CAAS INTRAVASCULAR

K123970 · Pie Medical Imaging BV · LLZ · Feb 6, 2013 · Radiology

Device Facts

• Record ID: K123970
• Device Name: CAAS INTRAVASCULAR
• Applicant: Pie Medical Imaging BV
• Product Code: LLZ · Radiology
• Decision Date: Feb 6, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

CAAS IntraVascular has been developed to review and analyze intravascular images. The software is used by or under supervision of a cardiologist or radiologist.

Device Story

CAAS IntraVascular is a stand-alone software application for PCs running Windows. It imports intravascular DICOM data (IVUS and OCT) to assist cardiologists or radiologists in clinical diagnosis. The device provides (semi-)automatic detection of vessel and stent structures, enabling quantitative analysis of dimensions. Key functions include stenosis, plaque, and stent analysis; linear, angular, and ROI measurements; and volume calculations. Outputs include study lists, cross-sectional views, longitudinal reconstructions, and 3D reconstructions, which can be exported as digital PDF or XML reports. By providing automated structural quantification, the device supports clinical decision-making regarding vessel and stent assessment.

Clinical Evidence

No clinical data. Performance was established through software verification and validation testing to evaluate accuracy and precision against predetermined specifications.

Technological Characteristics

Stand-alone software for MS Windows. Processes vendor-independent DICOM data (IVUS/OCT). Features include (semi-)automatic contour definition (lumen, EEM, stent), longitudinal/cross-sectional/3D reconstruction, and quantitative analysis (stenosis, plaque, stent, volume). Connectivity via DICOM import and XML/PDF export.

Indications for Use

Indicated for the quantification of artery and/or stent dimensions based on intravascular ultrasound (IVUS) and/or optical coherence tomography (OCT) images.

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

• echoPlaque Intra Vascular Analysis Software (K092842)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image contains the text "K123970" at the top. Below that, the words "PIE MEDICAL" are printed in a bold, sans-serif font. Underneath "PIE MEDICAL", the word "IMAGING" is printed in the same font style. To the left of the text, there is a geometric shape.

| 510(k) Summary | CAAS IntraVascular | | [QA858]v2.0 |
|---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|------------------|
| Submitter Name<br>Submitter Address<br>Contact Person:<br>Phone Number<br>Fax Number<br>Email Address<br>Preparation Date | Pie Medical Imaging BV<br>Becanusstraat 13D, 6216 BX Maastricht, The Netherlands<br>Florie Daniels, Regulatory Affairs Coordinator<br>[phone]<br>[phone]<br>[e-mail]<br>20 December 2012 | | FEB 6 2013 |
| Trade Name | CAAS IntraVascular | | |
| Common Name | CAAS IntraVascular | | |
| Classification Name | Picture Archiving and Communications System | | |
| Regulation Class | Class II (21 CFR, part 892.2050, LLZ) | | |
| Predicate Device | echoPlaque Intra Vascular Analysis Software (K092842) | | |
| Device Description | CAAS IntraVascular is a stand-alone software application intended to run on a<br>PC with a Windows operating system. CAAS IntraVascular is designed for<br>viewing and analyzing DICOM data from intravascular ultrasound (IVUS) and<br>optical coherence tomography (OCT) studies. CAAS Intravascular provides<br>(semi-)automatic detection of vessel and stent structures and quantitative analysis of the dimensions of these structures. CAAS IntraVascular is designed for use in clinical practice to support the physician to diagnose the patient. | | |
| Intended Use | CAAS IntraVascular has been developed to review and analyze intravascular<br>images. The software is used by or under supervision of a cardiologist or<br>radiologist. | | |
| Indications for use | Based on intravascular ultrasound (IVUS) and/or optical coherence tomography<br>(OCT) images CAAS IntraVascular enables quantification of artery and/or stent<br>dimensions. | | |
| Technological<br>Characteristics<br>Comparison | The underlying technology of the subject device is similar to the predicate<br>device. Both the subject device and predicate device can import intravascular<br>DICOM data, display this data in similar ways and provide similar contour<br>definition, vessel analysis and measurement methods. The technological<br>comparision table shows the equivalence between CAAS IntraVascular and the<br>predicated device. | | |
| | | New Device | Predicate Device |

| | New Device | Predicate Device |
|-----------|--------------------------------------------------------|------------------------------------------------|
| Data type | IVUS and OCT data in DICOM format (vendor independent) | IVUS data in DICOM format (vendor independent) |

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| | New Device | Predicate Device |
|---------------------------|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Import of Patient<br>Data | Manual through keyboard Automatic import with image file | Manual through keyboard Automatic import with image file |
| Image display | Study List creation Cross-sectional views Longitudinal reconstruction 3D OCT reconstruction | Cross-sectional views Longitudinal reconstruction 3D IVUS view |
| Contour definition | Lumen, EEM and stent contour Automatic Manual | Lumen, EEM and stent contour Automatic Manual |
| Vessel analysis | Stenosis analysis Plaque analysis Stent analysis | Stenosis analysis Plaque analysis Stent analysis |
| Image assessment | Linear (length and diameter), angular and ROI measurements Volume measurements | Linear (length and diameter), angular and ROI measurements Volume measurements |
| Storage of Results | Printout Reanalysis Digital PDF report XML export DICOM PDF report | Printout Reanalysis Digital Word report XML export |
| Operating System | MS Windows | MS Windows |

Performance Data Testing includes software verification and validation. The tests were made to evaluate CAAS IntraVascular.and yield accuracy and precision results within the predetermined specifications.

Substantial Equivalence CAAS IntraVascular is substantial equivalent to the predicate device in terms of intended use, indications for use, technological characteristics, measurements and operating environment of the predicate device. All found differences raise no new safety and effectiveness issues or concerns.

Conclusion The testing reported in this 510(k) establishes that CAAS IntraVascular is substantial equivalent to the predicate device and is safe and effective for its intended use.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

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

### February 6, 2013

Pie Medical Imaging BV C/O Florie Daniels Regulatory Affairs Coordinator BECANUSSTRAAT 13D 6212 BX MAASTRICHT THE NETHERLANDS

Re: K123970

Trade/Device Name: CAAS Intra Vascular Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 20, 2012 Received: December 26, 2012

Dear Ms. Daniels:

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 (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Sean M. Boyd -S 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): K123970

Device Name: CAAS IntraVascular

Indications for Use:

Based on Intravascular ultrasound (IVUS) and/or optical coherence tomography (OCT) images CAAS IntraVascular enables quantification of artery and/or stent dimensions.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

## Sean M. Boyd -S

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

K123970 510(k)

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