SYNGO NEURO PBV CT

K063507 · Siemens AG · JAK · Nov 30, 2006 · Radiology

Device Facts

• Record ID: K063507
• Device Name: SYNGO NEURO PBV CT
• Applicant: Siemens AG
• Product Code: JAK · Radiology
• Decision Date: Nov 30, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

syngo Neuro PBV CT is a dedicated post-processing application used in cases of suspected stroke. The application calculates a volume that represents the amount of blood in the parenchyma. Decreased blood volume in a certain region of the brain is an indicator for stroke. As syngo Neuro PBV CT calculates a blood volume the stroke region can be measured in 3D. Neuro PBV CT is calculated using a non-enhanced CT dataset (NECT) and a CT Angiography (CTA) that both are acquired during modern stroke protocol. The two volumes are first registered and after segmentation of bones, CSF, and vessels the volumes are low pass filtered and subtracted. The result is adjusted to the enhancement of a vessel to allow semi-quantitative measurements. Syngo Neuro PBV CT helps to diagnosing stroke while enlarging the cerebral blood volume (CBV) of perfusion CT (PCT) that covers only a portion of the brain. Thus it facilitates the treatment decision and is an addition to Perfusion CT.

Device Story

Software application for post-processing CT images in suspected stroke cases. Inputs: non-enhanced CT (NECT) and CT Angiography (CTA) datasets. Processing: image registration; segmentation of bones, CSF, and vessels; low-pass filtering; subtraction of volumes; adjustment to vessel enhancement. Output: 3D cerebral blood volume (CBV) map. Used in clinical settings by radiologists/physicians. Supplements Perfusion CT (PCT) by providing broader brain coverage. Assists in identifying stroke regions and facilitating treatment decisions.

Clinical Evidence

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

Technological Characteristics

Post-processing software application for CT systems. Performs image registration, segmentation, low-pass filtering, and subtraction of NECT and CTA datasets. Semi-quantitative measurement of cerebral blood volume. Operates on standard CT imaging hardware.

Indications for Use

Indicated for use in patients with suspected stroke to calculate cerebral blood volume in the brain parenchyma to assist in stroke diagnosis and treatment decision-making.

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

• NeuroDSA CT (K053024)
• Perfusion CT (K033832)
• Leonardo (syngo Fused Vision 3D) (K040970)

Submission Summary (Full Text)

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Summary

NOV 3 0 2006

# K063507

# Section 9

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 l.

#### Device Name and Classification 1.

syngo Neuro PBV CT Product Name: Accessory to Computed Tomography System Classification Name: Radiology Classification Panel: 21 CFR §892.1750 CFR Section: Class II Device Class: 90 JAK Product Code:

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

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

#### Manufacturing Facility: 3.

Siemens AG Medical Solutions Henkestrasse 127

D-91052 Erlangen, Germany

#### Contact Person: 4.

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

#### Date of Preparation of Summary: October 23(d 2006 5.

DA/CDRH/ODE/PM

NOV 20 P 12:21

RECEIVED

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Image /page/1/Picture/0 description: The image contains the word "Summary" in a simple, sans-serif font. The text is presented in a straightforward manner, with no additional design elements or formatting. The word is likely intended to introduce a concise overview or recap of information.

Image /page/1/Picture/1 description: The image shows the word "SIEMENS" in a stylized, outlined font. The letters are evenly spaced and appear to be a digital rendering. The overall impression is clean and modern, reflecting the brand's identity.

## SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL = 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 Neuro PBV CT 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 Siemens Medical Systems device:

| Manufacturer | Product | 510(k) | Clearance date |
|---------------|----------------------------------|---------|----------------|
| 1. Siemens | NeuroDSA CT | K053024 | 11/04/2005 NOW |
| 2. Siemens | Perfusion CT | K033832 | 12/23/2003 |
| 3. Siemens AG | Leonardo (syngo Fused Vision 3D) | K040970 | 07/08/2004 |

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

synqo Neuro PBV CT is a dedicated post-processing application used in cases of suspected stroke. The application calculates a volume that represents the amount of blood in the parenchyma. Decreased blood volume in a certain region of the brain is an indicator for stroke. As syngo Neuro PBV CT calculates a blood volume the stroke region can be measured in 3D.

Neuro PBV CT is calculated using a non-enhanced CT dataset (NECT) and a CT Angiography (CTA) that both are acquired during modern stroke protocol. The two volumes are first registered and after segmentation of bones, CSF, and vessels the volumes are low pass filtered and subtracted. The result is adjusted to the enhancement of a vessel to allow semi-quantitative measurements.

Syngo Neuro PBV CT helps to diagnosing stroke while enlarging the cerebral blood volume (CBV) of perfusion CT (PCT) that covers only a portion of the brain. Thus it facilitates the treatment decision and is an addition to Perfusion CT

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three wavy lines representing the three levels of government: federal, state, and local. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Stefan Preiss Responsible Third Party Official TÜV Product Service 1775 Old Hwy 8 NW, Ste 104 NEW BRIGHTON MN 55112-1891

NOV 3 0 2006

Re: K063507

Trade/Device Name: syngo Neuro PBV CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: November 16, 2006 Received: November 20, 2006

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.

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Protecting and Promoting Public Health

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issumos of the complies with other requirements of the Act that FDA has made a delemination an administered by other Federal agencies. You must of any rederal statutes and regulations and limited to: registration and listing (21 comply with an the Act 3 requirements) 11 CFR Part 801); good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); government and 120); and if applicable, the electronic forul in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manealing of substantial equivalence of your device to a legally premarket nothleadon. The PDA misms of beating 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 actives to: your of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" Also, picase note the regulation other general information on your responsibilities under (21CN Fall 607.97). 10d may octain offers, International and Consumer Assistance at its toll-free number [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrfvindustry/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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SIEMENS

Indications for use

## Section 3

Indication for use

510(k) Number (if known):

Kol 3507

Device Name:

syngo Neuro PBV CT

syngo Neuro PBV CT is a dedicated post-processing application used in cases of suspected stroke. The application calculates a volume that represents the amount of blood in the parenchyma. Decreased blood volume in a certain region of the brain is an indicator for stroke. As syngo Neuro PBV CT calculates a blood volume the stroke region can be measured in 3D.

Neuro PBV CT is calculated using a non-enhanced CT dataset (NECT) and a CT Angiography (CTA) that both are acquired during modern stroke protocol. The two volumes are first registered and after segmentation of bones, CSF, and vessels the volumes are low pass filtered and subtracted. The result is adjusted to the enhancement of a vessel to allow semi-quantitative measurements.

Syngo Neuro PBV CT helps to diagnosing stroke while enlarging the cerebral blood volume (CBV) of perfusion CT (PCT) that covers only a portion of the brain. Thus it facilitates the treatment decision and is an addition to Perfusion CT.

| (Part 21 CFR 801 Subpart D) | AND/OR | (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)

| Division Sign-Off | Nancy Brogdon |
|-----------------------------------------------------------|---------------|
| Division of Reproductive, Abdominal, Radiological Devices | |
| 510(k) Number | K063507 |

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