Agfa's IMPAX Next Generation is a Picture Archiving and Communications System (PACS). It provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks. IMPAX Next Generation is intended to be used by trained healthcare professionals including, but not limited to physicians, radiologists, orthopaedic surgeons, cardiologists, mammographers, technologists, and clinicians for diagnosis and treatment planning using DICOM compliant medical images and other healthcare data.

MPR, MIP and 3D rendering functionality allows the user to view image data from perspectives different from that in which it was acquired. Other digital image processing functionality such as multi-scale window leveling and image registration can be used to enhance image viewing.

As a comprehensive imaging suite, IMPAX Next Generation integrates with servers, archives, Radiology Information Systems (RIS), Hospital Information Systems (HIS), reporting and 3rd party applications for customer specific workflows.

Lossy compressed mammography images and digitized film images should not be used for primary image interpretation. Uncompressed or non-lossy compressed "for presentation" images may be used for diagnosis or screening on monitors that are FDA-cleared for mammographic use.

Device Description

The new device is largely similar to the predicate devices. It is a comprehensive PACS system that combines the features of IMPAX system with the mammography workstation. This new version includes improvements to the user interface and is designed for ease of deployment and service. It also includes an integrated patient information system, report generation and transcription features.

Principles of operation and technological characteristics of the new and predicate devices are the same. There is no change to the intended use of the device vs. the predicate devices.

Agfa's IMPAX Next Generation is a PACS device for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic and treatment planning purposes.

It is a software device running on commercially available computer equipment that allows users to view and modify DICOM compliant medical images and patient information.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the IMPAX Next Generation device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for IMPAX Next Generation does not explicitly state quantitative acceptance criteria or a specific performance study with measured results against those criteria in a typical format (e.g., sensitivity, specificity, accuracy thresholds). Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through functional comparison and adherence to relevant standards.

The "performance" described is largely functional and adherence to standards:

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence to Predicates:
- DICOM Communication	DICOM (Matches all predicates)
- Orthopedic Use, Treatment Planning	Supported (Matches K071972, adds this feature compared to K022292 and K081976)
- Mammographic Use	Supported (Matches K081976, adds this feature compared to K022292 and K071972)
- Network Access	Supported (Matches all predicates)
- Multiple Displays	Supported (Matches all predicates)
- Image Export (BMP, JPG, TIF, AVI)	Supported (Matches all predicates)
- Window Level	Supported (Matches all predicates)
- Multi-Scale Window Level	Supported (Matches all predicates)
- Pan/Zoom	Supported (Matches all predicates)
- Rotate	Supported (Matches all predicates)
- Calibrate/Measure	Supported (Matches all predicates)
- Annotate	Supported (Matches all predicates)
- MIP, MPR	Supported (New feature compared to K022292, K071972, K081976, though IMPAX General Predicate (K022292) lists MPR as a feature in the summary itself, but not in the comparison table; the new device combines features of the predicates including MPR and 3D functionality mentioned in the description.)
- 3D Rendering	Supported (Matches K022292 and K071972, adds this feature compared to K081976)
- Patient Information System (HIS/RIS)	Supported (New feature compared to all predicates)
- Dictation & Speech	Supported (New feature compared to all predicates)
Adherence to Standards:
- DICOM Conformance (ACR/NEMA PS3.1 - 3.18)	Conforms
- ISO 14971 (Risk Management)	Conforms
- ISO 13485 (Quality Management Systems)	Conforms
Image Quality / Usability:
- Image quality, usability, measurements, and image processing	Meet user expectations

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

The submission explicitly states: "No clinical trials were performed in the development of the device."

Therefore, there is no test set sample size and no data provenance as traditionally understood for performance evaluation against a dataset. The testing was limited to validation that usability, measurements, image processing, and image quality meet user expectations, and conformance to documented requirements and standards.

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

As no clinical trials or performance studies on a distinct test set were conducted, there were no experts used to establish ground truth for a test set. The evaluation was primarily based on internal validation and conformance to standards.

4. Adjudication Method for the Test Set

Since no clinical trials or test set performance evaluation were conducted, there was no adjudication method applied.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states, "No clinical trials were performed in the development of the device."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

The device is a Picture Archiving and Communications System (PACS), which is a software system for image management, display, and processing, intended to be used by healthcare professionals, not an AI algorithm that produces a diagnostic output on its own. Therefore, the concept of "standalone (algorithm only)" performance as typically applied to diagnostic AI algorithms does not apply to this device in the context of this 510(k). Its "performance" is its functional capability and adherence to standards for displaying and manipulating medical images for human interpretation.

7. The Type of Ground Truth Used

Given that no clinical trials or performance studies were conducted, there was no ground truth established in the sense of a medical truth (e.g., pathology, outcomes data, expert consensus on disease presence). The "ground truth" for the validation of this PACS system was its adherence to functional requirements and industry standards.

