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

Device Description

CAAS IntraVascular is a stand-alone software application intended to run on a PC with a Windows operating system. CAAS IntraVascular is designed for viewing and analyzing DICOM data from intravascular ultrasound (IVUS) and optical coherence tomography (OCT) studies. CAAS Intravascular provides (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.

AI/ML Overview

The provided document is a 510(k) summary for the CAAS IntraVascular device, which is a software application for viewing and analyzing DICOM data from intravascular ultrasound (IVUS) and optical coherence tomography (OCT) studies.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "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." However, it does not explicitly list specific quantitative acceptance criteria (e.g., specific accuracy thresholds or error margins) or provide detailed numerical performance results for the device against these criteria.

Instead, the conclusion focuses on "Substantial Equivalence" to a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Accuracy and Precision (of measurements and detections)	"Yield accuracy and precision results within the predetermined specifications."
Functional Equivalence (to predicate device)	"Substantial equivalent to the predicate device in terms of intended use, indications for use, technological characteristics, measurements and operating environment."
No new safety and effectiveness issues (compared to predicate)	"All found differences raise no new safety and effectiveness issues or concerns."

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "software verification and validation" and "tests were made to evaluate CAAS IntraVascular," but it does not specify the sample size used for the test set (number of cases, images, or measurements).

Data Provenance: The document does not explicitly state the country of origin of the data or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not provide information on the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set:

The document does not provide information on any adjudication methods used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size:

The document does not indicate that an MRMC comparative effectiveness study was performed. The focus is on demonstrating substantial equivalence to a predicate device, not on measuring human reader improvement with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:

The device is described as "a stand-alone software application" with "(semi-)automatic detection" and "quantitative analysis." This implies that the software itself performs these functions, suggesting that its standalone performance was likely evaluated as part of the verification and validation, but specific performance metrics for this standalone functionality are not detailed.

7. The Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). Given the device's function in quantitative analysis of anatomical structures (vessel and stent dimensions from IVUS/OCT images), it's highly probable that some form of "expert-drawn contours" or "manual measurements" by qualified individuals served as the ground truth for evaluating the software's accuracy and precision.

8. The Sample Size for the Training Set:

The document does not provide information on the sample size used for the training set. The descriptions of "(semi-)automatic detection" imply the use of algorithms that would typically require training data, but no specifics are given.

9. How the Ground Truth for the Training Set was Established:

The document does not provide information on how the ground truth for the training set was established.

Summary

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solutions in cardiovașcular ənəlysis

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 NameSubmitter AddressContact Person:Phone NumberFax NumberEmail AddressPreparation Date	Pie Medical Imaging BVBecanusstraat 13D, 6216 BX Maastricht, The NetherlandsFlorie Daniels, Regulatory Affairs Coordinator+31 43 32 81 328+31 43 32 81 329Florie.Daniels@pie.nl20 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 aPC with a Windows operating system. CAAS IntraVascular is designed forviewing and analyzing DICOM data from intravascular ultrasound (IVUS) andoptical coherence tomography (OCT) studies. CAAS Intravascular provides(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 intravascularimages. The software is used by or under supervision of a cardiologist orradiologist.
Indications for use	Based on intravascular ultrasound (IVUS) and/or optical coherence tomography(OCT) images CAAS IntraVascular enables quantification of artery and/or stentdimensions.
TechnologicalCharacteristicsComparison	The underlying technology of the subject device is similar to the predicatedevice. Both the subject device and predicate device can import intravascularDICOM data, display this data in similar ways and provide similar contourdefinition, vessel analysis and measurement methods. The technologicalcomparision table shows the equivalence between CAAS IntraVascular and thepredicated 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 PatientData	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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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 (800) 638-2041 or (301) 796-7100 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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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).