(79 days)
Not Found
No
The summary describes standard image processing and analysis techniques, and there is no mention of AI, ML, or related concepts.
No
The device is described as image analysis software for evaluating CT and MR images to provide diagnostic information, not to treat any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software is designed "to support the physician in conforming the presence or absence of physician identified lesion in blood vessels and evaluation, documentation and follow up of any such lesions" and "for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process."
Yes
The device description explicitly states that cvi42 vascular add-on is a "software application" and describes its function as analyzing images in a DICOM format. There is no mention of accompanying hardware components.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The provided text clearly states that this device analyzes CT and MR images of blood vessels. These are medical images, not biological specimens like blood, urine, or tissue.
- The intended use is image analysis and processing. The software is designed to help physicians evaluate and analyze existing medical images to support diagnostic decision-making. It does not perform tests on biological samples to provide diagnostic information.
Therefore, while this device is a medical device used for diagnostic purposes, it falls under the category of medical imaging software rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Cvi42 vascular analysis add-on is an image analysis software package add-on for evaluating CT and MR images of blood vessels. Combining digital image processing and visualization tools such as multiplaner reconstruction (MPR), think hink maximum intensity projection (MIP) thin and think, inverted MIP thin and think, volume rendering technique (VRT), curved planner reformation, processing tools as bone removal (based on both single energy and dual energy) table removal and evaluation tools (vessel centerline calculation, stenosis calculation) and reporting tools (lesion location, lesion characteristics) and key images), the software package is designed to support the physician in conforming the presence or absence of physician identified lesion in blood vessels and evaluation, documentation and follow up of any such lesions.
It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular CT or MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. cvi42 is a software application that can be used as a stand-alone product or in a networked environment.
The target population for the cvi42 is not restricted.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
cvi42 vascular add-on is software application for evaluating cardiovascular images in a DICOM Standard format. The software can be used as a stand-alone product that can be integrated into a hospital or private practice environment. cvi42 has a graphical user interface which allows users to qualitatively and quantitatively analyze cardiac CT & MR images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT and MR images
Anatomical Site
Blood vessels
Indicated Patient Age Range
The target population for the cvi42 is not restricted.
Intended User / Care Setting
Qualified medical professionals, experienced in examining and evaluating cardiovascular CT or MR images. The software can be used as a stand-alone product that can be integrated into a hospital or private practice 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)
The successful non-clinical testing demonstrates the safety and effectiveness of the cvi42 when used for the defined indications for use and demonstrates that the device for which the 510(k) is submitted performs as well as or better than the legally marketed predicate device.
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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2014
Circle Cardiovascular Imaging Inc % Shirantha Samarappuli VP- Regulatory Affairs and Quality Assurance 815 8th Avenue SW Suit 250 CALGARY, CA T2P 3P2 CANADA
Re: K141480
Trade/Device Name: cvi42 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: II Product Code: LLZ Dated: August 01, 2014 Received: August 04, 2014
Dear Mr. Samarappuli:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141480
Device Name cvi42
Indications for Use (Describe)
Cvi42 vascular analysis add-on is an image analysis software package add-on for evaluating CT and MR images of blood vessels. Combining digital image processing and visualization tools such as multiplaner reconstruction (MPR), think hink maximum intensity projection (MIP) thin and think, inverted MIP thin and think, volume rendering technique (VRT), curved planner reformation, processing tools as bone removal (based on both single energy and dual energy) table removal and evaluation tools (vessel centerline calculation, stenosis calculation) and reporting tools (lesion location, lesion characteristics) and key images), the software package is designed to support the physician in conforming the presence or absence of physician identified lesion in blood vessels and evaluation, documentation and follow up of any such lesions.
It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular CT or MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. cvi42 is a software application that can be used as a stand-alone product or in a networked environment.
The target population for the cvi42 is not restricted.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(K) SUMMARY
| Submitter's Name | Circle Cardiovascular Imaging Inc. |
|---|---|
| Address | Suite 250, 815 8th Avenue SW, Calgary, AB, Canada T2P 3P2 |
| Establishment Registration Number | 3007301305 |
| Date of Summary | May 29, 2014 |
| Telephone Number | 1 403 338 1870 |
| Fax Number | 1 403 338 1895 |
| shirantha@circlecvi.com | |
| Contact Person | Shirantha Samarappuli |
| Name of the Device | cvi42 |
| Common or Usual Name | Image Processing System |
| Classification Name | Picture Archiving and Communications System |
| Classification Name: | Picture Archiving and Communications System |
| Device Class: | II |
| Product Code: | LLZ |
| Regulation Number: | 21 CFR 892.2050 |
Indications for Use
cvi42 vascular analysis add-on is an image analysis software package add-on for evaluating CT and MR images of blood vessels. Combining digital image processing and visualization tools such as multiplaner reconstruction (MPR), thin/think maximum intensity projection (MIP) thin and think, inverted MIP thin and think, volume rendering technique (VRT), curved planner reformation, processing tools such as bone removal (based on both single energy and dual energy) table removal and evaluation tools (vessel centerline calculation, lumen calculation, stenosis calculation) and reporting tools (lesion location, lesion characteristics) and key images), the software package is designed to support the physician in conforming the presence or absence of physician identified lesion in blood vessels and evaluation, documentation and follow up of any such lesions.
