SYNGO CIRCULATION

K052029 · Siemens AG Medical Solutions · JAK · Aug 9, 2005 · Radiology

Device Facts

• Record ID: K052029
• Device Name: SYNGO CIRCULATION
• Applicant: Siemens AG Medical Solutions
• Product Code: JAK · Radiology
• Decision Date: Aug 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Indications for Use

syngo Circulation is a self-contained image analysis software package for evaluating cardiac CTA volume data sets. syngo Circulation combines commercially available digital image processing and visualization tools (MIP thin/thick, MPR thin/thick, VRT, CPR), evaluation tools (volumetric analysis of the left ventricle, coronary tree segmentation and stenosis evaluation) and reporting tools (lesion location and characteristics) with a workflow including dedicated scanning protocols. The software package is designed to support the physician in confirming the presence or absence of physician identified coronary lesions and evaluation of the hearts functional parameter in addition to evaluation, documentation and follow-up of any such lesions. These visualization/evaluation tools allow for volumetric analysis of the left ventricle and characterization of coronary lesions over time, helping the physician to assess the changes. It is also designed to help the physician classify conspicuous regions of tissue unambiguously, with respect to their size, dimensions, shape and position.

Device Story

syngo Circulation is a software package for cardiac CTA volume data analysis; inputs include cardiac CTA volume data sets. Device utilizes digital image processing and visualization tools (MIP, MPR, VRT, CPR) to perform volumetric analysis of the left ventricle, coronary tree segmentation, and stenosis evaluation. Output includes visualization, quantification, and reporting of lesion location/characteristics and functional parameters. Used in clinical settings by physicians to confirm presence/absence of coronary lesions, evaluate cardiac function, and document/follow-up on lesions over time. Assists physicians in classifying tissue regions by size, dimension, shape, and position. Supports clinical decision-making by providing quantitative data for longitudinal assessment of coronary changes.

Clinical Evidence

No clinical data provided. Safety and effectiveness are supported by hazard analysis, software verification, and validation testing.

Technological Characteristics

Software-based image analysis package. Features visualization tools (MIP, MPR, VRT, CPR), volumetric analysis, and coronary tree segmentation. Operates on cardiac CTA volume data. Software development follows recognized industry standards for risk management and hazard control.

Indications for Use

Indicated for use by physicians to analyze cardiac CTA volume data sets, including volumetric analysis of the left ventricle, coronary tree segmentation, stenosis evaluation, and characterization/follow-up of coronary lesions.

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

• CardIQ Analysis III (K041267)

Submission Summary (Full Text)

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# 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

## Device Name and Classification 1.

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

# Importer/Distributor Establishment: 2. 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. Rüdiger Körner Manager Regulatory Submissions Siemensstr.1; D-91301 Forchheim [phone] Phone: [phone] Fax:

# Date of Preparation of Summary: May 06th 2005 5.

Attachment 8

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# SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL 11. EQUIVALENCE DETERMINATION

# General Safety and Effectiveness Concerns: 6.

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, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.

## Substantial Equivalence: 7.

The syngo Circulation software package that is addressed in this premarket notification, is substantially equivalent to the following commercially available software package:

| Manufacturer | Product | 510(k) | Clearance date |
|---------------------|---------------------|---------|----------------|
| 1. General Electric | CardIQ Analysis III | K041267 | 05/27/2004 |

## Device Description and Intended Use: 8.

syngo Circulation is a self-contained image analysis software package for evaluating cardiac CTA volume data sets.

syngo Circulation combines commercially available digital image processing and visualization tools (MIP thin/thick, MPR thin/thick, VRT, CPR), evaluation tools (volumetric analysis of the left ventricle, coronary tree segmentation and stenosis evaluation) and reporting tools (lesion location and characteristics) with a workflow including dedicated scanning protocols. The software package is designed to support the physician in confirming the presence of physician identified coronary lesions and evaluation of the hearts functional parameter in addition to evaluation, documentation and follow-up of any such lesions.

These visualization/evaluation tools allow for volumetric analysis of the left ventricle and characterization of coronary lesions over time, helping the physician to assess the changes. It is also designed to help the physician classify conspicuous regions of tissue unambiguously, with respect to their size, dimensions, shape and position.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 9 - 2005

Siemens AG Medical Solutions % Mr. Stefan Preiss Responsible Third Party Official TÜV America, Inc. TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891 / Re: K052029 Trade/Device Name: syngo Circulation Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II

Product Code: JAK Dated: July 25, 2005 Received: July 27, 2005

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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin hantelling of substantial equivalence of your device to a legally prematication: The PDF maing of cassification 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 Part 801), please If you desire specific acrise for your of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, phease note the regulation on your responsibilities under the Act from the 807.97). Tou may obtain other general meeting 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,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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S. STEVENS

Indications for use

Attachment 2

Indication for use

510(k) Number (if known):

2029

Device Name:

syngo Circulation

syngo Circulation is a self-contained image analysis software package for evaluating cardiac CTA volume data sets.

syngo Circulation combines commercially available digital image processing and visualization tools (MIP thin/thick, MPR thin/thick, VRT, CPR), evaluation tools (volumetric analysis of the left ventricle, coronary tree segmentation and stenosis evaluation) and reporting tools (lesion location and characteristics) with a workflow including dedicated scanning protocols. The software package is designed to support the physician in confirming the presence or absence of physician identified coronary lesions and evaluation of the hearts functional parameter in addition to evaluation, documentation and follow-up of any such lesions.

These visualization/evaluation tools allow for volumetric analysis of the left ventricle and characterization of coronary lesions over time, helping the physician to assess the changes. It is also designed to help the physician classify conspicuous regions of tissue unambiguously, with respect to their size, dimensions, shape and position.

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

Prescription Use X (Per 21 CFR §801.109)

Over-the-Counter Use

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