(87 days)
No
The document describes image visualization and enhancement tools but does not mention AI, ML, or related concepts like deep learning or algorithms that learn from data.
No.
The device is a software application for reviewing and enhancing mammography and tomosynthesis images to aid a radiologist in diagnosis, but it does not directly provide therapy or treatment.
Yes
This device is a diagnostic device because its intended use is to aid a qualified radiologist in the review of digital mammography images and digital breast tomosynthesis datasets, with the radiologist being responsible for making the diagnosis.
Yes
The device description explicitly states that syngo.Breast Care is a "software application" and consists of "several software engines." It is described as an "optional application for syngo.via," which is also a software platform. There is no mention of accompanying hardware components that are part of the syngo.Breast Care device itself.
Based on the provided text, 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: syngo.Breast Care is a software application that processes and displays medical images (digital mammography and digital breast tomosynthesis datasets) to aid a radiologist in reviewing them. It does not analyze biological samples.
- Intended Use: The intended use is for "softcopy review environment for both screening and diagnostic mammography as well as digital breast tomosynthesis" and to "provide visualization and image enhancement tools to aid a qualified radiologist in the review of digital mammography images and digital breast tomosynthesis datasets." This clearly describes image analysis, not in vitro testing.
Therefore, syngo.Breast Care falls under the category of medical imaging software, not an IVD.
N/A
Intended Use / Indications for Use
syngo.Breast Care is a dedicated softcopy review environment for both screening and diagnostic mammography as well as digital breast tomosynthesis. Its user interface and workflow have been optimized to support experienced mammography and tomosynthesis reviewers in both screening and diagnostic reading. Efficiency and reading quality are supported by various specialized features.
syngo.Breast Care provides visualization and image enhancement tools to aid a qualified radiologist in the review of digital mammography images and digital breast tomosynthesis datasets. The radiologist is responsible for making the diagnosis of the images presented.
Product codes
LLZ
Device Description
syngo.Breast Care is a software application dedicated to the special needs in breast cancer detection and assessment. syngo.Breast Care consists of several software engines, syngo.Breast Care Reading, syngo.Breast Care CAD Display and syngo.Breast Care Tomo, all based on the syngo.Breast Care Reading module.
syngo.Breast Care is an optional application for syngo.via VA20 (K123375 cleared on November 20, 2012). Syngo.via (a Siemens product) offers multimodality applications and feature sets to support customers in diagnostic imaging for various clinical areas (e.g. general Radiology, Cardiology, Oncology, Neurology, Orthopedics and Women's Health's). Additionally to a multi-client installation, synqo.Breast Care may also be configured with syngo.via as a single workplace.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital mammography images and digital breast tomosynthesis datasets
Anatomical Site
breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified radiologist
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)
Reference Device(s)
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
K 123420
510(k) Summary: syngo.Breast Care Software
FEB U. 1 2013
Company:
Siemens Medical Systems, Inc. 1 Valley Stream Parkway Malvern, PA 19355
January 10, 2013 Date Prepared:
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
General Information:
Importer / Distributor:
Siemens Medical Solutions, Inc. 51 Valley Stream Parkway, E-50 Malvern, PA 19355 Establishment Registration Number: 2240869
Establishment Registration Number: 224086
Location of Manufacturing Site:
Siemens AG
Medical Solutions
X-Ray Products
Henkestrasse 127
DE-91052 Erlangen
Establishment Registration Number: 3002808157
Contact Person: . 2.
Ms. Patricia D Jones Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway D-02 Malvern, PA 19355 Phone: (610) 448 -3536 Fax: (610) 448-1787 Email: patricia.d.jones@siemens.com
Device Name and Classification syngo Breast Care Software Trade Name: Classification Name: System
Classification Panel: Submission Type: Classification Regulation: Device Class: Product Code:
Picture Archiving and Communications Radiology 510(k) Traditional 21 CFR §892.2050 Class II LLZ
1
| 4. | Legally Marketed Predicate Device | |
|---|---|---|
| Trade Name: | MammoReportPlus | |
| 510(k) #: | K042868 | |
| Clearance Date: | January 6, 2005 | |
| Classification Name: | Picture Archiving and Communications | |
| System | ||
| Classification Panel: | Radiology | |
| CFR Section: | 21 CFR §892.2050 | |
| Device Class: | II | |
| Product Code: | LLZ |
5. Device Description:
syngo.Breast Care is a software application dedicated to the special needs in breast cancer detection and assessment. syngo.Breast Care consists of several software engines, syngo.Breast Care Reading, syngo.Breast Care CAD Display and syngo.Breast Care Tomo, all based on the syngo.Breast Care Reading module.
