AMICAS PACS, VERSION 6.0

K082144 · Amicas, Inc. · LLZ · Sep 5, 2008 · Radiology

Device Facts

• Record ID: K082144
• Device Name: AMICAS PACS, VERSION 6.0
• Applicant: Amicas, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Sep 5, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

AMICAS PACS 6.0 is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, to include Digital Mammography. AMICAS PACS 6.0 receives images acquired from DICOM-compliant medical imaging systems, data from FDA-cleared Computer-Aided Detection systems and other FDA-cleared Image processing systems. AMICAS PACS 6.0 imports images and render said images, upon request, within the viewer component utilizing both lossless (reversible) and lossy (irreversible) compression. To support the diagnostic interpretation of Mammography studies, AMICAS PACS 6.0 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 must 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 AMICAS PACS 6.0, 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. AMICAS PACS 6.0 also offers the Patient Dashboard which provides a single view of all patient data, both imaging and non-imaging. AMICAS Reach is an optional component within AMICAS PACS 6.0 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 PACS 6.0 is not the creator, but instead the downstream recipient which relies on the validity of data from said systems. AMICAS PACS 6.0 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

Software-based Picture Archiving and Communication System (PACS); receives DICOM-compliant images from imaging modalities and FDA-cleared CAD/image processing systems; imports and renders images for soft copy reading; supports lossless/lossy compression; displays full-fidelity DICOM for mammography. Features include Real Time Worklist for workflow management, Patient Dashboard for consolidated patient data, and AMICAS Reach for secure clinician communication. Receives HIS/RIS data via HL7. Operated by radiologists, technologists, and clinicians in clinical settings. Provides tools for image manipulation (enlarging, highlighting, obscuring). Output used by clinicians for diagnostic interpretation; supports clinical decision-making by providing access to images and reports. Benefits include centralized data management, workflow efficiency, and secure communication of critical results.

Clinical Evidence

Bench testing only. Functional verification performed per Software Requirements Specifications. Design validation conducted in real-life client environments by licensed physicians to assess intended use, end-user expectations, and experience. No clinical trial data presented.

Technological Characteristics

Software-based PACS; runs on commercial-standard hardware. Supports DICOM (images, CAD Structured Reports, Grayscale SoftCopy Presentation State) and HL7 (HIS/RIS data). Features lossless/lossy compression. Requires FDA-cleared 5Mpixel monitors for mammography. Connectivity: Networked. Sterilization: N/A (software).

Indications for Use

Indicated for soft copy reading, communication, and storage of digital medical images, including digital mammography. Intended for use by radiologists, technologists, and clinicians. Contraindicated for primary diagnosis using lossy compressed mammography images or digitized film screen 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

• AMICAS Vision Series PACS 5.5 (K073526)

Submission Summary (Full Text)

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AMICAS PACS 6.0 510(k)

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

Date prepared:

July 24, 2008

Submitted by:

AMICAS, Inc. 20, Guest St. Suite 400 Boston, MA 02135

Contact: Contact email: Contact Telephone: Contact Fax:

Device Trade Name: Device Common Name: Regulation number: Device Classification: Name: Predicate Device: Predicate Device Manufacturer:

Predicate Device 510(k) number: Date received: Decision date: Decision: Panel Code Device reviewed by: Panel Code Device classified by: Product Code: Regulation number: Device Classification:

Patrice JC Nedelec [e-mail] 617-779-7858 or 617-372-1331 732-601-2512

AMICAS PACS 6.0 Picture Archiving Communication System (PACS) 892.2050 Class II AMICAS PACS AMICAS Vision Series PACS 5.5 AMICAS Inc. 20 Gucst Street Boston, MA 021235 K073526 12/17/2007 03/12/2008 Substantially equivalent Radiology Radiology LLZ 892.2050 Class II

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#### Device Description, intended use

AMICAS PACS 6.0 is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images. Typical users of AMICAS PACS 6.0 are radiologists, technologists and clinicians.

AMICAS PACS 6.0 is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, to include Digital Mammography. AMICAS PACS 6.0 receives images acquired from DICOM-compliant medical imaging systems, data from FDA-cleared Computer-Aided Detection systems and other FDAcleared Image processing systems.

AMICAS PACS 6.0 imports images and render said images, upon request, within the viewer component utilizing both lossless (reversible) and lossy (irreversible) compression.

