(29 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard ultrasound image display and analysis features inherited from a predicate device.
No.
The device is intended for displaying and analyzing ultrasound images for medical diagnosis, not for treating or preventing a disease or condition.
Yes
The "Intended Use / Indications for Use" states that the device is "intended for displaying and analyzing ultrasound images for medical diagnosis".
Yes
The device description explicitly states it is a "software package" applied to an existing workstation and consists of "software" measurement packages. It does not mention any accompanying hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The USWP-100A is a software package that processes and analyzes ultrasound images. Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
- Intended Use: The intended use clearly states it's for "displaying and analyzing ultrasound images for medical diagnosis." This aligns with the function of an imaging analysis tool, not an IVD.
Therefore, the USWP-100A falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use is displaying and analyzing ultrasound images for medical diagnosis in obstetric/gynecology and general examinations.
When used by a qualified physician, this device is intended for displaying and analyzing ultrasound images for medical diagnosis in obstetric/gynecology and general examinations.
This device is not intended for diagnosis of lossy compressed images.
Product codes
LLZ
Device Description
The USWP-100A is a software package that may be applied to an existing workstation that is capable of receiving volume data sets via DICOM from Toshiba Ultrasound systems that are configured for 4D imaging. This nofitware consists of measurement packages that were cleared on the predicate device, SSA-790A, AplioXG Diagnostic Ultrasound System.
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
qualified physician
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Toshiba Aplio XG; SSA-790A V2.2 [K081065]
Reference Device(s)
Not Found
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).
0
Kc. E 2624
OCT 1 4 2008
Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) USWP-100A, 4D Viewer-Radiology
510(k) Summary
| Date: | September 5, 2008 |
|---|---|
| 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, Director Regulatory Affairs, |
| (714)730-5000 | |
| Establishment Registration | |
| Number: | 2020563 |
| Device Proprietary Name: | USWP-100A; 4D Viewer-Radiology |
| Common Name: | System, Image Processing, Radiological |
| Regulatory Class: | II [21CFR820.2050, .1560, .1550] |
| Performance Standard: | None |
| Predicate Device(s): | Toshiba Aplio XG; SSA-790A V2.2 [K081065] |
| Reason for Submission | New Device |
Description of this Device:
The USWP-100A is a software package that may be applied to an existing workstation that is capable of receiving volume data sets via DICOM from Toshiba Ultrasound systems that are configured for 4D imaging. This nofitware consists of measurement packages that were cleared on the predicate device, SSA-790A, AplioXG Diagnostic Ultrasound System.
Summary of Intended Uses:
The intended use is displaying and analyzing ultrasound images for medical diagnosis in obstetric/gynecology and general examinations.
Safety and Effectiveness Concerns:
This software package is designed and manufactured in compliance with the Quality System Regulation. This device does not offer new indications or functions that have not been cleared via the predicate device, nor does it offer functions that are not already available through 510(k) cleared devices that are commercially available in the U.S.
1
Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) USWP-100A, 4D Viewer-Radiology
Substantial Equivalence:
This software package provides information to the user that is similar to that which is provided by the predicate device. The information is obtained in a manner that is similar to the predicate device. Additionally, the indications for use and intended uses are identical to those included with the predicate device. There are no new indications for use that are not already available in devices already marketed in the U.S.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo consists of a circular seal with the department's name around the perimeter. Inside the circle is a stylized symbol featuring three curved lines above a pair of wavy lines, representing the department's mission related to health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 4 2008
Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K082684
Trade/Device Name: USWP-100A, 4D Viewer-Radiology Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 30, 2008 Received: October 1, 2008
Dcar 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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2
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); 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.
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jaque In Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K082684
Device Name: USWP-100A, 4D Viewer-Radiology
Indications for Use:
When used by a qualified physician, this device is intended for displaying and analyzing ultrasound images for medical diagnosis in obstetric/gynecology and general examinations.
This device is not intended for diagnosis of lossy compressed images.
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 Device Evaluation (ODE)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Arunthirly
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________