Who is the manufacturer of Limbus Contour?

Limbus Ai, Inc. filed the 510(k) submission for Limbus Contour (K201232).

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: Traditional).

Does Limbus Contour use AI or machine learning?

Yes. Limbus Contour (K201232) 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

K201232 · Limbus Ai, Inc. · LLZ · Aug 13, 2020 · Radiology

Device Facts

Record ID	K201232
Device Name	Limbus Contour
Applicant	Limbus Ai, Inc.
Product Code	LLZ · Radiology
Decision Date	Aug 13, 2020
Decision	SESE
Submission Type	Traditional
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. Limbus Contour is not intended to automatically contour tumor clinical target volumes.

Device Story

Limbus Contour is a standalone software application for automatic segmentation of CT/MRI DICOM images. It uses pre-trained, expert-curated machine learning models to localize and define healthy anatomical structures. The device is used by radiation oncologists, dosimetrists, and physicists in clinical environments. It imports DICOM image files and exports segmented DICOM RT-Structure Sets. It does not display or store images, nor does it perform image fusion or 3D rendering; these functions are handled by external radiotherapy treatment planning systems (TPS) or DICOM viewers. By automating the contouring process, the device assists in treatment planning, adaptive therapy, and archiving, potentially improving workflow efficiency for radiation therapy.

Clinical Evidence

No clinical data. Substantial equivalence is supported by benchtop performance testing, including manual and automated software verification and validation testing of the automatic contouring function.

Technological Characteristics

Standalone software application; cross-platform (Windows/macOS). Uses pre-trained machine learning models for automatic segmentation. No patient-contacting materials, electrical components, or energy sources. Interfaces via DICOM file import/export. Software level of concern: Major.

Indications for Use

Indicated for trained radiation oncologists, dosimetrists, and physicists to derive optimal contours for radiation treatment planning using CT or MR images. Not for use with digital mammography or automatic contouring of tumor clinical target volumes.

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

Radiomics App v1.0 (K173420)

