(107 days)
Not Found
Yes
The document explicitly mentions "Deep Convolutional Image-to-Image Neural Network" in the "Mentions AI, DNN, or ML" section, which is a type of deep learning model.
No
The device is described as an image post-processing and measurement software tool that assists users in visualizing, measuring, and documenting out-of-range measurements from MR images. It explicitly states, "CoLumbo does not produce or recommend any type of medical diagnosis or treatment." Its purpose is to provide information and aid clinical workflow, not to treat.
No
The document explicitly states that CoLumbo "does not produce or recommend any type of medical diagnosis or treatment" and that its outputs "should not be interpreted or used as a diagnosis." It is an image post-processing and measurement tool that aids users in their review, analysis, and interpretation, but the final diagnostic judgment rests with the user.
Yes
The device description explicitly states "CoLumbo is a medical device (software)". While it processes images from an MRI machine, the device itself is the software component.
Based on the provided information, CoLumbo 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.
- CoLumbo's Function: CoLumbo processes and analyzes previously acquired medical images (MR images of the lumbar spine). It does not interact with or analyze biological specimens from the patient.
- Intended Use: The intended use clearly states that CoLumbo is an "image post-processing and measurement software tool" that provides quantitative spine measurements from MR images. It explicitly states it "does not produce or recommend any type of medical diagnosis or treatment."
- Device Description: The device description reinforces that it's a software tool for viewing and interpreting MRI images and assisting users in identifying and measuring features within those images.
Therefore, CoLumbo falls under the category of medical imaging software or image analysis software, not an In Vitro Diagnostic device.
No
The letter does not explicitly state that the FDA has reviewed and cleared a PCCP for this specific device. The provided text indicates "Not Found" for "Control Plan Authorized (PCCP) and relevant text."
Intended Use / Indications for Use
CoLumbo is an image post-processing and measurement software tool that provides quantitative spine measurements from previously-acquired DICOM lumbar spine Magnetic Resonance (MR) images for users' review, analysis, and interpretation. It provides the following functionality to assist users in visualizing, measuring and documenting out-of-range measurements:
- Feature segmentation;
- Feature measurement;
- Threshold-based labeling of out-of-range measurement; and
- Export of measurement results to a written report for user's revise and approval.
CoLumbo does not produce or recommend any type of medical diagnosis or treatment. Instead, it simply helps users to more easily identify and classify features in lumbar MR images and compile a report. The user is responsible for confirming/modifying settings, reviewing and verifying the software-generated measurements, inspecting out-of-range measurements, and approving draft report content using their medical judgment and discretion.
The device is intended to be used only by hospitals and other medical institutions.
Only DICOM images of MRI acquired from lumbar spine exams of patients aged 18 and above are considered to be valid input. CoLumbo does not support DICOM images of patients that are pregnant, undergo MRI scan with contrast media, or have post-operational complications, tumors, infections.
Product codes (comma separated list FDA assigned to the subject device)
QIH
Device Description
CoLumbo is a medical device (software) for viewing and interpreting magnetic resonance imaging (MRI) of the lumbar spine. The software is a quantitative imaging tool that assists radiologists and neuro- and spine surgeons ("users") to identify and measure lumbar spine features in medical images and record their observations in a report. The users then confirm whether the out-of-range measurements represent any true abnormality versus a spurious finding, such as an artifact or normal variation of the anatomy. The segmentation and measurements are classified using "modifiers" based on rule-based algorithms and thresholds set by each software user and stored in the user's individualized software settings. The user also identifies and classifies any other observations that the software may not annotate.
The purpose of CoLumbo is to provide information regarding common spine measurements confirmed by the user and the pre-determined thresholds confirmed or defined by the user. Every feature annotated by the software, based on the user-defined settings, must be reviewed and affirmed by the user before the measurements of these features can be stored and reported. The software semi-automatically initiates adjustable measurements resulting from segmentation. Segmentations are not intended to be a final output but serve the purpose of visualization and calculating measurements. The device outputs are intended to be a starting point for a clinical workflow and should not be interpreted or used as a diagnosis. The user is responsible for confirming segmentation and all measurement outputs. The output is an aid to the clinical workflow of measuring patient anatomy and should not be misused as a diagnosis tool.
