Who is the manufacturer of Radiomics App v1.0?

Microsoft Corp. filed the 510(k) submission for Radiomics App v1.0 (K173420).

What is the FDA product code for Radiomics App v1.0?

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

What is the regulatory pathway for Radiomics App v1.0?

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

Does Radiomics App v1.0 use AI or machine learning?

Yes. Radiomics App v1.0 (K173420) 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 Radiomics App v1.0?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like Radiomics App v1.0 get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

Radiomics App v1.0

K173420 · Microsoft Corp. · LLZ · Dec 27, 2017 · Radiology

Device Facts

Record ID	K173420
Device Name	Radiomics App v1.0
Applicant	Microsoft Corp.
Product Code	LLZ · Radiology
Decision Date	Dec 27, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

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 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.

Device Story

Software-only device for radiation treatment planning; integrates into clinical networks to receive CT and MR scans. Assists clinicians in segmenting solid tumors and healthy anatomical structures. Features include manual assisted contouring, machine-learning-based automatic contouring, and contour refinement tools. Outputs include 3D contours and rendered images for export to radiotherapy treatment planning systems. Used by radiation oncologists, dosimetrists, and physicists in clinical settings to aid adaptive therapy and patient follow-up. Benefits include optimized contouring workflows for treatment planning.

Clinical Evidence

No clinical data. Substantial equivalence supported by software verification and validation testing, including manual and automated verification, and validation of measurements, volumetric rendering, multi-planar reconstruction, and assisted/automatic contouring functions.

Technological Characteristics

Software-only device; operates on Microsoft Windows. Functions include assisted and automatic contouring, 2D distance measurement, tissue density calculation, 3D rendering, and CT/MR image fusion. Software level of concern: moderate.

Indications for Use

Indicated for trained radiation oncologists, dosimetrists, and physicists to derive organ and tumor contours for radiation treatment planning using CT and MR images. Not for primary image interpretation or 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

MIM 5.2 (BRACHY) (K103576)

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Submission Summary (Full Text)

