INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY

K071513 · Siemens Medical Solutions · JAK · Jun 26, 2007 · Radiology

Device Facts

• Record ID: K071513
• Device Name: INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
• Applicant: Siemens Medical Solutions
• Product Code: JAK · Radiology
• Decision Date: Jun 26, 2007
• 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

The In Space 4D - Software package is intended to assist the physician in skeletal and soft tissue imaging.

Device Story

syngo InSpace 4D is a self-contained image analysis software package for CT volume data. It transforms 2D CT images into 3D formats for interactive evaluation. Used by physicians in clinical settings to visualize blood vessels by removing interfering anatomical structures (bone) from CTA datasets. Also used for bone extraction/display in fracture analysis and thoracic CT analysis. Features include 3D segmentation, isolation of subcompartments, volumetric analysis, density evaluations, and low-density cluster analysis. Output is visualized by the physician to facilitate precise diagnosis and documentation of chest diseases. Benefits include improved visualization of vascular and skeletal structures and streamlined workflows for pulmonary tissue assessment.

Clinical Evidence

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

Technological Characteristics

Self-contained image analysis software package. Functions: 3D reconstruction, 3D segmentation, volumetric analysis, density evaluation, and low-density cluster analysis. Operates on CT volume datasets. Software-based processing.

Indications for Use

Indicated for physicians to assist in diagnosis of blood vessels using CT Angiography (CTA) datasets, removal of bone structures from CTA or non-CTA datasets for fracture analysis, and diagnosis/documentation of chest diseases including pulmonary tissue examination in thoracic CT datasets.

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

• InSpace 4D (K043469)
• Pulmo CT (K960635)

Submission Summary (Full Text)

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# SIEMENS

K0971513
510(k)

## 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.

JUN 2 6 2007

#### l. GENERAL INFORMATION

#### 1. Device Name and Classification

Product Name:

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

InSpace 4D

#### lmporter/Distributor Establishment: 2.

Registration Number: 2240869

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

#### Manufacturing Facility: 3.

Siemens AG Wittelsbacherplatz 2 D-80333 Muenchen, Germany

#### 4. Contact Person:

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

- 5. Date of Preparation of Summary: Apr. 25th, 2007

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

#### 1. 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.

#### 2. Substantial Equivalence

The syngo InSpace 4D Software Package, addressed in this pre-market notification, is substantially equivalent to the following commercially available software package:

| Manufacturer | Product | 510(k) | Clearance date |
|--------------|------------|---------|----------------|
| Siemens | InSpace 4D | K043469 | Feb. 03, 2005 |
| Siemens | Pulmo CT | K960635 | Apr. 03 1996 |

In summary, Siemens is of the opinion that syngo InSpace 4D Software Package does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate software components and the predicate device.

### 3. Intended Use

The In Space 4D - Software package is intended to assist the physician in skeletal and soft tissue imaging.

ﻳﺮ

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# SIEMENS

## 4. Device Description

syngo InSpace 4D - Software Package is a self-contained image analysis software package. This real-time interactive evaluation in space and time for CT volume data sets provides the reconstruction of two-dimensional images into a three-dimensional image format.

InSpace 4D can be used to assist the physician in the diagnosis of blood vessels on the basis of a CT Angiography dataset (CTA). For a CTA examination a contrast media (CM) is administered into the patient's blood vessels to enhance the contrast of the vessels in the CTA dataset, i.e. high values for the Hounsfield Unit (HU).

The goal is to visualize the blood vessels without other interfering anatomical structures.

The syngo InSpace 4D is developed to facilitate a precise diagnosis by removing bone structures from a CTA data set. It can be used in the same way for Non CTA datasets to remove bones or extract and display selected bones, e.g. for the analysis of a fracture.

Further, syngo InSpace 4D can be used to support the physician in the diagnosis and documentation of chest diseases, e.g. when examining the pulmonary tissue (i.e. lung parenchyma) in CT thoracic datasets. Evaluation tools (3D segmentation & isolation of subcompartments, volumetric analysis, density evaluations, low density cluster analysis) and reporting tools are combined with a dedicated workflow.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the address for the Food and Drug Administration. The address is listed as 9200 Corporate Blvd. in Rockville MD 20850. The text is in a serif font and is left-aligned.

Siemens AG Medical Solutions % Mr. Stefan Preiss Responsible Third Party Official TÜV SÜD America 1775 Old Hwy 8 NW, Ste 104 NEW BRIGHTON MN 55112-1891

Re: K071513

Trade/Device Name: InSpace 4D - Software Package with Extended Functionality Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 1, 2007 Received: June 4, 2007

#### 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 max. 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.

Image /page/3/Picture/9 description: The image shows a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are prominently displayed in the center of the logo. There are three stars below the word "Centennial". The logo appears to be a commemorative emblem for the centennial of the Food and Drug Administration.

moting Public Hoalth and Sto

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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.

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 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" (21CFR Part 807.97). 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/cdrl/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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# SIEMENS

510(k)

#### SECTION 3

### INDICATION FOR USE

510(k) Number (if known):

Device Name: InSpace 4D - Software package with extended functionality

Indications for Use:

syngo InSpace 4D - Software Package is a self-contained image analysis software package. This real-time interactive evaluation in space and time for CT volume data sets provides the reconstruction of two-dimensional images into a three-dimensional image format.

InSpace 4D can be used to assist the physician in the diagnosis of blood vessels on the basis of a CT Angiography dataset (CTA). For a CTA examination a contrast media (CM) is administered into the patient's blood vessels to enhance the contrast of the vessels in the CTA dataset, i.e. high values for the Hounsfield Unit (HU).

The goal is to visualize the blood vessels without other interfering anatomical structures.

The syngo InSpace 4D is developed to facilitate a precise diagnosis by removing bone structures from a CTA data set. It can be used in the same way for Non CTA datasets to remove bones or extract and display selected bones, e.g. for the analysis of a fracture.

Further, syngo InSpace 4D can be used to support the physician in the diagnosis and documentation of chest diseases, e.g. when examining the pulmonary tissue (i.e. lung parenchyma) in CT thoracic datasets. Evaluation tools (3D segmentation & isolation of subcompartments, volumetric analysis, density evaluations, low density cluster analysis) and reporting tools are combined with a dedicated workflow.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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) | |
|---------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | 2071513 |