User-confirmed/defined settings control the sensitivity of the software for labelling measurements in an image. The user (not the software) controls the threshold for identifying out-of-range measurements, and, in every case once an out-of-range measurement is identified, the user must confirm or reject its presence. The software facilitates this process by annotating or drawing contours (segmentations) around features of the relevant anatomy and displaying measurements based on these contours. The user maintains control of the process by inspecting the segmentation, measurements and annotations upon which the measurements are based. The user may also examine other features of the imaging not annotated by the software to form a complete impression and diagnostic judgment of the overall state of disease, disorder, or trauma.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Magnetic Resonance (MR) images
Anatomical Site
Lumbar Spine
Indicated Patient Age Range
18 and above
Intended User / Care Setting
Hospitals and other medical institutions.
Radiologist and neuro- and spine-surgeons
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
Standalone software performance assessment study included 100 MR image studies for 100 patients of different ages and racial groups. The standalone software performance assessment study compared the CoLumbo software outputs without any editing by a radiologist to the ground truth defined by 3 radiologists on segmentations and measurements.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Standalone Software Performance Validation: To validate the CoLumbo software, ver. 3, from a clinical perspective, a clinical data based standalone software performance assessment study was conducted in the U.S. The standalone software performance assessment study of CoLumbo included 100 MR image studies for 100 patients of different ages and racial groups. The standalone software performance assessment study compared the CoLumbo software outputs without any editing by a radiologist to the ground truth defined by 3 radiologists on segmentations and measurements.
No human clinical study was conducted to support the pre-market clearance.
The software verification and validation testing data, including the standalone software performance assessment study data, supports the safety of the devices and demonstrates that the CoLumbo software performs as intended in the specified use conditions.
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
August 15, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
Smart Soft Healthcare Nedelcho Georgiev CEO 113 Gen. Kolev str, suite 7.2 Varna, 9002 Bulgaria
Re: K241211
Trade/Device Name: CoLumbo Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: July 16, 2024 Received: July 16, 2024
Dear Nedelcho Georgiev:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Samul for
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
CoLumbo
Indications for Use (Describe)
CoLumbo is an image post-processing and measurement software tool that provides quantitative spine measurements from previously-acquired DICOM lumbar spine Magnetic Resonance (MR) images for users' review, analysis, and interpretation. It provides the following functionality to assist users in visualizing, measuring and documenting out-of-range measurements:
-
Feature segmentation;
-
Feature measurement;
-
Threshold-based labeling of out-of-range measurement; and
-
Export of measurement results to a written report for user's revise and approval.
CoLumbo does not produce or recommend any type of medical diagnosis or treatment. Instead, it simply helps users to more easily identify and classify features in lumbar MR images and compile a report. The user is responsible for confirming/modifying settings, reviewing and verifying the software-generated measurements, inspecting out-of-range measurements, and approving draft report content using their medical judgment and discretion.
The device is intended to be used only by hospitals and other medical institutions.
Only DICOM images of MRI acquired from lumbar spine exams of patients aged 18 and above are considered to be valid input. CoLumbo does not support DICOM images of patients that are pregnant, undergo MRI scan with contrast media, or have post-operational complications, tumors, infections.
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
510(k) Summary
1. Submitter
Smart Soft Healthcare AD Address: 113 General Kolev Str., Primorski District., Office 7.2 Varna 9002, Bulgaria Phone: +35952919513 Fax: None Contact Person: Nedelcho Georgiev Date Prepared: June 25, 2024
2. Device
Name of Device: CoLumbo Common or Usual Name: CoLumbo ver.3 Classification Name: Medical image management and processing system (21 CFR 892.2050) Product Code: OIH Regulatory Class: II
3. Predicate Device
Device Name: CoLumbo Manufacturer: Smart Soft Healthcare AD Classification Name: Medical image management and processing system (21 CFR 892.2050) Classification Product Code: QIH Classification Panel: Radiology Device Class: Class II 510(k) Number: K220497 cleared June 23, 2022
Device Description 4.
