DYNAPBV BODY SOFTWARE

K121292 · Siemens Medical Solutions USA, Inc. · LLZ · Jul 30, 2012 · Radiology

Device Facts

• Record ID: K121292
• Device Name: DYNAPBV BODY SOFTWARE
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jul 30, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended 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).

Device Story

syngo DynaPBV Body is an add-on software extension for InSpace 3D; operates on angiographic C-arm systems. Input: 2D X-ray images. Transformation: reconstructs 2D images into 3D format; generates color-coded maps representing relative contrast-enhanced blood distribution. Output: 3D visualization of blood flow/vessel structures. Used in clinical settings (e.g., interventional suites) by physicians. Output assists in diagnosing/treating vessel malformations (aneurysms, AVMs, stenoses) and surgical planning. Benefits include improved visualization of vascular perfusion to guide clinical decision-making.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, software verification, and validation of the software extension within the existing InSpace 3D framework.

Technological Characteristics

Software-only extension to InSpace 3D. Interfaces with angiographic C-arm hardware. Features include 3D image reconstruction, color-coded relative value mapping for blood distribution, and integration into existing InSpace 3D task cards. Operates as a non-standalone application.

Indications for Use

Indicated for physicians to assist in diagnosis, surgical planning, interventional procedures, and treatment follow-up of vessel malformations including aneurysms, AVMs, and stenoses in soft tissue, specifically for visualizing contrast-enhanced blood distribution in the body (thorax/abdomen).

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

• InSpace 3D Software Option (K011447)
• syngo Neuro PBV (K111052)

Submission Summary (Full Text)

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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: [phone] Phone: [phone] Email: [e-mail]

# 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:

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

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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 [phone]. 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 [phone] or [phone] 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:

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

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