Who is the manufacturer of RSI-MRI+?

Multimodal Imaging Services Corporation (Dba Healthlytix) filed the 510(k) submission for RSI-MRI+ (K191278).

What is the FDA product code for RSI-MRI+?

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

What is the regulatory pathway for RSI-MRI+?

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

Does RSI-MRI+ use AI or machine learning?

Yes. RSI-MRI+ (K191278) 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 RSI-MRI+?

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 RSI-MRI+ 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.

RSI-MRI+

K191278 · Multimodal Imaging Services Corporation (Dba Healthlytix) · LLZ · Nov 19, 2019 · Radiology

Device Facts

Record ID	K191278
Device Name	RSI-MRI+
Applicant	Multimodal Imaging Services Corporation (Dba Healthlytix)
Product Code	LLZ · Radiology
Decision Date	Nov 19, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

RSI-MRI+ is indicated for use as automatic post-acquisition image processing software for analysis of diffusionweighted and anatomical magnetic resonance imaging data. RSI-MRI+ is intended for automatic fusion of derived diffusion-weighted MRI data with anatomical T2-weighted MR images. RSI-MRI+ is additionally intended to provide automatic prostate segmentation, and reporting of derived image metrics. RSI-MRI+ is not intended for use in pediatric populations. RSI-MRI+ is not intended to diagnose, treat, or prevent diseases or conditions. RSI-MRI+ is intended to be used in a variety of settings such as hospitals, clinics, and medical offices.

Device Story

Standalone software for radiologists/clinicians; processes DICOM diffusion-weighted (DWI) and anatomical T2-weighted MRI data. Uses deep learning for automatic prostate segmentation; generates Restricted Signal Map for improved restricted diffusion conspicuity; performs image fusion of derived DWI data with T2-weighted images. Outputs DICOM-compatible reports, segmentation volumes, and fused image series for viewing on third-party PACS workstations. Used in hospitals, clinics, and medical offices. Clinicians review, accept, or reject outputs to assist in image analysis and interpretation. Benefits include improved visualization of restricted diffusion and automated quantification of prostate metrics.

Clinical Evidence

Bench testing only. Software verification and validation confirmed DICOM processing and output generation. Performance testing demonstrated increased conspicuity of Restricted Signal Maps compared to standard DWI, accuracy of automated prostate segmentation versus manual radiologist segmentations, and diffusion signal normalization across scanners. Retrospective clinical data (labeled ROIs, T2-weighted data, raw diffusion series) used for verification and validation of diffusion analysis.

Technological Characteristics

Standalone software for network-connected server or PC workstation. Inputs/outputs: DICOM. Processing: Multi-compartment RSI model for diffusion analysis; deep learning algorithm for prostate segmentation. Features: Restricted Signal Map generation, color fusion series, automated segmentation, and reporting. No manual segmentation, co-registration, or image annotation tools.

Indications for Use

Indicated for automatic post-acquisition processing of diffusion-weighted and anatomical MRI data for prostate segmentation, quantification, and reporting. Not for pediatric use. Not for diagnosis, treatment, or prevention of disease.

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

Eigen ProFuse CAD (K173744)

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Submission Summary (Full Text)

