(190 days)
No reference devices were used in this submission.
Yes
The device description explicitly states that "RSI-MRI+ uses artificial intelligence (Al) powered by a deep learning algorithm to automatically segment the prostate".
No
The 'Intended Use / Indications for Use' section explicitly states: "RSI-MRI+ is not intended to diagnose, treat, or prevent diseases or conditions." This indicates it is not a therapeutic device.
No
The Intended Use / Indications for Use section explicitly states: "RSI-MRI+ is not intended to diagnose, treat, or prevent diseases or conditions." This means it does not meet the definition of a diagnostic device, which typically involves identifying or determining the presence of a disease or condition. Its purpose is for "analysis and interpretation of medical images" and "automatic post-acquisition image processing."
Yes
The device description explicitly states that RSI-MRI+ is "standalone software" and accepts DICOM images as input, performing post-acquisition analysis and outputting in DICOM format. There is no mention of accompanying hardware components required for its function beyond the input image data.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: An In Vitro Diagnostic device is a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The tests are performed outside of the body (in vitro).
- RSI-MRI+ Function: RSI-MRI+ is described as "automatic post-acquisition image processing software for analysis of diffusionweighted and anatomical magnetic resonance imaging data." It processes existing medical images (MRI scans) that were acquired from the patient's body. It does not perform tests on biological samples taken from the patient.
- Intended Use Statement: The intended use explicitly states that it is "automatic post-acquisition image processing software" and "is not intended to diagnose, treat, or prevent diseases or conditions." While it assists clinicians in analyzing images, it doesn't perform the diagnostic test itself.
- Device Description: The description reinforces that it processes DICOM images from MRI scans.
In summary, RSI-MRI+ is a medical image processing software that aids in the interpretation of MRI data. It operates on images already acquired from the patient, rather than performing tests on biological samples in vitro. Therefore, it does not fit the definition of an In Vitro Diagnostic device.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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.
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.
Mentions image processing
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 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.
Mentions AI, DNN, or ML
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.
Input Imaging Modality
diffusion-weighted and anatomical magnetic resonance imaging data.
DICOM images
DWI-MRI
Anatomical Site
prostate
Indicated Patient Age Range
RSI-MRI+ is not intended for use in pediatric populations.
Intended User / Care Setting
radiologists, and other clinicians
hospitals, clinics, and medical offices.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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". 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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.