8. The Sample Size for the Training Set

Since this is a PACS system and not an AI/ML diagnostic algorithm, there is no training set in the traditional sense. The device's capabilities are based on established software development and display methodologies, not on learning from a dataset.

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

As there is no training set for this device, there is no ground truth established for a training set.

Summary

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K111945

510(K) SUMMARY: IMPAX Next Generation

AUG - 5 2011

Common/Classification Name: Picture Archiving and Communications System 21CFR 892.2050 Proprietary Name: IMPAX Next Generation Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel Belgium . Contact: Jodi Coleman, Prepared: June 8, 2011 Telephone: (519) 746-6210 Ext. 2485 Facsimile: (519) 746-3745

A. LEGALLY MARKETED PREDICATE DEVICES

This is a 510(k) for Agfa's IMPAX Next Generation, which is a picture archiving and communications system. It is substantially equivalent to Agfa's IMPAX workstations with MPR, Digital Subtraction and 3D (K02292), and for orthopedic use to its Agfa Orthopedic Software for IMPAX Workstations (K071972), and for mammography to Agfa's IMPAX MA3000 (K081976).

DEVICE DESCRIPTION B.

Principles of operation and technological characteristics of the new and predicate devices are the same. There is no change to the intended use of the device vs. the predicate devices.

C. INTENDED USE

IMPAX Next Generation is a Picture Archiving and Communications System (PACS). It provides an interface for the acquisition, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks. IMPAX Next Generation is intended to be used by trained healthcare professionals including, but not limited to physicians, radiologists, orthopaedic surgeons, cardiologists, mammographers, technologists, and clinicians for diagnosis and treatment planning using DICOM compliant medical images and other healthcare data.

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SUBSTANTIAL EQUIVALENCE SUMMARY D.

Agfa's IMPAX Next Generation has an Indications for Use statement largely similar to the statements for the predicate devices (K022292, K071972 and K081976). The statements have been combined and simplified. Intended uses are the same. The devices have technological characteristics. Descriptive characteristics and performance data are adequate to ensure equivalence.

Differences in devices do not alter the intended therapeutic/diagnostic effect.

PRODUCT COMPARISON TABLE
	IMPAX NextGeneration(NEW DEVICE)	IMPAX GeneralPREDICATE(K022292)	IMPAXOrthopedicPREDICATE(K071972)	IMPAXMammographyPREDICATE(K081976)
Communications	DICOM	DICOM	DICOM	DICOM
Orthopedic Use,Treatment planning	√		√
Mammographic Use	√			√
Operating system	Windows Vista	Windows 2000	Windows 7	Windows 7
Network Access	√	√	√	√
Multiple displays	√	√	√	√
Image Export	BMP, JPG,TIF, AVI	BMP, JPG,TIF, AVI	BMP, JPG,TIF, AVI	BMP, JPG,TIF, AVI
Window Level	√	√	√	√
Multi-Scale WindowLevel	√	√	√	√
Pan/Zoom	√	√	√	√
Rotate	√	√	√	√
Calibrate/Measure	√	√	√	√
Annotate	√	√	√	√
MIP, MPR	√
Musica ImageReprocessing	√
3D Rendering	√	√	√	√
Patient InformationSystem (HIS/RIS)	√
Dictation & Speech	√

Table 1: Device Predicate Comparison

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TECHNOLOGICAL CHARACTERISTICS E.

It is a software device running on commercially available computer equipment that allows users to view and modify DICOM compliant medical images and patient information.

F. TESTING

The new device includes proven technology from the Agfa predicates which has been tested to demonstrate its suitability for digital mammography.

The device has been designed and manufactured to conform to the following standards:

ACR/NEMA PS3.1 3.18 Digital Imaging and Communications in Medicine (DICOM) ●
ISO 14971 Application of Risk Management to Medical Devices .
ISO 13485 Medical Devices Quality Management Systems Requirements For Regulatory . purposes

IMPAX Next Generation has been tested and shown to conform to documented requirements. Validation testing confirms that usability, measurements, image processing and image quality meet user expectations.

No clinical trials were performed in the development of the device.

G. CONCLUSIONS

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 for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. 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 Room - WO66-G609 Silver Spring. MD 20993-0002

Agfa I-lealthCare N.V. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25" Street NW BUFFALO MN 55313

AUG - 5 2011

Re: K111945

Trade/Device Name: IMPAX Next Generation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 7, 2011 Received: July 8, 2011

Dear Mr. Job:

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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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 Viro 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.

Mary Pastel

Mary S. Pastel, Sc.D. 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): 长川 (1945

Device Name: IMPAX Next Generation

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) 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)

AND/OR

Mary S. Fratel

Division Sign-Off Office of In Vitro Diagnostic Device

ર I O(K

Page I of

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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).