k) Summary This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92. # Contact details Applicant Name: TheraPanacea SAS #### Applicant Address: 7 bis boulevard Bourdon 75004 Paris France #### Applicant Contact Telephone: +33620604982 #### Applicant Contact: Mrs. Bhairavi AJACHANDRA #### Applicant Contact Email: b.ajachandra@therapanacea.eu ### Device Name: | Device Trade Name | Regulation Number | Common name | Device Class | Product Code(s) | Classification Name | |-----------------------|----------------------|------------------------------------------------------|-----------------|------------------------------------------------------|-----------------------------------------------------------| | ART-Plan+ (v3.0.0) | 892.5050 | Medical charged-particle radiation therapy system | Class II | MUJ Associated Product Code(s): QKB, LLZ | System, Planning, Radiation Therapy Treatment | # Legally marketed predicate device | Predicate # | Predicate trade name (primary predicate is listed first) | Product code | |-------------|----------------------------------------------------------------|--------------| | K222728 | Radiation Planning Assistant (RPA) | MUJ | {5}------------------------------------------------ # Legally marketed reference devices | Reference device # | Reference device trade name | Product code | |--------------------|-----------------------------|--------------| | K213628 | VBrain | QKB | | K234068 | ART-Plan | MUJ | ### Device Description Summary: ART-Plan+ is a software platform allowing contour regions of interest on 3D images and to provide an automatic treatment plan. It includes several modules: -Home: tasks -Annotate and TumorBox: contouring of regions of interest -SmartPlan: creation of an automatic treatment plan based on a planning CT and a RTSS -Administration and settings : preferences management, user account management, etc. -Institute Management: institute information, including licenses, list of users, etc. -About: information about the software and its use, as well as contact details. Annotate, TumorBox and SmartPlan are partially based on a batch mode, which allows the user to launch the operations of autocontouring and autoplanning without having to use the interface or the viewers. In that way, the software is completely integrated into the radiotherapy workflow and offer to the user a maximum of flexibility. ART-Plan+ offers deep-learning based automatic segmentation of OARs and LNs for the following localizations: -Head and neck (on CT images) -Thorax/breast (on CT images) -Abdomen (on CT and male on MR images) -Pelvis male (on CT and MR images) -Pelvis female (on CT images) -Brain (on CT images and MR images) ART-Plan+ offers deep-learning based automatic segmentation of targets for the following localizations: {6}------------------------------------------------ -Brain (on MR images) ### Intended Use/Indication for use: ART-Plan+'s indicated target population is cancer patients for whom radiotherapy treatment has been prescribed. In this population, any patient for whom relevant modality imaging data is available. ART-Plan+'s includes several modules: - SmartPlan which allows automatic generation of radiotherapy treatment plan that the users import into their own Treatment Planning System (TPS) for the dose calculation, review and approval. This module is available for supported prescriptions for prostate only. - Annotate which allows automatic generation of contours for organs at risk, lymph nodes and tumors, based on medical practices, on medical images such as CT and MR images ART-Plan+ is not intended to be used for patients less than 18 years of age. The indicated users are trained medical professionals including, but not limited to, radiotherapists, radiation oncologists, medical physicists, dosimetrists and medical professionals involved in the radiation therapy process. The indicated use environments include, but are not limited to, hospitals, clinics and any health facility offering radiation therapy. ### Indication for use comparison: The intended use and indications for use of the proposed device, ART-Plan+ v3.0.0 and the primary predicate are similar as they are both softwares intended to be used in the planning of radiotherapy treatment: -They allow creation of contours -Thev allow the planification of external beam irradiation with photon beams using computerized tomography (CT) images. -They allow the user to import the generated plan into their own Treatment Planning System (TPS) for dose calculation, review and approval. The intended use and indications for use of the proposed device, ART-Plan+ v3.0.0 and the reference devices are similar as they are also softwares intended to be used in the planning of radiotherapy treatment in order to provide Al based segmentation tools to contour known (diagnosed) tumors, for organs at risk and lymph nodes. # Technological Comparison: ART-Plan+ is substantially equivalent to the Radiation Planning Assistant (RPA) (K222728) predicate device in the following aspects: {7}------------------------------------------------ - . Both devices allow the planification of external beam irradiation with photon beams using computerized tomography (CT) images. - . Both devices allow the creation of contours and treatment plans that the user imports into their own Treatment Planning System (TPS) for the dose calculation, review and approval. There are no differences between the proposed device and the predicate that represent an additional claim for the proposed device. | Technical Information | | | | |------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------| | Property | Proposed Device ART-Plan v3.0.0 | Primary Predicate Radiation Planning System (RPA) | Comment | | Delineation Method | AI | AI | The proposed device and primary predicate share an AI delineation method. | | Segmentation Features | Automatically delineates OARs and lymph nodes and targets. Deep learning algorithm. Automatic segmentation includes the following localizations: * head and neck (on CT) * thorax/breast (for male/female and on CT) * abdomen (on CT images and MR images) * pelvis male (on CT and MR) * pelvis female (on CT images) * brain (on CT images and MR images) | The RPA provides autocontouring for a range of structures | The proposed device proposes segmentation on the same localizations with the same medical images of different modalities using AI. | | Regions and Volumes of Interest (ROI) | AI Based autocontouring | AI Based autocontouring, | The proposed device and the primary predicate allow AI automatic contouring. | # Non-Clinical and/or