Who is the manufacturer of ART-Plan?

Therapanacea filed the 510(k) submission for ART-Plan (K202700).

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 (K202700) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for ART-Plan?

AccuContour (K191928); RTx (K130393); Workflow Box (K181572); MIM4.1 (SEASTAR) (K071964).

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

K202700 · Therapanacea · QKB · Jan 14, 2021 · Radiology

Device Facts

Record ID	K202700
Device Name	ART-Plan
Applicant	Therapanacea
Product Code	QKB · Radiology
Decision Date	Jan 14, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

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 functional images and display them with fused and non-fused displays to facilitate the comparison and delineation of image data by the user. The images created with rigid or elastic registrations, potential modifications, and then the validation of a trained user with professional qualifications in anatomy and radiotherapy. With the Annotate module, users can edit manually and semi-automatically the 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 on CT images. The contours created automatically, semi-automatically or manually require verifications, and then the validation of a trained user with professional qualifications in anatomy and radiotherapy. The device is intended to be used in a clinical setting, by trained professionals only.

Device Story

ART-Plan is a web-based software application for radiotherapy treatment planning; used in clinical settings by trained professionals. Inputs include 3D multi-modal medical images (CT, MR, PET). The device features two primary modules: SmartFuse and Annotate. SmartFuse performs rigid and elastic image registration to fuse anatomical and functional images, aiding comparison and delineation. Annotate uses deep learning algorithms to automatically generate contours for organs at risk and healthy lymph nodes on CT images; it also provides tools for manual and semi-automatic contour editing. Outputs include delineated structures and fusion results, which are saved for use in dosimetry processes. The device facilitates standardized, efficient contouring workflows. All automatically generated contours require verification and validation by a qualified user. The system supports DICOM 3.0 compliant datasets and integrates into existing clinical networks.

Clinical Evidence

No clinical studies were conducted. Evidence is based on bench testing, including usability testing (IEC 62366), autosegmentation performance testing against AAPM requirements and MIM software, and registration performance testing using the POPI-model protocol. Testing confirmed the device provides clinically acceptable contours and registration accuracy.

Technological Characteristics

Standalone software application accessed via web browser (Chrome/Firefox). Supports DICOM 3.0. Modalities: CT, MR, PET. Features deep learning-based automatic segmentation and rigid/deformable image registration. Software level of concern: Major.

Indications for Use

Indicated for cancer patients undergoing radiotherapy treatment planning. Used by trained professionals (radiologists, oncologists, dosimetrists, physicists) to assist in contouring target anatomical regions, organs at risk, and healthy lymph nodes on 3D images (CT, MR, PET).

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

AccuContour (K191928)
RTx (K130393)
Workflow Box (K181572)
MIM4.1 (SEASTAR) (K071964)