{0}------------------------------------------------ December 27, 2017 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 logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Microsoft Corp. % Donna-Bea Tillman, Ph.D. Senior Consultant Biologics Consulting Group, Inc. 1555 King Street. Suite 300 ALEXANDRIA VA 22314 Re: K173420 Trade/Device Name: Radiomics App v1.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 31, 2017 Received: November 1, 2017 Dear Dr. Tillman: 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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael D. O'Hara For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K173420 Device Name Radiomics App v1.0 ### Indications for Use (Describe) 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 applications including, but not limited to: transferring contours to radiotherapy treatment planning systems, aiding adaptive therapy, and archiving contours for patient followup. · 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. 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 #### 1. SUBMITTER | Submitter: | Microsoft Corp 1 Microsoft Way Redmond, WA 98052 Phone: 425-538-9419 | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Ivan Tarapov Ivan.Tarapov@microsoft.com | | Submission Correspondent: | Donna-Bea Tillman, Ph.D, MPA Biologics Consulting Group, Inc. 1555 King Street, Suite 300 Alexandria, VA 22314 Phone: 410-531-6542 dtillman@biologicsconsulting.com | | Date Prepared: | October 31, 2017 | #### 2. DEVICE | Name of Device: | Radiomics App v1.0 | |-----------------------|----------------------------------------------------------------| | Common or Usual Name: | Radiological Image Processing System | | Classification Name: | Picture Archiving and Communications System 21 CFR 892.2050 | | Regulatory Class: | Class II | | Product Code: | LLZ | #### 3. PREDICATE DEVICE | Predicate Device Name: | MIM 5.2 (BRACHY) | |------------------------|----------------------------------------------------| | Manufacturer: | MIM Software Inc. | | 510(k) Number: | K103576 | | Reference Devices: | No reference devices were used in this submission. | ### DEVICE DESCRIPTION 4. Microsoft Radiomics App v1.0 is a software-only medical device intended for use by trained radiation oncologists, dosimetrists and medical physicists for radiation treatment planning. Radiomics App stems from more than eight years of research in computerized medical image analysis, computer vision and machine learning. It applies well tested, state-of-the-art algorithms for the assisted delineation of anatomical structures of interest in three-dimensional, clinical radiological scans. Radiomics App works on computed tomography (CT) and magnetic resonance (MR) scans, and is designed to contour/delineate both healthy anatomical structures as well as lesions such as solid tumors. {4}------------------------------------------------ Radiomics App integrates into the clinical data network of radiation therapy treatment centers, receiving data from imaging devices such as CT and MR scanners. The purpose of the tool is to assist the expert user in producing segmentations (three-dimensional contours) of anatomical structures, for both solid tumors and healthy tissue structures. The following segmentation tools are provided: - Assisted Contouring. This module allows for the manual, user-guided segmentation of . structures of interest in both CT and MR images. - . Machine-learning based contouring. This module uses machine learning algorithms (ML) to provide an initial segmentation of certain structures of interest automatically. The user has the option to accept this initial segmentation or edit and refine it. - . Contour refinement. This module allows the user to edit and improve segmentations created by either the machine learning or the assisted contouring algorithms. These segmentations are then exported back into the clinical data network, and subsequently utilized in a radiotherapy treatment planning system to generate a treatment plan for a patient. ### ട്. INDICATION FOR USE 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 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. ## Comparison of Indications for Use Both devices are only intended for use by trained medical professionals. As noted below, both devices are intended for use during radiation therapy planning. The subject device supports a subset of the image modalities supported by the predicate device. Both devices accept DICOM images generated elsewhere as inputs. Both devices provide the user with tools to contour medical images for use in radiation therapy planning and patient follow-up. Both devices can be used to localize and define normal tissues as well as solid tumors. Both devices support the fusion of different image modalities. Both devices provide three-dimensional image rendering. The subject device is not intended for primary image interpretation or for use with digital mammography. This is a subset of the indications of the predicate device. {5}------------------------------------------------ The minor differences in indications of use between the subject Radiomics App and the predicate MIM software do not constitute a different intended use. ### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 6. WITH THE PREDICATE DEVICE | | Proposed Device | Predicate Device | |----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | TBD | K103576 | | Applicant | Microsoft | MIM Software | | Device Name | Radiomics App | MIM 5.2 | | Classification Regulation | 892.2050 - Picture Archiving and Communication System | 892.2050 – Picture Archiving and Communication System | | Product Code | LLZ | LLZ | | Indications for Use | Microsoft Radiomics Advanced Image Contouring v1.0 (Radiomics App) 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 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 | MIM 5.2 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 ACRINEMA DICOM 3.0. MIM 5.2 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. Evaluation of cardiac left ventricular function and perfusion, including left ventricular end-diastolic volume, end- systolic volume, and ejection fraction. Localization and definition of objects such as tumors and normal tissues in medical images. Creation, transformation, and modification of 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. | | | Proposed Device | Predicate Device | | | App software should not be used for primary image interpretations. Radiomics App is not for use with digital mammography. | and management. Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans. | | | | Planning and evaluation of permanent implant brachytherapy procedures. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using a FDA- approved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD. | | Intended users | Healthcare providers | Healthcare providers | | Contouring modes | Assisted and automatic | Assisted and automatic | | Types of tissue contoured | Tumors and normal tissues | Tumors and normal tissues | | Measurements | 2D distance measurement, average tissue density within a region (for CT), segmentation volume | 2D distance measurement, segmentation volume, average tissue density within a region (for CT) | | Image Fusion | Fuse only two 3D images, CT and MR | Fuse medical images from multiple modalities | | 3D image rendering | Yes | Yes | | Cardiac applications | No | Yes | | Dose visualization and manipulation | No | Yes | | Image modalities | CT and MR | CT, MRI, CR, DX, MG, US, SPECT, PET and XA | | Platform | Stand-alone package which operates on Microsoft Windows operating systems only. | Stand-alone package which operates on both Windows and Mac computer systems. | The table below provides a side-by-same comparison of the technological characteristics of the proposed Radiomics App and the predicate MIM Software. {6}------------------------------------------------ ### 7. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. # Biocompatibility {7}------------------------------------------------ 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) Not applicable. 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. ## Software Verification and Validation Testing Software verification and validation testing were conducted and documentation was provided 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 moderate level of concern. ## Verification 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 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 ## Animal Study Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device. ## Clinical Study Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device. #### CONCLUSIONS 8. The minor differences in indications of use between the subject Radiomics App and the predicate MIM software do not constitute a different intended use. The technological characteristics of the Radiomics App are similar to those of the MIM Software, with the biggest differences being that the Radiomics App offers a subset of the features provided by the MIM software. Results of software verification and validation testing demonstrate that the Radiomics App performs in accordance with specifications and that the performance is comparable to that of the predicate device. Therefore, the Radiomics App can be found to be substantially equivalent to the predicate MIM Software.