(66 days)
No
The description focuses on image processing, synchronization, alignment, and fusion of CT data, which are standard image processing techniques and do not inherently involve AI or ML. There is no mention of AI, ML, or related terms like deep learning or neural networks in the document.
No
The device is a CT image analysis software package that assists in the analysis and visualization of CT data. It is intended to aid physicians in visualizing collateral vessel information for stroke patients, but it does not directly treat or diagnose.
Yes
The "Intended Use / Indications for Use" section states that the software "will aid the physician in visualizing the presence or absence of collateral vessels in the brain" and that "Collateral vessel information may aid the physician in the evaluation of stroke patients." This clearly indicates its role in assisting with a medical diagnosis. The "Summary of Performance Studies" further supports this by stating it "aids the physician in visualizing the presence or absence of collateral vessels" and is a "useful tool for neuroradiologists in providing a comprehensive stroke work-up."
Yes
The device is described as a "CT image analysis software package" and its function is solely focused on processing and displaying existing CT data. While it runs on specific workstations/servers, the device itself is the software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- FastStroke's Function: FastStroke analyzes and visualizes CT image data. It does not perform tests on biological samples. It processes existing medical images to aid in diagnosis and evaluation.
Therefore, FastStroke falls under the category of medical image analysis software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
FastStroke is a CT image analysis software package that assists in the analysis and visualization of CT data derived from DICOM 3.0 compliant CT scans. FastStroke is intended for the purpose of displaying vasculature of the head and neck at different time points of enhancement.
The software will assist the user by providing optimized display settings to enable fast review of the images in synchronized formats, aligning the display of the images to the order of the scans and linking together multiple groups of scans. In addition, the software fuses the vascular information from different time points into a single colorized view. This multiphase information can aid the physician in visualizing the presence of collateral vessels in the brain. Collateral vessel information may aid the physician in the evaluation of stroke patients.
Product codes
JAK
Device Description
FastStroke is a CT image analysis software package that assists in the analysis and visualization of CT data derived from DICOM 3.0 compliant CT scans. FastStroke is intended for the purpose of displaying vasculature of the head and neck at different time points of enhancement.
The software will assist the user by providing optimized display settings to enable fast review of the images in synchronized formats, aligning the display of the images to the order of the scans and linking together multiple groups of scans. In addition, the software fuses the vascular information from different time points into a single colorized view. This multiphase information can aid the physician in visualizing the presence or absence of collateral vessels in the brain. Collateral vessel information may aid the physician in the evaluation of stroke patients.
FastStroke device has been tested with DICOM images from Discovery CT750 HD and Revolution CT using multi-phase CT Angiography. FastStroke is based on DICOM image based processing and would apply to any CT device that is able to acquire data in an equivalent multi-phase CT angiography (pursuant to the timing protocols in the user quide) manner.
FastStroke is also made available as a standalone post processing application on the AW VolumeShare workstation (K110834) and AW Server platform (K081985) that host advanced image processing applications.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
head and neck, brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician, neuroradiologists
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
A retrospective clinical evaluation was conducted by three board certified neuroradiologists who were considered experts. The primary endpoint of the study was meant to assess the following using multiple 5-point Likert Scales: Demonstrate increased diagnostic capability of FastStroke in a clinical setting of acute stroke.
Summary of Performance Studies
Study type: Retrospective clinical evaluation.
Sample size: Not Found.
Key results: The study results show that FastStroke aids the physician in visualizing the presence or absence of collateral vessels in the brain and is a useful tool for neuroradiologists in providing a comprehensive stroke work-up.
Key Metrics
Not Found
Predicate Device(s)
K041521 - Volume Viewer Plus
Reference Device(s)
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/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract design that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. The design features three figures in profile, possibly representing individuals or populations served by the department.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 26, 2017
GE Medical Systems SCS % Ms. Kristine Schraufnagel Regulatory Affairs Manager 283 rue de la Miniere Buc. Yvelines 78530 FRANCE
Re: K163281
Trade/Device Name: FastStroke Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: January 23, 2017 Received: January 24, 2017
Dear Ms. Schraufnagel:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K163281
Device Name FastStroke
Indications for Use (Describe)
FastStroke is a CT image analysis software package that assists in the analysis and visualization of CT data derived from DICOM 3.0 compliant CT scans. FastStroke is intended for the purpose of displaying vasculature of the head and neck at different time points of enhancement.