CoLumbo is a medical device (software) for viewing and interpreting magnetic resonance imaging (MRI) of the lumbar spine. The software is a quantitative imaging tool that assists radiologists and neuro- and spine surgeons ("users") to identify and measure lumbar spine features in medical images and record their observations in a report. The users then confirm whether the out-of-range measurements represent any true abnormality versus a spurious finding, such as an artifact or normal variation of the anatomy. The segmentation and measurements are classified using "modifiers" based on rule-based algorithms and thresholds set by each software user and stored in the user's individualized software settings. The user also identifies and classifies any other observations that the software may not annotate.
The purpose of CoLumbo is to provide information regarding common spine measurements confirmed by the user and the pre-determined thresholds confirmed or defined by the user. Every feature annotated by the software, based on the user-defined settings, must be reviewed and
4
affirmed by the user before the measurements of these features can be stored and reported. The software semi-automatically initiates adjustable measurements resulting from segmentation. Segmentations are not intended to be a final output but serve the purpose of visualization and calculating measurements. The device outputs are intended to be a starting point for a clinical workflow and should not be interpreted or used as a diagnosis. The user is responsible for confirming segmentation and all measurement outputs. The output is an aid to the clinical workflow of measuring patient anatomy and should not be misused as a diagnosis tool.
User-confirmed/defined settings control the sensitivity of the software for labelling measurements in an image. The user (not the software) controls the threshold for identifying outof-range measurements, and, in every case once an out-of-range measurement is identified, the user must confirm or reject its presence. The software facilitates this process by annotating or drawing contours (segmentations) around features of the relevant anatomy and displaying measurements based on these contours. The user maintains control of the process by inspecting the segmentation, measurements and annotations upon which the measurements are based. The user may also examine other features of the imaging not annotated by the software to form a complete impression and diagnostic judgment of the overall state of disease, disorder, or trauma.
Indications for Use న్.
CoLumbo is an image post-processing and measurement software tool that provides quantitative spine measurements from previously-acquired DICOM lumbar spine Magnetic Resonance (MR) images for users' review, analysis, and interpretation. It provides the following functionality to assist users in visualizing, measuring and documenting out-of-range measurements:
- Feature segmentation; ●
- Feature measurement; ●
- Threshold-based labeling of out-of-range measurement; and ●
- . Export of measurement results to a written report for user's revise and approval.
CoLumbo does not produce or recommend any type of medical diagnosis or treatment. Instead, it simply helps users to more easily identify and classify features in lumbar MR images and compile a report. The user is responsible for confirming/modifying settings, reviewing and verifying the software-generated measurements, inspecting out-of-range measurements, and approving draft report content using their medical judgment and discretion.
The device is intended to be used only by hospitals and other medical institutions.
Only DICOM images of MRI acquired from lumbar spine exams of patients aged 18 and above are considered to be valid input. CoLumbo does not support DICOM images of patients that are pregnant, undergo MRI scan with contrast media, or have post-operational complications, tumors, infections.
Comparison of the Technological Characteristics with the Predicate 6. Devices
In comparison to the Predicate Device, the Subject Device provides comparable outputs in terms
5
of segmentation, measurement and labeling. A tabular high-level comparison of the Subject Device and the Predicate Device is provided as Table 1 below.
