(91 days)
No
The document describes image reconstruction and visualization software, and explicitly states the software modification does not alter its fundamental scientific technology. There is no mention of AI, ML, or related concepts.
No
The device is described as an imaging software intended for diagnosis, surgical planning, interventional procedures, and treatment follow-up, specifically for visualizing contrast-enhanced blood distribution. It assists physicians in diagnosis and treatment planning but does not directly provide a therapeutic effect or administer treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software is "intended for imaging primarily soft tissue for diagnosis" and "is design for the visualization of contrast enhanced blood distribution in the body using color coded relative values for diagnosis." It also states, "This software is designed to visually assist physicians in the diagnosis and treatment of vessel malformations." These phrases clearly indicate its role in the diagnostic process.
Yes
The device is described as an "extended software application" and an "add-on software option" that processes images acquired from a separate hardware device (angiographic C-arm). The description focuses solely on the software's functionality and its relationship to existing software options, without mentioning any associated hardware components included with this specific submission.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The syngo DynaPBV Body software processes and visualizes images acquired from a standard angiographic C-arm device. It works with imaging data, not biological samples.
- Intended Use: The intended use is for imaging and visualization of contrast-enhanced blood distribution for diagnosis, planning, and follow-up. This is a function of medical imaging, not in vitro testing.
The device falls under the category of medical imaging software used for image processing and visualization.
N/A
Intended Use / Indications for Use
The syngo DynaPBV Body is an extended software application to the InSpace 3D software option which allows the reconstruction of two-dimentional images acquired with a standard angiographic C-arm device into a three-dimentional image format.
The syngo DynaPBV Body is intended for imaging primarily soft tissue for diagnosis, surgical planning, interventional procedures and treatment follow-up. It is design for the visualization of contrast enhanced blood distribution in the body using color coded relative values for diagnosis.
This software is designed to visually assist physicians in the diagnosis and treatment of vessel malformations (i.e. Aneurysms, AVM's and Stenoses).
Product codes
LLZ
Device Description
The syngo DynaPBV Body software is an optional extension to the Inspace 3D application originally cleared under Premarket Notification K011447 on 08/03/2001. It is also similar to the cleared syngo Neuro PBV IR (K111052, May 20, 2011) which was designed for the visualization of contrast enhanced blood distribution in the arterial and venous vessels in the head.
Similar to syngo Neuro PBV IR the synqo DynaPBV Body is an add-on software option used for the visualization of contrast enhanced blood distribution in the body (e.g. thorax and abdomen) using color coded relative values for diagnosis.
This software modification does not affect the intended use of the device nor does it alter its fundamental scientific technology.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
angiographic C-arm device (acquires two-dimensional images for 3D reconstruction)
Anatomical Site
body (e.g. thorax and abdomen)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians / 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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
SIEMENS
syngo DynaPBV Body 510(k) K121292 Al Response
510(k) Summary: syngo DynaPBV Body Software
JUL 30 2012
Siemens Medical Systems, Inc. Company: 51 Valley Stream Parkway Malvern, PA 19355
Date Prepared: July 25, 2012
This 510(k) summary of safety and effectiveness information is being submitted in i accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
1. General Information:
lmporter / Distributor: Siemens Medical Systems, Inc. 51 Valley Stream Parkway Malvern, PA 19355
Establishment Registration Number: 2240869 Manufacturing Site: SIEMENS AG Sector Healthcare Siemensstraße 1 D-91301 Forchheim, Germany
Establishment Registration Number: 3004977335
2. Contact Person:
Ms. Patricia D Jones Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway D-02 Malvern, PA 19355 Fax: (610) 448-1787 Phone: (610) 448 -3536 Email: patricia.d.jones@siemens.com
Device Name and Classification: 3.
syngo DynaPBV Body Trade Name: Classification Name: System, Image Processing Radiological Classification Panel: Radiology Classification Regulation: 21 CFR §892.2050 Class II Device Class: LLZ Product Code:
Legally Marketed Predicate Device 4. InSpace 3D Software Option Trade Name: K011447 510(k) #: Clearance Date: August 3, 2001
1
SIEMENS
Classification Name: Classification Panel: CFR Section: Device Class: Product Code:
Accessory to Angiographic X-Ray System Radiology 21 CFR §892.1600 Class II JAA
Legally Marketed Predicate Device Trade Name: syngo Neuro PBV K111052 510(k) #: May 20, 2011 Clearance Date: Classification Name: System, Image Processing Radiological Classification Panel: Radiology 21 CFR §892.2050 CFR Section: Class II Device Class: Product Code: LLZ
5. Device Description:
The syngo DynaPBV Body software is an optional extension to the Inspace 3D application originally cleared under Premarket Notification K011447 on 08/03/2001. It is also similar to the cleared syngo Neuro PBV IR (K111052, May 20, 2011) which was designed for the visualization of contrast enhanced blood distribution in the arterial and venous vessels in the head.
