(14 days)
No
The description focuses on image analysis, reconstruction, and filtering techniques (removing bone, CT table) based on Hounsfield Units, which are standard image processing methods, not explicitly AI/ML. There is no mention of AI, ML, or related concepts like training or test sets.
No
This device is a software package designed to assist physicians in diagnosis by processing and visualizing medical images. It does not directly provide therapy or treatment.
Yes
The text explicitly states that the device "can be used to assist the physician in the diagnosis of blood vessels" and "is developed to facilitate a precise diagnosis by removing bone structures" and "to facilitate fast and precise diagnosis by removing the CT table."
Yes
The device is explicitly described as a "Software Package" and "self-contained image analysis software package" that processes existing CT data. There is no mention of accompanying hardware components or control of hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that syngo® InSpace 4D processes CT volume data sets and CT Angiography datasets (CTA), which are medical images acquired from the patient's body, not specimens taken from the body.
- The purpose of this device is image analysis and visualization. It assists physicians in diagnosing conditions based on the interpretation of these images, not through the analysis of biological samples.
The device is a medical image processing and analysis software intended for diagnostic imaging interpretation.
N/A
Intended Use / Indications for Use
The syngo® InSpace 4D software package is intended to assist the physician in skeletal and soft tissue imaging in addition to the originally approved indications.
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 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.
Additionally syngo® InSpace 4D is developed to facilitate fast and precise diagnosis by removing the CT table from a CT data set.
Furthermore the syngo® InSpace 4D is embedded in the framework of a new server/client architecture also referred to as syngo® WebSpace. The server supports multiple sessions from remote "thin client" terminals at the same time. The thin client application is also a part of the syngo® WebSpace software suite, installed on a different computer, connected to the server by a network.
Product codes
JAK
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.
Syngo® InSpace 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.
For a vascular evaluation the option Advanced Vessel Analysis (AVA) is designed to create an edited version of a volume to highlight and measure the vessels.
Additionally syngo® InSpace 4D is developed to facilitate fast and precise diagnosis by removing the CT table from a CT data set.
Mentions image processing
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT volume data sets, CT Angiography dataset (CTA), Non CTA datasets
Anatomical Site
skeletal and soft tissue, blood vessels, bones
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows a handwritten string of characters, "Kob2673". The characters are written in a dark ink, and the background is white. The characters are a mix of letters and numbers. The letters are "K", "o", and "b", and the numbers are "2", "6", "7", and "3".
SEP 2 2 2006
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® InSpace 4D Product Name:
Computed tomography x-ray system Classification Name: Classification Panel: Radiology 21 CFR §892.1750 CFR Section: Class II Device Class: 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 Wittelsbacherplatz 2 D-80333 Muenchen, Germany
4. Contact Person:
(
Mr. Rüdiger Körner Manager Regulatory Submissions Siemensstr.1; D-91301 Forchheim +49 9191 18-9355 Phone: +49 9191 18-9782 Fax:
Date of Preparation of Summary: May 18th, 2006 ട്.
510(k)
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 | 02/03/2005 |
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 syngo® InSpace 4D software package is intended to assist the physician in skeletal and soft tissue imaging in addition to the originally approved indications.
2
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.
Syngo® InSpace 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.
For a vascular evaluation the option Advanced Vessel Analysis (AVA) is designed to create an edited version of a volume to highlight and measure the vessels.
Additionally syngo® InSpace 4D is developed to facilitate fast and precise diagnosis by removing the CT table from a CT data set.
3
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 eagle with its wings outstretched, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
DEC 1 9 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Siemens Medical Solutions, Inc. % Mr. Olaf Teichert Third Party Reviewer TUV Product Service 1775 Old Highway 8 NW, Ste 104 NEW BRIGHTON MN 55112-1891
Re: K062673
Trade/Device Name: syngo® InSpace 4D Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 6, 2006 Received: September 8, 2006
Dear Mr. Teichert:
This letter corrects our substantially equivalent letter of September 22, 2006.
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 (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 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/12 description: The image is a black and white circular logo. The logo is for the FDA Centennial, celebrating 100 years from 1906 to 2006. The letters FDA are in the center of the logo in a bold font. The word Centennial is below the letters FDA in a cursive font.
Protecting and Promoting Public Health
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 continue 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 (240) 276-. 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/cdrh/dsma/dsmamain.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
5
SECTION 3
INDICATION FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
syngo® InSpace 4D Device Name:
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 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.
Additionally syngo® InSpace 4D is developed to facilitate fast and precise diagnosis by removing the CT table from a CT data set.
Furthermore the syngo® InSpace 4D is embedded in the framework of a new server/client architecture also referred to as syngo® WebSpace. The server supports multiple sessions from remote "thin client" terminals at the same time. The thin client application is also a part of the syngo® WebSpace software suite, installed on a different computer, connected to the server by a network.
Prescription Use Over-The-Counter Use × AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)