Impax Volume Viewing is a visualization package for PACS workstations. It is intended to support radiographer, medical imaging technician, radiologist and referring physician in the reading, analysis and diagnosis of DICOM compliant volumetric medical datasets. The software is intended as a general purpose digital medical image processing tool, with optionality to facilitate visualization and measurement of vessel features.

Other optional functionality is intended for the registration of anatomical (CT) on functional volumetric image data (MR) to facilitate the comparison of various lesions. Volume and distance measurements are intended for evaluation and quantification of tumor measurements, and other analysis and evaluation of both hard and soft tissues. The software also supports interactive segmentation of a region of interest (ROI).

Device Description

Impax Volume Viewing software is a visualization package for PACS workstations. It is intended to support radiographer, medical imaging technician, radiologist and referring physician in the reading, analysis and diagnosis of DICOM compliant volumetric medical datasets. The software is a general purpose digital medical image processing tool, with optional functionality to facilitate visualization and measurement of vessel features.

Other optional functionality is intended for the registration of anatomical (CT) on functional volumerric image data (MR) to facilitate the comparison of various lesions. Volume and distance measurements are intended for evaluation and quantification of tumor measurements, and other analysis and evaluation of both hard and soft tissues. The software also supports interactive segmentation of a region of interest (ROI).

Impax Volume Viewing is a software accessory to Agfa's Impax Picture Archiving and Communications system.

It is a tool for conveniently viewing and manipulating cross-sectional image series' for display in any orientation and slice thickness. A second series can be registered or fused to the first automatically, manually or with user defined landmarks. Segmentation of blood vessels and airfilled structures facilitate the visualization of vessel features. Color maps, subtraction views, multiple screen layouts and tools for measurement, calculations and annotations are provided.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Impax Volume Viewing device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary does not explicitly define quantitative acceptance criteria for the Impax Volume Viewing software. Instead, it relies on demonstrating substantial equivalence to predicate devices through functional and technological comparisons, along with verification and validation testing. The reported "performance" is that the device "meets performance, measurement and usability requirements" and conforms to certain standards.

Therefore, the table will reflect the general performance claims rather than specific numerical acceptance criteria.

Acceptance Criteria Category	Specific Acceptance Criteria (as implied)	Reported Device Performance
Functional Equivalence	Device functions similarly to predicates.	"Similar to the predicate devices." "Principles of operation and technological characteristics... are the same." "Has an Indications For Use Statement largely similar to the statements for the two predicates."
Intended Use Equivalence	Device has the same intended use as predicates.	"Intended uses... are the same."
Technological Characteristics	Software processes 3D image data, offers viewing/manipulation, registration, segmentation, measurement, etc.	"Tool for conveniently viewing and manipulating cross-sectional image series," "second series can be registered or fused," "Segmentation of blood vessels and air-filled structures," "Color maps, subtraction views, multiple screen layouts and tools for measurement, calculations and annotations are provided."
Performance	Meets general performance, measurement, and usability requirements.	"Verification and validation testing confirm the device meets performance, measurement and usability requirements."
Standards Conformance	Conforms to specified medical device and quality management standards.	Conforms to EN12435:2006, ISO 14971:2007, and ISO 13485:2003.
Safety and Effectiveness	Differences from predicates do not alter therapeutic/diagnostic effects.	"Differences in the new device and the predicates do not alter their intended therapeutic/diagnostic effects."

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

Sample Size for Test Set: Not specified. The document states "Verification and validation testing" was performed but does not detail the size of the dataset used for these tests.
Data Provenance: Not specified. It's not mentioned if the data was retrospective or prospective, or its country of origin.

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

Number of Experts: Not specified. Given that no clinical trials were performed, it's unlikely that external experts were used for establishing a "ground truth" in a clinical context for the test set as typically understood in a performance study. The testing seems more focused on engineering verification and validation.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set:

Adjudication Method: Not specified. Without explicit information on expert review or clinical studies, there's no mention of an adjudication method like 2+1 or 3+1.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

MRMC Study Done: No. The document explicitly states: "No clinical trials were performed in the development of the device." An MRMC study would fall under clinical trials.
Effect Size of Human Readers Improvement with AI vs. without AI assistance: Not applicable, as no MRMC study was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Standalone Study Done: Yes, implicitly. The "Verification and validation testing" would primarily assess the software's ability to correctly perform its functions (e.g., rendering, registration accuracy, measurement accuracy, segmentation capabilities) without necessarily involving human interpretation as a primary performance metric beyond usability. However, the document doesn't provide specific standalone performance metrics.