Clinical Tests Summary & Conclusions In order to determine the substantial equivalence of ART-Plan + v3.0.0. the following tests have been performed: Non regression testing of autosegmentation of organs at risk - Validation of the performance of autoseqmentation (on CT and MR images) of already existing structures after retraining or algorithm improvement was performed by comparison of the DSC between contours generated by the previous version of ART-Plan (v2.2.0) and manual contours performed by medical experts and the DSC between contours generated by the new version of ART-Plan + (v3.0.0) and manual contours performed by medical experts. The evaluation was performed on a minimum sample size of 24 patients. {8}------------------------------------------------ The contours are considered acceptable for clinical use if the following acceptance criterion is achieved: -Mean DSC should not regress negatively between the current and last validated version of Annotate beyond a maximum tolerance marqin set to -5% relative error. Qualitative evaluation of autosegmentation of organs at risk - Validation of the performance of autosegmentation of new organs at risk (or organs at risk not passing the non regression testing) on CT images was performed by qualitative evaluation of the contours by medical experts. This evaluation was performed on a minimum sample size of 18 patients. The contours are considered acceptable for clinical use if the following acceptance criterion is achieved: -The clinicians' qualitative evaluation of the auto-segmentation is considered acceptable for clinical use without modifications (A) or with minor modifications / corrections (B) with a A+B % above or equal to 85% considering the following scale: A. the contour is acceptable for a clinical use without any modification B. the contour would be acceptable for clinical use after minor modifications/corrections C. the contour requires major modifications (e.g. it would be faster for the expert to manually delineate the structure)" Quantitative evaluation of autosegmentation of organs at risk - validation of the performance of autosegmentation of new organs at risk on CT images was performed by quantitative evaluation of the contours. This evaluation was performed on a minimum sample size of 24 patients. The contours are considered acceptable for clinical use if the following acceptance criterion is achieved: - Mean DSC (annotate) ≥ 0.8 Inter-expert variability evaluation of autosegmentation of organs at risk – validation of the performance of autosegmentation of new organs at risk on CT images was performed by an inter-expert variability evaluation of the contours. The same images were asked to be contoured by two independent medical experts. DSC was calculated between them and with contours generated by the software and the compared. This evaluation was performed on a minimum sample size of 13 patients. The contours are considered acceptable for clinical use if the following acceptance criterion is achieved: - Mean DSC (annotate) ≥ Mean DSC (inter-expert) with a tolerance margin of -5% of relative error {9}------------------------------------------------ Quantitative evaluation of autoseqmentation of Brain metastasis - Validation of the performance of autoseqmentation of brain metastasis on MR images was performed by quantitative evaluation. Contours provided by medical experts were compared with contours generated by the software. This evaluation was performed on a minimum sample size of 51 tients. The contours are considered acceptable for clinical use if the following acceptance criterion is achieved: - The lesion-wise sensitivity is equal to or superior to state-of-the-art as benchmark: mean lesion-wise sensitivity ≥ 0.86 #### AND - The lesion-wise precision is equal to or superior to state-of-the-art as benchmark: mean lesion-wise precision ≥ 0.70 #### AND - The lesion-wise DSC similarity coefficient (DSC) is equal to or superior to state-of-the-art as benchmark: mean lesion-wise DSC ≥ 0.78 #### AND - The patient-wise DSC similarity coefficient (DSC) is equal to or superior to state-of-the-art as benchmark: mean patient-wise DSC ≥ 0.83 #### AND - The patient-wise false positive (FP) is equal to or superior to state-of-the-art as benchmark: mean patient-wise FP ≤ 2.1 Quantitative evaluation of autosegmentation of Glioblastoma - Validation of the performance of autosegmentation of glioblastoma on MR images was performed by quantitative evaluation. Contours provided by medical experts were compared with contours generated by the software. This evaluation was performed on a minimum sample size of 43 patients. The contours are considered acceptable for clinical use if the following acceptance criterion is achieved: -The sensitivity is equal to or superior to state-of-the-art as benchmark: mean sensitivity ≥ 0.80 #### AND -The DSC is equal to or superior to state-of-the-art as benchmark: mean DSC ≥ 0.76 {10}------------------------------------------------ Quantitative and qualitative evaluation of automatic treatment plans generations - validation of the performance of automatic radiotherapy treatment plans generation was performed by both quantitative and qualitative evaluation. The quantitative evaluation consisted of direct comparison with manual plans. The qualitative evaluation consisted of medical experts determining the clinical acceptability of plans. These evaluations were performed on a minimum sample size of 20 patients. - The treatments plans are considered acceptable for clinical use if the following acceptance criteria are achieved: Quantitative evaluation: effectiveness difference (%) in DVH achieved goals between manual plans and automatic plans ≤ 5% AND Qualitative evaluation: % of clinical acceptable automatic plans ≥ 93% after expert review. All validation tests were carried out using datasets representative of the worldwide population receiving radiotherapy treatments. Finally, all tests passed their respective acceptance criteria, thus showing ART-Plan + v3.0.0 clinical acceptability. #### Not applicable Based on the information presented in these 510(k) premarket notifications the TheraPanacea ART-Plan is considered substantially equivalent. The TheraPanacea ART-Plan + 3.0.0 is as safe and effective as the currently marketed predicate device. Based on testing and comparison with the predicate device, TheraPanacea ART-Plan indicated no adverse indications or results. It is our determination that the TheraPanacea ART-Plan + 3.0.0 performs within its design specifications and is substantially equivalent to the predicate.