| | Predicate Device
CoLumbo
Version 2
(K193290) | Subject Device
CoLumbo
Version 3 | Remark/Discussion |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Regulation | 892.2050 | 892.2050 | Same |
| Product Code | QIH | QIH | Same |
| Indications for
Use | CoLumbo is an image post-
processing and measurement
software tool that provides
quantitative spine
measurements from
previously-acquired DICOM
lumbar spine Magnetic
Resonance (MR) images for
users' review, analysis, and
interpretation. It provides the
following functionality to
assist users in visualizing,
measuring and documenting
out-of-range measurements:
Feature segmentation; Feature measurement; Threshold-based labeling
of out-of-range
measurement; and Export of measurement
results to a written report
for user's review, revise
and approval. CoLumbo does not produce or
recommend any type of
medical diagnosis or
treatment. Instead, it simply
helps users to more easily
identify and classify features
in lumbar MR images and
compile a report. The user is
responsible for
confirming/modifying settings,
reviewing and verifying the
software-generated
measurements, inspecting out- | CoLumbo is an image post-
processing and measurement
software tool that provides
quantitative spine
measurements from
previously-acquired DICOM
lumbar spine Magnetic
Resonance (MR) images for
users' review, analysis, and
interpretation. It provides the
following functionality to
assist users in visualizing,
measuring and documenting
out-of-range measurements:
Feature segmentation; Feature measurement; Threshold-based labeling
of out-of-range
measurement; and Export of measurement
results to a written report
for user's review, revise
and approval. CoLumbo does not produce
or recommend any type of
medical diagnosis or
treatment. Instead, it simply
helps users to more easily
identify and classify features
in lumbar MR images and
compile a report. The user is
responsible for
confirming/modifying
settings, reviewing and
verifying the software-
generated measurements,
inspecting out-of-range
measurements, and approving
draft report content using | Highly similar
Indications for use
are the same with the
list of
contraindications
changed. |
| | Predicate Device
CoLumbo
Version 2
(K193290) | Subject Device
CoLumbo
Version 3 | Remark/Discussion |
| | of-range measurements, and
approving draft report content
using their medical judgment
and discretion. | their medical judgment and
discretion. | |
| | The device is intended to be
used only by hospitals and
other medical institutions. | The device is intended to be
used only by hospitals and
other medical institutions. | |
| | Only DICOM images of MRI
acquired from lumbar spine
exams of patients aged 18 and
above are considered to be
valid input. CoLumbo does not
support DICOM images of
patients that are pregnant,
undergo MRI scan with
contrast media, or have post-
operational complications,
scoliosis, tumors, infections,
fractures. | Only DICOM images of MRI
acquired from lumbar spine
exams of patients aged 18
and above are considered to
be valid input. CoLumbo
does not support DICOM
images of patients that are
pregnant, undergo MRI scan
with contrast media, or have
post-operational
complications, tumors,
infections. | |
| Intended User | Radiologist and neuro- and
spine-surgeons | Radiologist and neuro- and
spine-surgeons | Same |
| Intended Patient
Population | The intended patient
population is not subject to
any restrictions.
Automation support requires
images of patients of 18 years
and older, not pregnant,
without post-operational
complications, scoliosis,
tumors, infections, fractures. | The intended patient
population is not subject to
any restrictions.
Automation support requires
images of patients of 18 years
and older, not pregnant,
without post-operational
complications, tumors,
infections. | Highly similar |
| Supported Body
Part | Lumbar Spine | Lumbar Spine | Same |
| Segmentation | Yes
Segmentation and
quantitative analysis | Yes
Segmentation and
quantitative analysis | Same |
| Measurement | Yes
Quantitative comparison of
structure with normative data
or user-set thresholds | Yes
Quantitative comparison of
structure with normative data
or user-set thresholds | Same |
| | Predicate Device | Subject Device | Remark/Discussion |
| | CoLumbo
Version 2
(K193290) | CoLumbo
Version 3 | |
| Threshold-Based
Out-of-Range
Measurements | Yes
Quantitative comparison of
structure with normative data
or user-set thresholds | Yes
Quantitative comparison of
structure with normative data
or user-set thresholds | Same |
| Reporting | Yes | Yes | Same |
| SaMD | Yes | Yes | Same |
| Algorithm | Deep Convolutional
Image-to-Image Neural
Network | Deep Convolutional
Image-to-Image Neural
Network | Same |
| Supported
