(35 days)
Not Found
No
The summary describes image post-processing and 3D reconstruction, but there is no mention of AI, ML, or related concepts like training or testing data.
No.
This device is an image post-processing software intended for diagnosis and visualization, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for imaging primarily soft tissue for diagnosis" and is "designed to visually assist physicians in the diagnosis and treatment of vessel malformations."
Yes
The device is described as a "software application" and "post-processing software application" that operates on images acquired from a separate hardware device (angiographic C-arm). It does not appear to include any hardware components itself.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device function: The description clearly states that Syngo Neuro-PBV IR is a software application that processes and visualizes medical images acquired from a standard angiographic C-arm device. It works with imaging data of the head, not with biological specimens.
- Intended Use: The intended use is for imaging soft tissue and visualizing contrast-enhanced blood distribution for diagnosis, surgical planning, interventional procedures, and treatment follow-up. This is based on visual interpretation of images, not analysis of biological samples.
The device falls under the category of medical imaging software used for post-processing and visualization of anatomical structures and blood flow.
N/A
Intended Use / Indications for Use
Syngo Neuro-PBV IR is an extended software application to the InSpace 3D software option which allows the reconstruction of two-dimentional images acquired with a standard angiographic C-arm device into a three-dimentional image format.
Syngo Neuro-PBV-IR is intended for imaging primarily soft tissue for diagnosis, surgical planning, interventional procedures and treatment follow-up. It is design for the visualization of contrast enhanced blood distribution in the arterial and venous vessels in the head using color coded relative values for diagnosis.
This software is designed to visually assist physicians in the diagnosis and treatment of vessel malformations (i.e. Aneurysms, AVM's and Stenoses)
Product codes
90JAA, LLZ
Device Description
syngo Neuro-PBV IR is a post-processing software application designed to provide the physician with images similar to CT cerebral perfusion in the Interventional Radiography suite. The physician can use these images to visualize blood volume in the vasculature and blood-brain barrier without moving the patient to a CT system. A contrast agent is used to enhance the visualization of the blood flow. As with CT perfusion, the image is further enhanced using color as a reference of the amount of contrast filled blood in an area of the brain.
Mentions image processing
syngo Neuro-PBV IR is a post-processing software application designed to provide the physician with images similar to CT cerebral perfusion in the Interventional Radiography suite. The physician can use these images to visualize blood volume in the vasculature and blood-brain barrier without moving the patient to a CT system. A contrast agent is used to enhance the visualization of the blood flow. As with CT perfusion, the image is further enhanced using color as a reference of the amount of contrast filled blood in an area of the brain.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
angiographic C-arm device
Anatomical Site
head (in arterial and venous vessels of the head)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician, Interventional Radiography suite
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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MAY 2 0 2011
K1110S2
510(k) Summary For syngo Neuro PBV IR
Submitted by: Siemens Medical Systems, Inc. 51 Valley Stream Parkway Malvern, PA 19355
April 08, 2011
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
General Information 1.
Importer / Distributor Siemens Medical Solutions, Inc. 51 Valley Stream Parkway, G-01 Malvern, PA 19355 Establishment Registration Number 2240869
Manufacturing Site
SIEMENS AG Sector Healthcare Siemensstraße 1 D-91301 Forchheim, Germany
2. Contact Person
Mr. Gary Johnson Sr. Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 51 Vallev Stream Parkway G-01 Malvem, PA 19355-1406 Fax: (610) 448-1787 Phone: (610) 448 1778 Email: garyjohnson@siemens.com
3. Device Name and Classification
Trade Name: Classification Name: Classification Panel: CFR Section: Device Class: Product Code:
syngo Neuro PBV IR Accessory to Angiographic X-Ray System Radiology 21 CFR §892.1600 Class II 90JAA
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বঁ.
