(68 days)
Not Found
No
The document describes a PACS system with image processing capabilities but makes no mention of AI, ML, or related concepts.
No.
The device is a Picture Archiving and Communication System (PACS) used for displaying, processing, and storing digital medical images for diagnosis and treatment planning, rather than providing direct therapy.
No
The device is described as a Picture Archiving and Communication System (PACS) for digital medical images, focusing on display, storage, and manipulation. While it supports the physician in diagnosis, its primary function is image management and processing rather than generating a diagnostic output itself.
Yes
The device description explicitly states that syngo® Dynamics is a "software only" medical device and that the hardware it runs on is not considered a medical device and is outside the scope of the 510(k).
Based on the provided text, syngo® Dynamics is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Intended Use of syngo® Dynamics: The intended use of syngo® Dynamics is focused on the management and manipulation of digital medical images. It's a PACS system for storing, displaying, processing, and reporting on images.
- No Mention of Specimens: The description and intended use do not mention the analysis of any biological specimens.
Therefore, syngo® Dynamics falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
syngo® Dynamics is a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
syngo® Dynamics is not intended to be used for reading of mammography images.
Product codes
LLZ
Device Description
This premarket notification addresses the Siemens syngo® Dynamics version 9.0 Picture Archiving and Communication System.
syngo® Dynamics is intended to display, process, read, report, communicate, distribute and store digital medical images. The system is a "software only" medical device. It defines recommended requirements to the hardware it runs on.
The hardware itself is not considered a medical device and not in the scope of this 510(k) submission.
syngo® Dynamics supports the physician in diagnosis and treatment planning. It also supports storage and archiving of DICOM Structured Reports. In a comprehensive imaging suite syngo® Dynamics integrates Hospital / Radiology / Cardiology Information Systems (HIS/RIS/CIS) to enable customer specific workflows.
The syngo® Dynamics new release focuses on support of web based reporting. Also, in syngo® Dynamics 9.0, server as well as the workplaces will be offered as "software-only".
Mentions image processing
syngo® Dynamics is intended to display, process, read, report, communicate, distribute and store digital medical images.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital medical images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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
FDA CDRH DMC
SIEMENS Received
JUL 2 9 2010 Healthcare
K102 150
510(k) Summary
OCT - 5 2010
syngo® Dynamics (version 9.0)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
-
- General Information
Date of Summary Preparation: July 12, 2010 Siemens Medical Solutions USA, Inc. Address: 400 W. Morgan Road Ann Arbor, MI 48108 Registration Number: 1836549 Contact Person: Ms. Yuri Ikeda Quality Engineer, Quality & Regulatory Phone: (734) 205-2442 Fax: (734) 205-2683 Email: yuri.ikeda@siemens.com
- General Information
2. Device Name and Classification
| Trade Name: | syngo® Dynamics |
|---|---|
| Version 9.0 | |
| Classification Name: | Picture Archiving and Communications System |
| Classification Panel: | Radiology |
| CFR Number: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | LLZ |
3. Substantial Equivalence
The syngo® Dynamics version 9.0, addressed in this premarket modification is substantially equivalent to the following commercially available device:
| Manufacturer | Predicate Device Name | FDA Clearance
Number |
|--------------|----------------------------|-------------------------|
| Siemens | syngo Dynamics Version 7.0 | K081018 |
4. Device Description
This premarket notification addresses the Siemens syngo® Dynamics version 9.0 Picture Archiving and Communication System.
syngo® Dynamics is intended to display, process, read, report, communicate, distribute and store digital medical images. The system is a "software only" medical device. It defines recommended requirements to the hardware it runs on.
Siemens Medical Solutions USA, Inc.
400 West Morgan Roid Tel.: +1-734-205-2400 ww.usa.siemens.com/healthcare Ann Arbor, MI 48108 USA
1
The hardware itself is not considered a medical device and not in the scope of this 510(k) submission.
syngo® Dynamics supports the physician in diagnosis and treatment planning. It also supports storage and archiving of DICOM Structured Reports. In a comprehensive imaging suite syngo® Dynamics integrates Hospital / Radiology / Cardiology Information Systems (HIS/RIS/CIS) to enable customer specific workflows.
The syngo® Dynamics new release focuses on support of web based reporting. Also, in syngo® Dynamics 9.0, server as well as the workplaces will be offered as "software-only".
5. Intended Use
{
syngo® Dynamics is a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
syngo® Dynamics is not intended to be used for reading of mammography images.
6. Summary of Technological Characteristics of the Principal Device as Compared with the Predicate Device
syngo® Dynamics version 9.0 has been modified to add capability for web based reporting as well as providing a complete "software only" solution. syngo® Dynamics version 9.0 has the same intended use and the same fundamental scientific technology as the predicate device.
7. 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 this device.
Risk management is ensured via a risk analysis in compliance with ISO 14971:2007 to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing.
Siemens Medical Solutions USA, Inc. complies with voluntary standards DICOM Version 3.0, IEC/ISO 10918-1:1994 (JPEG), SMPTE RP 133-1991, ISO 14971:2007, IEC 62304:2006, HL7 Version 2.x, IEC 60601-1-4:2000, and IEC 60601-1-6:2006. Software Unit, Integration and System Testing are performed for verification and validation.
The device has no patient contacting materials and is utilized only by trained professionals. The output of the device is evaluated by trained professionals allowing sufficient review for identification and intervention in the event of a malfunction.
Siemens believes that syngo® Dynamics version 9.0 is as safe and effective as its predicate device as it does not introduce new indications for use, raise new
2
types of safety and effectiveness, or introduce new technology.
8. Conclusion as to Substantial Equivalence
The potential hazards of modifications to the device have been evaluated and controlled as part of the product development process, including risk analysis and design considerations. Siemens conducts testing to verify the design output met the design input requirements and to validate the device conformance to the intended use. Predefined acceptance criteria was met and demonstrated that the device is as safe and effective as the predicate device.
In summary, Siemens is of the opinion that syngo® Dynamics 9.0 does not introduce any new significant potential safety risks and is substantially equivalent to and performs as well as the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Siemens Medical Solutions, Inc. % Mr. Norbert Stuiber Responsible Third Party Official TÜV SÜD America, Inc. 1775 Old Highway 8 NEW BRIGHTON MN 25112-1891
OCT 5 2010
Re: K102150
Trade/Device Name: syngo® Dynamics (version 9.0) Regulation Number: 21 CFR 892.2050 · Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 20, 2010 Received: July 29, 2010
Dear Mr. Stuiber:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
4
Page 2
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.
Sincerely yours,
Signature
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use Form
| 510(k) Number (if known): . | |
|---|---|
| Device Name: |
syngo® Dynamics (version 9.0)
Indications for Use:
syngo® Dynamics is a Picture Archiving and Communication System (PACS) Intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
syngo@ Dynamics is not intended to be used for reading of mammography images.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use
(21 CFR 801 Subpart C) AND/OR
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH. Office of In Vitro Diagnostic Devices (OIVD)
Blush L.D. Allen Line David G. Brown~
Division Sign-Off
X
Offica of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102150
Page 1 of 1