(75 days)
This device is to serve as a workstation for the capture, storage, review and analysis of ultrasound images, both still and dynamic. This device is designed to support functional diagnosis by performing display, processing, measurement and analysis of ultrasound images.
Retrieval and storage of both passive and active ultrasound images
Analysis of ultrasound images
Reconstruction and display of three dimensional images.
The UIDM-400A. PowerView Ultrasound Workstation, is an all digital workstation that can be integrated with the Toshiba PowerVision diagnostic ultrasound scanners. Its function is to provide the user with the ability to view images, annotate images, store image data and perform analysis on image data. The unit is comprised of a standard desktop type personal computer, keyboard, mouse, and connecting cables.
This device, the Toshiba PowerView Ultrasound Workstation, UIDM-400A, is a Picture Archiving and Communications System (PACS) and, as such, there are no specific performance acceptance criteria or a dedicated study described to "prove" the device meets such criteria in the provided documents.
The submission is a 510(k) for a new product, and the claim for substantial equivalence relies on comparison to existing predicate devices (Toshiba Workstation, UIWS-300A, Dicomit Image Manager, Tomtec Echo-Scan). The primary focus of the 510(k) process for this type of device is often on demonstrating that the new device does not introduce new questions of safety or effectiveness compared to legally marketed predicate devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Devices: Device performs functions similar to predicate devices (capture, storage, review, analysis of ultrasound images, 3D image reconstruction). | "The user features of the UIDM-400A PowerView Ultrasound Workstation are similar to the functions included in the three predicate device does not offer any new functions that have not received previous market clearance from the Agency." |
| No New Safety or Efficacy Concerns: Device does not introduce new safety or efficacy issues compared to predicates. | "This system poses no new safety concerns or efficacy concerns that were not addressed in previous submissions." |
| Verification and Validation Testing: Equivalent to testing reported in previous 510(k) submissions for similar software components. | "The verification and validation testing is equivalent to that of the testing reported in previous 510k submissions." (Note: Specific parameters or results of this testing are not provided.) |
| Compliance with General Controls: Adherence to annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. | The FDA letter states: "You may, therefore, market the device, subject to the general controls provisions of the Act." And, "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." |
| Manufacturing Standards: ISO-9001 certified and follows Quality System Regulations. | "The manufacturing facility is ISO-9001 certified and follows the Quality System Regulations as administered by the Food and Drug Administration." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The provided documents describe a 510(k) submission for a PACS workstation, not a clinical study on a diagnostic algorithm. There is no mention of a specific "test set" of patient data in the context of diagnostic performance. The verification and validation testing mentioned refers to software and system functionality testing, not clinical performance studies with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. As above, there is no mention of a clinical test set requiring expert ground truth establishment for diagnostic performance.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The documents do not mention or describe any MRMC comparative effectiveness study. This type of study is typically performed for diagnostic devices where human interpretation plays a significant role and the AI aims to assist or replace that interpretation. This device is a workstation for viewing and analyzing images, not an AI-powered diagnostic algorithm in itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is a workstation, which is inherently designed for human interaction ("human-in-the-loop"). It is not a standalone diagnostic algorithm.
7. The Type of Ground Truth Used
Not applicable in the context of clinical diagnostic accuracy. The "ground truth" for this device would relate to its functional correctness (e.g., does it accurately display images, does it perform measurements as expected) and software quality, validated against technical specifications and predicate device equivalence, rather than a clinical outcome.
8. The Sample Size for the Training Set
Not applicable. This device is a workstation for image management and analysis, not an AI model that undergoes a "training" process with a dataset of images.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device in the AI sense.
Summary of the Study (as described in the 510(k) submission):
The "study" or justification for clearance in this context is a benchmarking and equivalence assessment against predicate devices, coupled with internal verification and validation (V&V) testing for software and system functionality.
- Objective: To demonstrate that the PowerView Ultrasound Workstation, UIDM-400A, is substantially equivalent to legally marketed predicate devices and does not raise new questions of safety or effectiveness.