It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular CT or MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. cvi42 is a software application that can be used as a stand-alone product or in a networked environment.
The target population for the cvi42 is not restricted. however the image acquisition by a cardiac CT or MR scanner may limit the use of the device for certain sectors of the general public.
4
Device Description
cvi42 vascular add-on is software application for evaluating cardiovascular images in a DICOM Standard format. The software can be used as a stand-alone product that can be integrated into a hospital or private practice environment. cvi42 has a graphical user interface which allows users to qualitatively and quantitatively analyze cardiac CT & MR images.
Indications for Use
| DEVICE | INDICATIONS FOR USE |
|---|---|
| cvi42 | cvi42 vascular analysis add-on is an image analysis software package add-on for evaluating CT and MR images of blood vessels. Combining digital image processing and visualization tools such as multiplaner reconstruction (MPR), thin/think maximum intensity projection (MIP) thin and think, inverted MIP thin and think, volume rendering technique (VRT), curved planner reformation, processing tools such as bone removal (based on both single energy and dual energy) table removal and evaluation tools (vessel centerline calculation, lumen calculation, stenosis calculation) and reporting tools (lesion location, lesion characteristics) and key images), the software package is designed to support the physician in conforming the presence or absence of physician identified lesion in blood vessels and evaluation, documentation and follow up of any such lesions. |
It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular CT or MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. cvi42 is a software application that can be used as a stand-alone product or in a networked environment.
The target population for the cvi42 is not restricted, however the image acquisition by a cardiac CT or MR scanner may limit the use of the device for certain sectors of the general public. |
| DEVICE | INDICATIONS FOR USE |
| iNtuition
K121916 | To receive, store, transmit, post-process, display and allow
manipulation of reports and medical images from acquisition
devices, including optical or other non-DICOM format images,
DICOM images with modality type XA, US, CR, DR, SPECT, NM
and MG, and images from volumetric medical scanning devices such
as EST, CT, PET or MRI. To provide access to images derived data
and derived images via client-server software, web browser and
mobile technology. |
| | Visualization in 2D, 3D and 4D are supported for single or multiple
datasets, or combinations thereof. Tools are provided to define and
edit paths through structures such as centerlines, which may be used
to analyze cross-sections of structures, or to provide flythrough
visualizations rendered along such a centerline. Segmentation of
regions of interest and quantitative analysis tools are provided, for
images of vasculature, pathology and morphology, including
distance, angle, volume, histogram, ratios thereof, and tracking of
quantities over time. A database is provided to track and compare
results using published comparison techniques such as RECIST and
WHO. Calcium scoring for quantification of atherosclerotic plaque
is supported. |
| | Support is provided for digital image processing to derive metadata
or new images from input image sets, for internal use or for
forwarding to other devices using the DICOM protocol. Image
processing tools are provided to extract metadata to derive
parametric images from combinations of multiple input images, such
as temporal phases, or images co-located in space but acquired with
different imaging parameters, such as different MR pulse sequences,
or different CT image parameters (e.g. dual energy). |
| | iNtuition is designed for use by healthcare professionals and is
intended to assist the physician in diagnosis, who is responsible for
making all final patient management decisions. |
| | Interpretation of mammographic images or digitized film screen
images is supported only when the software is used without
compression and with an FDA-Approved monitor that offers at least
5Mpixel resolution and meets other technical specifications
reviewed and accepted by the FDA. |
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| Feature | iNtuition | cvi42 | Remarks |
|---|---|---|---|
| 510k # | K121916 | TBD | |
| Device Class | II | II | |
| Device Classification | LLZ | LLZ |
Device Comparison Table
6
| Regulation Name | Picture Archiving and
communications
systems | Picture
Archiving and
communications
systems |
|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|-------------------------------------------------------|
| Regulation Number | 21 CFR 892.2050 | 21 CFR
892.2050 |
| Receive, store, transmit,
post process, display and
allow manipulation of
medical MR and CT
images | YES | YES |
| Client server
functionality | YES | YES |
| Visualization in 2D, 3D
and 4D of single or
multiple datasets | YES | YES |
| Define and edit paths
through structures such
as centerlines | YES | YES |
| Analysis of cross
references of structures | YES | YES |
| Fly-through
visualization | YES | YES |
| Segmentation of regions
of interest | YES | YES |
| Quantitative analysis
including distance,
angle, volume,
histogram, and tracking
quantities over time. | YES | YES |
| Derive metadata or new
images from input
image sets | YES | YES |
| Creating/forwarding
DICOM images | YES | YES |
| DICOM complaint | YES | YES |
Description and Conclusion of Testing
cvi42 have been tested according to the specifications that are documented in a Master Software Test Plan. Testing is an integral part of Circle Cardiovascular Imaging Inc software development process as described in the company's product development process.
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Conclusion:
The successful non-clinical testing demonstrates the safety and effectiveness of the cvi42 when used for the defined indications for use and demonstrates that the device for which the 510(k) is submitted performs as well as or better than the legally marketed predicate device.