(98 days)
Yes
The device description explicitly states that it uses "pre-trained and expert curated machine learning models" for automatic contouring.
No
The device is a software-only medical device intended for deriving optimal contours for input to radiation treatment planning, and assists in the creation, transformation, and modification of contours for applications including transferring contours to radiotherapy treatment planning systems, aiding adaptive therapy, and archiving contours for patient follow-up, and localization and definition of healthy anatomical structures. It does not directly provide therapy but instead assists in the planning process of radiation treatment.
No
Explanation: The device is used for contouring in radiation treatment planning, which is a part of treatment rather than diagnosis. It helps in defining anatomical structures for treatment purposes, not for identifying the presence or nature of a disease.
Yes
The device description explicitly states "Limbus Contour is a stand-alone software medical device." and the intended use states "Limbus Contour is a software-only medical device". It relies on existing systems for image display and storage, indicating it does not include hardware components for these functions.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Limbus Contour is for "deriving optimal contours for input to radiation treatment planning." This is a function related to medical imaging and treatment planning, not the analysis of biological samples (blood, urine, tissue, etc.) to diagnose or monitor a disease or condition.
- Device Description: The device description reinforces this by stating it's for "automatic contouring (segmentation) of CT/MRI DICOM images." Again, this is image processing, not in vitro analysis of biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body. Limbus Contour operates on medical images, which are representations of the body, not biological samples themselves.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
Limbus Contour is a software-only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to derive optimal contours for input to radiation treatment planning. Supported image modalities are Computed Tomography and Magnetic Resonance. The Limbus Contour Software assists in the following scenarios:
· Operates in conjunction with radiation treatment planning systems or DICOM viewing systems to load, save, and display 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 healthy anatomical structures.
Limbus Contour is not intended for use with digital mammography.
Limbus Contour is not intended to automatically contour tumor clinical target volumes.
Product codes
LLZ
Device Description
Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user's operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
Mentions image processing
Yes
Mentions AI, DNN, or ML
automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models.
The Limbus Contour software segments normal tissues using models and further post-processing on machine learning model prediction outputs.
Input Imaging Modality
Computed Tomography and Magnetic Resonance.
Anatomical Site
healthy anatomical structures.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained radiation oncologists, dosimetrists and physicists/Healthcare environment
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)
Software Verification and Validation 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 of the following functions of the Limbus Contour application demonstrated that the software meets user needs and intended uses and to support substantial equivalence:
• Automatic Contouring - Validation Test
Clinical Studies:
Clinical testing was not required to demonstrate the safety and effectiveness of Limbus Contour. Instead, substantial equivalence is based upon benchtop performance testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
August 13, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Limbus AI Inc. % Ms. Mary Vater 510(k) Consultant Medical Device Academy 245 Lincoln Hill Road SHREWSBURY VT 05738
Re: K201232
Trade/Device Name: Limbus Contour Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: July 17, 2020 Received: July 17, 2020
Dear Ms. Vater:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting
1
combination-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) K201232
Device Name Limbus Contour
Indications for Use (Describe)
Limbus Contour is a software-only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to derive optimal contours for input to radiation treatment planning. Supported image modalities are Computed Tomography and Magnetic Resonance. The Limbus Contour Software assists in the following scenarios:
· Operates in conjunction with radiation treatment planning systems or DICOM viewing systems to load, save, and display 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 healthy anatomical structures.
Limbus Contour is not intended for use with digital mammography.
Limbus Contour is not intended to automatically contour tumor clinical target volumes.
| 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)
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510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
- l. SUBMITTER Limbus AI, Inc. 2076 Athol Street Regina, Saskatchewan, Canada, S4T3E5 Tel: 1-306-502-5982
Contact Person: Mary Vater Date Prepared: May 1, 2020
| II. DEVICE | |
|---|---|
| Name of Device: | Limbus Contour |
| Classification Name: | Radiological Image Processing System |
| Regulation: | 21 CFR §892.2050 |
| Regulatory Class: | Class II |
| Product Classification Code: | LLZ |
PREDICATE DEVICE ============================================================================================================================================================================== Predicate Manufacturer: Microsoft Corp. Predicate Trade Name: Radiomics App v1.0 Predicate 510(k): K173420
No reference devices were used in this submission.
DEVICE DESCRIPTION IV.
Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user's operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
INDICATIONS FOR USE V.
Limbus Contour is a software-only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to derive optimal contours for input to radiation treatment planning. Supported image modalities are Computed Tomography and Magnetic Resonance. The Limbus Contour Software assists in the following scenarios:
- Operates in conjunction with radiation treatment planning systems to load, save, and display ● 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.
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- o Localization and definition of anatomical structures.
Limbus Contour is not intended for use with digital mammography.
Limbus Contour is not intended to automatically contour tumor clinical target volumes.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVCE
The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:
- Indications for Use The predicate and subject device are identical with the exception that the . predicate has additional indications specific to tumor and organ contouring, whereas the subject device is not specifically indicated for that purpose.
- o Materials - The predicate and subject device are software-only devices and do not inherently contain material.
- Design - The predicate and subject device have equivalent designs.
- o Energy Source - The predicate and subject device are software-only devices, powered by the computer system.
- Other Design Features - The contours generated from Limbus Contour are edited in external treatment planning or contouring tools and it does not contain an image viewer, whereas the predicate has these features integrated. The subject device also does not perform image fusion or subsequent contouring of fused images, or 3D image rendering, which are not necessary to achieve the intended use. Both devices are offered as a stand-alone package that operate on Microsoft Windows operating system. Limbus Contour also functions on a Mac OS.
