ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE

K121076 · Toshiba America Medical Systems, In.C · LLZ · Oct 9, 2012 · Radiology

Device Facts

• Record ID: K121076
• Device Name: ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: LLZ · Radiology
• Decision Date: Oct 9, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The UltraExtend FX (TUW-U001S) is designed to allow the user to observe images and perform analysis using the examination data acquired with specified diagnostic ultrasound systems Aplio 500, Aplio 400 and Aplio 300.

Device Story

UltraExtend FX is post-processing software installed on a general-purpose PC; enables loading and analysis of diagnostic ultrasound data acquired from Aplio 300, 400, and 500 systems. Provides seamless image reading environment; implements functionality equivalent to diagnostic ultrasound systems. Features include basic measurement, cardiac measurement, vascular measurement, stress echo, 4D review, Elastography, Auto-IMT, and 2D wall motion tracking. Used by clinicians in a reading environment to observe images and perform analysis; output facilitates clinical decision-making by extending diagnostic capabilities from the ultrasound system to a PC workstation.

Clinical Evidence

Bench testing only. Verification and validation tests were conducted to confirm device safety and effectiveness. No clinical data provided.

Technological Characteristics

PC-based software package. Implements functionality equivalent to diagnostic ultrasound systems. Supports 2D, M-mode, spectral Doppler, 4D review, Elastography, Auto-IMT, and 2D wall motion tracking. Software development follows IEC 62304 standards.

Indications for Use

Indicated for users to observe and analyze diagnostic ultrasound examination data acquired from Aplio 300, 400, and 500 systems. Prescription use only.

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

• UltraExtend (Model USWS-900A)

Reference Devices

• Aplio 500/400/300 Diagnostic Ultrasound System (K110870)

Submission Summary (Full Text)

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K121076

Toshiba America Medical Syst Pre-Market Notification 510(k) UltraExtend FX, TUW-U001S

#### 510(k) SUMMARY AND EFFECTIVENESS

OCT

- 1. DEVICE NAME:
System, Image Processing, Radiological Generic Name: Ultrasound Workstation Package, UltraExtend FX Trade/ Proprietary Name: TUW-U001S Model Name:

#### 2. ESTABLISHMENT REGISTRATION: 2020563

# 3. CONTACT PERSON AND U.S AGENT INFORMATION:

Charlemagne Chua Contact Person: Manager, Regulatory Affairs [phone]

U.S. Agent Name: Paul Biggins Director, Regulatory Affairs [phone] Establishment Name and Address: Toshiba America Medical Systems, Inc. 2441 Michelle Drive Tustin, CA. 92780

Toshiba Medical Systems Corporation 4. MANUFACTURING SITE: 1385 Shimoishigami Otawara-shi, Tochigi 324-8550 Japan

5. DATE OF SUBMISSION: April 3, 2012 (revised August 3, 2012)

#### 6. DEVICE DESCRIPTION:

UltraExtend FX is a software package that can be installed in a general-purpose personal computer (PC) to enable data acquired from Aplio diagnostic ultrasound system (Aplio 300, Aplio 400 and Aplio 500), to be loaded onto the PC for image processing with other application software product. UltraExtend FX is a post-processing software that implements functionality and operability equivalent to that of the diagnostic ultrasound system, providing a seamless image reading environment from examination using the diagnostic ultrasound system to diagnosis using the PC.

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#### 7. INDICATION FOR USE

The UltraExtend FX (TUW-U001S) is designed to allow the use to observe images and perform analysis using the examination data acquired with specified diagnostic ultrasound systems Aplio 300, Aplio 400 and Aplio 500.

#### DESIGN CHANGE 8.

The change allows the ability for the UltraExtend FX Workstation to process images from the Aplio Ultrasound System.

### 9. SUMMARY OF DESIGN CONTROL ACTIVITIES

PS Risk List for software is attached. Risk Analysis and Design Reviews were conducted. Verification and validations tests were conducted on the subject device through bench testing to confirm device safety and effectiveness. IEC 62304 processes was implemented in the development of the subject device. A declaration of conformity with design controls is included in this submission.

#### 10. TRUTHFUL AND ACCURACY CERTIFICATION

A certification of the truthfulness and accuracy of the UltraExtend FX Workstation described in this submission is provided in this submission.

#### 11. SUBSTANTIAL EQUIVALENCE

UltraExtend (Predicate) is a software that can be installed in a general-purpose personal computer (PC) to enable data acquired using diagnostic ultrasound systems (Aplio Artida SSH-880CV, Aplio XG SSA-790A, or Xario XG SSA-680A) to be loaded onto the PC for various application software programs. This software (UltraExtend) implements functions and operability of the basic measurement, cardiac application measurements using 2D, M and spectral Doppler, and report generation.

UltraExtend FX (Subiect) is designed to allow the user to observe images and perform analysis using the examination data acquired from an Aplio diagnostic ultrasound system (Aplio 300, Aplio 400 and Aplio 500), It has the application of basic measurement, cardiac measurement, vasicular measurement, stress echo, 4D review, Elastography, Auto-IMT and 2D wall motion tracking.

UltraExtend (Model USWS-900A) and UltraExtend FX (Model TUW-U001S) Ultrasound Workstation Package are capable of acquiring images from a specific ultrasound diagnostic systems and perform analysis. Their applications are not the same but the intended use of the software is the same. The UltraExtend FX has been found substantially equivalent to the previously cleared UltraExtend Workstation (Model USWS-900A) and Aplio 500/400/300 Diagnostic Ultrasound System (K110870) referenced in this submission.

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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 stylized eagle with three stripes representing the three branches of government. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

OCT

Toshiba Medical Systems Corporation, Japan % Ms. Charlemagne Chua Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K121076

Trade/Device Name: UltraExtend FX, TUW-U0001S, v2.02 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, IYN, and IYL Dated: September 28, 2012 Received: October 1, 2012

#### Dear Ms. Chua:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Janine M. Morris

Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

K121076

Device Name:

UltraExtend FX, TUW-U001S, v2.02

Indications for Use:

The UltraExtend FX (TUW-U001S) is designed to allow the user to observe images and perform analysis using the examination data acquired with specified diagnostic ultrasound systems Aplio 500, Aplio 400 and Aplio 300.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Signature

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K121076