AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0

K022970 · Amicas, Inc. · LLZ · Nov 22, 2002 · Radiology

Device Facts

• Record ID: K022970
• Device Name: AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0
• Applicant: Amicas, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Nov 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The AMICAS Diagnostic Workstation (ADW) is software intended for viewing and diagnostic interpretation of images acquired from CT, MR, CR, DR, US and other DICOM-compliant medical imaging systems when installed on suitable commercial-standard hardware. The ADW receives imaging studies over a network from AMICAS servers or directly from CD with images utilizing both lossless (reversible) and lossy (irreversible) compression. It is the user's responsibility to ensure that monitor quality, ambient light conditions and image compression ratios are consistent with the clinical application.

Device Story

Software-based diagnostic workstation for viewing/interpreting DICOM-compliant medical images (CT, MR, CR, DR, US). Inputs received via network from servers or CD; supports lossless and lossy JPEG2000 compression. Provides tools for multi-planar reformatting, volume rendering, maximum intensity projection, image measurement, and editing. Operated by radiologists, technologists, and clinicians on commercial-standard hardware. Output displayed on monitors for clinical diagnostic decision-making. Benefits include enhanced visualization of anatomy through 2D/3D reconstruction and efficient image management.

Clinical Evidence

Bench testing only. Verification performed against Software Requirements Specifications. Functional testing conducted as part of the product development process.

Technological Characteristics

Software-only diagnostic workstation. Operates on commercial-standard computer hardware. Supports DICOM image data. Features include multi-planar reformatting, volume rendering, maximum intensity projection, and JPEG2000 compression (lossless/lossy).

Indications for Use

Indicated for viewing and diagnostic interpretation of medical images (CT, MR, CR, DR, US) 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

• Voxar Plug'n View 3D, Version 1.0 (K992654)

Submission Summary (Full Text)

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022970

## 510(k) Summary of Safety and Effectiveness - as required by section 807.92(c)

| Date prepared: | September 1, 2002 | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Submitted by: | Amicas, Inc.<br>20, Guest St.<br>Boston, MA 02135 | |
| Contact:<br>Contact email:<br>Contact Telephone:<br>Contact Fax: | Patrice Nedelec<br>[e-mail]<br>617-779-7858<br>617-783-7209 or 617-779-7879 | |
| Device Trade Name:<br>Device Common Name:<br>Regulation number:<br>Device Classification:<br>Name:<br>Predicate Device:<br>Predicate Device Manufacturer: | Amicas Light Beam Workstation<br>Picture Archiving Communication System (PACS)<br>892.2050<br>Class II<br>Diagnostic Workstation<br>Voxar Plug'n View 3D, Version 1.0<br>Voxar Limited<br>Bonnington Bond<br>2 Anderson Pl.<br>Edinburgh, UK EH6 5NP | |
| Predicate Device 510(k) number:<br>Date received:<br>Decision date:<br>Decision:<br>Panel Code Device reviewed by:<br>Panel Code Device classified by:<br>Product Code:<br>Regulation number:<br>Device Classification: | K992654<br>08/09/1999<br>11/05/1999<br>Substantially equivalent<br>Radiology<br>Radiology<br>LLZ<br>892.2050<br>Class II | |

Device Description and intended use:

AMICAS Light Beam Workstation (ALBW) 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 ALBW are radiologists, technologists and clinicians.

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| Feature | ALBW | Voxar Plug'n View 3D<br>version 1.0 |
|----------------------------------|------|-------------------------------------|
| Software Only | Yes | Yes |
| Image Measurements | Yes | Yes |
| Multi-planar reformatting | Yes | Yes |
| Volume Rendering | Yes | Yes |
| Maximum Intensity | Yes | Yes |
| Projection | Yes | Yes |
| Image editing | Yes | Yes |
| Printing | Yes | Yes |
| DICOM Images | Yes | Yes |
| Lossless JPEG2000<br>Compression | Yes | No |
| Lossy JPEG2000<br>Compression | Yes | No |

Technological characteristics:

General Safety Considerations

ALBW 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.

The ALBW 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:

ALBW 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)

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing right, with flowing lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 2002

Mr. Patrice Nedelec Director, Quality Assurance and Regulatory Affairs Amicas, Inc. 20 Guest St. BOSTON MA 02135

Re: K022970

Trade/Device Name: Amicas Light Beam Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: September 1, 2002 Received: September 6, 2002

Dear Mr. Nedelec:

This letter corrects our substantially equivalent letter of November 22, 2002, regarding the incorrect address.

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 iddications for use stated in the enclosure) to legally marketed predicate devices marketed in interent commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmint or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drig and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You, Diug, therefore, market the device, subject to the general controls provisions of the Act. The greneral 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 additional controls. Existing major regulations affecting your device an 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.

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. Your must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Mr. Nedelec

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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number [phone] or at [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

David A. Sezmann

Nora S. Bozeman

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

Enclosure

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Page 1 of 1

510(k) Number (if known): Ko22970

Device Name: Amicas Light Beam Workstation

Indications For Use:

The AMICAS Diagnostic Workstation (ADW) is software intended for viewing and diagnostic interpretation of images acquired from CT, MR, CR, DR, US and other DICOM-compliant medical imaging systems when installed on suitable commercial-standard hardware. The ADW receives imaging studies over a network from AMICAS servers or directly from CD with images utilizing both lossless (reversible) and lossy (irreversible) compression. It is the user's responsibility to ensure that monitor quality, ambient light conditions and image compression ratios are consistent with the clinical application.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional format 3-10-98)

*Prescription Use*

Daniel G. Loomis

(Division Sign-Off) Division of Reproductive, Abdon and Radiological Device 510(k) Number