ULTRAEXTEND USWS-900A

K082596 · Toshiba America Medical Systems, In.C · LLZ · Sep 23, 2008 · Radiology

Device Facts

• Record ID: K082596
• Device Name: ULTRAEXTEND USWS-900A
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: LLZ · Radiology
• Decision Date: Sep 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

The intended use is for displaying and analyzing ultrasound images for medical diagnosis in cardiac and general examinations.

Device Story

USWS-900A UltraExtend is a software package for existing workstations; receives 2D, M-mode, spectral Doppler, and 3D ultrasound data via DICOM. Software provides measurement packages previously cleared on the SSH-880CV Artida Diagnostic Ultrasound System. Used by physicians for medical diagnosis in cardiac and general examinations. Output consists of displayed and analyzed ultrasound images to assist clinical decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence is based on the device's use of measurement packages previously cleared on the predicate SSH-880CV system.

Technological Characteristics

Software package for DICOM-compatible workstations. Supports 2D, M-mode, spectral Doppler, and 3D ultrasound data. Implements measurement packages derived from the SSH-880CV Artida Diagnostic Ultrasound System.

Indications for Use

Indicated for use by qualified physicians for displaying and analyzing ultrasound images for medical diagnosis in cardiac and general examinations.

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

• TomTec Image-Arena Applications (k071232)
• Toshiba, SSH-880CV, Artida Diagnostic Ultrasound System (k080160)

Submission Summary (Full Text)

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## Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) USWS-900A, UltraExtend

K082596

SEP 2 3 2008

## 510(k) Summary

| Date: | May 12, 2008 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive,<br>Tustin, CA 92781-2068 |
| Submitter's Contact: | Paul Biggins, Regulatory Affairs Specialist,<br>[phone] |
| Establishment Registration<br>Number: | 2020563 |
| Device Proprietary Name: | USWS-900A; UltraExtend Ultrasound<br>WorkStation Package |
| Common Name: | System, Image Processing, Radiological |
| Regulatory Class: | II [21CFR820.2050, .1560, .1550] |
| Performance Standard: | None |
| Predicate Device(s): | TomTec Image-Arena Applications [k071232]<br>Toshiba, SSH-880CV, Artida Diagnostic<br>Ultrasound System [k080160] |
| Reason for Submission | New Device |

#### Description of this Device:

The USWS-900A is a software package that may be applied to an existing workstation that is capable of receiving 2D, M-mode, spectral Doppler and 3D data sets via DICOM. This software consists of measurement packages that were cleared on the predicate device, SSH-880CV Artida Diagnostic Ultrasound System.

## Summary of Intended Uses:

The intended use is for displaying and analyzing ultrasound images for medical diagnosis in cardiac and general examinations.

## Safety and Effectiveness Concerns:

This software package is designed and manufactured in compliance with the Quality System Regulation. This device does not offer new indications or functions that have not

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## Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) USWS-900A, UltraExtend

been cleared via the predicate devices, nor does it offer functions that are not already available through 510(k) cleared devices that are commercially available in the U.S.

#### Substantial Equivalence:

This software package provides information to the user that is similar to that which is provided by the predicate devices. The information is obtained in a manner that is similar to the predicate devices, or in a manner that is a combination of the predicate devices. Additionally, the indications for use and intended uses are identical to the predicate devices. There are no new indications for use that are not already available in devices already marketed in the U.S.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms. The symbol is composed of three curved lines that create a sense of movement and dynamism.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP & 3 2008

Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K082596

Trade/Device Name: USWS-900A, UltraExtend Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 5, 2008 Received: September 8, 2008

#### Dear Mr. Job:

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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#### Page 2

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 (OS) 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (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 Biometrics' (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 yours.

loque M. Whang

Joyce M. Whang, Ph.D. Acting 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: USWS-900A, UltraExtend

Indications for Use:

The USWS-900A Ultrasound Workstation, when used by a qualified physician, is intended for displaying and analyzing ultrasound images for medical diagnosis in cardiac and general examinations.

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 Device Evaluation (ODE)

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(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _

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