Who is the manufacturer of Limbus Contour?

Limbus Ai, Inc. filed the 510(k) submission for Limbus Contour (K230575).

What is the FDA product code for Limbus Contour?

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

What is the regulatory pathway for Limbus Contour?

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

Does Limbus Contour use AI or machine learning?

Yes. Limbus Contour (K230575) 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 Limbus Contour?

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 Limbus Contour 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.

Limbus Contour

K230575 · Limbus Ai, Inc. · LLZ · Apr 7, 2023 · Radiology

Device Facts

Record ID	K230575
Device Name	Limbus Contour
Applicant	Limbus Ai, Inc.
Product Code	LLZ · Radiology
Decision Date	Apr 7, 2023
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

Limbus Contour is a software-only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to derive optimal contours for input to radiation treatment planning. Supported image modalities are Computed Tomography and Magnetic Resonance. The Limbus Contour Software assists in the following scenarios: Operates in conjunction with radiation treatment planning systems or DICOM viewing systems to load, save, and display medical images and contours for treatment evaluation and treatment planning. Creation, transformation, and modification of contours for applications including, but not limited to: transferring contours to radiotherapy treatment planning systems, aiding adaptive therapy and archiving contours for patient follow-up. Localization and definition of healthy anatomical structures. Limbus Contour is not intended for use with digital mammography.

Device Story

Limbus Contour is a standalone software application for automatic segmentation (contouring) of CT and MRI DICOM images. It utilizes pre-trained, expert-curated machine learning models to identify and define healthy anatomical structures. The software operates on Windows-based systems in clinical environments, used by radiation oncologists, dosimetrists, and physicists. It imports DICOM image files and exports segmented DICOM RT-Structure Sets. The device does not store or display images directly, instead interfacing with existing radiotherapy treatment planning systems (TPS) or DICOM viewers. By automating the contouring process, the device assists in treatment evaluation, adaptive therapy planning, and patient follow-up, potentially increasing efficiency and consistency in radiation therapy workflows.

Clinical Evidence

No clinical studies were required. Substantial equivalence is supported by benchtop performance testing, including manual and automated software verification and validation testing to ensure contouring accuracy and adherence to software requirements.

Technological Characteristics

Standalone software-only device; no physical materials or electrical components. Operates on Windows 10/Windows Server 2016 or higher. Hardware requirements: 2 GHz+ multi-core processor, 8 GB RAM, and optional CUDA-capable NVIDIA GPU. Connectivity via file system import/export of DICOM files. Segmentation performed via pre-trained machine learning models with post-processing.

Indications for Use

Indicated for trained radiation oncologists, dosimetrists, and physicists to derive optimal contours for radiation treatment planning using CT or MRI images. Not intended for use with digital mammography.

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

Limbus Contour (K201232)

