ABVS WORKPLACE

K092067 · Siemens AG Medical Solutions · LLZ · Sep 18, 2009 · Radiology

Device Facts

• Record ID: K092067
• Device Name: ABVS WORKPLACE
• Applicant: Siemens AG Medical Solutions
• Product Code: LLZ · Radiology
• Decision Date: Sep 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

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.

Device Story

ABVS Workplace is an offline image viewing workstation for breast ultrasound. It accepts B-mode ultrasound images acquired from automatic or handheld linear transducers. Physicians use the workstation to review and analyze these images. The device functions as an adjunct to mammography, aiding in clinical assessment. It is intended for use in a clinical environment by physicians. The system utilizes standard IT hardware running Windows XP to display and process images for diagnostic review, supporting clinical decision-making by providing supplemental imaging data to mammography.

Clinical Evidence

No clinical data provided. Safety and effectiveness are supported by risk analysis, software development, and verification/validation testing.

Technological Characteristics

Workstation consisting of common IT hardware running Windows XP. Supports display and analysis of B-mode ultrasound images. Connectivity via standard IT infrastructure. Risk management and software validation used to control hazards.

Indications for Use

Indicated for use as an adjunct to mammography for the display, review, and analysis of breast ultrasound images acquired via B-mode imaging (automatic or handheld linear transducers). Not for use as a replacement for screening mammography.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Automated Breast Ultrasound System (ABUS) (K080930)

Submission Summary (Full Text)

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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.

K092067

- 1. GENERAL INFORMATION
## Estabilshment:

- o Address:
Siemens AG, Medical Solutions Henkestrasse 127 D-91052 Erlangen Germany

- o Registration Number: 3002808157
- Contact Person; Shelly Pearce Q Regulatory Affairs [phone] 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 Device<br>Name | FDA Clearance<br>Number | Clearance Date |
|--------------|-------------------------------------------------|-------------------------|----------------|
| U-systems | Automated Breast<br>Ultrasound System<br>(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 [phone] or [phone] 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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