The Siemens syngo Perfusion-CT software package has been designed to evaluate areas of brain perfusion. The software can calculate cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e. time to start, time to peak) and vascular permeability (blood brain barrier disturbances) from sets of images reconstructed from continuously acquired CT data after the injection of contrast media. The package also allows the calculation of mirrored regions of interest and the visual inspection of time density curves.

One potential clinical application is to visualize the apparent blood perfusion in brain tissue affected by acute stroke. Areas of decreased perfusion, as is observed in acute cerebral infarcts, appear as areas of changed signal intensity (lower for CBF and CBV, higher for time to peak).

Syngo Perfusion-CT is sensitive in identifying the areas of decreased perfusion which indicates the occurrence of acute stroke, during the first 6 hours after onset of symptoms.

A second potential application is the visualization of blood-brain-barrier disturbances in brain tumors. A modified Patlak approach is used for the modeling of extra-vascular leakage of blood into the interstitial space. This additional capability may improve the differential diagnosis of brain tumors and be helpful in therapy monitoring.

Device Description

Syngo Perfusion-CT is a post-processing software package, which runs on an Intelbased PC platform designed to post-process images acquired with SOMATOM CT scanners, which meet certain minimal requirements (i.e. Siemens Sensation 16, Sensation 10, Sensation Cardiac, Sensation 4, Volume Zoom, Volume Access, Emotion 6, Emotion Duo, Emotion, SOMATOM Plus 4, SOMATOM AR.STAR, SOMATOM Classic). It is a package containing evaluation software that supports the evaluation of Dynamic CT data gathered after the injection of a compact bolus of contrast media, where the contrast media acts as a pure intravascular tracer.

Syngo Perfusion-CT calculates the parameters related to brain perfusion and cerebral blood flow (CBF) using a simple linear relationship between the defected change of signal and the actual concentration of contrast media.

The Siemens syngo Perfusion-CT package has been designed to image cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e. time to start, time to peak) and vascular permeability from sets of images reconstructed from CT data that were continuously acquired after the injection of a bolus of contrast media. It also allows the calculation of mirrored regions of interest and the visual inspection of time density curves.

AI/ML Overview

The provided document does not contain all the requested information for acceptance criteria and the study proving the device meets them. Here's a summary of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device's intended use and capabilities, but it does not provide a table of acceptance criteria or specific reported performance metrics. It focuses on demonstrating substantial equivalence to predicate devices rather than defining and validating performance against specific criteria.

2. Sample Size for Test Set and Data Provenance:

This information is not available in the provided document.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not available in the provided document.

4. Adjudication Method for Test Set:

This information is not available in the provided document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention a multi-reader multi-case comparative effectiveness study or any effect size of human reader improvement with AI.

6. Standalone (Algorithm Only) Performance:

The document describes the device as a "post-processing software package" that "calculates parameters," implying a standalone algorithm's function. However, it does not provide performance metrics specifically for standalone algorithm-only performance.

7. Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used for any validation. It mentions "syngo Perfusion-CT is sensitive in identifying the occurrences of acute stroke," implying a clinical correlation.

8. Sample Size for the Training Set:

This information is not available in the provided document.

9. How the Ground Truth for the Training Set Was Established:

This information is not available in the provided document.

Summary of Available Information from the Document:

The document is a 510(k) summary for the "syngo Perfusion-CT" software. Its primary purpose is to establish substantial equivalence to previously cleared predicate devices (Siemens syngo Perfusion-CT K982536 and General Electric CT Perfusion 2 K010042).

Intended Use: To post-process images acquired with SOMATOM CT scanners to calculate parameters related to brain perfusion and cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (time to start, time to peak), and vascular permeability.
Clinical Applications:
- Visualizing apparent brain perfusion in brain tissue affected by acute stroke. It is stated to be "sensitive in identifying the occurrences of acute stroke during the first 6 hours after onset of symptoms."
- Visualization of blood-brain-barrier disturbances in brain tumors, which "may improve the differential diagnosis of brain tumors and be helpful in therapy monitoring."
Methodology: Calculates parameters using a simple linear relationship between the defected change of signal and the actual concentration of contrast media. A modified Patlak approach is used for modeling extra-vascular leakage in brain tumors.

Why the requested information is largely absent:

This document is a 510(k) summary for a Class II medical device. For such devices, a common pathway to clearance is demonstrating substantial equivalence to a legally marketed predicate device. This often means showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. Extensive de novo clinical studies with detailed acceptance criteria, ground truth establishment, and expert adjudication are often not required for 510(k) clearance if substantial equivalence can be demonstrated effectively. The document focuses on this substantial equivalence argument rather than presenting detailed performance study results against predefined acceptance criteria.

Summary

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SIEMENS

DEC 2 3 2003

Ko33832

Attachment 8

510(k)

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.

GENERAL INFORMATION .

Device Name and Classification 1.

Product Name:	syngo Perfusion-CT
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

Contact Person: 4.

Mr. Rüdiger Körner Manager Regulatory Submissions Siemensstr.1; D-91301 Forchheim Phone: +49 9191 18-9355 +49 9191 18-9988 Fax:

Date of Preparation of Summary: Oct 15th 2003 5.

▪ 510(k) submission for SIEMENS 'syngo Perfusion-CT '

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Image /page/1/Picture/0 description: The image shows the word "SIEMENS" written in a pixelated style. The letters are formed by small dots, giving the word a textured appearance. The overall effect is a digital or low-resolution representation of the brand name.

ll. 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, Siemens adheres to recognized and established industry practice and standards.

7. Substantial Equivalence:

The syngo Perfusion-CT 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. Siemens	syngo Perfusion-CT	K982536	Nov. 24, 1998
2. General Electric	CT Perfusion 2	K010042	Jan. 30, 2001

8. Device Description and Intended Use:

■ 510(k) submission for SIEMENS 'syngo Perfusion-CT '

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One potential clinical application is to visualize the apparent brain perfusion in brain tissue affected by acute stroke. Areas of decreased perfusion, as is observed in acute cerebral infarcts, appear as areas of changed image intensity (lower for CBF and CBV, higher for time to peak).

Syngo Perfusion-CT is sensitive in identifying the occurrences of acute stroke during the first 6 hours after onset of symptoms.

A second potential application is the visualization of blood-brain-barrier disturbances in brain tumors. Assessing vascular permeability may improve the differential diagnosis of brain tumors and be helpful in therapy monitoring.

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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 body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 2003

Siemens Medical Solutions, Inc. % Mr. Stefan Preiss Responsible Third Party TÜV America, Inc. TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891 Re: K033832

Trade/Device Name: syngo Perfusion CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: December 5, 2003

Received: December 10, 2003

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 (PMA), 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) 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Bugden

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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SIEMENS

Attachment 2

Indication for use

510(k) Number (if known):

K033832

Device Name:

syngo Perfusion-CT

Syngo Perfusion-CT is sensitive in identifying the areas of decreased perfusion which indicates the occurrence of acute stroke, during the first 6 hours after onset of symptoms.

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

Prescription Use

(Per 21 CFR §801.109)

OR Over-The-Counter Use

Daniel A. Larson

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

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
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.(b)
Classification. Class II.