AMICAS VISION SERIES PACS, MODEL 5.5

K073526 · Amicas, Inc. · LLZ · Mar 12, 2008 · Radiology

Device Facts

• Record ID: K073526
• Device Name: AMICAS VISION SERIES PACS, MODEL 5.5
• Applicant: Amicas, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Mar 12, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Vision Series PACS 5.5 is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, to include Digital Mammography. Vision Series PACS receives images acquired from DICOM-compliant medical imaging systems, data from FDA-cleared Computer-Aided Detection systems and other FDA-cleared Image processing systems. Vision Series PACS imports images and render said images, upon request, within the AMICAS LightBeam Diagnostic Workstation utilizing both lossless (reversible) and lossy (irreversible) compression. To support the diagnostic interpretation of Mammography studies, Vision Series PACS will display the full fidelity DICOM image in a non-compressed format. Images will be rendered with patient and clinical information clearly displayed as part of the DICOM Overlay as required by MQSA, on monitors cleared by FDA for use in Digital Mammography. Lossy compressed mammography images and digitized film screen images should not be used for the purpose of primary diagnosis. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Within Vision Series PACS 5.5, the AMICAS Real Time Worklist offers real-time status of radiology activity and provides customizable workflow management capabilities. Communication of critical results is facilitated and documented through optional, and configurable, components within the Real Time Worklist. Vision Reach is an optional component within the PACS 5.5 offering which provides clinicians secure, proactive communication and access to clinical reports and images. Order and Report information generated by HIS/RIS and report creation systems are received and displayed in PACS via the transmission of HL7 messaging. For this data. AMICAS is not the creator, but instead the downstream recipient which relies on the validity of data from said systems. Vision Series PACS must be installed on suitable, commercial-standard hardware. It is the user's responsibility to ensure monitor quality, ambient light conditions and image compression ratios are consistent with the clinical application.

Device Story

AMICAS Vision Series PACS 5.5 is a software-only system for soft-copy reading, communication, and storage of digital medical images. It receives DICOM-compliant images from imaging modalities and data from FDA-cleared CAD or image processing systems. The system imports and renders images via the AMICAS LightBeam Diagnostic Workstation, supporting both lossless and lossy compression. For mammography, it displays full-fidelity, non-compressed DICOM images on FDA-cleared 5Mpixel monitors with MQSA-compliant overlays. The system includes a Real-Time Worklist for workflow management and critical results communication, and an optional 'Vision Reach' component for secure clinician access to reports and images. It integrates with HIS/RIS via HL7 messaging. Used in clinical settings by radiologists, technologists, and clinicians, the device facilitates diagnostic interpretation by providing tools for image manipulation (enlarging, highlighting, obscuring). Users are responsible for ensuring appropriate hardware, display quality, and ambient lighting conditions to prevent erroneous interpretation.

Clinical Evidence

No clinical data. The device relies on bench testing and functional verification against Software Requirements Specifications to demonstrate safety and effectiveness.

Technological Characteristics

Software-only PACS; operates on commercial-standard computer hardware. Features include DICOM image processing, multi-planar reformatting, volume rendering, and maximum intensity projection. Supports lossless/lossy JPEG2000 compression. Integrates with HIS/RIS via HL7. Requires FDA-cleared 5Mpixel monitors for mammography. User-controlled image manipulation tools (enlarging, highlighting, obscuring).

Indications for Use

Indicated for soft copy reading, communication, and storage of digital medical images, including digital mammography, for use by radiologists, technologists, and clinicians.

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

• Amicas Vision Series PACS 4.3 (K062477)

Submission Summary (Full Text)

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K073526

# 510(k) Summary of Safety and Effectiveness - as required by 21 CFR part 807.92

| Date prepared: | December 12 2007 |
|----------------------------------|------------------------------------------------------------------|
| Submitted by: | Amicas, Inc.<br>20, Guest St.<br>Boston, MA 02135<br>MAR 12 2008 |
| Contact: | Patrice Nedelec |
| Contact email: | [e-mail] |
| Contact Telephone: | 617-779-7858 or 617-372-1331 |
| Contact Fax: | 806-313-1214 |
| Device Trade Name: | Amicas Vision Series PACS 5.5 |
| Device Common Name: | Picture Archiving Communication System (PACS) |
| Regulation number: | 892.2050 |
| Device Classification: | Class II |
| Name: | Amicas Vision Series PACS |
| Predicate Device: | Amicas Vision Series PACS 4.3 |
| Predicate Device Manufacturer: | AMICAS Inc.<br>20 Guest Street<br>Boston, MA 021235 |
| Predicate Device 510(k) number: | K062477 |
| Date received: | 08/24/2006 |
| Decision date: | 10/27/2006 |
| Decision: | Substantially equivalent |
| Panel Code Device reviewed by: | Radiology |
| Panel Code Device classified by: | Radiology |
| Product Code: | LLZ |
| Regulation number: | 892.2050 |
| Device Classification: | Class II |

#### Device Description and intended use:

AMICAS Vision Series PACS 5.5 is software intended to create and display twodimensional and three-dimensional images of anatomy from a series of digitally acquired images.

