X-RAY VVA

K112807 · Medis Medical Imaging Systems BV · LLZ · Feb 27, 2012 · Radiology

Device Facts

• Record ID: K112807
• Device Name: X-RAY VVA
• Applicant: Medis Medical Imaging Systems BV
• Product Code: LLZ · Radiology
• Decision Date: Feb 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

X-RAY VVA is software intended to be used for performing calculations in X-ray angiographic images of the chambers of the heart and of blood vessels. These calculations are based on contours that are either manually drawn by the clinician or trained medical technician who is operating the software, or automatically detected by the software and subsequently presented for review and manual editing. X-RAY VVA is also intended to be used for performing caliper measurements. The results obtained are displayed on top of the images and provided in reports. The analysis results obtained with X-RAY VVA are intended for use by cardiologists and radiologists: - to support clinical decisions concerning the heart and vessels - to support the evaluation of interventions or drug therapy applied for conditions of the heart and vessels.

Device Story

X-RAY VVA is standalone image post-processing software for viewing and quantifying digital X-ray angiographic images of heart chambers and blood vessels. It operates on Windows-based systems; imports images via CD/DVD, PACS, or network. Core functionality relies on semi-automatic contour detection; clinicians or technicians review and manually edit automatically detected contours. Device provides caliper measurements and analysis results for right/left ventricles, stents, sub-segments, coronary aneurysms, and bifurcations. Cardiologists and radiologists use output to support clinical decisions and evaluate interventions or drug therapies. Benefits include standardized, reproducible quantification to assist in patient diagnosis and treatment monitoring.

Clinical Evidence

Bench testing only. Validation and verification testing confirmed that the software meets design input requirements and performs consistently with predicate devices. No clinical study data provided.

Technological Characteristics

Standalone software application for Windows OS. Modular architecture incorporating previously cleared algorithms for vessel and ventricular analysis. Features semi-automatic contour detection, caliper measurement tools, and image export capabilities (PACS/network/CD/DVD). Vendor-neutral image acquisition compatibility.

Indications for Use

Indicated for use in clinical settings to provide validated, reproducible quantified results from X-ray angiographic images of the heart and blood vessels in individual patients with cardiovascular disease. Intended for use by cardiologists and radiologists to support clinical decision-making for diagnosis or treatment evaluation. Not for use as the sole, irrefutable basis for clinical diagnosis.

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

• QCA-CMS (K993763)
• OLV-CMS (K993765)
• OVA-CMS (K023970)
• CMS-VIEW (K993761)
• CAAS (K052988)

Submission Summary (Full Text)

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K112807

# 5. 510(k) Summary of Safety and Effectiveness

FEB 2 7 2012

Submission in accordance with the requirements of 21 CFR Part 807.87(h).

| Submitter | : Medis medical imaging systems bv |
|------------------------|-----------------------------------------------|
| Address | : Schuttersveld 9 |
| | : 2316 XG Leiden |
| | : The Netherlands |
| Contact Person | : J.H.C. Reiber, PhD, CEO |
| Email | : [e-mail] |
| Telephone | : [phone] |
| Fax | : [phone] |
| Prepared | : February 17, 2012 |
| Trade / Device Name | : X-RAY VVA |
| Common Name | : Radiological Image Processing Software |
| Regulatory Class | : II |
| Regulatory Class | : II |
| Regulation Description | : Picture Archiving and Communications System |
| Regulation / Procode | : 21 CFR 892.2050 / LLZ |

### Predicate Devices

- · The Medis medical imaging system bv: QCA-CMS (K993763)
- · The Medis medical imaging system bv: OLV-CMS (K993765)
- · The Medis medical imaging system bv: OVA-CMS (K023970)
- · The Medis medical imaging system bv: CMS-VIEW (K993761)
- · The Pie Medical Imaging bv: CAAS (K052988)

## Device Description

X-RAY VVA (Vessel and Ventricular Analysis) is image post-processing software for the viewing and quantification of digital x-ray angiographic images of blood vessels and of the chambers of the heart. Semi-automatic contour detection forms the basis for the analyses. Its functionality is independent of the type of vendor acquisition equipment. The analysis results are available on screen, and can be exported in various electronic formats.