To support the diagnostic interpretation of Mammography studies. AMICAS PACS 6.0 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 must 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 AMICAS PACS 6.0, 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.

AMICAS PACS 6.0 also offers the Patient Dashboard which provides a single view of all patient data, both imaging and non-imaging.

AMICAS Reach is an optional component within AMICAS PACS 6.0 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 PACS 6.0 is not the creator, but instead the downstream recipient which relies on the validity of data from said systems.

AMICAS PACS 6.0 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.

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

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#### General Safety Considerations

AMICAS PACS 6.0 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 PACS 6.0, 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.

#### Testing

AMICAS PACS 6.0 is tested with reference to its Software Requirements Specifications, as documented in the Functional Verification Procedure included in this 510(k) filing.

Functional testing is an integral part of AMICAS, Inc. Product Development process known as "VDEV" (Vision Development Elaboration Validation), also documented in this filing (see part G section B).

Before undergoing Functional testing, a PACS application undergoes technical, lowerlevel testing known as "Unit Testing"; related verification, test cases and results are as well documented in this 510(k) filing (see part G section I).

Design Validation activities, as depicted in Part D of this filing, consist of testing in reallife client environments by Licensed Physicians, and address intended use, end-user expectations and experience.

The AMICAS Quality Department, per procedure, independently verifies completeness of all deliverables -to include testing reports and assessment of safety and effectiveness as well as Risk Analysis Record- before issuing a recommendation to release to Management.

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#### Some more detail on CAD SR support and GSPS

CAD (Computer Aided Detection), or more specifically "Mammo CAD Markers" are generated by 3rd party Medical Devices approved by FDA. They are in the form of nonimage DICOM Structured Reports (S/R) and contain vector and text information that is rendered on the image, to show possible areas of concern. The workflow is that the images (study) are captured and imported into the AMICAS system from the imaging modality, and in parallel, the images (study) are also sent to CAD for processing. The output of these the CAD systems are non-imaging DICOM S/R files that also get imported into the AMICAS system.

When the user loads a study, we display the images as we normally do, and provide indicators on the images if these CAD are available. The CAD markers are not displayed initially, only after the user has viewed the images. These markers can be manually turned on.

GSPS (Grayscale SoftCopy Presentation State) is a non-image DICOM format. By default, the initial presentation state of images are derived from a limited number of DICOM tags (such as the initial Window/Level values, or LUT (look up table). GSPS is a much more general format, which provides for many presentation (rendering) parameters (window/level, LUTs, zoom/pan, invert, and orientation) as well as annotations. AMICAS PACS 6.0 uses GSPS objects for our native format, for the rendering parameters as well as annotations. It is possible to take our generated GSPS objects and use them to display it exactly as it appears in AMICAS PACS 6.0 on any DICOM compliant device, assuming it supports GSPS.

Mammography workstations were probably the first to start to use GSPS. It is also the basic of IHE CPI (Consistent Presentation of Images) Profile, so any DICOM device that generates GSPS object can be used as input into our server for studies we display.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol with three curved lines, resembling a person with outstretched arms. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Patrice J.C. Nedelec Director of Quality AMICAS, Inc. 20 Guest Street Suite 400 BOSTON MA 02170

Re: K082144

Trade/Device Name: AMICAS PACS 6.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 28, 2008 Received: July 30, 2008

Dear Ms. 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 (PMA), 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.

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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. B rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

.

Enclosure

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# Indications for Use

510(k) Number (if known):

Device Name: AMICAS PACS 6.0

Indications For Use:

AMICAS PACS 6.0 is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, to include Digital Mammography. AMICAS PACS 6.0 receives images acquired from DICOM-compliant medical imaging systems, data from FDA-cleared Computer-Aided Detection systems and other FDA-cleared Image processing systems.

AMICAS PACS 6.0 imports images and render said images, upon request, within the viewer component utilizing both lossless (reversible) and lossy (irreversible) compression. To support the diagnostic interpretation of Mammography studies, AMICAS PACS 6.0 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 must 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 AMICAS PACS 6.0, 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.

AMICAS PACS 6.0 also offers the Patient Dashboard which provides a single view of all patient data, both imaging and non-imaging.

AMICAS Reach is an optional component within AMICAS PACS 6.0 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 PACS 6.0 is not the creator, but instead the downstream recipient which relies on the validity of data from said systems.

AMICAS PACS 6.0 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 _ (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)

Hut Leeee

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