{0}------------------------------------------------ November 19, 2019 MultiModal Imaging Services Corporation (dba HealthLytix) % Stephen Kosnosky, PMP, ASQ CMQ/OE Quality and Regulatory Manager 4747 Executive Drive, Suite 820 SAN DIEGO CA 92121 Re: K191278 Trade/Device Name: RSI-MRI+ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: November 8, 2019 Received: November 12, 2019 Dear Mr. Kosnosky: 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/cfpmp/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, 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) K191278 Device Name RSI-MRI+ #### Indications for Use (Describe) RSI-MRI+ is indicated for use as automatic post-acquisition image processing software for analysis of diffusionweighted and anatomical magnetic resonance imaging data. RSI-MRI+ is intended for automatic fusion of derived diffusion-weighted MRI data with anatomical T2-weighted MR images. RSI-MRI+ is additionally intended to provide automatic prostate segmentation, and reporting of derived image metrics. RSI-MRI+ is not intended for use in pediatric populations. RSI-MRI+ is not intended to diagnose, treat, or prevent diseases or conditions. RSI-MRI+ is intended to be used in a variety of settings such as hospitals, clinics, and medical offices. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/>Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input type="checkbox"/>Over-The-Counter Use (21 CFR 801 Subpart C)</div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for HealthLytix. To the left of the company name is a circular design made up of many small circles. The name HealthLytix is in blue, with the "Health" portion in a darker blue and the "Lytix" portion in a lighter blue. # 510(k) Summary # K191278 ### Submission Information: | Submitter's Name | MultiModal Imaging Services Corporation (dba HealthLytix) | |------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter's Address | 4747 Executive Drive, Suite 820 San Diego, CA 92121 | | Submitter Telephone | +001.619.340.0503 | | Contact Name | Stephen Kosnosky PMP, ASQ CMQ/OE | | Date Prepared | Sept 18, 2019 | | Trade or Proprietary Name | RSI-MRI+ | | Common or Usual Name | Picture Archiving and Communications System | | Classification Name | System, Image Processing, Radiological) (21 CFR 892.2050) | | Regulatory Class | Class II | | Product Code | LLZ | | Predicate Device | Eigen ProFuse CAD (K173744) As of submission date this predicate device has not been subject to a design-related recall. No reference devices were used in this submission. | ## Device Description: RSI-MRI+ is standalone software that is used by radiologists, and other clinicians to assist with analysis and interpretation of medical images. RSI-MRI+ accepts DICOM images using supported protocols and performs automatic post-acquisition analysis of diffusion-weighted magnetic resonance imaging (DWI) data and optional automated fusion of derived image data with anatomical T2weighted MR images. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for HealthLytix. The logo consists of a circular design on the left, made up of many small dots arranged in concentric circles. To the right of the circular design is the company name, "HealthLytix", with the "Health" part in a darker blue and the "Lytix" part in a lighter blue. Some of the features of RSI-MRI+ include: - Restricted Signal Map: The derived image data produced by RSI-MRI+ includes an enhanced DWI map (the Restricted Signal Map), which demonstrates improved conspicuity of restricted diffusion compared to standard DWI maps. - . Color Fusion Series: RSI-MRI+ can be configured to produce a color fusion series which overlays the Restricted Signal Map intensity onto the anatomical T2-weighted image series. - Automated Prostate Segmentation: RSI-MRI+ uses artificial intelligence (Al) powered by a deep learning algorithm to automatically segment the prostate on anatomical T2-weighted images. The segmentation result is provided in the separate Prostate Seqmentation Series. - . Automated Segmentation Report: RSI-MRI+ generates a report of segmentation volume and images of the segmented prostate as a colored outline on the anatomical image. - . Export: RSI-MRI+ outputs are provided in standard DICOM format, which is compatible with most third-party commercial PACS workstation software. NOTE: The RSI-MRI+ supported protocols differ from PI-RADS v2.1 in that they have lower in-plane resolution for T2W images and thicker slices for the GE DWI. ### Indications for Use: RSI-MRI+ is indicated for use as automatic post-acquisition image processing software for analysis of diffusion-weighted and anatomical magnetic resonance imaging data. RSI-MRI+ is intended for automatic fusion of derived diffusion-weighted MRI data with anatomical T2-weighted MR images. RSI-MRI+ is additionally intended to provide automatic prostate segmentation, quantification, and reporting of derived image metrics. RSI-MRI+ is not intended for use in pediatric populations. RSI-MRI+ is not intended to diagnose, treat, or prevent diseases or conditions. RSI-MRI+ is intended to be used in a variety of settings such as hospitals, clinics, and medical offices. ### Substantial Equivalence: {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the Healthlytix logo. The logo consists of a circular arrangement of blue dots on the left and the word "HealthLytix" on the right. The word "Health" is in a darker blue color, while "Lytix" is in a lighter blue color. The product's technical features are substantially