Related Devices

K201232 — Limbus Contour · Limbus Ai, Inc. · Aug 13, 2020
K241837 — Limbus Contour · Limbus Ai, Inc. · Oct 9, 2024
K232928 — DeepContour (V1.0) · Wisdom Technologies., Inc. · May 7, 2024
K230685 — AutoContour Model RADAC V3 · Radformation, Inc. · Apr 14, 2023
K210632 — Contour ProtegeAI · Mim Software, Inc. · Oct 20, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. April 7, 2023 Limbus AI Inc. % Mary Vater 510(k) Consultant Medical Device Academy 345 Lincoln Hill Rd SHREWSBURY VT 05738 Re: K230575 Trade/Device Name: Limbus Contour Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: March 1, 2023 Received: March 29, 2023 Dear Mary Vater: 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 {1}------------------------------------------------ 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-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 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, Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for Lora D. Weidner. The date of the signature is April 7, 2023. The time of the signature is 20:09:21 -04'00'. 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K230575 Device Name Limbus Contour #### Indications for Use (Describe) Limbus Contour is a software-only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to derive optimal contours for input to radiation treatment planning Supported image modalities are Computed Tomography and Magnetic Resonance. The Limbus Contour Software assists in the following scenarios: · Operates in conjunction with radiation treatment planning systems to load, save, and display medical images and contours for treatment evaluation and treatment planning. - · Creation, transformation, and modification of contours for applications including, but not limited to: transferring - contours to radiotherapy treatment planning systems, aiding adaptive therapy and archiving contours for patient follow-up. · Localization and definition of healthy anatomical structures. - · Limbus Contour is not intended for use with digital mammography. | 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 summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92: SUBMITTER -Limbus AI, Inc. 2076 Athol Street Regina, Saskatchewan, Canada, S4T3E5 Tel: 1-306-502-5982 | Contact Person: | Mary Vater | |-----------------|-------------------| | Email: | mary@fdaecopy.com | | Date Prepared: | February 28, 2023 | | II. DEVICE | | |------------------------------|------------------------------------------------| | Name of Device: | Limbus Contour | | Classification Name: | Radiological Image Processing System | | Regulation: | 21 CFR §892.2050 | | Regulation Name: | Medical image management and processing system | | Regulatory Class: | Class II | | Product Classification Code: | LLZ | III. PREDICATE DEVICE Predicate Manufacturer: Limbus Al, Inc. Predicate Trade Name: Limbus Contour Predicate 510(k): K201232 No reference devices were used in this submission. ### IV. DEVICE DESCRIPTION Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further postprocessing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user's operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files). # V. INDICATIONS FOR USE Limbus Contour is a software-only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to derive optimal contours for input to radiation treatment planning. Supported image modalities are Computed Tomography and Magnetic Resonance. The Limbus Contour Software assists in the following scenarios: {4}------------------------------------------------ - -Operates in coniunction with radiation treatment planning systems or DICOM viewing systems to load, save, and display medical images and contours for treatment evaluation and treatment planning. - -Creation, transformation, and modification of contours for applications including, but not limited to: transferring contours to radiotherapy treatment planning systems, aiding adaptive therapy and archiving contours for patient follow-up. - -Localization and definition of healthy anatomical structures. - -Limbus Contour is not intended for use with digital mammography. # VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence: - Indications for Use The predicate and subject device are identical with the exception . that the predicate has support for MacOS while the subject device does not and the predicate has less structures for automatic contouring available. - . Materials – The predicate and subject device are software-only devices and do not inherently contain material. - Design - The predicate and subject device have equivalent designs. - . Energy Source – The predicate and subject device are software-only devices, powered by the computer system. - . Performance Testing - The predicate and subject device were both were validated using an automatic contouring test to ensure the contours were accurate. | | Limbus Contour v1.7 | Limbus Contour v1.1 - K201232 | Similarities / Differences | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification Regulation | 892.2050 – Picture Archiving and Communication System | 892.2050 – Picture Archiving and Communication System | Same | | Product Code | LLZ | LLZ | Same | | Indications for Use | | | | | Limbus Contour is a software