(183 days)
No
The summary describes post-processing software for ultrasound images and does not mention AI, ML, or related concepts.
No
The device is described as a software package for image processing and analysis of diagnostic ultrasound data, not for treating any condition or ailment.
No
The device is a software for post-processing and viewing data from diagnostic ultrasound systems. It does not acquire diagnostic data itself, but rather allows for the observation and analysis of already acquired examination data. The description explicitly states it provides a "seamless image reading environment from examination using the diagnostic ultrasound system to diagnosis using the PC," implying the diagnostic function resides within the original ultrasound system.
Yes
The device is described as a "software package" installed on a general-purpose PC for post-processing ultrasound data. It does not include any hardware components.
Based on the provided information, it is unlikely that the UltraExtend FX (TUW-U001S) is an IVD (In Vitro Diagnostic) device. Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- UltraExtend FX's Function: The description clearly states that UltraExtend FX is a software package that processes examination data acquired with specified diagnostic ultrasound systems. Ultrasound is an imaging modality that examines the body directly, not through in vitro analysis of specimens.
- Intended Use: The intended use is to "observe images and perform analysis using the examination data acquired with specified diagnostic ultrasound systems." This aligns with post-processing of in vivo imaging data, not in vitro diagnostic testing.
- Lack of Specimen Handling: There is no mention of handling or analyzing biological specimens.
In summary, UltraExtend FX is a post-processing software for ultrasound imaging data, which is not considered an IVD.
N/A
Intended Use / 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.
Product codes
LLZ, IYN, and IYL
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Verification and validations tests were conducted on the subject device through bench testing to confirm device safety and effectiveness.
Key Metrics
Not Found
Predicate Device(s)
UltraExtend Workstation (Model USWS-900A)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
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Toshiba America Medical Syst Pre-Market Notification 510(k) UltraExtend FX, TUW-U001S
510(k) SUMMARY AND EFFECTIVENESS
OCT
-
- DEVICE NAME:
System, Image Processing, Radiological Generic Name: Ultrasound Workstation Package, UltraExtend FX Trade/ Proprietary Name: TUW-U001S Model Name:
- DEVICE NAME:
2. ESTABLISHMENT REGISTRATION: 2020563
3. CONTACT PERSON AND U.S AGENT INFORMATION:
Charlemagne Chua Contact Person: Manager, Regulatory Affairs (714) 730-5000
U.S. Agent Name: Paul Biggins Director, Regulatory Affairs (714) 730-5000 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
- 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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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):
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