X-RAY VVA has been developed as a standalone application to run on a Windows based operating system. The import of images and the export of analysis results are via CD / DVD, a PACS or network environment.

X-RAY VVA has a modular structure that consists of its previously cleared predicate devices: OCA-CMS, QVA-CMS, QLV-CMS, and CMS-VIEW. X-RAY VVA comprises their respective functionalities for analyzing the blood vessels and the left ventricle. In addition, X-RAY VVA includes new functionality for the analysis of: the right ventricle, stent and sub-segments, coronary anewysms, and bifurcations.

## Intended Use

X-RAY VVA is software intended to be used for performing calculations in X-ray angiographic images of the chambers of the heart and of blood vessels. These calculations are based on contours that are either manually drawn by the clinician or trained medical technician who is operating the software, or automatically detected by the software and subsequently presented for review and manual editing.

| X-RAY VVA 510(k) Submission Addendum | |
|--------------------------------------|---|
| Date: February 17, 2012 | 4 |

Document version: v3c0 Status: FINAL

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X-RAY VVA is also intended to be used for performing caliper measurements. The results obtained are displayed on top of the images and provided in reports.

The analysis results obtained with X-RAY VVA are intended for use by cardiologists and radiologists:

- to support clinical decisions concerning the heart and vessels •
- to support the evaluation of interventions or drug therapy applied for conditions of the heart . and vessels.

## Indications for Use

X-RAY VVA is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the calculations in X-ray angiographic images of the heart and of blood vessels, for use on individual patients with cardiovascular disease.

When the quantified results provided by X-RA Y VVA are used in a clinical setting on X-ray images of an individual patient, they can be used to support the clinical decisions making for the diagnoiss of the patient or the evaluation of the treatment applied. In this case, the results are explicitly not to be regarded as the sole, intefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians.

# Substantial Equivalence Information

Medis X-RAY VVA has technological features and characteristics similar to QCA-CMS, QVA-CMS, QLV-CMS, CMS-VIEW, and the CAAS product from Pie Medical Inaging.

X-RAY VVA has the same intended uses as the predicate devices.

#### Conclusions

X-RAY VVA has the same intended uses as the predicate devices. X-RAY VVA also includes similar technical features and characteristics as the predicate devices.

Testing and validation have produced results consistent with design input requirements.

During the development, potential hazards were controlled by a risk management plan, including risk analysis, risk mitigation, verification and evaluation.

Medis concludes that X-RAY VVA is a safe and effective medical device, and is at least as safe and effective as its predicate devices. The use of X-RAY VVA does not change the intended use of X-ray image scanners, nor does the use of this software result in any new potential hazards.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

FEB 2 7 2012

Mr. Hans Reiber Chief Executive Officer Medis Medical Imaging Systems BV Schuttersveld 9 2316 XG LEIDEN THE NETHERLANDS

Re: K112807

Trade/Device Name: X-RAY VVA Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 17, 2012 Received: February 23, 2012

Dear Mr. Reiber:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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## Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket whitication. The FDA finding of substantial equivalence of your device to a legally marketed nonicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 11 Jou don't be office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket 9 1561 Thous productions of the regarding the reporting 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use Form

510(k) Number (if known): K112807

# Device Name: X-RAY VVA

Indications for Use:

X-RAY VVA is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the calculations in X-ray angiographic images of the heart and of blood vessels, for use on individual patients with cardiovascular disease.

When the quantified results provided by X-RAY VVA are used in a clinical setting on X-rav images of an individual patient, they can be used to support the clinical decisions making for the diagnosis of the patient or the evaluation of the treatment applied. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S Pastel

Division Sign-Off Office of In Vitro Diagnostic Device

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