(10 days)
Not Found
No
The description details standard image processing techniques (registration, segmentation, filtering, subtraction) and does not mention AI, ML, or any learning-based algorithms.
No.
This device is a post-processing application that aids in diagnosing stroke and facilitating treatment decisions, it does not directly treat or provide therapy to patients.
Yes
The device "helps to diagnosing stroke" by calculating blood volume in the brain, and "decreased blood volume in a certain region of the brain is an indicator for stroke." This directly indicates its use in identifying a disease state.
Yes
The device is described as a "dedicated post-processing application" that performs calculations and image manipulation on existing CT datasets. There is no mention of any associated hardware components being part of the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples (like blood, urine, tissue) outside of the body. The description clearly states that syngo Neuro PBV CT is a "dedicated post-processing application" that uses "non-enhanced CT dataset (NECT) and a CT Angiography (CTA)". These are imaging modalities that capture data from within the patient's body.
- The device processes imaging data, not biological samples. The core function is to calculate a blood volume based on CT scans.
Therefore, syngo Neuro PBV CT falls under the category of medical imaging software or a medical device that processes imaging data, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
JAK
Device Description
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
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT), CT Angiography (CTA)
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
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 the word "SIEMENS" in a stylized, outlined font. The letters are evenly spaced and appear to be a light color against a darker background. The font style gives the word a modern and technical look.
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 +49 9191 18-8170 Phone: +49 9191 18-9782 Fax:
Date of Preparation of Summary: October 23(d 2006 5.
DA/CDRH/ODE/PM
NOV 20 P 12:21
RECEIVED
1
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
2
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.
Image /page/2/Picture/10 description: The image is a black and white circular logo. The logo commemorates a centennial, with the years "1906-2006" displayed at the top. The letters "FDA" are prominently featured in the center of the logo. The word "Centennial" is written in a cursive font below the letters "FDA".
Protecting and Promoting Public Health
3
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 (800) 638-2041 or (240) 276-3150
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
4
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 |
Over-The-Counter Use
Prescription Use
×