বাংলাদেশের বিশ্ববিদ্যালয় বিশ্ববিদ্যালয় বিশ্ববিদ্যালয় বিশ্ববিদ্যালয় বিশ্বকাপ বিশ্ববিদ্যালয় বিশ্বকাপ বিশ্ববিদ্যালয় বিশ্বকাপ করে বিশ্ববিদ্যালয় বিশ্বকাপ করে বিশ্ববিদ্যালয় বি Legally Marketed Device
| Trade Name: | InSpace 3D Soft |
|---|---|
| 510(k) Clearance | K011447 |
| Clearance Date | August 3, 2001 |
| Classification Name: | Accessory to An |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.16 |
| Device Class: | Class II |
| Product Code: | 90JAA |
ware Option giographic X-Ray System 00
ട്. Device Description
syngo Neuro-PBV IR is a post-processing software application designed to provide the physician with images similar to CT cerebral perfusion in the Interventional Radiography suite. The physician can use these images to visualize blood volume in the vasculature and blood-brain barrier without moving the patient to a CT system. A contrast agent is used to enhance the visualization of the blood flow. As with CT perfusion, the image is further enhanced using color as a reference of the amount of contrast filled blood in an area of the brain.
ર્ભ. Intended Use
Syngo Neuro-PBV IR is an extended software application to the InSpace 3D software option which allows the reconstruction of two-dimentional images acquired with a standard angiographic C-arm device into a three-dimentional image format.
Syngo Neuro-PBV-IR is intended for imaging primarily soft tissue for diagnosis, surgical planning, interventional procedures and treatment follow-up. It is design fro the visualization of contrast enhanced blood distribution in the arterial and venous vessels in the head using color coded relative values for diagnosis.
This software is designed to visually assist physicians in the diagnosis and treatment of vessel malformations (i.e. Aneurysms, AVM's and Stenoses)
7. Substantial Equivalence
syngo Neuro-PBV IR Software Application is substantially equivalent to the commercially available Siemens ssoftware application, Inspace 3D. The Inspace 3D software option was described in premarket notification K011447 which received FDA Clearance on August 03, 2001.
The syngo Neuro-PBV IR software is an extension to InSpace 3D and uses the same hardware and software components as the InSpace 3D software option.
Summary of Technological Characteristics of the Principal Device as Compared with 8. the Predicate Device
syngo Neuro PBV IR is a software extension to Inspace 3D. The principal device syngo Neuro PBV IR features the same Postprocessing software, user interface, archiving and
Siemens Medical Systems, Inc.
2
communication like the predicate Inspace 3D. The design of the syngo Neuro PBV IR is the same as it is integrated into the Inspace 3D task card.
9. General Safety and Effectiveness Concerns
Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner.
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 all equipment is subject to final performance testing. Furthermore the operators are health care professionals familiar with and responsible for the evaluating and post processing of X-ray images.
10. Conclusion as to Substantial Equivalence
syngo Neuro PBV IR is intended for the same indications for use as the predicate Inspace 3D. syngo Neuro PBV IR Software Application is a further post processing and enhanced visualization technique within Inspace 3D (K011447).
Most of the functionality remains the same as used with the predicate device Inspace 3D (K011447). The functionality is the same or similar to the predicate device with enhanced algorithm to display syngo Neuro PBV IR images.
It is Siemens opinion, that the syngo Neuro PBV IR is substantially equivalent to the Inspace 3D (K011447).
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Gary L. Johnson Senior Regulatory Technical Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway G-01 MALVERN PA 19355-1406
MAY 20 2011
Re: K111052
Trade/Device Name: syngo Neuro-PBV IR Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 9, 2011 Received: April 15, 2011
Dear Mr. Johnson:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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SECTION 7
INDICATIONS FOR USE
510(k) Number (if known): __
Device Name:
Indications for Use:
Syngo Neuro-PBV IR is an extended software application to the InSpace 3D software option which allows the reconstruction of two-dimentional images acquired with a standard angiographic C-arm device into a three-dimentional image format.
Syngo Neuro-PBV-IR is intended for imaging primarily soft tissue for diagnosis, surgical planning, interventional procedures and treatment follow-up. It is design for the visualization of contrast enhanced blood distribution in the arterial and venous vessels in the head using color coded relative values for diagnosis.
This software is designed to visually assist physicians in the diagnosis and treatment of vessel malformations (i.e. Aneurysms, AVM's and Stenoses)
(Please do not write below this line - continue on another page if needed)
Concurrence of the CDRH, Office of Device Evaluation (ODE)
Prescription Use X (per 21 CFR 801.109)
OR Over-The-Counter Use _
Mary Shatt
Division Sign-Off Division of Radiological Devic Office of In Vitro Diagnostic Device Evaluation and Safety
510K K11052
Page 13 of 60 510(k) for Siemens 'syngo Neuro PBV IR'
Siemens Medical Systems, Inc.