(122 days)
Not Found
Yes
The device description explicitly states that the software uses a "convolutional network-based algorithm," which is a type of deep learning neural network commonly used in AI/ML for image processing.
No.
The device is described as image processing software for image enhancement in MRI images, and its outputs are images with enhanced image quality, not directly providing therapy.
No
The device is an image processing software that enhances MRI images by reducing noise or increasing sharpness. It provides improved images for interpretation by radiologists but does not directly diagnose any disease or condition itself.
Yes
The device description explicitly states "SubtleMR is Software as a Medical Device (SaMD) consisting of a software algorithm". It also clarifies that it "only processes images for the end user" and "has no user interface", indicating it is purely a software solution that takes image data as input and outputs processed image data.
Based on the provided information, SubtleMR is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves analyzing biological samples like blood, urine, tissue, etc.
- SubtleMR's Function: SubtleMR is an image processing software that enhances existing MRI images. It does not analyze biological specimens. Its purpose is to improve the quality of the image itself, which is then interpreted by a radiologist.
- Intended Use: The intended use is to enhance MRI images for various anatomical sites to aid radiologists in their interpretation. This is distinct from analyzing a biological sample to diagnose a condition.
Therefore, SubtleMR falls under the category of medical image processing software, not an In Vitro Diagnostic device.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device.
Intended Use / Indications for Use
SubtleMR is an image processing software that can be used for image enhancement in MRI images. It can be used to reduce image noise for head, spine, pelvis, prostate, breast and musculosketal MRI, or increase image sharpness for head MRI.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
SubtleMR is Software as a Medical Device (SaMD) consisting of a software algorithm that enhances images taken by MRI scanners. As it only processes images for the end user, the device has no user interface. It is intended to be used by radiologists in an imaging center, clinic, or hospital. The software can be used with MR images acquired as part of MRI exams on 1.2 Tesla. 1.5 Tesla or 3 Tesla scanners. The device's inouts are standard of care MRI images. The outputs are images with enhanced image quality.
Mentions image processing
Yes
Mentions AI, DNN, or ML
The software uses a convolutional network-based algorithm to improve image quality by reducing noise or enhancing the image sharpness. The algorithm's specific parameters vary depending on the choice of image enhancement: noise reduction or sharpness enhancement, while the network designs are similar. For each choice, there is a fixed set of parameters and the algorithm is working as a fixed nonlinear filter.
Input Imaging Modality
MRI
Anatomical Site
head, spine, neck, abdomen, pelvis, prostate, breast and musculoskeletal MRI
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists in an imaging center, clinic, or hospital.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The main performance study, utilizing retrospective clinical data, was divided into two tests. For the noise reduction performance test, acceptance criteria were that signal-to-noise ratio (SNR) of a selected region of interest (ROI) in each test dataset is on average improved by greater than or equal to 5% after SubtleMR enhancement compared to the original images, and (ii) the visibility of small structures in the test datasets before and after SubtleMR is on average less than or equal to 0.5 Likert scale points. This test passed. For the sharpness enhancement performance test, acceptance criteria were that the thickness of anatomic structure and the sharpness of structure boundaries are improved after SubtleMR enhancement in at least 90% of the test datasets. This test passed.
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.
Not Found
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
February 26, 2021
Image /page/0/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
Subtle Medical, Inc. % Jared Seehafer Regulatory Consultant Enzyme Corporation 611 Gateway Blvd #120 SOUTH SAN FRANCISCO CA 94080
Re: K203182
Trade/Device Name: SubtleMR Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: November 28, 2020 Received: December 1, 2020
Dear Jared Seehafer:
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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-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 mediation-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.
Michael D. O'Hara 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
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Indications for Use
510(k) Number (if known) K203182
Device Name SubtleMR
Indications for Use (Describe)
SubtleMR is an image processing software that can be used for image enhancement in MRI images. It can be used to reduce image noise for head, spine, nelvis, prostate, breast and musculosketal MRI, or increase image sharpness for head MRI.
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 |
|---|---|
| --------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------- |
| X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Submitter's Name: | Subtle Medical, Inc. |
|---|---|
| Address: | 883 Santa Cruz Ave, Suite 205 |
| Menlo Park, CA 94025 | |
| Contact Person: | Jared Seehafer |
| Title: | Regulatory Consultant |
| Telephone Number: | 415-857-9554 |
| Fax Number: | 415-367-1279 |
| Email: | jared@enzyme.com |
| Date Summary Prepared: | 18-FEB-2021 |
| Device Proprietary Name: | SubtleMR |
| Model Number: | V 2.0.0 |
| Common Name: | SubtleMR |
| Regulation Number: | 21 CFR 892.2050 |
| Regulation Name: | System, Image Processing, Radiological |
| Product Code: | LLZ |
| Device Class: | Class II |
| Predicate Device | Trade name: SubtleMR |
| Manufacturer: Subtle Medical, Inc. | |
| Regulation Number: 21 CFR 892.2050 | |
| Regulation Name: System, Image Processing, | |
| Radiological | |
| Device Class: Class II | |
| Product Code: LLZ | |
| 510(k) Number: K191688 | |
| 510(k) Clearance Date: September 16, 2019 |
Table 1. Subject Device Overview.