only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to derive optimal contours for input to radiation treatment planning. Supported image modalities are Computed Tomography and Magnetic Resonance. The Limbus Contour Software assists in the following scenarios: • Operates in conjunction with radiation treatment planning systems or DICOM viewing systems to load, save, and display medical images and contours for treatment evaluation and treatment planning. • Creation, transformation, and modification of contours for applications including, but not limited to: transferring contours to radiotherapy treatment planning systems, aiding adaptive therapy and archiving contours for patient follow-up. • Localization and definition of healthy anatomical structures. | Limbus Contour is a software only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to derive optimal contours for input to radiation treatment planning. Supported image modalities are Computed Tomography and Magnetic Resonance. The Limbus Contour Software assists in the following scenarios: • Operates in conjunction with radiation treatment planning systems or DICOM viewing systems to load, save, and display medical images and contours for treatment evaluation and treatment planning. • Creation, transformation, and modification of contours for applications including, but not limited to: transferring contours to radiotherapy treatment planning systems, aiding adaptive therapy and archiving contours for patient follow-up. • Localization and definition of healthy anatomical structures. | Same | | | | Limbus Contour is not intended for use with digital mammography. | Limbus Contour is not intended for use with digital mammography. | Same | | Intended User | Healthcare providers | Healthcare providers | Same | | Contouring Modes | Automatic | Automatic | Same | | Measurements | No measurement function. | No measurement function. | Same. | | Image Fusion | No fusion support. | No fusion support. | Same | | 3D image rendering | No image rendering function. | No image rendering function. | Same | | Image Modalities | CT and MR | CT and MR | Same | | Platform | Stand-alone package which operates on Microsoft Windows operating system operating system | Stand-alone package which operates on Microsoft Windows operating system and MacOS operating system | Limbus Contour v1.7 does not support MacOS operating system | | Environment of Use | Healthcare environment | Healthcare environment | Same | | Materials | N/A – Standalone Software | N/A - Standalone Software | Same | | Energy Source | N/A - Standalone Software | N/A - Standalone Software | Same | | Feature Comparison: • Operating System • Hardware Requirements • Etc. | Operating System • Windows 10 / Windows Server 2016 and Above Hardware Requirements • 2 GHz or faster multi- core processor • 8 GB of RAM • For GPU versions, a CUDA capable NVIDIA GPU is required | Operating System • Windows 10 / Windows Server 2016 • Mac OS 10.14 Hardware Requirements • 2 GHz or faster multi- core processor • 4 GB of RAM • For GPU versions, a CUDA capable NVIDIA GPU is required | Limbus Contour v1.7 does not support MacOS operating system. RAM requirements are increased to 8GB in Limbus Contour v1.7 | | Performance Testing | Two different types of verification testing were conducted to verify the software requirements: Manual and Automated. All tests passed, demonstrating that the software performance is in accordance with the stated software requirements. Validation testing of the following functions of the Limbus Contour application demonstrated that the | Two different types of verification testing were conducted to verify the software requirements: Manual and Automated. All tests passed, demonstrating that the software performance is in accordance with the stated software requirements. Validation testing of the following functions of the Limbus Contour application demonstrated that the software meets user needs and intended uses and to support | Same | | | software meets user needs and intended uses and to support substantial equivalence: • Automatic Contouring - Validation-Test | substantial equivalence: • Automatic Contouring - Validation-Test | | | Structures available for automatic contouring | A_Aorta A_Aorta_I A_Celiac A_LAD A_Mesenteric_S A_Pulmonary Bag_Bowel Bag_Bowel_Extend Bag_Bowel_Full Bag_Bowel_S Bladder Bladder Body Bone_Hyoid Bone_Ilium Bone_Ilium_L Bone_Ilium_R Bone_Mandible Bowel Bowel_Extend Bowel_Full Bowel_S BrachialPlex_L BrachialPlex_R BrachialPlexs Brain Brainstem Brainstem Breast_L Breast_R Breasts Bronchus Canal_Anal CaudaEquina Cavity_Oral Chestwall Chestwall_L Chestwall_R Clavicle_L Clavicle_R Cochlea_L Cochlea_R | A_Aorta Bladder Brain BrainStem LN_Neck_L LN_Neck_R Esophagus Femur_Head_L Femur_Head_R Globe_L Globe_R Heart Glnd_Lacrimal_L Glnd_Lacrimal_R Lens_L Lens_R Lung_L Lung_R Mandible OpticNrv_L OpticNrv_R Parotid_L Parotid_R Prostate Rectum Glnd_Submand_L Glnd_Submand_R SpinalCord Trachea | Limbus Contour v1.7.0 contains new structures for automatic contouring | | Colon_Sigmoid | | | | | Cornea_L | | | | | Cornea_L | | | | | Cornea_R | | | | | Cornea_R | | | | | Cricoid | |…

Limbus Contour

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Intended Use

Device Story

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