FastStroke

K163281 · Gef Medical Systems Scs · JAK · Jan 26, 2017 · Radiology

Device Facts

• Record ID: K163281
• Device Name: FastStroke
• Applicant: Gef Medical Systems Scs
• Product Code: JAK · Radiology
• Decision Date: Jan 26, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device

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 of collateral vessels in the brain. Collateral vessel information may aid the physician in the evaluation of stroke patients.

Device Story

FastStroke is a CT image analysis software package; inputs DICOM 3.0 compliant multi-phase CT angiography data. Software transforms inputs by synchronizing scan groups, optimizing display settings, and fusing vascular information from different time points into a single colorized view. Used in clinical settings by neuroradiologists/physicians to aid in stroke work-up. Output is a colorized visualization of brain vasculature; assists physicians in identifying collateral vessels. Benefits include improved visualization of collateral vessels, aiding clinical decision-making during acute stroke evaluation.

Clinical Evidence

Retrospective clinical evaluation conducted by three board-certified neuroradiologists. Primary endpoint assessed diagnostic capability using 5-point Likert scales. Results demonstrated that FastStroke aids physicians in visualizing collateral vessels in the brain and serves as a useful tool for comprehensive stroke work-up.

Technological Characteristics

Software-based CT image analysis; DICOM 3.0 compliant; utilizes thresholding and fusion algorithms for multi-phase CT angiography data. Operates on AW VolumeShare workstation or AW Server platform. Complies with NEMA PS 3.1-3.20 (2016) standards. Software level of concern: Moderate.

Indications for Use

Indicated for use by physicians to assist in the analysis and visualization of head and neck CT data for the evaluation of stroke patients, specifically for visualizing collateral vessels in the brain.

Regulatory Classification

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.

Predicate Devices

• Volume Viewer Plus (K041521)

Reference Devices

• AW VolumeShare workstation (K110834)
• AW Server platform (K081985)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## 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)

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# 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<br>283, rue de la Minière<br>78530 Buc, France |
| Primary Contact Person: | Kristine Schraufnagel<br>Regulatory Affairs Manager<br>Tel: [phone]<br>Fax: [phone] |
| Secondary Contact Person: | Jeme Ertl<br>Regulatory Affairs Director<br>GE Healthcare<br>Tel: [phone]<br>Fax: [phone] |
| 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 /<br>Intended Use: | FastStroke is a CT image analysis software package that<br>assists in the analysis and visualization of CT data derived from<br>DICOM 3.0 compliant CT scans. FastStroke is intended for the |
| purpose of displaying vasculature of the head and neck at<br>different time points of enhancement.<br>The software will assist the user by providing optimized display<br>settings to enable fast review of the images in synchronized<br>formats, aligning the display of the images to the order of the<br>scans and linking together multiple groups of scans. In addition,<br>the software fuses the vascular information from different time<br>points into a single colorized view. This multiphase information<br>can aid the physician in visualizing the presence or absence of<br>collateral vessels in the brain. Collateral vessel information may<br>aid the physician in the evaluation of stroke patients. | |
| FastStroke device has been tested with DICOM images from<br>Discovery CT750 HD and Revolution CT using multi-phase CT<br>Angiography. FastStroke is based on DICOM image based<br>processing and would apply to any CT device that is able to<br>acquire data in an equivalent multi-phase CT angiography<br>(pursuant to the timing protocols in the user quide) manner. | |
| FastStroke is also made available as a standalone post<br>processing application on the AW VolumeShare workstation<br>(K110834) and AW Server platform (K081985) that host<br>advanced image processing applications. | |
| Indications for Use: | FastStroke is a CT image analysis software package that<br>assists in the analysis and visualization of CT data derived from<br>DICOM 3.0 compliant CT scans. FastStroke is intended for the<br>purpose of displaying vasculature of the head and neck at<br>different time points of enhancement.<br>The software will assist the user by providing optimized display<br>settings to enable fast review of the images in synchronized<br>formats, aligning the display of the images to the order of the<br>scans and linking together multiple groups of scans. In addition,<br>the software fuses the vascular information from different time<br>points into a single colorized view. This multiphase information<br>can aid the physician in visualizing the presence or absence of<br>collateral vessels in the brain. Collateral vessel information may<br>aid the physician in the evaluation of stroke patients. |
| Technology: | The FastStroke software employs the same fundamental<br>scientific technology as its predicate device. |
| Determination of<br>Substantial Equivalence: | Summary of Non-Clinical Tests:<br>The FastStroke software complies with NEMA PS 3.1 - 3.20<br>(2016) Digital Imaging and Communications in Medicine (DICOM)<br>Set (Radiology) standard.<br>The FastStroke software employs the same fundamental<br>scientific technology as its predicate device (Volume Viewer).<br>FastStroke software uses the equivalent CT DICOM image data<br>input requirements. It has equivalent display, formatting,<br>archiving and visualization technologies compared to the<br>predicate device. FastStroke utilizes the thresholding and fusion<br> |
| | Summary of Clinical tests: |
| | A retrospective clinical evaluation was conducted by three<br>board certified neuroradiologists who were considered experts.<br>The primary endpoint of the study was meant to assess the<br>following using multiple 5-point Likert Scales: |
| | Demonstrate increased diagnostic capability of<br>FastStroke in a clinical setting of acute stroke. |
| | The study results show that FastStroke aids the physician in<br>visualizing the presence or absence of collateral vessels in the<br>brain and is a useful tool for neuroradiologists in providing a<br>comprehensive stroke work-up. |
| | The substantial equivalence determination is based on the<br>software documentation for a MODERATE level of concern<br>device. |
| Conclusion: | GE Healthcare considers the FastStroke software application to<br>be as safe, as effective, and performance is substantially<br>equivalent to the predicate device. |

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