7. Type of Ground Truth Used:

Type of Ground Truth: For the "verification and validation testing," the ground truth would likely be established through:
- Engineering specifications and requirements: The software's output would be compared against predefined correct behaviors, mathematical principles, and known accurate measurements.
- Known good datasets: Using datasets with established characteristics to confirm the software's processing and display accuracy.
- Comparative analysis with predicate devices: Ensuring the new device's output is consistent with the established performance of the predicate devices.
- Given the nature of the device (visualization and manipulation tool), "pathology" or "outcomes data" are less likely to be the primary ground truth for its technical performance rather than its diagnostic utility.

8. Sample Size for the Training Set:

Sample Size for Training Set: Not applicable. This device is described as a "visualization package" and a "general purpose digital medical image processing tool." It is not leveraging machine learning or AI models in the sense that requires a "training set" for model development. The software's functionality (rendering, registration, segmentation, measurement) is based on deterministic algorithms and user interaction rather than learned patterns from a training dataset.

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

How Ground Truth for Training Set Was Established: Not applicable, as there is no mention of a training set for machine learning.

Summary

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K 111638

JUN 2 4 2011

510(K) SUMMARY: IMPAX VOLUME VIEWING

Common/Classification Name: Picture Archiving and Communications System 21 CFR 892.2050 Proprietary Name: Impax Volume Viewing Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Koen Cobbaert, Prepared: May 6, 2011 Telephone: 32 3 444 7539

LEGALLY MARKETED PREDICATE DEVICES A.

This is a 510(k) for Agfa's Impax Volume Viewing software, which is an accessory to its Impax picture archiving and communications systems. It is substantially equivalent to Agfa's Registration and Fusion software (K080013) in the majority of its functionality and to the Voxar 3D Enterprise with ColonMetrix and PET/CT Perfusion (K070831) with respect to its vessel viewing functionality.

B. DEVICE DESCRIPTION

The new device is similar to the predicate devices. All are PACS system accessories that allow the user to view and manipulate three dimensional image data sets.

Principles of operation and technological characteristics of the new and predicate devices are the same. The intended uses of the new and predicate devices are also the same.

c. INTENDED USE

D. SUBSTANTIAL EQUIVALENCE SUMMARY

Agfa's Impax Volume Viewing has an Indications For Use Statement largely similar to the statements for the two predicate. Intended uses are the same. As software accessories to PACS systems, the predicate and new devices have the same technological characteristics. Software is used to identify characteristic patterns within 3D image data which the user can then view and manipulate. Descriptive characteristics and performance data are adequate to ensure equivalence.

Differences in the new device and the predicates do not alter their intended therapeutic/diagnostic effects.

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Agfa HealthCare NV

Premarket Notification: Impax Volume Viewing

PRODUCT COMPARISON TABLE
	ImpaxVolume Viewing(NEW DEVICE)	ImpaxRegistration and Fusion(PREDICATE K080013)	Voxar 3D Enterprisewith ColonMetrix andPET/CT Perfusion(PREDICATE K070831)
3D Volume rendering	√	√	√
MPR CPR	√	MPR	√
MIP MiniP AveIP	√	MIP	√
Fusion and subtraction views	√	√	-
Can load and register two data sets for comparison	√	√	-
Multi-modality (CT and MR) image registration	√	√	-
Vessel analysis	√	-	√
Manual slice by slice volume-of-interest	√	√	-
DICOM and AVI movie generation	√	√	√
Reformat to a new dataset	√	√	√
Color maps	√	√	√
Annotations and measurements	√	√	√
Automatic table top removal	√	√	√
User Interface	Impax	Impax	Voxar

5 - 4

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TECHNOLOGICAL CHARACTERISTICS C.

Impax Volume Viewing is a software accessory to Agfa's Impax Picture Archiving and Communications system.

F. TESTING

Verification and validation testing confirm the device meets performance, measurement and usability requirements. No clinical trials were performed in the development of the device.

The new device and Agfa's management systems conform to the following standards:

EN12435:2006 Health Informatics Expression of Results of Measurements in Health ● Sciences
. ISO 14971:2007 - Application of Risk Management to Medical Devices
ISO 13485:2003 Medical Devices Quality Management Systems Requirements For . Regulatory Purposes

CONCLUSIONS G.

This 510(k) has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

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Image /page/3/Picture/0 description: The image shows the logo of the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three arms, enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around it. The text "DEPARTMENT" is written in bold, sans-serif font to the right of the logo.

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

AGFA Healthcare N.V. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO NY 55313

AUG 2 3 2013

Re: K111638

Trade/Device Name: Impax Volume Viewing Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 10, 2011 Received: June 13, 2011

Dear Mr. Job:

This letter corrects our substantially equivalent letter of June 24, 2011.

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 I va may a 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 or mr) 2 vith 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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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 notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/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

510(k) Number (if known):

Device Name: Impax Volume Viewing

Indications for Use:

Prescription Use X (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 OF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S Patil

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K111638

Page 1 of

FDA CDRH DMC

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).