Typical users of Vision PACS Series 5.5 are radiologists, technologists and clinicians.

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| Feature | Amicas Vision Series<br>PACS 4.3 (predicate) | Amicas Vision Series<br>PACS 5.5 |
|-----------------------------------------------------------------------------|----------------------------------------------|----------------------------------|
| Software Only | Yes | Yes |
| Image Measurements | Yes | Yes |
| Multi-planar reformatting | Yes | Yes |
| Volume Rendering | Yes | Yes |
| Maximum Intensity Projection | Yes | Yes |
| Image editing | Yes | Yes |
| Printing | Yes | Yes |
| DICOM Images | Yes | Yes |
| Lossless JPEG2000<br>Compression | Yes | Yes |
| Lossy JPEG2000 Compression | Yes | Yes |
| DICOM Overlay supporting<br>MQSA-requirements | Yes | Yes |
| Support for all DICOM transfer<br>syntax and photometric<br>interpretations | No | Yes |

#### Technological characteristics:

## General Safety Considerations

Amicas Vision Series 5.5 software and the computer platform that it is installed on together constitute a system for the interpretation of medical image data by trained and qualified professionals. It is the user's responsibility to ensure that image quality, display quality, environmental lighting and other possible distractions are consistent with the clinical application. Refer to the instruction manuals for your specific computer and display hardware for information regarding installation, calibration and additional safety issues.

Amicas Vision Series 5.5, as its predicate, includes tools for enlarging, highlighting and obscuring portions of an image relative to other portions. Inappropriate application of these tools can result in the obscuration of important anatomy and contribute to an erroneous interpretation. It is the user's responsibility to understand the effect of image manipulation tools and to apply in a manner consistent with the clinical application. The user must review the cautionary statements in the User's guide.

Be sure to limit access to patient data to authorized individuals who are fully trained and qualified to use this equipment.

Part B: Administrative Information - Section A: 510(k) Summary of Safety and effectiveness Page 2 of 3

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## Testing:

Amicas Vision Series 5.5 is tested with reference to its Software Requirements Specifications, as documented in the Verification Procedure included in this 510(k) filing.

Functional testing is an integral part of Amicas, Inc. Product Development process, also included in this filing (see section G, Quality Procedure 0019).

The Amicas Quality Assurance Team, per process, independently verifies completeness of all deliverables -to include testing reports and assessment of safety and effectivenessbefore issuing release advisories.

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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 consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and is relatively small compared to the eagle symbol.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAR 1 2 2008

Mr. Patrice J. C. Nedelec Director of Quality AMICAS, Incorporated 20 Guest Street BOSTON MA 02135

Re: K073526

Trade/Device Name: AMICAS Vision Series PACS 5.5 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 13, 2007 Received: December 17, 2007

Dear Mr. Nedelec:

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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/3/Picture/10 description: The image is a circular logo or emblem. It commemorates the centennial of the FDA from 1906-2006. The central design features the letters 'FDA' in a stylized font, with the word 'Centennial' written below. Three stars are arranged beneath the word 'Centennial'. The text around the circle reads 'Food and Drug Administration Centennial'.

Protecting and Promoting Public Health.

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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); 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.

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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known): K073524

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Device Name: AMICAS Vision Series PACS 5.5

Indications For Use:

Vision Series PACS 5.5 is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, to include Digital Mammography. Vision Series PACS receives images acquired from DICOM-compliant medical imaging systems, data from FDA-cleared Computer-Aided Detection systems and other FDA-cleared Image processing systems.

Vision Series PACS imports images and render said images, upon request, within the AMICAS LightBeam Diagnostic Workstation utilizing both lossless (reversible) and lossy (irreversible) compression.

To support the diagnostic interpretation of Mammography studies, Vision Series PACS will display the full fidelity DICOM image in a non-compressed format. Images will be rendered with patient and clinical information clearly displayed as part of the DICOM Overlay as required by MQSA, on monitors cleared by FDA for use in Digital Mammography. Lossy compressed mammography images and digitized film screen images should not be used for the purpose of primary diagnosis. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Within Vision Series PACS 5.5, the AMICAS Real Time Worklist offers real-time status of radiology activity and provides customizable workflow management capabilities. Communication of critical results is facilitated and documented through optional, and configurable, components within the Real Time Worklist.

Vision Reach is an optional component within the PACS 5.5 offering which provides clinicians secure, proactive communication and access to clinical reports and images.

Order and Report information generated by HIS/RIS and report creation systems are received and displayed in PACS via the transmission of HL7 messaging. For this data. AMICAS is not the creator, but instead the downstream recipient which relies on the validity of data from said systems.

Vision Series PACS must be installed on suitable, commercial-standard hardware. It is the user's responsibility to ensure monitor quality, ambient light conditions and image compression ratios are consistent with the clinical application.

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Prescription Use __ レ (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 IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Arun Thaker

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number