POWERVIEW ULTRASOUND WORKSTATION, UIDM-400A

K992886 · Toshiba America Medical Systems, In.C · LLZ · Nov 9, 1999 · Radiology

Device Facts

• Record ID: K992886
• Device Name: POWERVIEW ULTRASOUND WORKSTATION, UIDM-400A
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: LLZ · Radiology
• Decision Date: Nov 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

This device is to serve as a workstation for the capture, storage, review and analysis of ultrasound images, both still and dynamic. This device is designed to support functional diagnosis by performing display, processing, measurement and analysis of ultrasound images.

Device Story

PowerView Ultrasound Workstation (UIDM-400A) is a digital workstation integrated with Toshiba PowerVision diagnostic ultrasound scanners. Input consists of still and dynamic ultrasound image data. Device transforms inputs via software-based processing to enable image viewing, annotation, storage, analysis, and 3D reconstruction. System comprises a standard desktop PC, keyboard, mouse, and cables. Used in clinical settings by healthcare professionals to support functional diagnosis. Output is displayed on the workstation monitor, allowing clinicians to review and measure images to inform clinical decision-making and patient diagnosis.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and verification/validation of software functions equivalent to previously cleared predicate devices.

Technological Characteristics

Desktop PC-based workstation; integrates with Toshiba PowerVision ultrasound scanners. Functions include image capture, storage, review, analysis, and 3D reconstruction. Software-based processing. Manufacturing facility is ISO-9001 certified.

Indications for Use

Indicated for the retrieval, storage, analysis, reconstruction, and display of passive and active ultrasound images for diagnostic support.

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

• Toshiba Workstation, UIWS-300A (K982976)
• Dicomit Image Manager (K990248)
• Tomtec Echo-Scan (K963807)

Submission Summary (Full Text)

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K99.2886

NOV - 9 1999

| | 510(k) Summary |
|--|----------------|
|--|----------------|

| Date: | 25 August 1999 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive, |
| Submitter's Contact: | Tustin, CA 92781-2068<br>Paul Biggins, Regulatory Affairs Specialist, [phone] |
| Establishment Registration<br>Number: | 2020563 |
| Device Proprietary Name: | PowerView Ultrasound Workstation, UIDM-400A |
| Common Name: | Picture Archiving and Communications System |
| Regulatory Class: | Class II per 21 CFR § 892.2050; 90LLZ |
| Predicate Device: | Toshiba Workstation, UIWS-300A (K982976)<br>Dicomit Image Manager (K990248)<br>Tomtec Echo-Scan (K963807) |
| Reason For Submission | New Product |

## Description of this Device:

The UIDM-400A. PowerView Ultrasound Workstation, is an all digital workstation that can be integrated with the Toshiba PowerVision diagnostic ultrasound scanners. Its function is to provide the user with the ability to view images, annotate images, store image data and perform analysis on image data. The unit is comprised of a standard desktop type personal computer, keyboard, mouse, and connecting cables.

## Summary of Intended Uses:

This device is to serve as a workstation for the capture, storage, review and analysis of ultrasound images, both still and dynamic. This device is designed to support functional diagnosis by performing display, processing, measurement and analysis of ultrasound images.

## Comparison to Predicate Device

The user features of the UIDM-400A PowerView Ultrasound Workstation are similar to the functions included in the three predicate device does not offer any new functions that have not received previous market clearance from the Agency.

## Safety Considerations:

The UIDM-400A is comprised of a personal computer that is mounted into the Toshiba PowerVision Ultrasound System. The software is comprised of various vendor programs that have received previous 510k clearances. The verification and validation testing is equivalent to that of the testing reported in previous 510k submissions. This system poses no new safety concerns or efficacy concerns that were not addressed in previous submissions. The manufacturing facility is ISO-9001 certified and follows the Quality System Regulations as administered by the Food and Drug Administration.

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Re:

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 9 1999

Paul Biggins Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. 2441 Michelle Dr. Tustin, CA 92781

K992886 PowerView Ultrasound Workstation Model UIDM-400A Dated: August 25, 1999 Received: August 26, 1999 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Mr. Biggins:

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, 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 vour 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 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 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 submission 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 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 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 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,

[signature]

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

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Page __ 1 __ of ______________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: __ PowerView Ultrasound Workstation, UIDM-400A

Indications for Use:

Retrieval and storage of both passive and active ultrasound images Analysis of ultrasound images Reconstruction and display of three dimensional images.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use _

David b. Glynn

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

(Optional Format 1-2-96)