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1 Device Description
SubtleMR is Software as a Medical Device (SaMD) consisting of a software algorithm that enhances images taken by MRI scanners. As it only processes images for the end user, the device has no user interface. It is intended to be used by radiologists in an imaging center, clinic, or hospital. The software can be used with MR images acquired as part of MRI exams on 1.2 Tesla. 1.5 Tesla or 3 Tesla scanners. The device's inouts are standard of care MRI images. The outputs are images with enhanced image quality.
The software uses a convolutional network-based algorithm to improve image quality by reducing noise or enhancing the image sharpness. The algorithm's specific parameters vary depending on the choice of image enhancement: noise reduction or sharpness enhancement, while the network designs are similar. For each choice, there is a fixed set of parameters and the algorithm is working as a fixed nonlinear filter. The choice of image enhancement is made by the end user via the DICOM Series Description, command line argument, or environment variable.
2 Indications for Use
SubtleMR is an image processing software that can be used for image enhancement in MRI images. It can be used to reduce image noise for head, spine, neck, abdomen, pelvis, prostate, breast and musculoskeletal MRI, or increase image sharpness for head MRI.
3 Purpose of Submission
The purpose of this 510(k) is to provide premarket notification for an expansion in the indications for use of SubtleMR to include: a) additional anatomical locations for which SubtleMR can reduce image and b) that SubtleMR can increase image sharpness in both contrast-enhanced and non-contrast-enhanced head MRI.
Summary of Technological Characteristics Comparison 4
Table 2 shows the similarities and differences between the technological characteristics of the two products.
| Topic | Predicate Device | Subject Device |
|---|---|---|
| Physical | ||
| Characteristics | Software package that operates on | |
| off-the-shelf hardware | Same | |
| Computer | Linux Compatible | Same |
| DICOM | ||
| Standard | ||
| Compliance | The software processes DICOM | |
| compliant image data | Same | |
| Topic | Predicate Device | Subject Device |
| Operating | ||
| System | Linux | Same |
| Modalities | MRI | Same |
| User Interface | None | Same |
| Image | ||
| Enhancement | ||
| Algorithm | ||
| Description | SubtleMR software implements | |
| an image enhancement algorithm | ||
| using convolutional neural | ||
| network based filtering. Original | ||
| images are enhanced by running | ||
| through a cascade of filter banks, | ||
| where thresholding and scaling | ||
| operations are applied. Separate | ||
| neural network based filters are | ||
| obtained for noise reduction and | ||
| sharpness enhancement. The | ||
| parameters of the filters were | ||
| obtained through an image-guided | ||
| optimization process. | Same | |
| Workflow | The software operates on DICOM | |
| files on the file system, enhances | ||
| the images, and stores the | ||
| enhanced images on the file | ||
| system. The receipt of original | ||
| DICOM image files and delivery | ||
| of enhanced images as DICOM | ||
| files depends on other software | ||
| systems. Enhanced images co- | ||
| exist with the original images. | Same | |
| Target | ||
| Anatomical | ||
| Locations | Head, spine, neck, and knee MRI | Head, spine, neck, abdomen, |
| pelvis, prostate, breast and | ||
| musculoskeletal MRI |
Table 2. Summary of Technological Characteristics Comparison.
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Performance Data 5
Subtle Medical conducted the following performance testing:
- Software verification and validation testing .
- . Study that utilized retrospective clinical data to demonstrate the software enhanced image quality in MR images via a reduction of noise or sharpness enhancement.
6
The main performance study, utilizing retrospective clinical data, was divided into two tests.
For the noise reduction performance test, acceptance criteria were that signal-to-noise ratio (SNR) of a selected region of interest (ROI) in each test dataset is on average improved by greater than or equal to 5% after SubtleMR enhancement compared to the original images, and (ii) the visibility of small structures in the test datasets before and after SubtleMR is on average less than or equal to 0.5 Likert scale points. This test passed.
For the sharpness enhancement performance test, acceptance criteria were that the thickness of anatomic structure and the sharpness of structure boundaries are improved after SubtleMR enhancement in at least 90% of the test datasets. This test passed.
Based upon the results of this testing, the SubtleMR performance was determined to be substantially equivalent to the predicate device.
Substantial Equivalence Conclusion 6
The predicate for the subject device is its legally marketed prior revision (K191688). The two devices have the same intended use and similar indications for use. The two devices have nearly identical technological characteristics, the lone exception being the subject device's expanded target anatomical locations relative to the predicate device. The subject device was verified and validated using the same test methods and acceptance criteria as the predicate device and does not introduce any additional risk relative to its predicate. Therefore, this difference in technological characteristics does not raise different questions of safety and effectiveness. Consequently, SubtleMR is substantially equivalent to the predicate device.