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 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.

AI/ML Overview

The provided text describes the cvi42 device, an image analysis software for CT and MR images of blood vessels, but it does not contain the detailed acceptance criteria or the study results that specifically prove the device meets those criteria.

The document states that "cvi42 have been tested according to the specifications that are documented in a Master Software Test Plan," and that "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." However, it does not provide the specifics of these tests, acceptance criteria, or performance metrics.

Therefore, I cannot fill out the requested table or answer the specific questions about the study design, sample sizes, ground truth establishment, or expert involvement based on the provided text.

The information related to the predicate device "iNtuition (K121916)" is largely for functional comparison, showing both devices have similar capabilities, but it does not present performance data for either the predicate or the cvi42 device.

Summary

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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.

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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,

FDA

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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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.

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)

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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
Email	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

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.

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Device Description

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
iNtuitionK121916	To receive, store, transmit, post-process, display and allowmanipulation of reports and medical images from acquisitiondevices, including optical or other non-DICOM format images,DICOM images with modality type XA, US, CR, DR, SPECT, NMand MG, and images from volumetric medical scanning devices suchas EST, CT, PET or MRI. To provide access to images derived dataand derived images via client-server software, web browser andmobile technology.
	Visualization in 2D, 3D and 4D are supported for single or multipledatasets, or combinations thereof. Tools are provided to define andedit paths through structures such as centerlines, which may be usedto analyze cross-sections of structures, or to provide flythroughvisualizations rendered along such a centerline. Segmentation ofregions of interest and quantitative analysis tools are provided, forimages of vasculature, pathology and morphology, includingdistance, angle, volume, histogram, ratios thereof, and tracking ofquantities over time. A database is provided to track and compareresults using published comparison techniques such as RECIST andWHO. Calcium scoring for quantification of atherosclerotic plaqueis supported.
	Support is provided for digital image processing to derive metadataor new images from input image sets, for internal use or forforwarding to other devices using the DICOM protocol. Imageprocessing tools are provided to extract metadata to deriveparametric images from combinations of multiple input images, suchas temporal phases, or images co-located in space but acquired withdifferent 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 isintended to assist the physician in diagnosis, who is responsible formaking all final patient management decisions.
	Interpretation of mammographic images or digitized film screenimages is supported only when the software is used withoutcompression and with an FDA-Approved monitor that offers at least5Mpixel resolution and meets other technical specificationsreviewed and accepted by the FDA.

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Feature	iNtuition	cvi42
510k #	K121916	TBD
Device Class	II	II
Device Classification	LLZ	LLZ

Device Comparison Table

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Regulation Name	Picture Archiving andcommunicationssystems	PictureArchiving andcommunicationssystems
Regulation Number	21 CFR 892.2050	21 CFR892.2050
Receive, store, transmit,post process, display andallow manipulation ofmedical MR and CTimages	YES	YES
Client serverfunctionality	YES	YES
Visualization in 2D, 3Dand 4D of single ormultiple datasets	YES	YES
Define and edit pathsthrough structures suchas centerlines	YES	YES
Analysis of crossreferences of structures	YES	YES
Fly-throughvisualization	YES	YES
Segmentation of regionsof interest	YES	YES
Quantitative analysisincluding distance,angle, volume,histogram, and trackingquantities over time.	YES	YES
Derive metadata or newimages from inputimage sets	YES	YES
Creating/forwardingDICOM 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.

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).