SYNGO BREVIS

K090038 · Siemens Medical Solutions USA, Inc. · LNH · Apr 28, 2009 · Radiology

Device Facts

• Record ID: K090038
• Device Name: SYNGO BREVIS
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNH · Radiology
• Decision Date: Apr 28, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

syngo BreVis is a software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. syngo BreVis supports evaluation of dynamic MR data. Depending on the region of interest, contrast agents may or may not be used. syngo BreVis automatically registers serial patient motion to minimize the impact of patient motion and visualizes different enhancement characteristics in those areas that are within the scope of the indications for use of MRI FDA approved contrast agents (parametric image maps). Furthermore, it performs other user-defined post-processing functions such as image subtractions; multiplanar reformats and maximum intensity projections. The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto the source image. syngo BreVis can also be used to provide measurements of the diameters, areas and volumes. Furthermore syngo BreVis can evaluate the uptake characteristics of segmented tissues that are within the scope of the indications for use of MRI FDA approved contrast agents. syngo BreVis includes software to support the use of interventional coils and MR stereotactic localization devices to perform MR-guided interventional procedures (syngo BreVis Biopsy). Using information from MR images regarding the coordinates of a user-specified region of interest and fiducial coordinates, syngo BreVis provides an-automatic-calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion. syngo BreVis is optimized for viewing breast MR studies, and it also displays images from a number of other imaging modalities, like digitized mammographic images. The images by other imaging modalities displayed with syngo BreVis must not be used for primary diagnostic interpretation. syngo BreVis also includes the option to add annotations based on the American College of Radiology's BI-RADS (Breast Imaging and Data System). When interpreted by a skilled physician, syngo BreVis provides information that may be useful in diagnosis. Patient management decisions should not be made based solely on the results of syngo BreVis analysis.

Device Story

Software package for viewing/analyzing MRI studies; optimized for breast MR. Inputs: dynamic MR image data, user-defined regions of interest, fiducial coordinates. Processing: automatic registration of serial patient motion; parametric image mapping of contrast enhancement; image subtraction; multiplanar reformatting; maximum intensity projections; measurement of diameters, areas, and volumes; calculation of biopsy target location/depth for MR-guided interventions. Output: processed images, parametric maps, measurements, and biopsy coordinates displayed to physician. Used in clinical settings by radiologists/physicians to assist in diagnosis and interventional planning. Does not replace clinical judgment; patient management decisions require physician interpretation.

Clinical Evidence

No clinical data provided. Safety and effectiveness established through risk analysis, software verification, and validation testing.

Technological Characteristics

Software-based MRI post-processing package. Features include automatic motion registration, parametric mapping, multiplanar reformatting, and biopsy coordinate calculation. Compatible with interventional coils and stereotactic localization devices. Supports BI-RADS annotation. Operates on standard MR imaging workstations.

Indications for Use

Indicated for viewing and analyzing MRI studies, specifically optimized for breast MR. Supports evaluation of dynamic MR data, including contrast-enhanced studies. Used for post-processing, measurement, and MR-guided interventional biopsy planning. Not for primary diagnostic interpretation of non-MRI modalities.

Regulatory Classification

Identification

A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

Special Controls

*Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• CADstream V4.0 (K043216)
• DynaCAD V1.0 (K041286)

Submission Summary (Full Text)

{0}------------------------------------------------

Section 5: 510(k) Summar

# 5 510(k) Summary

# APR 2 8 2009

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92.

#### I. General Information

| Establishment | Siemens Medical Solutions. Inc. |
|---------------|---------------------------------|
| | 51 Valley Stream Parkway |
| | Malvern. PA 19355 |

Registration Number 2240869

_Manufacturer_________________________________________________________________________________________________________________________________________________________________ Siemens AG. - -Henkestrasse 127 D-91052 Erlangen. Germany

Registration Number

#### 8010024

Contact Person

Judith Campbell Regulatory Technical Specialist. 51 Valley Stream Parkway Malvern, PA 19355 Phone: [phone] Fax: [phone]

| Trade name | syngo BreVis |
|-----------------------|---------------------------------------------|
| Classification Name | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| Regulation number: | 21 CFR § 892.1000 |
| Device Class: | II |
| Product Code: | LNH |

#### Summary Device Description

syngo BreVis is a software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. syngo BreVis supports evaluation of dynamic MR data. Depending on the region of interest, contrast agents may or may not be used.