Modality | MR | MR | Same |
| Supported
Measurements | Focal disk material outside VB projection and its migration – descending and ascending; Disk outside VB projection; Dural sac cross-sectional area; Nerve root deviation; Vertebral body height; Disk height; Lordotic angle; Spondylolisthesis slippage; | Focal disk material outside VB projection; Descending (caudal) and ascending (cranial) disk material outside of the intervertebral space; Disk outside VB projection; Dural sac cross-sectional area; Nerve root deviation; Vertebral body height; Disk height; Lordotic angle; Spondylolisthesis slippage; Angle of lateral spinal curvature; Facet joint diameter; Posterior epidural fat size; Muscle fat infiltration percentage; Foramen diameter; Lateral recess diameter; Dural sac anterior-posterior diameter; Spinal canal diameter; Disk Material Outside of Endplate Margins Size; | Highly similar
The Subject Device supports several more measurements. |
| Predicate Device
CoLumbo
Version 2
(K193290) | Subject Device
CoLumbo
Version 3 | Remark/Discussion | |
| | Ligament Flavum Thickness; Vertebral Body Zone with Changed Intensity Size. Vertebral Body Width Difference AP Size. | | |
Table 1 – Comparison of Technological Characteristics with Predicate Device
6
7
8
The Subject Device is substantially equivalent in comparison to the Predicate Device. The information regarding the Subject Device does not raise new questions about safety and effectiveness, and demonstrates that CoLumbo is at least as safe and effective as its previously legally marketed version.
7. Performance Data
7.1. Biocompatibility Testing
Not applicable.
7.2. Electrical Safety and Electromagnetic Compatibility (EMC)
Not applicable.
7.3. Animal Study
Not applicable.
7.4. Voluntary Conformance Standards
CoLumbo has been tested to meet the requirements of conformity to multiple industry standards. Non-clinical performance testing demonstrated that CoLumbo complies with the following voluntary FDA recognized Consensus Standards listed in Table 2 below.
| Recognition
| Standard |
|------------------|-----------------------------------------------------------------------------------------------------------------|
| 13-79 | IEC 62304:2006/AMD 1:2015 Medical device software — Software life cycle
processes — Amendment 1 |
| 13-97 | IEC 82304-1:2016 Health software — Part 1: General requirements for product safety |
| 5-125 | ISO 14971:2019 Medical devices — Application of risk management to medical
devices |
| 5-129 | IEC 62366-1:2015+AMD1:2020 Medical devices — Part 1: Application of usability
engineering to medical devices |
Table 2 - Voluntary Conformance Standards
9
| 5-135 | ISO 20417:2021 Medical devices — Information to be supplied by the manufacturer |
|---|---|
| ------- | --------------------------------------------------------------------------------- |
7.5. Nonclinical Tests
Smart Soft Healthcare has performed software design verification testing and has sponsored external standalone performance assessment study. The performance data demonstrates continued conformance for medical devices containing software.
Smart Soft Healthcare conforms to the cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed or transferred from a medical device to an external recipient. The vulnerability assessment and penetration testing demonstrates satisfactory security performance with no critical and high risk vulnerabilities.
Standalone Software Performance Validation
To validate the CoLumbo software, ver. 3, from a clinical perspective, a clinical data based standalone software performance assessment study was conducted in the U.S. The standalone software performance assessment study of CoLumbo included 100 MR image studies for 100 patients of different ages and racial groups. The standalone software performance assessment study compared the CoLumbo software outputs without any editing by a radiologist to the ground truth defined by 3 radiologists on segmentations and measurements.
7.6. Clinical Validation Study
No human clinical study was conducted to support the pre-market clearance.
8. Conclusions
The CoLumbo software is as safe and effective as the predicate device. The subject device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences between subject and predicate device in indications do not alter the intended use of the device and do not raise new or different questions regarding its safety and effectiveness when used as labeled.
The software verification and validation testing data, including the standalone software performance assessment study data, supports the safety of the devices and demonstrates that the CoLumbo software performs as intended in the specified use conditions.
Therefore, the CoLumbo software is substantially equivalent.