CVI42

K141480 · Circle Cardiovascular Imaging, Inc. · LLZ · Aug 22, 2014 · Radiology

Device Facts

• Record ID: K141480
• Device Name: CVI42
• Applicant: Circle Cardiovascular Imaging, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Aug 22, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

Software application for qualitative/quantitative analysis of cardiovascular CT and MR images in DICOM format. Inputs: DICOM CT/MR image datasets. Processing: Digital image processing/visualization including MPR, MIP (thin/thick), inverted MIP, VRT, curved planar reformation, bone/table removal. Evaluation tools: vessel centerline, lumen, and stenosis calculation. Output: Visualizations, lesion location/characteristics, and reports. Used in hospital/private practice by qualified medical professionals. Supports physician in confirming lesion presence/absence and clinical decision-making. Benefits: Assists in comprehensive diagnostic evaluation and documentation of vascular lesions.

Clinical Evidence

Bench testing only. No clinical data presented. Software verification and validation performed according to a Master Software Test Plan to demonstrate safety and effectiveness.

Technological Characteristics

Software-only image analysis package. Operates on standard computing hardware in standalone or networked environments. Processes DICOM standard images. Features include MPR, MIP, VRT, curved planar reformation, and automated vessel/lumen/stenosis calculation tools. Bone removal supports single and dual-energy data. No specific hardware or sterilization requirements.

Indications for Use

Indicated for use by qualified medical professionals to evaluate cardiovascular CT and MR images of blood vessels for lesion identification, documentation, and follow-up. No specific age or gender restrictions; usage limited by patient eligibility for cardiac CT/MR scanning.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• iNtuition (K121916)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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

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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.

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 |
| Email | [e-mail] |
| 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.

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## 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.<br><br>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.<br><br>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<br>K121916 | To receive, store, transmit, post-process, display and allow<br>manipulation of reports and medical images from acquisition<br>devices, including optical or other non-DICOM format images,<br>DICOM images with modality type XA, US, CR, DR, SPECT, NM<br>and MG, and images from volumetric medical scanning devices such<br>as EST, CT, PET or MRI. To provide access to images derived data<br>and derived images via client-server software, web browser and<br>mobile technology. |
| | Visualization in 2D, 3D and 4D are supported for single or multiple<br>datasets, or combinations thereof. Tools are provided to define and<br>edit paths through structures such as centerlines, which may be used<br>to analyze cross-sections of structures, or to provide flythrough<br>visualizations rendered along such a centerline. Segmentation of<br>regions of interest and quantitative analysis tools are provided, for<br>images of vasculature, pathology and morphology, including<br>distance, angle, volume, histogram, ratios thereof, and tracking of<br>quantities over time. A database is provided to track and compare<br>results using published comparison techniques such as RECIST and<br>WHO. Calcium scoring for quantification of atherosclerotic plaque<br>is supported. |
| | Support is provided for digital image processing to derive metadata<br>or new images from input image sets, for internal use or for<br>forwarding to other devices using the DICOM protocol. Image<br>processing tools are provided to extract metadata to derive<br>parametric images from combinations of multiple input images, such<br>as temporal phases, or images co-located in space but acquired with<br>different imaging parameters, such as different MR pulse sequences,<br>or different CT image parameters (e.g. dual energy). |
| | iNtuition is designed for use by healthcare professionals and is<br>intended to assist the physician in diagnosis, who is responsible for<br>making all final patient management decisions. |
| | Interpretation of mammographic images or digitized film screen<br>images is supported only when the software is used without<br>compression and with an FDA-Approved monitor that offers at least<br>5Mpixel resolution and meets other technical specifications<br>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

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| Regulation Name | Picture Archiving and<br>communications<br>systems | Picture<br>Archiving and<br>communications<br>systems |
|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|-------------------------------------------------------|
| Regulation Number | 21 CFR 892.2050 | 21 CFR<br>892.2050 |
| Receive, store, transmit,<br>post process, display and<br>allow manipulation of<br>medical MR and CT<br>images | YES | YES |
| Client server<br>functionality | YES | YES |
| Visualization in 2D, 3D<br>and 4D of single or<br>multiple datasets | YES | YES |
| Define and edit paths<br>through structures such<br>as centerlines | YES | YES |
| Analysis of cross<br>references of structures | YES | YES |
| Fly-through<br>visualization | YES | YES |
| Segmentation of regions<br>of interest | YES | YES |
| Quantitative analysis<br>including distance,<br>angle, volume,<br>histogram, and tracking<br>quantities over time. | YES | YES |
| Derive metadata or new<br>images from input<br>image sets | YES | YES |
| Creating/forwarding<br>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.