Related Devices

K230575 — Limbus Contour · Limbus Ai, Inc. · Apr 7, 2023
K241837 — Limbus Contour · Limbus Ai, Inc. · Oct 9, 2024
K232928 — DeepContour (V1.0) · Wisdom Technologies., Inc. · May 7, 2024
K212915 — MVision AI Segmentation · MVision AI · May 3, 2022
K230685 — AutoContour Model RADAC V3 · Radformation, Inc. · Apr 14, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ August 13, 2020 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Limbus AI Inc. % Ms. Mary Vater 510(k) Consultant Medical Device Academy 245 Lincoln Hill Road SHREWSBURY VT 05738 Re: K201232 Trade/Device Name: Limbus Contour Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: July 17, 2020 Received: July 17, 2020 Dear Ms. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting {1}------------------------------------------------ combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about 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) K201232 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 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. Limbus Contour is not intended to automatically contour tumor clinical target volumes. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### 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 K201232 This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92: - l. SUBMITTER Limbus AI, Inc. 2076 Athol Street Regina, Saskatchewan, Canada, S4T3E5 Tel: 1-306-502-5982 Contact Person: Mary Vater Date Prepared: May 1, 2020 | II. DEVICE | | |------------------------------|--------------------------------------| | Name of Device: | Limbus Contour | | Classification Name: | Radiological Image Processing System | | Regulation: | 21 CFR §892.2050 | | Regulatory Class: | Class II | | Product Classification Code: | LLZ | PREDICATE DEVICE ============================================================================================================================================================================== Predicate Manufacturer: Microsoft Corp. Predicate Trade Name: Radiomics App v1.0 Predicate 510(k): K173420 No reference devices were used in this submission. #### DEVICE DESCRIPTION IV. 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 models and further post-processing 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). #### INDICATIONS FOR USE V. 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. {4}------------------------------------------------ - o Localization and definition of anatomical structures. Limbus Contour is not intended for use with digital mammography. Limbus Contour is not intended to automatically contour tumor clinical target volumes. #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVCE 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 additional indications specific to tumor and organ contouring, whereas the subject device is not specifically indicated for that purpose. - o 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. - o Energy Source - The predicate and subject device are software-only devices, powered by the computer system. - Other Design Features - The contours generated from Limbus Contour are edited in external treatment planning or contouring tools and it does not contain an image viewer, whereas the predicate has these features integrated. The subject device also does not perform image fusion or subsequent contouring of fused images, or 3D image rendering, which are not necessary to achieve the intended use. Both devices are offered as a stand-alone package that operate on Microsoft Windows operating system. Limbus Contour also functions on a Mac OS. - . Performance Testing - The predicate and subject device were both were validated using an automatic contouring test to ensure the contours were accurate. | | Limbus AI | Radiomics App v1.0 – K173420 | 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. | Microsoft Radiomics App v1.0 is a software-only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to derive optimal organ and tumor contours for input to radiation treatment planning. Supported image modalities are Computed Tomography and Magnetic Resonance. Radiomics App assists in the following scenarios: • Load, save and display of medical images and contours for treatment evaluation and treatment planning. • Creation, transformation, and modification of contours for | Indications for use are similar other than the device not displaying medical images and contours. Related to that difference; the device is also not capable of fusing compatible images for treatment planning or three- dimensional rendering of medical | | | | | | | | • 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. Limbus Contour is not intended to automatically contour tumors or tumor clinical target volumes. | 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 both solid tumors and healthy anatomical structures. • Fusion display of compatible images for treatment planning. • Three-dimensional rendering of medical images and the segmented contours. Images reviewed using the Radiomics App software should not be used for primary image interpretations. Radiomics App is not for use with digital mammography. | images and segmented contour. Unlike the predicate device, the Limbus Contour does not display images, and therefore it cannot be used for "primary image interpretations" so that is not included in the Limbus Contour indications. In addition, the device only localizes and defines healthy anatomical structures (not solid tumors like the predicate device). | | Intended User | Healthcare providers | Healthcare providers | Same | | Contouring Modes | Automatic | Assisted and Automatic | Contours generated from Limbus Contour are edited in external treatment- planning or contouring tools. | | Measurements | No measurement function. | 2D distance measurement, average tissue density within a region (for CT), segmentation volume | Limbus Contour does not contain an image viewer. No measurement functionality is provided because of this. | | | | | | | Image Fusion | No fusion support. | Fuse only two 3D images, CT and MR | measurements are not necessary to achieve intended use. Limbus Contour does not perform image fusion and subsequent contouring on fused images. Not necessary to achieve intended use. | | 3D image rendering | No image rendering function. | Yes | Limbus Contour does not contain a viewer. Images are rendered in a separate viewing tool. | | Image Modalities | CT and MR | CT and MR | Same | | Platform | Stand-alone package which operates on Microsoft Windows operating system and MacOS operating system | Stand-alone package which operates on Microsoft Windows operating system only. | Limbus Contour will also support Mac OS operating systems | | 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 • Windows 10 / Windows Server 2016 • Mac OS 10.14 | Operating System • Not specified. | | | Hardware Requirements Etc. | Hardware Requirements • 2 GHz or faster multi-core processor • 4 GB of RAM • For GPU versions, a CUDA capable NVIDIA GPU is required | | | | Performance Testing | Two different types of verification testing were conducted to verify the software requirements: | Two different types of verification testing were conducted to verify the software requirements: | Rendering and measurement tests are not applicable for the subject | | Manual and Automated. All tests passed, demonstrating that the software performance is in accordance with the stated software requirements. | Manual and Automated. All tests passed, demonstrating that the software performance is in accordance with the stated software requirements. | device because it does not have those functions. | | | Validation testing of the following functions of the Limbus Contour application demonstrated that the software meets user needs and intended uses and to support substantial equivalence: • Automatic Contouring – Validation Test | Validation testing of the following functions of the Radiomics App demonstrated that the software meets user needs and intended uses and to support substantial equivalence: • Measurements - Validation Test • Volumetric Rendering – Validation Test • Multi-Planar Reconstruction – Validation Test • Assisted Contouring – Validation Test • Automatic Contouring – Validation Test | | | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ ### VII. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. ### Sterilization & Shelf-life Testing The subject device is a software-only device. Therefore sterilization and shelf-life are not applicable. ### Biocompatibility The subject device is a software-only device. There are no direct patient-contacting components of the subject device. Therefore, patient contact information is not needed for this device ### Electrical safety and electromagnetic compatibility (EMC) The subject device is a software-only device. It contains no electric components, generates no electrical emissions, and uses no electrical energy of any type; therefore, this section is not applicable. ### Software Verification and Validation Testing Software verification and validation testing were conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a major level of concern. 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 substantial equivalence: {8}------------------------------------------------ - Automatic Contouring - Validation Test ## Mechanical and Acoustic Testing Not Applicable (Standalone Software) ## Animal Study Animal performance testing was not required to demonstrate safety and effectiveness of the device. ### Clinical Studies Clinical testing was not required to demonstrate the safety and effectiveness of Limbus Contour. Instead, substantial equivalence is based upon benchtop performance testing. ## VIII. CONCLUSIONS The minor differences in indications of use between the subject Limbus Contour software and the predicate Radiomics software do not constitute a different intended use. The technological characteristics of the Limbus Contour software are similar to those of the Radiomics App. Results of software verification and validation testing demonstrate that the Limbus Contour software performs in accordance with specifications and that the performance is comparable to that of the predicate device. Therefore, the Limbus Contour software can be found to be substantially equivalent to the predicate Radiomics App software device.

Limbus Contour

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