Similar to syngo Neuro PBV IR the synqo DynaPBV Body is an add-on software option used for the visualization of contrast enhanced blood distribution in the body (e.g. thorax and abdomen) using color coded relative values for diagnosis.
This software modification does not affect the intended use of the device nor does it alter its fundamental scientific technology.
6. Indication for Use:
The syngo DynaPBV Body is an extended software application to the InSpace 3D software option which allows the reconstruction of two-dimentional images acquired with a standard angiographic C-arm device into a three-dimentional image format.
The syngo DynaPBV Body is intended for imaging primarily soft tissue for diagnosis, surgical planning, interventional procedures and treatment follow-up. It is design for the visualization of contrast enhanced blood distribution in the body using color coded relative values for diagnosis.
This software is designed to visually assist physicians in the diagnosis and treatment of vessel malformations (i.e. Aneurysms, AVM's and Stenoses).
Substantial Equivalence: 7.
The syngo DynaPBV Body software application is substantially equivalent to the commercially available Siemens software application, syngo Neuro PBV IR which is an option to the Siemens InSpace 3D software. The InSpace 3D software option was described in premarket notification K011447 which received 510(k) clearance
2
on August 03, 2001. The syngo Neuro PBV IR software option was described in premarket notification K111052 and received 510(k) clearance on May 20, 2011.
The syngo DynaPBV Body software is an optional extension to InSpace 3D and uses the same hardware and software components as the inSpace 3D software.
Summary of Technological Characteristics of the Subject Device as Compared 8. with the Predicate Device:
The syngo DynaPBV Body is a software extension to InSpace 3D. The syngo DynaPBV Body features the same post processing software, user interface, archiving and communication as the predicate InSpace 3D. The syngo DynaPBV Body software is not a stand-alone software. It interfaces with InSpace 3D. The syngo DynaPBV Body user function keys are integrated into the InSpace 3D task card. The user function is similar to InSpace 3D task card except for an additional activation button for the syngo DynaPBV Body software features.
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.
Risk management is ensured via a hazard 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 all equipment is subject to final performance testing. Furthermore, the operators are health care professionals familiar with and responsible for the evaluating and post processing of X-ray images.
10. Conclusion as to Substantial Equivalence:
syngo DynaPBV Body software is intended for similar indications as cleared in the predicate InSpace 3D. The syngo DynaPBV Body Software add-on application is designed for use with the InSpace 3D (K011447) for the visualization of contrast enhanced blood distribution in the body using color coded relative values for diagnosis.
The functionality of syngo DynaPBV Body software is similar to the predicate device. It is Siemens opinion, that the syngo DynaPBV Body add-on software is substantially equivalent to the InSpace 3D software (K011447) and the syngo Neuro PBV IR software (K111052).
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
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
JUL 30 2012
Ms. Patricia D. Jones Technical Specialist. Regulatory Submissions Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway D-02 MALVERN PA 19355
Re: K121292
Trade/Device Name: Syngo DynaPBV Body Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 25, 2012 Received: July 26, 2012
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.
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 i Toure of act note 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 or any I vatual 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
- for argument in
4
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,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
SIEMENS
Special 510(k) Submission: syngo DynaPBV Body
Indications for Use Statement
510(k) Number (if known):
Device Name: syngo DynaPBV Body
Indications for Use:
syngo DynaPBV Body is an extended software application to the InSpace 3D software option which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format.
syngo DynaPBV Body is intended for imaging primarily soft tissue for diagnosis, surgical planning, interventional procedures and treatment follow-up. It is design for the visualization of contrast enhanced blood distribution in the body using color coded relative values for diagnosis.
This software is designed to visually assist physicians in the diagnosis and treatment of vessel malformations (i.e. Aneurysms, AVM's and Stenoses)
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 Diagnostic Devices (OIVD)
Martin D. Thoma
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K121292
Page 1 of
Special 510(k) syngo Liver PBV-IR Software
Siemens Medical Systems, Inc.