Who is the manufacturer of Contour ProtegeAI?

Mim Software, Inc. filed the 510(k) submission for Contour ProtegeAI (K210632).

What is the FDA product code for Contour ProtegeAI?

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

What is the regulatory pathway for Contour ProtegeAI?

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

Does Contour ProtegeAI use AI or machine learning?

Yes. Contour ProtegeAI (K210632) 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 Contour ProtegeAI?

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 Contour ProtegeAI 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.

Contour ProtegeAI

K210632 · Mim Software, Inc. · QKB · Oct 20, 2021 · Radiology

Device Facts

Record ID	K210632
Device Name	Contour ProtegeAI
Applicant	Mim Software, Inc.
Product Code	QKB · Radiology
Decision Date	Oct 20, 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

Contour ProtégéAl is an accessory to MIM software. It includes processing components to allow the contouring of anatomical structures using machine-learning-based algorithms automatically. Appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAI. Contour ProtégéAl is not intended to detect or contour lesions.

Device Story

Contour ProtégéAI is an accessory to MIM software that automates anatomical contouring on CT and MR images. It utilizes machine-learning models to segment normal structures; outputs are intended for quantitative analysis, adaptive therapy, and radiation treatment planning. The device operates on Windows, Mac, or Linux systems, either via local workstation/server deployment or remote MIMcloud service. Clinicians review and edit the automatically generated contours using appropriate visualization software. The device does not detect or contour lesions. By automating the contouring process, it aims to improve efficiency in radiation therapy workflows and patient management.

Clinical Evidence

Bench testing only. Neural network models were trained on data excluding test subjects. Performance was evaluated using Dice coefficients calculated for each structure. A leave-one-out analysis was performed using the MIM Maestro reference device to create atlases for comparison. Equivalence was defined as the lower 95% confidence bound of the subject device's Dice coefficient being no more than 0.1 lower than the mean Dice coefficient of the reference device. Results confirmed equivalent or superior performance to the reference.

Technological Characteristics

Software-based medical image processing system. Operates on Windows, Mac, and Linux. Supports DICOM 3.0. Deployment models include local workstation/server or cloud-based (MIMcloud). Utilizes machine-learning-based neural network models for automated segmentation of anatomical structures. No physical materials or energy sources.

Indications for Use

Indicated for trained medical professionals to assist in automated processing of digital CT and MR images (ACR/NEMA DICOM 3.0). Supports creation of contours for quantitative analysis, adaptive therapy, transfer to radiation therapy planning systems, and archiving for patient follow-up. Segments normal structures in various CT anatomical locations and normal structures of the prostate, seminal vesicles, and urethra in T2-weighted MR images.

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

Contour ProtégéAI (K193252)

Reference Devices

MIM 4.1 SEASTAR (MIM Maestro) (K071964)