- . Performance Testing - The predicate and subject device were both were validated using an automatic contouring test to ensure the contours were accurate.
| | Limbus AI | Radiomics App v1.0 –
K173420 | Similarities /
Differences |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification
Regulation | 892.2050 – Picture Archiving
and Communication System | 892.2050 – Picture Archiving
and Communication System | Same |
| Product Code | LLZ | LLZ | Same |
| Indications for
Use | Limbus Contour is a software-
only medical device intended
for use by trained radiation
oncologists, dosimetrists and
physicists to derive optimal
contours for input to radiation
treatment planning.
Supported image modalities
are Computed Tomography
and Magnetic Resonance. The
Limbus Contour Software
assists in the following
scenarios:
• Operates in conjunction with
radiation treatment planning
systems or DICOM viewing
systems to load, save, and
display medical images and
contours for treatment
evaluation and treatment
planning. | 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 | Indications for
use are similar
other than the
device not
displaying
medical
images and
contours.
Related to that
difference; the
device is also
not capable of
fusing
compatible
images for
treatment
planning or
three-
dimensional
rendering of
medical |
| | | | |
| | • 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 healthy anatomical
structures.
Limbus Contour is not
intended for use with digital
mammography.
Limbus Contour is not
intended to automatically
contour tumors or tumor
clinical target volumes. | 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. | images and
segmented
contour.
Unlike the
predicate
device, the
Limbus
Contour does
not display
images, and
therefore it
cannot be used
for "primary
image
interpretations"
so that is not
included in the
Limbus
Contour
indications.
In addition, the
device only
localizes and
defines healthy
anatomical
structures (not
solid tumors
like the
predicate
device). |
| Intended User | Healthcare providers | Healthcare providers | Same |
| Contouring
Modes | Automatic | Assisted and Automatic | Contours
generated from
Limbus
Contour are
edited in
external
treatment-
planning or
contouring
tools. |
| Measurements | No measurement function. | 2D distance measurement,
average tissue density within a
region (for CT), segmentation
volume | Limbus
Contour does
not contain an
image viewer.
No
measurement
functionality is
provided
because of this. |
| | | | |
| Image Fusion | No fusion support. | Fuse only two 3D images, CT
and MR | measurements
are not
necessary to
achieve
intended use.
Limbus
Contour does
not perform
image fusion
and subsequent
contouring on
fused images.
Not necessary
to achieve
intended use. |
| 3D image
rendering | No image rendering function. | Yes | Limbus
Contour does
not contain a
viewer. Images
are rendered in
a separate
viewing tool. |
| Image Modalities | CT and MR | CT and MR | Same |
| Platform | Stand-alone package which
operates on Microsoft
Windows operating system
and MacOS operating system | Stand-alone package which
operates on Microsoft
Windows operating system
only. | Limbus
Contour will
also support
Mac OS
operating
systems |
| Environment of
Use | Healthcare environment | Healthcare environment | Same |
| Materials | N/A – Standalone Software | N/A – Standalone Software | Same |
| Energy Source | N/A – Standalone Software | N/A – Standalone Software | Same |
| Feature
Comparison: | Operating System
• Windows 10 / Windows
Server 2016
• Mac OS 10.14 | Operating System
• Not specified. | |
| Hardware
Requirements
Etc. | Hardware Requirements
• 2 GHz or faster multi-core
processor
• 4 GB of RAM
• For GPU versions, a
CUDA capable NVIDIA
GPU is required | | |
| Performance
Testing | Two different types of
verification testing were
conducted to verify the
software requirements: | Two different types of
verification testing were
conducted to verify the
software requirements: | Rendering and
measurement
tests are not
applicable for
the subject |
| Manual and Automated. All
tests passed, demonstrating
that the software performance
is in accordance with the
stated software requirements. | Manual and Automated. All
tests passed, demonstrating
that the software performance
is in accordance with the
stated software requirements. | device because
it does not
have those
functions. | |
| Validation testing of the
following functions of the
Limbus Contour application
demonstrated that the software
meets user needs and intended
uses and to support substantial
equivalence:
• Automatic Contouring –
Validation Test | 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 | | |
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6
7
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Sterilization & Shelf-life Testing
The subject device is a software-only device. Therefore sterilization and shelf-life are not applicable.
Biocompatibility
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)
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; therefore, this section is not applicable.
Software Verification and Validation Testing
Software verification and validation testing were conducted 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 major level of concern.
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 of the following functions of the Limbus Contour application demonstrated that the software meets user needs and intended uses and to support substantial equivalence:
8
- Automatic Contouring - Validation Test
Mechanical and Acoustic Testing
Not Applicable (Standalone Software)
Animal Study
Animal performance testing was not required to demonstrate safety and effectiveness of the device.
Clinical Studies
Clinical testing was not required to demonstrate the safety and effectiveness of Limbus Contour. Instead, substantial equivalence is based upon benchtop performance testing.
VIII. CONCLUSIONS
The minor differences in indications of use between the subject Limbus Contour software and the predicate Radiomics software do not constitute a different intended use. The technological characteristics of the Limbus Contour software are similar to those of the Radiomics App. Results of software verification and validation testing demonstrate that the Limbus Contour software performs in accordance with specifications and that the performance is comparable to that of the predicate device. Therefore, the Limbus Contour software can be found to be substantially equivalent to the predicate Radiomics App software device.