The software will assist the user by providing optimized display settings to enable fast review of the images in synchronized formats, aligning the display of the images to the order of the scans and linking together multiple groups of scans. In addition, the software fuses the vascular information from different time points into a single colorized view. This multiphase information can aid the physician in visualizing the presence of collateral vessels in the brain. Collateral vessel information may aid the physician in the evaluation of stroke patients.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a blue circle. The letters are stylized and connected, giving the logo a distinctive and recognizable appearance.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | January 23, 2017 |
|---|---|
| Submitter: | GE Medical Systems SCS |
| 283, rue de la Minière | |
| 78530 Buc, France | |
| Primary Contact Person: | Kristine Schraufnagel |
| Regulatory Affairs Manager | |
| Tel: (262) 312 7344 | |
| Fax: (262) 548 2317 | |
| Secondary Contact Person: | Jeme Ertl |
| Regulatory Affairs Director | |
| GE Healthcare | |
| Tel: (847) 277 4468 | |
| Fax: (847) 277 5240 | |
| Device Trade Name: | FastStroke |
| Common/Usual Name: | FastStroke |
| Regulation Number: | 21CFR 892.1750 |
| Regulation Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| Regulatory Class: | Class II |
| Product Code: | JAK |
| Predicate Device: | K041521 - Volume Viewer Plus |
| Regulation Number: | 21CFR 892.1750 |
| Regulation Name: | Computed Tomography X-ray System |
| Regulation Number: | 21CFR 892.1000 |
| Regulation Name: | Magnetic Resonance Diagnostic Device |
| Regulatory Class: | Class II |
| Product Code: | JAK and LNH |
| Device Description / | |
| Intended Use: | FastStroke is a CT image analysis software package that |
| assists in the analysis and visualization of CT data derived from | |
| DICOM 3.0 compliant CT scans. FastStroke is intended for the | |
| purpose of displaying vasculature of the head and neck at | |
| different time points of enhancement. | |
| The software will assist the user by providing optimized display | |
| settings to enable fast review of the images in synchronized | |
| formats, aligning the display of the images to the order of the | |
| scans and linking together multiple groups of scans. In addition, | |
| the software fuses the vascular information from different time | |
| points into a single colorized view. This multiphase information | |
| can aid the physician in visualizing the presence or absence of | |
| collateral vessels in the brain. Collateral vessel information may | |
| aid the physician in the evaluation of stroke patients. | |
| FastStroke device has been tested with DICOM images from | |
| Discovery CT750 HD and Revolution CT using multi-phase CT | |
| Angiography. FastStroke is based on DICOM image based | |
| processing and would apply to any CT device that is able to | |
| acquire data in an equivalent multi-phase CT angiography | |
| (pursuant to the timing protocols in the user quide) manner. | |
| FastStroke is also made available as a standalone post | |
| processing application on the AW VolumeShare workstation | |
| (K110834) and AW Server platform (K081985) that host | |
| advanced image processing applications. | |
| Indications for Use: | FastStroke is a CT image analysis software package that |
| assists in the analysis and visualization of CT data derived from | |
| DICOM 3.0 compliant CT scans. FastStroke is intended for the | |
| purpose of displaying vasculature of the head and neck at | |
| different time points of enhancement. | |
| The software will assist the user by providing optimized display | |
| settings to enable fast review of the images in synchronized | |
| formats, aligning the display of the images to the order of the | |
| scans and linking together multiple groups of scans. In addition, | |
| the software fuses the vascular information from different time | |
| points into a single colorized view. This multiphase information | |
| can aid the physician in visualizing the presence or absence of | |
| collateral vessels in the brain. Collateral vessel information may | |
| aid the physician in the evaluation of stroke patients. | |
| Technology: | The FastStroke software employs the same fundamental |
| scientific technology as its predicate device. | |
| Determination of | |
| Substantial Equivalence: | Summary of Non-Clinical Tests: |
| The FastStroke software complies with NEMA PS 3.1 - 3.20 | |
| (2016) Digital Imaging and Communications in Medicine (DICOM) | |
| Set (Radiology) standard. | |
| The FastStroke software employs the same fundamental | |
| scientific technology as its predicate device (Volume Viewer). | |
| FastStroke software uses the equivalent CT DICOM image data | |
| input requirements. It has equivalent display, formatting, | |
| archiving and visualization technologies compared to the | |
| predicate device. FastStroke utilizes the thresholding and fusion |
|
| | Summary of Clinical tests: |
| | A retrospective clinical evaluation was conducted by three
board certified neuroradiologists who were considered experts.
The primary endpoint of the study was meant to assess the
following using multiple 5-point Likert Scales: |
| | Demonstrate increased diagnostic capability of
FastStroke in a clinical setting of acute stroke. |
| | The study results show that FastStroke aids the physician in
visualizing the presence or absence of collateral vessels in the
brain and is a useful tool for neuroradiologists in providing a
comprehensive stroke work-up. |
| | The substantial equivalence determination is based on the
software documentation for a MODERATE level of concern
device. |
| Conclusion: | GE Healthcare considers the FastStroke software application to
be as safe, as effective, and performance is substantially
equivalent to the predicate device. |
4
Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. The circle is surrounded by a series of curved, wave-like shapes, also in blue, that give the impression of motion or energy emanating from the central letters.
5
Image /page/5/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized, cursive font, enclosed within a blue circle. The circle has a white border with wave-like designs around the edge, giving it a dynamic and recognizable appearance.
6
Image /page/6/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. The circle has a wavy or swirling pattern around the letters, giving it a dynamic and recognizable appearance.