Related Devices

K213976 — Contour ProtégéAI · Mim Software, Inc. · Feb 3, 2022
K231765 — Contour ProtégéAI · Mim Software, Inc. · Nov 8, 2023
K250035 — Contour ProtégéAI+ · Mim Software, Inc. · Feb 3, 2025
K193252 — Contour ProtegeAI · Mim Software, Inc. · Jul 2, 2020
K223774 — Contour ProtégéAI · Mim Software, Inc. · Apr 6, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). 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. MIM Software Inc. % Lynn Hanigan Quality Assurance Director 25800 Science Park Drive - Suite 180 CLEVELAND OH 44122 Re: K210632 Trade/Device Name: Contour ProtégéAI Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QKB Dated: September 17, 2021 Received: September 20, 2021 Dear Lynn Hanigan: 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 {1}------------------------------------------------ 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, 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) K210632 Device Name Contour ProtégéAI Indications for Use (Describe) Trained medical professionals use Contour ProtegeAI as a tool to assist in the automated processing of digital medical images of modalities CT and MR, as supported by ACR/NEMA DICOM 3.0. In addition, Contour ProtégéAI supports the following indications: · Creation of contours using maching algorithms for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management. · Segmenting normal structures across a variety of CT anatomical locations. · And segmenting normal structures of the prostate, seminal vesicles, and urethra within T2-weighted MR images. Appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAI. 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one red and one gray, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it. The logo is clean and modern, with a simple color palette. # 510(k) Summary K210632 (The following information is in conformance with 21 CFR 807.92) #### Submitter: MIM Software Inc. 25800 Science Park Drive - Suite 180 Cleveland, OH 44122 Phone: 216-455-0600 Fax: 216-455-0601 Contact Person: Lynn Hanigan Date Summary Prepared: October 12, 2021 #### Device Name | Trade Name: | Contour ProtégéAl | |-----------------------------------|------------------------------------------------| | Common Name: | Medical Imaging Software | | Regulation Number / Product Code: | 21 CFR 892.2050 / Product Code QKB | | Classification Name: | Medical image management and processing system | ## Predicate Device | K193252 | Contour ProtégéAl | MIM Software Inc. | |------------------|-----------------------------------------|-------------------| | Reference Device | | | | K071964 | MIM 4.1 SEASTAR (tradename MIM Maestro) | MIMvista Corp. | #### Intended Use Contour ProtégéAl is an accessory to MIM software. It includes processing components to allow the contouring of anatomical structures using machine-learning-based algorithms automatically. Appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAI. Contour ProtégéAl is not intended to detect or contour lesions. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it. The logo is clean and modern, and the colors are eye-catching. ## Indications for Use Trained medical professionals use Contour ProtégéAl as a tool to assist in the automated processing of digital medical images of modalities CT and MR, as supported by ACR/NEMA DICOM 3.0. In addition, Contour ProtégéAl supports the following indications: - Creation of contours using machine-learning algorithms for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management. - Segmenting anatomical structures across a variety of CT anatomical locations. - . And segmenting normal structures of the prostate, seminal vesicles, and urethra within T2-weighted MR images. Appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAI. #### Device Description Contour ProtégéAl is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAl is deployed on a remote server using the MIMcloud service for data management and transfer; or locally on the workstation or server running MIM software. ## Substantial Equivalence | ITEM | Contour ProtégéAl | Contour ProtégéAl (K193252) | MIM 4.1 SEASTAR [i.e., MIM Maestro] (K071964) | |--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Clearance Dates | TBD | 7/2/2020 | 9/26/2007 | | Intended Use | Contour ProtégéAl is an accessory to MIM software used for the contouring of anatomical structures in imaging data using machine-learning-based algorithms automatically. Appropriate image visualization software must be used to review and, if | Contour ProtégéAl is an accessory to MIM software used for the contouring of anatomical structures in imaging data using machine-learning-based algorithms automatically. Contour ProtégéAl must be used in conjunction with MIM software to | MIM 4.1 (SEASTAR) software is intended for trained medical professionals including, but not limited to, radiologists, oncologists, physicians, medical technologists, dosimetrists, and physicists. | | ITEM | Contour ProtégéAl | Contour ProtégéAl (K193252) | MIM 4.1 SEASTAR [i.e., MIM Maestro] (K071964) | | | necessary, edit results automatically generated by Contour ProtégéAl. Contour ProtégéAl is not intended to detect or contour lesions. | review and, if necessary, edit results automatically generated by Contour ProtégéAl. Contour ProtégéAl is not intended to detect or contour lesions automatically. | MIM 4.1 (SEASTAR) is a medical image and information management system that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, as well as create, display and print reports from those images. The medical modalities of these medical imaging systems include, but are not limited to, CT, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM 4.1 (SEASTAR) provides tools to quickly create, transform, and modify contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems and archiving contours for patient follow-up and management. | | ITEM | Contour ProtégéAl | Contour ProtégéAl (K193252) | MIM 4.1 SEASTAR [i.e., MIM Maestro] (K071964) | | Indications for Use | Trained medical professionals use Contour ProtégéAl as a tool to assist in the automated processing of digital medical images of modalities CT and MR, as supported by ACR/NEMA DICOM 3.0. In addition, Contour ProtégéAl supports the following indications: Creation of contours using machine-learning algorithms for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management. Segmenting normal structures across a variety of CT anatomical