SYNGO.CT CORONARY ANALYSIS

K100637 · Siemens AG Medical Solutions · JAK · May 26, 2010 · Radiology

Device Facts

• Record ID: K100637
• Device Name: SYNGO.CT CORONARY ANALYSIS
• Applicant: Siemens AG Medical Solutions
• Product Code: JAK · Radiology
• Decision Date: May 26, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

Syngo.CT Coronary is an image analysis software package for evaluating cardiac CT angiography (CTA) volume data sets. Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR)), evaluation tools (coronary vessel centerline calculation, stenosis calculation and plaque analysis) and reporting tools (lesion location, lesion characteristics and key images), the software package is designed to support the physician in confirming the presence or absence of physician-identified coronary lesions and evaluation, documentation and follow-up of any such lesion. These visualization/evaluation tools allow for characterization of coronary lesions and lesion size over time, helping the physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue.

Device Story

Software package for post-processing cardiac CT angiography (CTA) volume data. Inputs: CT volume data sets. Processing: Digital image processing/visualization (MPR, MIP, inverted MIP, VRT, CPR); automated coronary vessel centerline calculation; stenosis calculation; plaque analysis. Outputs: Visualizations, lesion location/characteristics, and key images for reporting. Used in clinical settings by physicians to confirm presence/absence of coronary lesions, document findings, and track lesion size changes over time. Assists in classifying conspicuous tissue regions. Benefits: Supports clinical decision-making regarding coronary artery disease assessment and longitudinal follow-up.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by software development, hazard analysis, and verification and validation testing.

Technological Characteristics

Software-based image analysis package. Features visualization (MPR, MIP, VRT, CPR) and evaluation tools (centerline calculation, stenosis/plaque analysis). Operates on CT volume data. Software development follows recognized industry standards for risk management and hazard control. Standalone software package for use with CT systems.

Indications for Use

Indicated for use by physicians to evaluate cardiac CT angiography (CTA) volume data sets for the presence, absence, and characterization of coronary lesions, and to document and follow up on lesion growth over time.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• syngo® Circulation (K063762)
• syngo®.x (K092519)
• CardIQ Xpress 2.0 (K073138)

Submission Summary (Full Text)

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K100637

MAY 2 G 2010

## SIEMENS

510(k)

Section 8

## 510(k) - Summary

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

#### l. GENERAL INFORMATION

- t. Device Name and Classification

| Product Name: | syngo.CT Coronary Analysis |
|-----------------------|-----------------------------------------|
| Classification Name: | Accessory to Computed Tomography System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | 90 JAK |

### 2. lmporter/Distributor Establishment: Registration Number: 2240869

Siemens Medical Solutions, Inc. 51 Valley Stream Pkwy Malvern, PA 19355

#### 3. Manufacturing Facility:

Siemens AG Medical Solutions Henkestrasse 127

D-91052 Erlangen, Germany

#### 4. Contact Person:

.

Mr. Ralf Hofmann Regulatory Affairs Specialist Siemensstr.1; D-91301 Forchheim Phone: [phone] Fax: [phone]

- Date of Preparation of Summary: Nov. 16th 2009 5.

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## SIEMENS

II.

## SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION

#### 6. 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 the device.

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, Slemens adheres to recognized and established industry practice and standards.

#### Substantial Equivalence: 7.

syngo.CT Coronary Analysis software package, designed for post processing images that have been continuously acquired with computed tomography (CT) imaging systems which meet certain minimal requirements, is substantially equivalent to the following devices:

| Manufacturer | Product | 510(k) | Clearance date |
|-----------------------|--------------------|---------|----------------|
| 1. Siemens AG | syngo® Circulation | K063762 | 01/05/2007 |
| 2. Siemens AG | syngo®.x | K092519 | 08/27/2009 |
| 3. GE Medical Systems | CardIQ Xpress 2.0 | K073138 | 02/26/2008 |

#### 8. Device Description and Intended Use:

Syngo.CT Coronary is an image analysis software package for evaluating cardiac CT angiography (CTA) volume data sets.

Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR)), evaluation tools (coronary vessel centerline calculation, stenosis calculation and plaque analysis) and reporting tools (lesion location, lesion characteristics and key images), the software package is designed to support the physician in confirming the presence or absence of physician-identified coronary lesions and evaluation, documentation and follow-up of any such lesion. These visualization/evaluation tools allow for characterization of coronary lesions and lesion size over time, helping the physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue.

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Image /page/2/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

### 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 AG, Medical Solutions % Mr. Stefan Preiss Official Third Party Official TÜV SÜD America 1775 Old Highway 8 NW, Ste 104 NEW BRIGHTON MN 5112-1891

MAY 2 & 2010

Re: K100637

Trade/Device Name: syngo.CT Coronary Analysis Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: May 11, 2010 Received: May 14, 2010

### Dear Mr. Preiss:

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

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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 vours.

tter, years,

Donald J. St.Pierre 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

Indication for use

510(k) Number (if known):

Device Name:

syngo.CT Coronary Analysis

Syngo.CT Coronary is an image analysis software package for evaluating cardiac CT angiography (CTA) volume data sets.

Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR)), evaluation tools (coronary vessel centerline calculation, stenosis calculation and plaque analysis) and reporting tools (lesion location, lesion characteristics and key images), the software package is designed to support the physician in confirming the presence or absence of physician-identified coronary lesions and evaluation, documentation and follow-up of any such lesion.

These visualization/evaluation tools allow for characterization of coronary lesions and lesion size over time, helping the physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue.

Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) OIVD

| | <img alt="signature" src="signature"/><br>(Division Sign-Off) |
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Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety510(k) submission for SIEMENS ' syngo.CT Coronary Analysis (CT-QCA)

510K

Section 2