(71 days)
The ABVS Workplace is intended to display ultrasound images of the breast acquired from B-mode imaging using an automatic or handheld scanning linear transducer. The images may be reviewed and analyzed by the physician. The ABVS Workplace is indicated for use as an adjunct to mammography. The ABVS Workplace is not Intended to be used as a replacement for screening mammography.
This premarket notification covers the Siemens ABVS Workplace, an offline image viewing workstation. The ABVS workplace consists of common IT hardware and preinstalled software to ensure that defined hardware requirements are met. The workplace is based on Windows XP.
The provided text describes the Siemens ABVS Workplace, an offline image viewing workstation for breast ultrasound images, and its substantial equivalence to a predicate device. However, it does not contain any information regarding specific acceptance criteria, a study proving device performance against those criteria, sample sizes for test or training sets, expert qualifications, or adjudication methods.
The document is a 510(k) summary for regulatory clearance, primarily focusing on establishing substantial equivalence to a legally marketed predicate device rather than detailing specific performance studies against pre-defined acceptance criteria for a novel device.
Therefore, I cannot extract the requested information from the provided text. The output will reflect the lack of this information.
Summary of Unavailable Information:
The provided document, a 510(k) summary for the Siemens ABVS Workplace, details the device's general information, intended use, and technological characteristics, and establishes its substantial equivalence to a predicate device for regulatory clearance. However, it does not contain any information regarding specific acceptance criteria for device performance, the results of a study demonstrating the device meets such criteria, the sample sizes used for testing or training, the provenance of data, expert qualifications, adjudication methods, or whether MRMC or standalone performance studies were conducted.
Therefore, I cannot complete the requested tables and sections with the information about acceptance criteria and performance studies.
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SEP 1 8 2009
Section K: 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR $807.92.
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- GENERAL INFORMATION
Estabilshment:
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o Address:
Siemens AG, Medical Solutions Henkestrasse 127 D-91052 Erlangen Germany -
o Registration Number: 3002808157
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Contact Person; Shelly Pearce Q Regulatory Affairs (650) 694-5988 o Telephone:
Device Name and Classification:
| Trade Name: | ABVS Workplace |
|---|---|
| Classification Name: | Picture Archiving and Communications System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | LLZ |
2. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION
o Device Description and Intended Use:
This premarket notification covers the Siemens ABVS Workplace, an offline image viewing workstation.
The ABVS Workplace is intended to display ultrasound images of the breast acquired from B-mode imaging using an automatic or handheld scanning linear transducer. The images may be reviewed and analyzed by the physician. The ABVS Workplace is indicated for use as an adjunct to mammography. The ABVS Workplace is not Intended to be used as a replacement for screening mammography.
Technological Characteristics:
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The ABVS workplace consists of common IT hardware and preinstalled software to ensure that defined hardware requirements are met. The workplace is based on Windows XP.
o General Safety and Effectiveness Concerns:
The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device. Risk management is ensured via a risk analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards Siemens adheres to recognized and established industry practice and standards.
ං Substantial Equivalence
The ABVS Workplace is substantially equivalent to the following commercially available devices:
| Manufacturer | Predicate DeviceName | FDA ClearanceNumber | Clearance Date |
|---|---|---|---|
| U-systems | Automated BreastUltrasound System(ABUS) | K080930 | 08/07/2008 |
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
SEP 1 8 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Siemens Medical Solutions USA, Inc., Ultrasound Division % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K092067
Trade/Device Name: ABVS Workplace Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 3, 2009 Received: September 4, 2009
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 (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 of medical
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section A: Indications for Use
510(k) Number (if known): _KO92067
Device Name: ABVS Workplace
Indications for Use:
The ABVS Workplace is intended to display ultrasound images of the breast acquired from B-mode Imaging using an automatic or handheld scanning Ilnear transducer. The images may be reviewed and analyzed by the physician. The ABVS Workplace is indicated for use as an adjunct to mammography. The ABVS Workplace is not Intended to be used as a replacement for screening mammography.
Prescription Use X (Part 21 CFR 801 Subpart D) AND / OR Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(Please do not write below this line - continue on another page If needed)
Concurrence of the CDRH, Office of Device Evaluation (ODE)
Aonm Whang
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
Radiological Devices
510(k) Number K912062
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§ 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).