DDS, DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3000, (AMONGST OTHER NAMES)

K993532 · Impax Technology, Inc. · LLZ · Dec 15, 1999 · Radiology

Device Facts

• Record ID: K993532
• Device Name: DDS, DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3000, (AMONGST OTHER NAMES)
• Applicant: Impax Technology, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Dec 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

DDS software is combined with appropriate hardware to form a diagnostic review station. DDS is used to display and manipulate patient images and demographic information, for diagnostic, review and referral purposes. It is a software package which may be marketed as a software only solution, or in conjunction with standard hardware. DDS can be used as a stand-alone system or in connection with a larger system.

Device Story

DDS is a diagnostic review station software package; operates on standard PC (Windows NT) or Unix (Solaris) hardware. Inputs include patient images and demographic data; system enables image retrieval, transmission over networks/phone lines, digital processing, measurement, and annotation. Used by clinicians for diagnostic review and referral; functions as a standalone system or integrated into larger imaging networks. Output is high-quality image display for clinical decision-making; benefits include efficient access to diagnostic information and improved workflow for image review.

Clinical Evidence

Bench testing only. Software underwent extensive testing by programmers, quality assurance specialists, and potential customers using standard procedures including automated and manual test plans.

Technological Characteristics

Software-based diagnostic review station; runs on standard PC (Windows NT) or Unix (Solaris) hardware. Features image processing, measurement, and annotation tools. Connectivity via network or phone lines for image retrieval and transmission.

Indications for Use

Indicated for diagnostic, review, and referral purposes involving the display and manipulation of patient images and demographic information in a clinical setting.

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

• Radworks Medical Imagining Software with Quality Control Module

Submission Summary (Full Text)

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

K993532

## 510K Summary of Safety and Effectiveness for DDS

DEC 1 5 1990

### COMPANY INFORMATION:

Impax Technology Inc., 455 Phillip Street, Waterloo, Ontario Canada N2L 3X2

Phone: [phone] Fax: [phone]

#### CONTACT:

Paula Pfeifle, Regulatory Affairs

# DATE OF SUBMISSION:

October 18, 1999

#### DEVICE:

DEVICE NAME: DDS

TRADE/PROPRIETARY NAME: DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3000, (amongst other names)

COMMON NAME: Diagnostic Review Station CLASSIFICATION NAME: System, Image Processing

#### DEVICE DESCRIPTION AND INTENDED USE:

DDS software is combined with appropriate hardware to form a diagnostic review station. DDS is used to display and manipulate patient images and demographic information, for diagnostic, review and referral purposes. It is a software package which may be marketed as a software only solution, or in conjunction with standard hardware. DDS can be used as a stand-alone system or in connection with a larger system.

#### SUBSTANTIAL EQUIVALENCE DEVICE:

Radworks Medical Imagining Software with Quality Control Module

#### SUBSTANTIAL EQUIVALENCE TECHNOLOGICAL COMPARISON:

Both DDS and Radworks are sold as software packages which can be used on standard PC hardware with Windows NT, and the DDS can also be used on standard Unix hardware with Solaris.

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

Both systems can query, retrieve, and transmit medical images over phone lines or networks. Both systems provide high quality display capability. Both systems allow digital processing, measurement and annotation of images.

### SUBSTANTIAL EQUIVALENCE NON-CLINICAL PERFORMANCE AND TEST DATA:

Software testing follows standard procedures: test plans are developed, testing is carried out through a variety of automated and manual testing, and test results are recorded and reported. The DDS software has been extensively tested by programmers, quality assurance specialists, and potential customers.

#### SUBSTANTIAL EQUIVALENCE CONCLUSIONS:

Impax Technology Inc. concludes that the intended use for the DDS is that same as that of the predicate device, and that the technological characteristics demonstrate that they are equivalent to the predicate device. Thus, this premarket notification has demonstrated Substantial Equivalence.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with the profiles overlapping to create a sense of unity. The profiles are rendered in black, and the text is also in black.

Food and Drug Administration 1 9200 Corporate Boulevard Rockville MD 20850

DEC 1 5 1999

Paula Pfeifle Regulatory Affairs Impax Technology, Inc. 455 Phillip Street Waterloo, Ontario Canada N2L 3X2

Re:

K993532 DDS Software (Diagnostic Image Review Station) Dated: October 18, 1999 Received: October 19, 1999 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Ms. Pfeifle:

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 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). You may, therefore, 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 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 Requlations, 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 Regulation (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 notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 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 labeling requlation (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 regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# Statement of Indications of Use

510(k) Number: K993532

Device Name: Impax Technology Inc., DDS

Indications for Use:

DDS software is combined with appropriate hardware to form a diagnostic review station. DDS is used to display and manipulate patient images and demographic information, for diagnostic, review and referral purposes. It is a software package which may be marketed as a software only solution, or in conjunction with standard hardware. DDS can be used as a stand-alone system or in connection with a larger system.

### (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE)

David C. Segerson

ision of Reproductive, Abdominal, ENT and Radiological D 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over the Counter Use