(90 days)
This device is to serve as a workstation for the capture, storage, review and analysis of ultrasound images, both still and dynamic. This devices is designed to support functional diagnósis by performing display, processing, measurement and analysis of ultrasound images.
Retrieval and storage of both passive and active ultrasound images
Analysis of ultrasound images
The UIWS-300A, Ultrasound Workstation, is an all digital workstation that can be connected to Toshiba PowerVision diagnostic ultrasound scanners. Its function is to provide the user with the ability to view images, annotate image data and perform analysis on image data. The unit is comprised of a standard desktop type personal computer, keyboard, mouse, monitor and connecting cables.
This 510(k) submission describes an Ultrasound Workstation, UIWS-300A, which is an all-digital workstation designed to capture, store, review, and analyze ultrasound images. It is not a device that uses an AI algorithm to perform diagnosis or analysis, but rather a tool for human users to perform these functions. Therefore, many of the typical acceptance criteria and study elements associated with AI/ML-enabled devices are not applicable.
Here's an analysis based on the provided text, while acknowledging the device's nature:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a workstation for viewing and analyzing images, the 'acceptance criteria' are primarily related to its functional performance and compliance with relevant standards, rather than diagnostic accuracy metrics like sensitivity or specificity.
| Acceptance Criteria Category | Specific Criteria/Standard | Device Performance (Based on submission) |
|---|---|---|
| Image Storage | DICOM SCU Storage | Conforms to DICOM SCU Storage |
| Monitor Testing | JIS C6101 | Conforms to JIS C6101 |
| Safety | IEC 60601-1-1 (AMD1) [1992] | Conforms to IEC 60601-1-1 (AMD1) [1992] |
| Image Compression | Compressed -AVI format (MJPEG) | Supports compressed AVI format (MJPEG) |
| Non-compressed - IMG format | Supports non-compressed IMG format | |
| Intended Use Fulfillment | Ability to view images, annotate image data, perform analysis on image data. | "Its function is to provide the user with the ability to view images, annotate image data and perform analysis on image data." "This device is to serve as a workstation for the capture, storage, review and analysis of ultrasound images, both still and dynamic." |
| Substantial Equivalence | Compared to Nova MicroSonics, Image View DCR (K961972) | "The user features of the UIWS-300A Ultrasound Workstation and the Nova MicroSonics Image Vue DCR (K) are very similar." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the submission. For a device like this, the "test set" would likely refer to a set of images or data used to verify the proper functioning of the workstation's display, storage, and analysis tools. The submission focuses on functional conformance and substantial equivalence, not retrospective or prospective studies on diagnostic accuracy.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided and is not applicable for this type of device. The UIWS-300A is a tool that allows human experts (e.g., radiologists, sonographers) to analyze images. It does not generate its own "ground truth" or diagnostic output that would require expert consensus for verification in the context of FDA clearance.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers or an AI algorithm make a diagnostic call, and discrepancies need to be resolved to establish a definitive ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done and is not relevant for this device. Such studies are typically performed for AI/ML diagnostic tools to assess whether the AI improves human reader performance (e.g., sensitivity, specificity, reading time). The UIWS-300A is a workstation, not a diagnostic AI.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was not done and is not applicable. This device is a workstation designed for human interaction; it does not have a standalone algorithm that performs diagnostic tasks independently of a human operator. Its performance is related to its ability to display, store, and process images as intended.
7. Type of Ground Truth Used
The concept of "ground truth" as a diagnostic reference (e.g., pathology, outcomes data) is not applicable to this device in the context of its regulatory clearance. The "ground truth" for this device's performance would be against functional specifications and standards (e.g., does it accurately display DICOM images? Does it perform measurements correctly?).
8. Sample Size for the Training Set
This information is not provided and is not applicable. As a workstation, the UIWS-300A does not employ machine learning or AI algorithms that require a "training set" of data in the diagnostic sense. Its development involved software engineering and hardware integration, not data-driven model training.
9. How Ground Truth for the Training Set Was Established
This information is not provided and is not applicable. Since there is no "training set" in the context of machine learning, there is no process for establishing its ground truth.
In summary, the provided 510(k) submission for the Toshiba UIWS-300A Ultrasound Workstation focuses on demonstrating substantial equivalence to a predicate device and compliance with relevant technical standards for image handling, display, and safety. It is not an AI/ML diagnostic device, and therefore, many of the typical study elements for such devices (e.g., expert reads, ground truth adjudication, training/test sets, MRMC studies) are not present or relevant.
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510(k) Summary
K98 2976
| Date: | 25 August 1998 |
|---|---|
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive,Tustin, CA 92781-2068 |
| Submitter's Contact: | Paul Biggins, Regulatory Affairs Specialist, (714)730-5000 |
| Establishment RegistrationNumber: | 2020563 |
| Device Proprietary Name: | Ultrasound Workstation, UIWS-300A |
| Common Name: | Picture Archiving and Communications System |
| Regulatory Class: | Class II per 21 CFR § 892.2050; 90LLZ |
| Predicate Device: | Nova MicroSonics, Image View DCR |
| Reason For Submission | New Product |
Description of this Device:
The UIWS-300A, Ultrasound Workstation, is an all digital workstation that can be connected to Toshiba PowerVision diagnostic ultrasound scanners. Its function is to provide the user with the ability to view images, annotate image data and perform analysis on image data. The unit is comprised of a standard desktop type personal computer, keyboard, mouse, monitor 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 devices is designed to support functional diagnósis by performing display, processing, measurement and analysis of ultrasound images.
Comparison to Predicate Device
The user features of the UIWS-300A Ultrasound Workstation and the Nova MicroSonics Image Vue DCR (K) are very similar.
Conformance to Standards
The following standards apply to the design and manufacture of the UIWS-300A Ultrasound Workstation:
| Image Storage: | DICOM SCU Storage |
|---|---|
| Monitor Testing: | JIS C6101 |
| Safety: | IEC 60601-1-1 (AMD1) [1992] |
| Image Compression: MJPEG: | Compressed -AVI formatNon-compressed - IMG format |
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Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a bird-like figure with three overlapping profiles, suggesting a sense of community or interconnectedness.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 24 1998
Paul Biggins Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. 2441 Michelle Drive PO Box 2068 Tustin, CA 92781-2068
Re:
Ultrasound Workstation, UIWS-300A Dated: August 25, 1998 Received: August 26, 1998 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 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 your device is classified (see above) into either class II (Special Controls) or 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 yitn diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrt/dsmaldsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
Director, Division of Reproductiv Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page ____ of _________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
Retrieval and storage of both passive and active ultrasound images Analysis of ultrasound images
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence/off CDRH, Office of Device Evaluation (ODE)
Vorid a. Seym
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________
(Optional Format 1-2-96)
§ 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).