(105 days)
Not Found
No
The description focuses on the technical aspects of the MR pulse sequence and image processing techniques (subtraction, quantitative calculation) without mentioning any AI/ML components.
No
The device, 3D ASL, is a software option for MR systems used to generate maps representing blood flow in the brain for diagnostic purposes. It is not intended to treat or prevent a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "When interpreted by a trained physician, images generated by 3D ASL provide information that can be useful in determining a diagnosis." This indicates its role in the diagnostic process.
No
The device is described as a "software option intended for use on GE 1.5T and 3.0T MR systems," and its function involves controlling the MR system's RF pulses and acquisition sequences to generate images. While it is a software component, it is inextricably linked to and controls the hardware of the MR system to perform its intended function. It is not a standalone software application that processes pre-existing data.
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 intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The 3D ASL software option is used on MR systems to generate images of the brain representing blood flow. It utilizes an endogenous contrast agent (water in arterial blood) within the body during the MR scan.
- Specimen Handling: The device does not involve the examination of specimens outside the human body. The imaging is performed directly on the patient.
- Intended Use: While the images provide information useful for diagnosis, the device itself is an imaging tool that visualizes physiological processes in vivo.
Therefore, because the device operates in vivo and does not involve the examination of specimens in vitro, it does not fit the definition of an In Vitro Diagnostic. It is a medical imaging software option.
N/A
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Intended Use / Indications for Use
3D ASL is a software option intended for use on GE 1.5T and 3.0T MR systems. It is indicated for magnetic resonance imaging of the brain.
3D ASL allows for generation of maps representing blood flow without the use of an exogenous contrast agent. 3D ASL utilizes water in arterial blood as an endogenous contrast media, to visualize tissue perfusion and evaluate cerebral blood flow (CBF).
When interpreted by a trained physician, images generated by 3D ASL provide information that can be useful in determining a diagnosis.
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Product codes (comma separated list FDA assigned to the subject device)
90-LNH
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Device Description
Arterial Spin Labeling (ASL) is an MR technique using the water in arterial blood as an endogenous tracer to evaluate perfusion non-invasively. It provides a non-contrast way to visualize brain perfusion and functional physiology by allowing quantitative cerebral blood flow (CBF) measurements.
GE 3D ASL is an integration of a novel pulsed-continuous labeling technique and a 3D fast spin echo (FSE) acquisition.
The application involves performing inversion of the spins using multiple RF pulses (based on the theory of adiabatic inversion) to label the artery blood spins for the first labeling image. The second image acquisition (also known as control) is performed without inversion of the blood spins. The subtraction of the labeling and control images gives perfusion-weighted images. Additional acquisition of proton density weighted images is then used in combination with the difference images to compute quantitative cerebral blood flow.
The pulsed continuous labeling allows for high labeling efficiency leading to high SNR perfusion images while the 3D FSE readout allows for whole brain coverage and robustness to susceptibility artifacts. The high labeling efficiency is in part due to significantly reduced Magnetization Transfer (MT) effects. The short RF pulses also lead to a significant decrease in the duty cycle when compared to continuous labeling. In addition background suppression is used to reduce the sensitivity of 3D ASL to motion artifacts.
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Mentions image processing
The subtraction of the labeling and control images gives perfusion-weighted images. Additional acquisition of proton density weighted images is then used in combination with the difference images to compute quantitative cerebral blood flow.
-
Mentions AI, DNN, or ML
Not Found
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Input Imaging Modality
MR
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Anatomical Site
brain
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Indicated Patient Age Range
Not Found
-
Intended User / Care Setting
trained physician
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Description of the training set, sample size, data source, and annotation protocol
Not Found
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Description of the test set, sample size, data source, and annotation protocol
Not Found
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance parameters have been measured:
Reproducibility
Repeatability
Signal-to-noise ratio (SNR)
The following clinical testing has been performed to validate the 3D ASL technique:
Clinical evaluation
Volunteer imaging
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The design is simple and recognizable, representing the company's brand identity.
'JAN - 6 2010
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
Date: 09/18/2009 Submitter: GE Healthcare, (GE Medical Systems, LLC) 3200 N. Grandview Blvd. Waukesha, WI 53188 USA Yuan Ma Person: Regulatory Affairs Leader GE Healthcare 3200 N Grandview Blvd., Mail Code: W-828 Waukesha, WI-53188 USA Phone: 262 521 6223 Fax: 414 908 9390 Glen Sabin Regulatory Affairs Manager GE Healthcare (GE Medical Systems, LLC.) Establishment Registration Number: 2183553 3200 N Grandview Blvd., Mail Code - W-827 Waukesha, WI-53188 USA. Phone: 262-521-6848
Primary Contact
Secondary Contact Person:
Regulatory Affairs Manager
GE Healthcare (GE Medical Systems, LLC.)
