PEGASYS ULTRA

K993946 · Adac Laboratories · LLZ · Mar 9, 2000 · Radiology

Device Facts

• Record ID: K993946
• Device Name: PEGASYS ULTRA
• Applicant: Adac Laboratories
• Product Code: LLZ · Radiology
• Decision Date: Mar 9, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

Pegasys Ultra is a nuclear medicine image processing and display workstation that provides software applications used to process, analyze, and display medical images/data. The results obtained may be used as a tool, by a nuclear physician, in determining the diagnosis of patient disease conditions in various organs, tissues, and other anatomical structures. The data processed may be derived from any nuclear medicine procedure. The Pegasys Ultra system should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.

Device Story

Pegasys Ultra is a UNIX-based SUN workstation and processing console for nuclear medicine. It receives image data from nuclear medicine gamma cameras; allows operators to process, enhance, and reconstruct data sets; and produces quantitative data from regions of interest. The system features a graphical user interface with icons and menus for applications like Renal Analysis. Operators display images, curves, and text in various color maps, intensities, and zoom factors. The device aids nuclear physicians in determining diagnoses by providing processed images and quantitative analysis. It is intended for use in clinical settings by trained healthcare professionals. The system includes a remote service package (TeleLOGIC).

Clinical Evidence

Bench testing only. Verification and validation testing were performed in compliance with ADAC Laboratories procedures to demonstrate that the device met all specifications and performed equivalently to the predicate device.

Technological Characteristics

UNIX-based SUN workstation; high-resolution graphics display console; software-based image processing applications; menu-driven user interface; supports multi-viewport display; remote service connectivity via TeleLOGIC.

Indications for Use

Indicated for use by nuclear physicians as a tool to process, analyze, and display nuclear medicine images/data for the diagnosis of disease conditions in various organs, tissues, and anatomical structures. Operated by qualified healthcare professionals trained in nuclear medicine equipment.

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

• PEGASYS Nuclear Medicine Imaging Computer (K892358)

Submission Summary (Full Text)

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# 510(k) SUMMARY

K993946

| Submitter name: | ADAC Laboratories, Inc. |
|------------------------|---------------------------------------|
| Submitter Address: | 540 Alder Drive<br>Milpitas, CA 95035 |
| Submitter Telephone: | [phone] |
| Submitter Fax: | [phone] |
| Contact Person: | Janice Brown |
| Date Summary Prepared: | February 23, 2000 |

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## 510(k) SUMMARY

| Device trade name: | PEGASYS Ultra |
|----------------------|-----------------------------------------------------------------------------|
| Common name: | Nuclear Medicine Imaging Workstation |
| Classification name: | Picture Archiving and Communications System<br>(per 21CFR section 892.2050) |
| Predicate Devices: | PEGASYS Nuclear Medicine Imaging Computer, K892358 |

#### Device Description:

Pegasys Ultra is a UNIX-based SUN display workstation and central processor, a high resolution processing console and TeleLOGIC remote service package. It provides for operator interaction with comprehensive ADAC PEGASYS clinical software provided by ADAC Laboratories and includes On-Line User Documentation.

The workstation allows a qualified operator to process and enhance the data, reconstruct data sets, produce quantitative data from regions of interest, display images, curves and text. Images can be displayed in color, show fluorescence intensity, and different zoom factors. Identification parameters include volume, size, and shape. Use of multiple viewports allows the operator to display images with different color maps, intensities, and zoom factors simultaneously. The PEGASYS desktop contains graphic icons allowing selection of an application such as Renal Analysis, and a menu selection, which consists of a main menu and submenus for image processing of the multiple applications.

#### Intended Use:

Pegasys Ultra is a nuclear medicine image processing and display workstation that provides software applications used to process, analyze, and display medical images/data. The results obtained may be used as a tool, by a nuclear physician, in determining the diagnosis of patient disease conditions in various organs, tissues, and other anatomical structures. The data processed may be derived from any nuclear medicine procedure. The Pegasys Ultra system should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.

#### Summary of Technological Characteristics Compared to Predicate Devices:

The predicate device is the "PEGASYS" Nuclear Medicine Imaging Computer, Class II, K892358/A. The FDA determined "PEGASYS" (K892358/A) was substantially equivalent to devices marketed prior to May 28, 1976, the enactment date of the Medical Device Amendments. Both the PEGASYS "Ultra" and the "PEGASYS" Nuclear Medicine Imaging Computer are workstations with SUN UNIX based computers, high resolution graphics and image display consoles for use with ADAC software image processing applications. Both devices use menus and allow the qualified operator to define regions of interest. The PEGASYS "Ultra" software and hardware is more sophisticated, and has progressed with the field of computers and nuclear medicine, but,

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the basic algorithms and original calculations have not changed. The functions have been built into the monoliths and protocols in use today, and in conjunction with the upgraded hardware have added speed and an enhanced user interface for the processing of nuclear images, which aid the physician towards a suggestive diagnosis. Additionally, the acquisition software portion has been removed to a separate computer system and is no longer a part of the base Pegasys software.

#### Summary of Testing

Non-clinical testing was performed for Verification and Validation testing. Testing were completed in compliance with ADAC Laboratories procedures to demonstrate that the Pegasys "Ultra" has met all its specifications, demonstrating substantially equivalent performance to its predicate device, and is safe and effective for its intended use.

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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 or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

19 2000 MAR

Janice E. Brown, RAC Corporate Director, Regulatory Affairs ADAC Laboratories 540 Alder Drive Milpitas, CA 95035

Re:

K993946 Pegasys Ultra Dated: February 23, 2000 Received: February 25, 2000 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Ms. Brown:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the inclusions for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce pror 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). 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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Aproval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requirition (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notfication submission you micht have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requilation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D.

Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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510 (k) NUMBER (IF KNOWN) : __ K993946

DEVICE NAME: __ PEGASYS Ultra

INDICATIONS FOR USE:

Pegasys Ultra is a nuclear medicine image processing and display workstation that provides software applications used to process, and display medical images/data. The results obtained may be used as a tool, by a nuclear physician, in determining the diagnosis of patient disease conditions in various organs, tissues, and other anatomical structures. The data processed may be derived from any nuclear medicine gamma camera. The Pegasys Ultra system should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter-Use_ (Optional Format 1-2-96)

David A. Segner
(Division Sign Off)

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