(17 days)
syngo® US Workplace is used to view post processed ultrasound images, to store and print images, and to manipulate and make measurements on images using a personal computer or a compatible DICOM compliant PACS system.
The syngo US Workplace is used to view images, to store and print images, and to make measurements on images using a personal computer. The software is userinstallable. The images are acquired by ultrasound systems using standardized formatting and are transferred from the ultrasound system to the PC hosting the software by CD-ROM and DVD or a network connection.
This 510(k) submission (K060992) for the syngo US Workplace does not contain a study that establishes acceptance criteria or reports on device performance against such criteria.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device's absolute performance against predefined acceptance criteria through specific studies. The core of this submission is the claim that the "syngo US Workplace is substantially equivalent to the Siemens family of ultrasound imaging systems and the TomTec Image Arena (K040546)."
The description of the device's function involves viewing, storing, printing, and making measurements on ultrasound images. The FDA's acceptance of the 510(k) indicates that they found the device "substantially equivalent" to existing and legally marketed predicate devices, implying it meets similar safety and effectiveness standards as those predicates. However, there is no detailed study within this document that provides specific performance metrics (e.g., accuracy of measurements, speed of image rendering) or defines acceptance criteria for these metrics.
Therefore, I cannot provide the requested table or answer most of the questions because the information is not present in the provided text.
Here's what can be extracted from the document:
- Device Name: syngo® US Workplace
- Purpose of the Device: To view post-processed ultrasound images, store and print images, and manipulate and make measurements on images using a personal computer or a compatible DICOM compliant PACS system.
Missing Information (Not provided in the document):
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The sample size for the training set
- How the ground truth for the training set was established
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510(K) SUMMARY syngo US Workplace Prepared April 24, 2006
APR 2 8 2006
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.
1. Submitted By:
Siemens Medical Solutions USA, Inc., Ultrasound Division 1230 Shorebird Way Mountain View, CA 94043
Contact Person:
Sheila W. Pickering Regulatory Affairs
Phone: (650) 943 7187 FAX: (650) 943 7053
Date Prepared:
March 30, 2006
Proprietary Name: 2. syngo® US Workplace
Common/ Usual Name:
System, Image Processing, Radiological
Classification Name:
21 CFR 892.2050 Picture Archiving and Communications System 21 CFR # 892.2050 Product Code 90-LLZ
3. Predicate Devices:
Siemens Ultrasound Systems (K052410, K051139, K041319, K032144. K022567,K050034,K033196,K023720,K021497,K010950,K891449,K904017, K052895, K 022896) and the TomTec Image Arena (K040546)
4. Device Description:
The syngo US Workplace is used to view images, to store and print images, and to make measurements on images using a personal computer. The software is userinstallable. The images are acquired by ultrasound systems using standardized formatting and are transferred from the ultrasound system to the PC hosting the software by CD-ROM and DVD or a network connection.
5. Intended Uses:
syngo US Workplace is used to accept and view post processed ultrasound images, to store and print images, and to manipulate and make measurements on images using a personal computer or a compatible DICOM compliant PACS system.
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Technological Comparison to Predicate Device: 6.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
APR 2 8 2006
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Siemens Medical Solutions USA, Inc., Ultrasound Group % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K060992
Trade/Device Name: syngo® US Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 7, 2006 Received: April 11, 2006
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.
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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number : K060992
Device Name: syngo® US Workplace
Indications For Use:
syngo® US Workplace is used to view post processed ultrasound images, to store and print images, and to manipulate and make measurements on images using a personal computer or a compatible DICOM compliant PACS system.
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)
Manuel Buadon
Page 1 of 1
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 5 I ()(k) Number _
§ 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).