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)

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.

AI/ML Overview

The provided text is a 510(k) summary for the syngo DynaPBV Body software. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed standalone performance studies with specific acceptance criteria or quantitative analysis of device performance.

Therefore, many of the requested sections about acceptance criteria, detailed study design, sample sizes for test sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies, cannot be found or fully addressed based on the provided document.

However, I can extract the information that is present and indicate where information is missing.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., specific sensitivity, specificity, accuracy thresholds) for the syngo DynaPBV Body. Instead, the submission relies on demonstrating substantial equivalence to previously cleared devices. The "reported device performance" is implicitly that it performs comparably to the predicate devices.

Acceptance Criteria	Reported Device Performance
Not explicitly stated as quantitative metrics.	The device is considered substantially equivalent to predicate devices, implying comparable performance for its intended use.

1. A table of acceptance criteria and the reported device performance
As noted above, no quantitative acceptance criteria or corresponding reported performance metrics are provided in this 510(k) summary. The summary focuses on showing substantial equivalence in functionality and intended use to predicate devices, rather than a standalone performance study with specific benchmarks.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in this document. No specific "test set" for performance evaluation is mentioned. The submission describes the device as an "add-on software option" and "software extension" that uses the "same post processing software, user interface, archiving and communication as the predicate InSpace 3D."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not provided. Since no specific test set or performance evaluation study is described, there is no mention of experts establishing ground truth for such a set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not provided, as no specific test set or performance evaluation study is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study is mentioned. The device is a post-processing software for visualization, intended to assist physicians, but its comparative effectiveness with or without AI assistance is not quantified in this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This type of standalone algorithm performance study is not described in the document. The device is presented as a software tool for "visualization of contrast enhanced blood distribution... using color coded relative values for diagnosis" to "visually assist physicians." The document emphasizes its integration with existing systems and similar functionality to predicate devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no dedicated performance study with a defined ground truth is described in the provided summary.

8. The sample size for the training set
Not provided. A training set would be relevant for a machine learning or AI-driven algorithm. While the device processes images for visualization, this document does not indicate that it uses a training set in the context of machine learning, nor does it specify any data used to "train" the software in any other sense.

9. How the ground truth for the training set was established
Not applicable, as no training set is mentioned or described.

Summary

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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

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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:

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

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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).

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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

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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

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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:

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.

Regulation Number and Section

§ 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).