locations. And segmenting normal structures of the prostate, seminal vesicles, and urethra within T2-weighted MR images. Appropriate image visualization software must be used to review and, if necessary, edit results | Contour ProtégéAl is used by trained medical professionals as a tool to aid in the automated processing of digital medical images of modalities CT and MR, as supported by ACR/NEMA DICOM 3.0. Contour ProtégéAl assists in the following indications: The creation of contours using machine-learning algorithms for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management. Segmenting normal structures across a variety of CT anatomical locations. And segmenting normal structures of the prostate, seminal vesicles, and urethra within T2-weighted MR images. Contour ProtégéAl must be used in conjunction with MIM software to review and, if necessary, edit contours that were | MIM 4.1 (SEASTAR) software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM 4.1 (SEASTAR) assists in the following indications: Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects. Create, display and print reports from medical images. Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning. Localization and definition of objects such as tumors and normal tissues in medical images. Creation, transformation, and modification of contours for applications | | ITEM | Contour ProtégéAl | Contour ProtégéAl (K193252) | MIM 4.1 SEASTAR [i.e., MIM Maestro] (K071964) | | | automatically generated by Contour ProtégéAl. | automatically generated by Contour ProtégéAl. | including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management. | | Modalities | CT and MR | CT and MR | CT, MRI, CR, DX, MG, US, SPECT, PET and XA | | Atlas-Based Segmentation | No | No | Yes | | Automatically Contour Imaging Data Using Machine-Learning | Yes | Yes | No | | ITEM | Contour ProtégéAl | Contour ProtégéAl (K193252) | MIM 4.1 SEASTAR [i.e., MIM Maestro] (K071964) | | Neural Network Models included | (1.0.0 models) Head and Neck CT Prostate CT Thorax CT Liver CT Prostate MR (1.1.0 model) Prostate MR (2.0.0 models) Head and Neck CT Prostate CT Thorax CT Abdomen CT Lungs and Liver CT | (1.0.0 models) Head and Neck CT Prostate CT Thorax CT Liver CT Prostate MR | None | | Operating Platform | Server-based application supporting Linux-based OS - and - Local deployment on Windows or Mac | Server-based application supporting Linux-based OS | Windows, Mac | | Cloud-based deployment | Yes | Yes | No | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping squares, one red and one gray, with a white circle cut out of the red square. To the right of the squares is the text "mim" in black, bold letters. Below the text "mim" is the text "SOFTWARE" in smaller, black letters. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle in the red square. To the right of the squares is the text "mim" in a bold, sans-serif font. Below the text "mim" is the text "SOFTWARE" in a smaller, sans-serif font. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle cut out of the red square. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it. The logo is simple and modern, and the colors are eye-catching. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it. The logo is clean and modern, with a focus on simplicity and readability. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one red and one gray, with a white circle cut out of the red square. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" underneath in a smaller font. The logo is simple and modern, and the colors are eye-catching. | ITEM | Contour ProtégéAl | Contour ProtégéAl (K193252) | MIM 4.1 SEASTAR [i.e., MIM Maestro] (K071964) | |------------------------------------|-------------------|--------------------------------|-----------------------------------------------------| | Locally deployed (or installed) | Yes | No | Yes | # Discussion Changes within this submission include a slightly modified Intended Use and Indications for Use, new and modified CT neural network models with additional contours, a modified Prostate MR neural network model, and added functionality to install locally on a MIM workstation or server. These changes differ when comparing to Contour ProtégéAl 510(k)193252. Non-inferiority testing was used to compare the proposed Contour ProtégéAl device to atlases created from the MIM Maestro reference device. # Testing and Performance Data For the proposed Contour ProtégéAl device, neural network models were trained for each modality (CT and MR) on a pool of training data that did not include any patients from the same institution as the test subjects. The models were then evaluated on the test subjects, and a Dice coefficient was calculated for each structure. These Dice coefficients were then aggregated, overall patients. With the MIM Maestro atlas segmentation reference device, multiple atlases were created over the test subjects. Each Atlas contained images of the same anatomical field of view from the same institution. Each structure appeared in one Atlas. For each patient in an Atlas was used to segment the structures in that patient. The test patient itself was excluded from this Atlas (leave-one-out analysis). The mean and standard deviation Dice coefficients, along with the lower 95th percentile confidence bound, were calculated for both the proposed Contour ProtégéAl device and the MIM Maestro atlas segmentation reference device for each structure of each neural network model. Contour ProtégéAI results were equivalent or had better performance than the MIM atlas seqmentation reference device. Equivalence is defined such that the lower 95th percentile confidence bound of the Contour ProtégéAl segmentation is greater than 0.1 Dice lower than the mean MIM Maestro atlas segmentation reference device performance. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping squares, one gray and one red, with a white circle cut out of the red square. To the right of the squares is the text "mim" in a bold, sans-serif font. Below the text "mim" is the text "SOFTWARE" in a smaller, sans-serif font. # Conclusion Based on the Discussion and Testing and Performance Data above, the proposed device is determined to be as safe and effective as its predicate device, Contour ProtégéAl 510(k)193252. In addition, the proposed device performs as well as the reference device, MIM 4.1 SEASTAR (k)071964 [MIM Maestro].

Contour ProtegeAI

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