{1}------------------------------------------------

## II. Safety and Effectiveness Information Supporting Substantial Equivalence.

#### Intended Use

syngo BreVis is a software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. syngo BreVis supports evaluation of dynamic MR data. Depending on the region of interest, contrast agents may or may not be used.

syngo BreVis automatically registers serial patient motion to minimize the impact of patient motion and visualizes different enhancement characteristics in those areas that are within the scope of the indications for use of MRI FDA approved contrast agents (parametric image maps).

Furthermore, it performs other user-defined post-processing functions such as image subtractions; multiplanar reformats and maximum intensity projections.

The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto the source image. syngo BreVis can also be used to provide measurements of the diameters, areas and volumes.

Furthermore syngo BreVis can evaluate the uptake characteristics of segmented tissues that are within the scope of the indications for use of MRI FDA approved contrast agents.

syngo BreVis includes software to support the use of interventional coils and MR stereotactic localization devices to perform MR-guided interventional procedures (syngo BreVis Biopsy). Using information from MR images regarding the coordinates of a user-specified region of interest and fiducial coordinates, syngo BreVis provides an-automatic-calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion.

syngo BreVis is optimized for viewing breast MR studies, and it also displays images from a number of other imaging modalities, like digitized mammographic images. The images by other imaging modalities displayed with syngo BreVis must not be used for primary diagnostic interpretation.

syngo BreVis also includes the option to add annotations based on the American College of Radiology's BI-RADS (Breast Imaging and Data System).

When interpreted by a skilled physician, syngo BreVis provides information that may be useful in diagnosis. Patient management decisions should not be made based solely on the results of syngo BreVis analysis.

{2}------------------------------------------------

## Performance Standards

None established under Section 514 the Food. Drug. and Cosmetic Act.

## Substantial Equivalence

syngo BreVis is substantially equivalent to the following cleared medical devices:

| Predicate Software<br>Name | FDA Clearance Number | FDA Clearance Date |
|----------------------------|----------------------|--------------------|
| CADstream V4.0 | K043216 | Jan 6, 2005 |
| DynaCAD V1.0 | K041286 | July 21, 2004 |

#### General Safety and Effectiveness Concerns:

The introduction of syngo BreVis has no significant concerns of safety and efficacy.

The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.

Risk management is ensured via Risk Analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing.

syngo BreVis will conform to the measurement of safety and performance parameters to the international IEC and ISO standards, where applicable.

{3}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 2009

Ms. Judith Campbell Regulatory Technical Specialist Siemens Medical Solutions, Inc. 51 Valley Stream Parkway MALVERN PA 19355

Re: K090038 ·

Trade/Device Name: syngo BreVis Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: March 20, 2009 Received: March 23, 2009

Dear Ms. Campbell:

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 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}------------------------------------------------

Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Page 1 of 2

Section 4: Indications for Use Statement

# 4 Indications for Use Statement

510(k) Number (if known)

090038

#### Indications for Use:

syngo BreVis is a software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. syngo BreVis supports evaluation of dynamic MR data. Depending on the region of interest, contrast agents may or may not be used.

syngo BreVis automatically registers serial patient motion to minimize the impact of patient motion and visualizes different enhancement characteristics in those areas that are within the scope of the indications for use of MRI FDA approved contrast agents (parametric image maps).

Furthermore, it performs other user-defined post-processing functions such as image subtractions, multiplanar reformats and maximum intensity projections.

The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto the source image. syngo BreVis can also be used to provide measurements of the diameters, areas and volumes.

Furthermore syngo BreVis can evaluate the uptake characteristics of segmented tissues that are within the scope of the indications for use of MRI FDA approved contrast agents.

syngo BreVis includes software to support the use of interventional coils and MR stereotactic localization devices to perform MR-quided interventional procedures (syngo BreVis Biopsy). Using information from MR images regarding the coordinates of a user-specified region of interest and fiducial coordinates, syngo BreVis provides an automatic calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion.

syngo BreVis is optimized for viewing breast MR studies, and it also displays images from a number of other imaging modalities, like digitized mammographic images. The images by other imaging modalities displayed with syngo BreVis must not be used for primary diagnostic interpretation.

syngo BreVis also includes the option to add annotations based on the American College of Radiology's BI-RADS (Breast Imaging and Data System).

{6}------------------------------------------------

Page 2 of 2

Section 4: Indications for Use Statement

When interpreted by a skilled physician, syngo BreVis provides information that may be useful in diagnosis. Patient management decisions should not be made based solely on the results of syngo BreVis analysis.

(please do not write below this line- continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation

Prescription Use X .

OR

Over-The-Counter Use_

Page of

Hela Pemen

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.

Siemens 510(k) Premarket Notification syngo BreVis