- Methodology:
- Comparison to Predicate Devices: The submission highlights that the UIDM-400A offers similar user features and no new functions compared to the Toshiba Workstation (UIWS-300A), Dicomit Image Manager (K990248), and Tomtec Echo-Scan (K963807). This is a qualitative assessment of functional equivalence.
- Verification and Validation (V&V) Testing: The document states that "The verification and validation testing is equivalent to that of the testing reported in previous 510k submissions" for the various vendor programs comprising the software. This implies internal engineering and software quality assurance testing (e.g., unit testing, integration testing, system testing, performance testing) to ensure the device performs as intended and meets its specifications. The specific details of this V&V are not provided in this summary.
- Safety Considerations: The claim is made that the system poses no new safety concerns, attributed to it being comprised of a standard personal computer and previously cleared software components.
- Manufacturing Standards: Compliance with ISO-9001 and Quality System Regulations is stated.
Conclusion:
The provided documents do not detail a clinical performance study with patient data, acceptance criteria related to diagnostic accuracy, or an AI algorithm’s performance. Instead, they describe a 510(k) submission focused on demonstrating substantial equivalence for a medical image management and analysis workstation by comparing its features and safety aspects to existing, cleared devices and referencing standard software verification and validation practices.
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K99.2886
NOV - 9 1999
| 510(k) Summary | |
|---|---|
| -- | ---------------- |
| Date: | 25 August 1999 |
|---|---|
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive, |
| Submitter's Contact: | Tustin, CA 92781-2068Paul Biggins, Regulatory Affairs Specialist, (714)730-5000 |
| Establishment RegistrationNumber: | 2020563 |
| Device Proprietary Name: | PowerView Ultrasound Workstation, UIDM-400A |
| Common Name: | Picture Archiving and Communications System |
| Regulatory Class: | Class II per 21 CFR § 892.2050; 90LLZ |
| Predicate Device: | Toshiba Workstation, UIWS-300A (K982976)Dicomit Image Manager (K990248)Tomtec Echo-Scan (K963807) |
| Reason For Submission | New Product |
Description of this Device:
The UIDM-400A. PowerView Ultrasound Workstation, is an all digital workstation that can be integrated with the Toshiba PowerVision diagnostic ultrasound scanners. Its function is to provide the user with the ability to view images, annotate images, store image data and perform analysis on image data. The unit is comprised of a standard desktop type personal computer, keyboard, mouse, 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 device is designed to support functional diagnosis by performing display, processing, measurement and analysis of ultrasound images.
Comparison to Predicate Device
The user features of the UIDM-400A PowerView Ultrasound Workstation are similar to the functions included in the three predicate device does not offer any new functions that have not received previous market clearance from the Agency.
Safety Considerations:
The UIDM-400A is comprised of a personal computer that is mounted into the Toshiba PowerVision Ultrasound System. The software is comprised of various vendor programs that have received previous 510k clearances. The verification and validation testing is equivalent to that of the testing reported in previous 510k submissions. This system poses no new safety concerns or efficacy concerns that were not addressed in previous submissions. The manufacturing facility is ISO-9001 certified and follows the Quality System Regulations as administered by the Food and Drug Administration.
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Re:
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 9 1999
Paul Biggins Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. 2441 Michelle Dr. Tustin, CA 92781
K992886 PowerView Ultrasound Workstation Model UIDM-400A Dated: August 25, 1999 Received: August 26, 1999 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 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). 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 vour device is classified (see above) into either 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 vitro 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
[signature]
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page __ 1 __ of ______________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: __ PowerView Ultrasound Workstation, UIDM-400A
Indications for Use:
Retrieval and storage of both passive and active ultrasound images Analysis of ultrasound images Reconstruction and display of three dimensional images.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use _
David b. Glynn
(Division Sign-Off) Division of Reproductive, Abdominal, E and Radiological De 510(k) Number
(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).