Related Devices

K230023 — ART-Plan · Therapanacea Sas · Apr 19, 2023
K220813 — ART-PLAN · Therapanacea · Jun 17, 2022
K232479 — ART-Plan · Therapanacea · Dec 22, 2023
K234068 — ART-Plan (v.2.2.0) · Therapanacea Sas · Apr 22, 2024
K192065 — Syngo.Via RT Image Suite · Siemens Medical Solutions USA, Inc. · Sep 18, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ January 14, 2021 Image /page/0/Picture/1 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 letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format. TheraPanacea % Mr. Edwin Lindsay QA/RA Consultant Pépinière Cochin Paris Santé 29 rue du Faubourg Saint-Jacques Paris. 75014 FRANCE Re: K202700 Trade/Device Name: ART-Plan Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: QKB Dated: December 9, 2020 Received: December 14, 2020 Dear Mr. 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 {1}------------------------------------------------ 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-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, 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) K202700 Device Name ART-Plan Indications for Use (Describe) 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 functional images and display them with fused and non-fused displays to facilitate the comparison and delineation of image data by the user. The images created with rigid or elastic registrations, potential modifications, and then the validation of a trained user with professional qualifications in anatomy and radiotherapy. With the Annotate module, users can edit manually and semi-automatically the 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 on CT images. The contours created automatically, semi-automatically or manually require verifications, and then the validation of a trained user with professional qualifications in anatomy and radiotherapy. The device is intended to be used in a clinical setting, by trained professionals only. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ## 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 Cochin Paris Santé 29 rue du Faubourg Saint-Jacques 75014 Paris France Telephone: +33 9 62 52 78 19 ## Establishment Registration Number: Still to be established ## Contact Person: Edwin Lindsay Telephone +44 (0) 7917134922 ## Date Prepared: 7th September 2020 {4}------------------------------------------------ ## 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 device software, radiology | Class 2 | QKB | Radiology | #### Device Trade Name: ART-Plan ## Device Common Name: ART-Plan #### Intended/ Indications Use: ART-Plan is a software designed to assist the contouring process of the target anatomical reqions 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 functional images and display them with fused and non-fused displays to facilitate the comparison and delineation of image data by the user. The images created with rigid or elastic registration require verifications, potential modifications, and then the validation of a trained user with professional qualifications in anatomy and radiotherapy. With the Annotate module, users can edit manually and semi-automatically the contours for the regions of interest. It also allows to generate automatically, and based on medical practices, the contours for the orqans at risk and healthy lymph nodes on CT images. The contours created automatically, semi-automatically or manually require verifications, potential modifications, and then the validation of a trained user with professional qualifications in anatomy and radiotherapy. The device is intended to be used in a clinical setting, by trained professionals only. {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 | Primary Predicate AccuContour | Secondary Predicate RTx | Secondary Predicate Workflow Box | Secondary Predicate MIM4.1 (SEASTAR) | Comment | | | Common Name | Radiological image processing software for radiation therapy | Radiological image processing software for radiation therapy | System, image processing, radiological | System, image processing, radiological | System, image processing, radiological | N/A | | | Device Manufacturer | TheraPanacea | Xiamen Manteia Technology LTD | Mirada Medical Ltd. | Mirada Medical Ltd. | MIMvista Corp (now MIM Software Inc) | N/A | | | 510k | N/A | K191928 | K130393 | K181572 | K071964 | N/A | | | Device Classification | II | II | II | II | II | N/A | | | Primary Product Code | QKB | QKB | LLZ | LLZ | LLZ | As advised by the FDA the new product code, QKB, has been created in-lieu of LLZ which uses Al algorithms and is intended for radiation therapy, and is the proposed product code for ART- Plan. | | | Secondary Product Code | - | - | - | - | - | N/A | | | Target Population | Any patient type for whom relevant modality scan data is available | Not stated | Any patient type for whom relevant modality scan data is available. | Any patient type for whom relevant modality scan data is available. | Not stated | The proposed device has identical target populations to the secondary predicates. | | | Environment | Hospital | Hospital | Hospital | Hospital | Hospital | The proposed device and predicates have identical target environments | | | Intended Use/ Indication for | Intended Use ART-Plan is a software designed | It is used by radiation oncology | Workflow Box is a system designed to allow users to route | RTx is intended to be used by trained medical | Intended Use MIM 4.1 (SEASTAR) software is intended for trained medical | The intended use and indications for use of the proposed device, ART-Plan | | | | | General Information | | | | | | | Property | Proposed Device ART-Plan | Primary Predicate AccuContour | Secondary Predicate RTx | Secondary Predicate Workflow Box | Secondary Predicate MIM4.1 (SEASTAR) | Comment | | | Use | 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 functional images and display them with fused and non-fused displays to facilitate the comparison and delineation of image data by the user. The images created with rigid or elastic registration require verifications, potential modifications, and then the validation of a trained user with professional qualifications in anatomy and radiotherapy. With the Annotate module, users can | department to register multimodality images and segment (non- contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation. | DICOM-compliant data to and from automated processing components. Workflow Box includes processing components for automatically contouring imaging data using deformable image registration and machine learning based algorithms. Workflow Box must be used in conjunction with appropriate software to review and edit results generated automatically by Workflow Box components, for example image visualization software must be used to facilitate the review and edit of contours generated by Workflow Box component applications. Workflow Box is not intended to automatically detect lesions. | professionals including, but not limited to, radiologists, nuclear medicine physicians, radiation oncologists, dosimetrists and physicists. RTx is a software application intended to display and visualize 2D & 3D multi-modal medical image data. The user may process, render, review, store, print and distribute DICOM 3.0 compliant datasets within the system and/or across computer networks. Supported modalities include static and gated a, PET, MR, SPECT and planar NM. The user may also create, display, print, store and distribute reports resulting from interpretation of the datasets. RTx allows the user to register combinations of | professionals including, but not limited to, radiologists, oncologists, physicians, medical technologists, dosimetrists and physicists. 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…