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.

Device Description

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

AI/ML Overview

This 510(k) submission for the Siemens InSpace 4D Software Package does not contain a detailed study proving the device meets acceptance criteria.

The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices (Siemens InSpace 4D K043469 and Siemens Pulmo CT K960635) rather than presenting a performance study against specific acceptance criteria.

The "Safety and Effectiveness Information Supporting the Substantial Equivalence Determination" section states that "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." This suggests that the device's safety and effectiveness were primarily supported by adherence to established industry practices, risk management, and internal verification/validation, rather than a specific clinical performance study with predefined acceptance criteria.

Therefore, many of the requested details about acceptance criteria, sample sizes, ground truth establishment, and comparative effectiveness studies are not present in this document.

Here's how the requested information would be addressed based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission focuses on substantial equivalence to predicate devices, implying that its performance is implicitly acceptable if it functions similarly to those already cleared. No specific quantitative acceptance criteria or reported performance metrics are listed.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. No specific test set or data provenance (e.g., country of origin, retrospective/prospective) is described.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. There is no mention of a test set with expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the document. No adjudication method is mentioned as there is no described test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not provided in the document. There is no mention of an MRMC study or any assessment of human reader improvement with or without AI assistance. The device is intended to "assist the physician" but no quantitative data on this assistance is provided.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not provided in the document. The device is described as an "image analysis software package" intended to "assist the physician," implying it is not a standalone diagnostic tool without human oversight. No standalone performance data is presented.

7. The Type of Ground Truth Used

This information is not provided in the document. Since no specific performance study against a ground truth is detailed, the type of ground truth used is unknown.

8. The Sample Size for the Training Set

This information is not provided in the document. There is no mention of a training set or its size.

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

This information is not provided in the document. As no training set is described, the method of establishing its ground truth is unknown.

Summary

{0}------------------------------------------------

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: +49 9191 18-8170 Fax: +49 9191 18-9782

1. Date of Preparation of Summary: Apr. 25th, 2007

{1}------------------------------------------------

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

{2}------------------------------------------------

SIEMENS

4. Device Description

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

{3}------------------------------------------------

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

{4}------------------------------------------------

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 (800) 638-2041 or (240) 276-3150

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

{5}------------------------------------------------

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:

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

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

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.