IMPAX NEXT GENERATION

K111945 · Agfa Healthcare N.V. · LLZ · Aug 5, 2011 · Radiology

Device Facts

• Record ID: K111945
• Device Name: IMPAX NEXT GENERATION
• Applicant: Agfa Healthcare N.V.
• Product Code: LLZ · Radiology
• Decision Date: Aug 5, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

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. 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 Story

IMPAX Next Generation is a comprehensive PACS software suite for clinical environments. It ingests multimodality DICOM medical images, patient demographic data, and reports from hospital networks, RIS, and HIS. The system provides tools for digital image processing (multi-scale window leveling, image registration), visualization (MPR, MIP, 3D rendering), annotation, and report generation. Operated by trained healthcare professionals, the system facilitates diagnostic review and treatment planning. Output is displayed on clinical monitors; clinicians use these visualizations to inform diagnostic decisions and clinical workflows. The system benefits patients by centralizing imaging data and providing advanced viewing tools to support accurate diagnosis and efficient care coordination.

Clinical Evidence

Bench testing only. No clinical trials were performed. Validation testing confirmed that usability, measurements, image processing, and image quality met documented requirements and user expectations.

Technological Characteristics

Software-based PACS running on commercial computer equipment. Supports DICOM (ACR/NEMA PS3.1) standards. Features include multi-scale window leveling, image registration, MPR, MIP, and 3D rendering. Integrates with RIS/HIS and third-party reporting applications. Conforms to ISO 14971 (risk management) and ISO 13485 (quality management).

Indications for Use

Indicated for use by trained healthcare professionals (physicians, radiologists, orthopaedic surgeons, cardiologists, mammographers, technologists, clinicians) for acquisition, display, processing, review, storage, and distribution of DICOM-compliant multimodality medical images, reports, and demographic data for diagnosis and treatment planning. Contraindicated for primary image interpretation using lossy compressed mammography images or digitized film 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

• IMPAX workstations with MPR, Digital Subtraction and 3D (K022292)
• Agfa Orthopedic Software for IMPAX Workstations (K071972)
• IMPAX MA3000 (K081976)

Submission Summary (Full Text)

{0}------------------------------------------------

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: [phone] Ext. 2485 Facsimile: [phone]

#### 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.

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.

#### 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.

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.

{1}------------------------------------------------

# 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 Next<br>Generation<br>(NEW DEVICE) | IMPAX General<br>PREDICATE<br>(K022292) | IMPAX<br>Orthopedic<br>PREDICATE<br>(K071972) | IMPAX<br>Mammography<br>PREDICATE<br>(K081976) |
| Communications | DICOM | DICOM | DICOM | DICOM |
| Orthopedic Use,<br>Treatment planning | √ | | √ | |
| Mammographic Use | √ | | | √ |
| Operating system | Windows Vista | Windows 2000 | Windows 7 | Windows 7 |
| Network Access | √ | √ | √ | √ |
| Multiple displays | √ | √ | √ | √ |
| Image Export | BMP, JPG,<br>TIF, AVI | BMP, JPG,<br>TIF, AVI | BMP, JPG,<br>TIF, AVI | BMP, JPG,<br>TIF, AVI |
| Window Level | √ | √ | √ | √ |
| Multi-Scale Window<br>Level | √ | √ | √ | √ |
| Pan/Zoom | √ | √ | √ | √ |
| Rotate | √ | √ | √ | √ |
| Calibrate/Measure | √ | √ | √ | √ |
| Annotate | √ | √ | √ | √ |
| MIP, MPR | √ | | | |
| Musica Image<br>Reprocessing | √ | | | |
| 3D Rendering | √ | √ | √ | √ |
| Patient Information<br>System (HIS/RIS) | √ | | | |
| Dictation & Speech | √ | | | |

Table 1: Device Predicate Comparison

{2}------------------------------------------------

## TECHNOLOGICAL CHARACTERISTICS E.

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.

## 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.

{3}------------------------------------------------

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

{4}------------------------------------------------

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 [phone]. 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 [phone] or [phone] 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

{5}------------------------------------------------

# Indications for Use

510(k) Number (if known): 长川 (1945

Device Name: IMPAX Next Generation

Indications for Use:

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.

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

4 - 3