equivalent to the ProFuse CAD (K173744). Many of the features of the ProFuse CAD (K173744) software are included in RSI-MRI+ is standalone software that runs on a network connected server or PC workstation. The RSI-MRI+ device accepts DICOM image data as input to perform image processing including diffusion series analysis, automatic segmentation, fusion of images, and automated reporting from MRI scans. At a high level, the subject and predicate devices are based on the following same technological elements: - Software devices ● - DICOM compatibility for input and output - Diffusion-series analysis - Image fusion - Automated reporting - MRI Image analysis - Display and measurement data may be viewed, accepted, or rejected by a clinician - For use in hospital, clinic, or medical office The following differences exist between the subject and predicate devices: - Image format compatibility (RSI-MRI+ is compatible with DWI-MRI, predicate has additional compatibility with MRI, CT, PET) - Contrast image processing (RSI-MRI+ does not contain this functionality) - Co-registration (RSI-MRI+ does not contain this functionality) - Image annotation (RSI-MRI+ does not contain this functionality) - Manual segmentation (RSI-MRI+ has automatic segmentation, predicate uses manual segmentation) - Image viewing (RSI-MRI+ does not contain this functionality, images are viewable on most 3ª party commercial PACS workstation software) {6}------------------------------------------------ ### Predicate Device: | Function | RSI-MRI+ (Subject Device) | ProFuse CAD (K173744) | |--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | LLZ | LLZ | | DICOM Input | DICOM compatible | DICOM compatible | | Diffusion - series analysis | Post-processing analysis of Diffusion MRI data with multi-compartment RSI model. | Post-processing analysis of Diffusion MRI data with single compartment DWI model. | | Segmentation | Automated Prostate Segmentation: RSI-MRI+ software provides automatic prostate segmentation, quantification, and reporting of derived image metrics. | Manual Prostate Segmentation: ProFuse CAD has a marking feature that allows the user to manually segment the prostate and provides quantification and reporting of derived image metrics. | | Co-Registration | Does not contain this functionality. | Performs co-registration of images. | | Fusion | Automated fusion of derived Diffusion MRI data with anatomical MRI data | Automated fusion of derived Diffusion MRI data with anatomical MRI data in addition to other data sources | | Report | Yes | Yes | | DICOM output | DICOM compatible | DICOM compatible | | Data Source | MRI Scanner | MRI Scanner, CT Scanner, PET Scanner | | Safety | Display/measurement data can be viewed, accepted, or rejected by a physician. | Display/measurement data can be viewed, accepted, or rejected by a physician. | | Environment for use | Hospital, Clinic, Medical Office | Hospital, Clinic, Medical Office, Home Office | ### Testing and Performance Data: The following performance data were provided in support of the substantial equivalence determination: 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 {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for HealthLytix. The logo consists of a circular design on the left, made up of small blue dots arranged in concentric circles. To the right of the circular design is the company name, "HealthLytix", with "Health" in a darker blue and "Lytix" in a lighter blue. Submissions for Software Contained in Medical Devices". All product and engineering specifications were verified and validated. Software validation was performed to demonstrate that RSI MRI+ processes DICOM images and presents the processed images and quantitative results in all instances RSI-MRI+ functioned as intended and outputs were created as expected. Performance testing included protocols demonstrating; - । Increased conspicuity of the RSI-MRI+ Restricted Signal Map to standard DWI maps in regions of restricted diffusion - -Accuracy of automated segmentation compared to manual radiologist segmentations - -Diffusion signal normalization across acquisitions and scanners Retrospective clinical data (including professionally labeled regions-of-interest, T2-weighted anatomical data, and raw diffusion image series) were used for verification and validation of the diffusion analysis (diffusion signal normalization and Restricted Signal Map conspicuity). ### Nonclinical Testing and Performance Information Nonclinical and performance testing has been performed by designated individuals as required by HealthLytix quality procedures. Verification & Validation Test Plans were designed to evaluate all input functions, output functions, and actions performed by RSI-MRI+ in each operational mode. RSI-MRI+ has been assessed and tested at the manufacturer's facility and has passed all in-house testing criteria including validating design, function and specifications. Measurement validation was performed on clinically acquired images and shows that RSI-MRI+ is safe and effective. Nonclinical and performance testing results are provided in the 510(k) and demonstrate that the predetermined acceptance criteria are met. ### Conclusion: The results of comparing the intended use, features and functionality, technological characteristics, mode of operation, and specifications of RSI-MRI+ with those of the predicate device demonstrate that RSI-MRI+ is substantially equivalent. Any differences between RSI-MRI+ and the predicate device do not raise any new questions of safety or effectiveness.