Establishment Registration Number: 2183553
3200 N Grandview Blvd., Mail Code - W-827
Waukesha, WI - 53188
USA
Phone: 262-521-6848
| Device: Trade Name: | 3DASL |
|---|---|
| Common/Usual Name: | 3D ASL |
| Classification Names: | 21 CFR |
| Product Code: | 90-LNH |
K083147, Discovery MR450 (GE Medical Systems, LLC) Predicate Device(s):
892.1000
Device Description:
K072237, MAGNETOM Verio (Siemens AG)
Arterial Spin Labeling (ASL) is an MR technique using the water in arterial blood as an endogenous tracer to evaluate perfusion non-invasively. It provides a non-contrast way to visualize brain perfusion and functional physiology by allowing quantitative cerebral blood flow (CBF) measurements.
GE 3D ASL is an integration of a novel pulsed-continuous labeling technique and a 3D fast spin echo (FSE) acquisition.
Section 5 - 510(k) Summary
3D ASL Traditional 510(k)
1
Image /page/1/Picture/0 description: The image shows the text "KD92925 page 2/3 GE Healthcare". The text is arranged in three lines, with "KD92925" on the top right, "page 2/3" below it, and "GE Healthcare" on the bottom left. The text appears to be part of a document or report, possibly indicating a page number and the name of the organization.
3D ASL 510(k) Premarket Notification
Image /page/1/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular frame. The logo is black and white and appears to be a vintage or historical version of the GE logo. The image quality is somewhat grainy, suggesting it may be a scan or a reproduction of an older image.
The application involves performing inversion of the spins using multiple RF pulses (based on the theory of adiabatic inversion) to label the artery blood spins for the first labeling image. The second image acquisition (also known as control) is performed without inversion of the blood spins. The subtraction of the labeling and control images gives perfusion-weighted images. Additional acquisition of proton density weighted images is then used in combination with the difference images to compute quantitative cerebral blood flow.
The pulsed continuous labeling allows for high labeling efficiency leading to high SNR perfusion images while the 3D FSE readout allows for whole brain coverage and robustness to susceptibility artifacts. The high labeling efficiency is in part due to significantly reduced Magnetization Transfer (MT) effects. The short RF pulses also lead to a significant decrease in the duty cycle when compared to continuous labeling. In addition background suppression is used to reduce the sensitivity of 3D ASL to motion artifacts.
Intended Use:
3D ASL is a software option intended for use on GE 1.5T and 3.0T MR systems. It is indicated for magnetic resonance imaging of the brain.
3D ASL allows for generation of maps representing blood flow without the use of an exogenous contrast agent. 3D ASL utilizes water in arterial blood as an endogenous contrast media, to visualize tissue perfusion and evaluate cerebral blood flow (CBF).
When interpreted by a trained physician, images generated by 3D ASL provide information that can be useful in determining a diagnosis.
Technology:
3D ASL uses pulsed continuous labeling method to achieve the effects of continuous labeling. A train of very short RF pulses is used to obtain inversion (label) of blood spins. The amplitude and phase of the RF pulses are adjusted to achieve the labeling. In addition multiple selective and non-selective inversion pulses are employed to obtain static tissue suppression (aka background suppression). This allows for limited motion insensitivity as well as higher dynamic range for the perfusion images. 3DFSE with spiral readout is used for acquisition, combining the robustness of 3DFSE method and inherent oversampling nature of spiral trajectory. 3D ASL employs the same fundamental scientific technology as its predicate devices.
2
K092925
page 3/3
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GE Healthcare
3D ASL: 510(k) Premarket Notification
Determination of Substantial Equivalence:
Summary of Testing:
The 3D ASL application complies with voluntary standards as detailed in Section 9 of this premarket submission. The following quality assurance measures were applied to the development of the application:
Risk Analysis
Requirements Reviews
Design Reviews
Design Verification
Design Validation
The following safety parameters have been measured:
Acoustic noise
dB/dt
SAR
The following performance parameters have been measured:
Reproducibility
Repeatability
Signal-to-noise ratio (SNR)
The following clinical testing has been performed to validate the 3D ASL technique:
Clinical evaluation
Volunteer imaging
Conclusion:
GE Healthcare considers the 3D ASL to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized eagle or bird in flight.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Yuan Ma Regulatory Affairs Leader, MR Modality GE Medical Systems LLC 3200 N. Grandview Blvd. WAUKESHA WI 53188
JAN - 3 2010
Re: K092925
Trade/Device Name: 3D ASL Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: December 11, 2009 Received: December 14, 2009
Dear Mr. Ma:
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 (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 of medical
4
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K U42725
Image /page/5/Picture/1 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'GE' intertwined within a circular border. The image quality is somewhat degraded, giving the logo a slightly distressed or vintage appearance.
GE Healthcare 3D ASL 510(k) Premarket Notification
510(k) Number (if known): K092925
Device Name: 3D ASL
Indications for Use:
3D ASL is a software option intended for use on GE 1.5T and 3.0T MR systems. It is indicated for magnetic resonance imaging of the brain.
3D ASL allows for generation of maps representing blood flow without the use of an exogenous contrast agent. 3D ASL utilizes water in arterial blood as an endogenous contrast media, to visualize tissue perfusion and evaluate cerebral blood flow (CBF).
When interpreted by a trained physician, images generated by 3D ASL provide information that can be useful in determining a diagnosis.
Prescription Use_ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part.21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helent Reen
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Section 4 - Indications for Use Statement
3D ASL Traditional 510(k)
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