(33 days)
No
The summary describes postprocessing software for ultrasound images with functionality equivalent to the original ultrasound system. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies. The focus is on image processing and providing a seamless reading environment.
No
The device is described as software for displaying and analyzing ultrasound images for medical diagnosis. It does not provide any form of treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the software is "intended for displaying and analyzing ultrasound images for medical diagnosis". The "Device Description" also mentions providing "a seamless image reading environment from examination using the diagnostic ultrasound system to diagnosis using the PC."
Yes
The device is explicitly described as a "software package" that is installed on a general-purpose PC and processes data acquired from separate ultrasound systems. The description focuses solely on the software's functionality and validation, without mentioning any accompanying hardware components included with the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "displaying and analyzing ultrasound images for medical diagnosis in cardiac and general examinations." This describes a device that processes and presents images obtained from a patient's body, not a device that analyzes samples taken from the body (like blood, urine, or tissue).
- Device Description: The description clearly states it's "postprocessing software that implements functionality and operability equivalent to that of the diagnostic ultrasound system the data was acquired from." This reinforces its role in handling and displaying imaging data, not analyzing biological samples.
- Input Imaging Modality: The input is "Ultrasound," which is an imaging technique applied to the body, not a method for analyzing biological samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This software operates on images generated by an ultrasound system, which is a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
This software is intended for displaying and analyzing ultrasound images for medical diagnosis in cardiac and general examinations.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, IYN
Device Description
UltraExtend USWS-900A v2.1 and v3.1 is a software package that can be installed in a general-purpose personal computer (PC) to enable data acquired from Aplio diagnostic ultrasound systems (Aplio XG, Aplio MX, Aplio Artida, Aplio 300, Aplio 400 and Aplio 500), to be loaded onto a PC for image processing with other application software product. UltraExtend USWS-900A v2.1 and v3.1 is a postprocessing software that implements functionality and operability equivalent to that of the diagnostic ultrasound system the data was acquired from, 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
medical diagnosis
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Risk Analysis, Verification/Validation testing conducted through bench testing, as well as software validation documentation as required by the FDA Guidance Document titled, "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices," are presented in TABS 5 and 7. This documentation demonstrates that the device meets established performance and safety requirements and is therefore deemed safe and effective. Additionally, IEC 62304 processes were implemented in the development of the subject device.
UltraExtend USWS-900A v2.1 and v3.1 did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string appears to be a combination of letters and numbers. The string starts with the letter 'K', followed by the numbers '131822'. The characters are written in a cursive style, with some of the numbers connected to each other.
ТОЯНІВА АМЕRICA MEDICAL БУБТЕМБ, INC. 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-5000
510(k)-SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with 21 CFR 807.92, the following summary of the information is provided.
-
- Submitter's Name: Toshiba America Medical Systems, Inc.
-
- Submitter's Address: 2441 Michelle Drive Tustin, CA 92781-2068
-
- Establishment Registration Number: 2020563
-
- Contact Person: Charlemagne Chua Manager Regulatory Affairs (714) 730-5000
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- Date Prepared: February 25, 2013
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- Device Proprietary Name: UltraExtend USWS-900A, v2.1 UltraExtend USWS-900A, v3.1
7. Common Name: System, Picture Archiving and Communications
-
- Classification: 21 CFR §892.2050 Class II
Product Code: LLZ
- Classification: 21 CFR §892.2050 Class II
-
- Predicate Devices:
| Product | Marketed by | 510(k) Number | Clearance Date |
|---|---|---|---|
| UltraExtend | Toshiba America | K082596 | September 23, 2008 |
| USWS-900A | Medical Systems | ||
| UltraExtend FX | Toshiba America | K121076 | October 9. 2012 |
| TUW-U001S v2.02 | Medical Systems |
JUL 2 3 2013
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10. Reason for Submission:
Modification of the cleared device UltraExtend USWS-900A, K082596
11. Device Description:
UltraExtend USWS-900A v2.1 and v3.1 is a software package that can be installed in a general-purpose personal computer (PC) to enable data acquired from Aplio diagnostic ultrasound systems (Aplio XG, Aplio MX, Aplio Artida, Aplio 300, Aplio 400 and Aplio 500), to be loaded onto a PC for image processing with other application software product. UltraExtend USWS-900A v2.1 and v3.1 is a postprocessing software that implements functionality and operability equivalent to that of the diagnostic ultrasound system the data was acquired from, providing a seamless image reading environment from examination using the diagnostic ultrasound system to diagnosis using the PC.
12. Indications for Use:
This software is intended for displaying and analyzing ultrasound images for medical diagnosis in cardiac and general examinations.
13. Determination of Substantial Equivalence:
UltraExtend USWS-900A v2.1 and v3.1 functions in a manner similar to and is intended for the same use as the predicate devices UltraExtend, USWS-900A (K082596) and UltraExtend FX (K121076), marketed by Toshiba America Medical Systems.
UltraExtend USWS-900A v2.1 and v3.1 include modifications to the previously cleared device, UltraExtend USWS-900A, which allows data acquired by Aplio 300, Aplio 400 and Aplio 500 Diagnostic Ultrasound Systems (K121422) to be accessible on a PC running UltraExtend USWS-900A v2.1 and v3.1. Additionally, two applications, CHI-Q and TDI-Q, as well as the new feature, 2D wall motion tracking for the images acquired by the Aplio 300, Aplio 400 and Aplio 500 were added. UltraExtend USWS-900A v2.1 runs under Windows XP and v3.1 runs under Windows 7.
UltraExtend USWS-900A v2.1 and v3.1 employs the same fundamental scientific technology as the predicate devices.
A complete comparison of the subject device versus the predicate devices is available in TAB 3 of this submission.
14. Safety:
This device is designed and manufactured under the Ouality System Regulations as outlined under 21 CFR§820 and ISO 13485 Standards.
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15. Summary of Testing:
Software Documentation a.
Risk Analysis, Verification/Validation testing conducted through bench testing, as well as software validation documentation as required by the FDA Guidance Document titled, "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices," are presented in TABS 5 and 7. This documentation demonstrates that the device meets established performance and safety requirements and is therefore deemed safe and effective. Additionally, IEC 62304 processes were implemented in the development of the subject device.
b. Clinical Test
UltraExtend USWS-900A v2.1 and v3.1 did not require clinical studies to support substantial equivalence.
16. Conclusion:
The modifications implemented in the subject device do not change the the intended use of the device. Based upon the safety and effectiveness data/information provided, the clinical performance of UltraExtend USWS-900A v2.1 and v3.1 are deemed to be substantially equivalent to the predicate devices.
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Image /page/3/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 that resembles an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 23, 2013
Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street N W BUFFALO MN 55313
Re: K131822
Trade/Device Name: UltraExtend USWS-900A v2.1 and v3.1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ and IYN Dated: June 19, 2013 Received: June 20, 2013
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Job
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.ltm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K131822
Device Name: UltraExtend, USWS-900A, v2.1 and v3.1
Indications for Use:
This software 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 In Vitro Diagnostics and Radiological Health (OIR)
Sm(i,j)
(Division Sign-Off) Division of Radiological Health Office of In Viro Diagnostics and Radiological Health
510(k) K131822 ___________
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