Predicate Devices

Reference Devices

No reference devices were used in this submission.

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The device description explicitly states that it uses "pre-trained and expert curated machine learning models" for automatic contouring.

Therapeutic

No
The device is a software tool used for automatic contouring (segmentation) of medical images to assist in radiation treatment planning, but it does not directly administer treatment or provide therapy.

Diagnostic

No

Limbus Contour is a software tool designed to assist in radiation treatment planning by providing optimal contours of anatomical structures. While it processes medical images, its primary function is to facilitate treatment planning and not to diagnose diseases or medical conditions.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states "Limbus Contour is a stand-alone software medical device" and the intended use also specifies "Limbus Contour is a software-only medical device". The description further clarifies that it relies on existing systems for image display and modification, reinforcing its software-only nature.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
Limbus Contour's Intended Use: The intended use of Limbus Contour is to "derive optimal contours for input to radiation treatment planning." It processes medical images (CT and MR) to assist in localizing and defining anatomical structures for radiotherapy.
Lack of Specimen Analysis: Limbus Contour does not analyze any specimens derived from the human body. It works directly with medical images.
Focus on Treatment Planning: The primary purpose is to aid in the planning of radiation therapy, not to diagnose a disease or condition based on biological samples.

Therefore, Limbus Contour falls under the category of a medical image processing or analysis software device used for treatment planning, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

No
The input letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this device; it states "Not Found" for "Control Plan Authorized (PCCP) and relevant text".

Overview

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 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.

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 machine learning models and further postprocessing 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

Yes

Input Imaging Modality

Computed Tomography and Magnetic Resonance

Anatomical Site

Not Found

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: Manual and Automated. All tests passed, demonstrating that the software performance is in accordance with the stated software requirements.
Automatic Contouring Validation Test: Demonstrated that the software meets user needs and intended uses and to support substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K201232

Reference Device(s)

No reference devices were used in this submission.

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 7, 2023

Limbus AI Inc. % Mary Vater 510(k) Consultant Medical Device Academy 345 Lincoln Hill Rd SHREWSBURY VT 05738

Re: K230575

Trade/Device Name: Limbus Contour Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: March 1, 2023 Received: March 29, 2023

Dear Mary 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

1

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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for Lora D. Weidner. The date of the signature is April 7, 2023. The time of the signature is 20:09:21 -04'00'.

Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K230575

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 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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:

SUBMITTER -Limbus AI, Inc. 2076 Athol Street Regina, Saskatchewan, Canada, S4T3E5 Tel: 1-306-502-5982

Contact Person:	Mary Vater
Email:	mary@fdaecopy.com
Date Prepared:	February 28, 2023

II. DEVICE
Name of Device:	Limbus Contour
Classification Name:	Radiological Image Processing System
Regulation:	21 CFR §892.2050
Regulation Name:	Medical image management and processing system
Regulatory Class:	Class II
Product Classification Code:	LLZ

III. PREDICATE DEVICE Predicate Manufacturer:

Limbus Al, Inc. Predicate Trade Name: Limbus Contour Predicate 510(k): K201232

No reference devices were used in this submission.

IV. 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 machine learning models and further postprocessing 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).

V. 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:

4

-Operates in coniunction 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.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

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 support for MacOS while the subject device does not and the predicate has less structures for automatic contouring available.
. 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.
. Energy Source – The predicate and subject device are software-only devices, powered by the computer system.
. Performance Testing - The predicate and subject device were both were validated using an automatic contouring test to ensure the contours were accurate.

| | Limbus Contour v1.7 | Limbus Contour v1.1 -
K201232 | 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.
• 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 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. | Same | |
| | Limbus Contour is not
intended for use with
digital
mammography. | Limbus Contour is not
intended for use with
digital mammography. | Same |
| Intended User | Healthcare providers | Healthcare providers | Same |
| Contouring
Modes | Automatic | Automatic | Same |
| Measurements | No measurement
function. | No measurement
function. | Same. |
| Image Fusion | No fusion support. | No fusion support. | Same |
| 3D image
rendering | No image rendering
function. | No image rendering
function. | Same |
| Image
Modalities | CT and MR | CT and MR | Same |
| Platform | Stand-alone package
which operates on
Microsoft
Windows operating
system operating
system | Stand-alone package
which operates on
Microsoft
Windows operating
system and MacOS
operating system | Limbus
Contour v1.7
does not
support
MacOS
operating
system |
| 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
• Hardware
Requirements
• Etc. | Operating System
• Windows 10 /
Windows Server
2016 and Above

Hardware Requirements
• 2 GHz or faster multi-
core processor
• 8 GB of RAM
• For GPU versions, a
CUDA capable
NVIDIA GPU is
required | Operating System
• Windows 10 /
Windows Server
2016
• Mac OS 10.14

Hardware Requirements
• 2 GHz or faster multi-
core processor
• 4 GB of RAM
• For GPU versions, a
CUDA capable
NVIDIA GPU is
required | Limbus
Contour v1.7
does not
support
MacOS
operating
system.

RAM
requirements
are increased
to 8GB in
Limbus
Contour v1.7 |
| Performance
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 | 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.

5

Limbus Al Limbus Contour 510(k) Submission

6

7

8

9

10

11

LN_Neck_2347AB_R
LN_Neck_IA
LN_Neck_IA6
LN_Neck_IB_L
LN_Neck_IB_R
LN_Neck_II_L
LN_Neck_II_R
LN_Neck_III_L
LN_Neck_III_R
LN_Neck_IV_L
LN_Neck_IV_R
LN_Neck_L
LN_Neck_R
LN_Neck_V_L
LN_Neck_V_R
LN_Neck_VI
LN_Neck_VIIAB_L
LN_Neck_VIIAB_R
LN_Pelvics
LN_Sclav_L
LN_Sclav_R
Lung_L
Lung_R
Lungs
Musc_Constrict
Musc_PecMinor_L
Musc_PecMinor_R
Musc_Sclmast_L
Musc_Sclmast_R
OpticChiasm
OpticNrv_L
OpticNrv_R
Optics
Pancreas
Parotid_L
Parotid_R
PelvisVessels
PenileBulb
PenileBulb
Pituitary
Prostate
Prostate
Prostate + SeminalVes
PubicSymphys
Rectum
Rectum
Retina_L
Retina_L
Retina_R
Retina_R
Ribs
Ribs_L
Ribs_R
Sacrum
SeminalVes
SeminalVes
Skin
SpinalCanal
SpinalCord
Spleen
Sternum
Stomach
Trachea
Uterus_Cervix
V_Venacava_I
V_Venacava_S
Vagina
Ventricle_L

12

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 moderate 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:

· Automatic Contouring Validation Test

13

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 Limbus Contour software do not constitute a different intended use. The technological characteristics of the Limbus Contour software are similar to those of the predicate Limbus Contour software. Results of software verification 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 Limbus Contour software device.