syngo.Breast Care is an optional application for syngo.via VA20 (K123375 cleared on November 20, 2012). Syngo.via (a Siemens product) offers multimodality applications and feature sets to support customers in diagnostic imaging for various clinical areas (e.g. general Radiology, Cardiology, Oncology, Neurology, Orthopedics and Women's Health's). Additionally to a multi-client installation, synqo.Breast Care may also be configured with syngo.via as a single workplace.
6. Indication for Use:
syngo.Breast Care is a dedicated softcopy review environment for both screening and diagnostic Mammography as well as digital breast tomosynthesis. Its user interface and workflow have been optimized to support experienced mammography and tomosynthesis reviewers in both screening and diagnostic reading. Efficiency and reading quality are supported by various specialized features.
syngo.Breast Care provides visualization and image enhancement tools to aid a qualified radiologist in the review of digital mammography images and digital breast tomosynthesis datasets. The radiologist is responsible for making the diagnosis of the images presented.
7. Substantial Equivalence:
The Siemens syngo Breast Care is substantially equivalent to the commercially available Siemens MammoReport" 169. The MammoReportPus was described in Premarket Notification K042868, cleared 01/06/2005.
2
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- Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device: syngo.Breast Care has a similar intended use as the predicate MammoReport"145. The syngo.Breast Care is a software only solution to run on compatible client server environment together with monitor displays cleared for Mammography as compared to the predicate MammoReportPlus that is a complete hardware and software package.
An optional module enables the display of tomosynthesis datasets providing tomosynthesis specific layouts and tools.
- Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device: syngo.Breast Care has a similar intended use as the predicate MammoReport"145. The syngo.Breast Care is a software only solution to run on compatible client server environment together with monitor displays cleared for Mammography as compared to the predicate MammoReportPlus that is a complete hardware and software package.
General Safety and Effectiveness Concerns: 9.
Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Several safety features including visual and audible warnings are incorporated into the system design. In addition the syngo.Breast Care is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed.
Furthermore the operators are health care professionals familiar with and responsible for the X-ray examinations to be performed.
Conclusion as to Substantial Equivalence: 10.
The syngo.Breast Care is intended for similar indications for use as the predicate MammoReportPlus. Image display devices with the same or similar specifications will be used to display the mammography images. It is Siemens opinion, that the synqo.Breast Care is substantially equivalent to the MammoReportPlus
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 1, 2013
Siemens Medical Solutions USA, Inc. c/o Ms. Patricia D. Jones Technical Specialist, Regulatory Submissions 51 Valley Stream Parkway, E-50 MALVERN PA 19355
Re: K123420
Trade/Device Name: syngo.Breast Care Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 10, 2013 Received: January 11, 2013
Dear Ms. Jones:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 (reporting of medical 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.
4
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,
Sean M. Boyd -S for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Traditional 510(k) Submission syngo. Breast Care Software
Indications for Use Statement
510(k) Number (if known):
Device Name: syngo.Breast Care Software
Indications for Use:
syngo.Breast Care is a dedicated softcopy review environment for both screening and diagnostic mammography as well as digital breast tomosynthesis. Its user interface and workflow have been optimized to support experienced mammography and tomosynthesis reviewers in both screening and diagnostic reading. Efficiency and reading quality are supported by various specialized features.
syngo.Breast Care provides visualization and image enhancement tools to aid a qualified radiologist in the review of digital mammography images and digital breast tomosynthesis datasets. The radiologist is responsible for making the diagnosis of the images presented.
Prescription Use X (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 In Vitro Diagnostics and Radiological Health (OIR)
Sean M. Boyd -S
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