(177 days)
Not Found
No
The summary describes a specific MR pulse sequence for diffusion-weighted imaging, a standard technique in MRI. There is no mention of AI, ML, or any advanced image processing beyond the inherent physics of the pulse sequence. The performance evaluation focuses on safety standards and accuracy statements related to the pulse sequence itself, not on algorithmic performance metrics typically associated with AI/ML.
No
The device is described as an "additional imaging option" that helps visualize the "apparent loss of diffusion" in brain tissues, making it a diagnostic tool rather than a therapeutic one. It provides images to "identify the occurrence of acute stroke" but does not treat it.
Yes
The device is described as producing images whose contrast is dependent on the local diffusion coefficient of water, and that it is "useful in visualizing" and "more accurate than conventional MRI pulse sequence... in identifying the occurrence of acute stroke." This indicates its role in detecting or identifying a medical condition, which aligns with the definition of a diagnostic device.
No
The device description explicitly states it is an "imaging option" and a "pulse sequence," which are components of an MRI system, a hardware device. The performance studies also refer to evaluation against a safety standard for "Magnetic Resonance Systems," further indicating it is part of a hardware system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this device is used for imaging brain tissues directly within the patient using Magnetic Resonance (MR). It does not involve analyzing samples like blood, urine, or tissue biopsies outside of the body.
- The device is an imaging option for an MR system. It's a component or feature of a larger medical imaging device, not a standalone diagnostic test performed on a specimen.
The description aligns with a medical imaging device used for diagnostic purposes, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Diffusion Weighted EPI imaging produces magnetic resonance (MR) images whose contrast is dependent on the local diffusion coefficient of water. Diffusion Weighted EPI can be useful in visualizing the apparent loss of diffusion (mobility) by water molecules in brain tissues affected by acute stroke. Diffusion Weighted EPI is more accurate than conventional MRI pulse sequence (ie Fast FLAIR and Fast Spin Echo) in identifying the occurrence of acute stroke.
Product codes
90 LNH
Device Description
The Diffusion Weighted EPI Imaging Option provides an additional imaging option to the Echo Planar Imaging pulse sequence. The DW-EPI option is a single shot EPI pulse designed to create images that differentiates tissues with restricted diffusion from tissues with normal diffusion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance (MR)
Anatomical Site
brain tissues
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
The Diffusion Weighted EPI Imaging Option was evaluated to the IEC 601-2-33 International medical equipment safety standard for Magnetic Resonance Systems. Evaluation testing confirmed accuracy statements in the User Manual.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows a black and white logo. The logo is circular and contains the letters 'GE' in a stylized font. The letters are intertwined and appear to be handwritten. The logo is simple and recognizable.
GE Medical Systems
PO Box 414. W-709 Milwaukee, WI 53201 USA
SUMMARY OF SAFETY AND EFFECTIVENESS
FEB - 5 1998
- o This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
- o Identification of Submitter Larry A. Kroger, Ph.D., 414-544-3894, August 13, 1997
- o Identification of the Product Diffusion Weighted EPI Imaging Option
Manufactured by:
GE Medical Systems 3200 N. Grandview Blvd. Waukesha. Wi 53188
- o Device Description
The Diffusion Weighted EPI Imaging Option provides an additional imaging option to the Echo Planar Imaging pulse sequence. The DW-EPI option is a single shot EPI pulse designed to create images that differentiates tissues with restricted diffusion from tissues with normal diffusion.
o Indications for Use
Diffusion Weighted EPI imaging produces magnetic resonance (MR) images whose contrast is dependent on the local diffusion coefficient of water. Diffusion Weighted EPI can be useful in visualizing the apparent loss of diffusion (mobility) by water molecules in brain tissues affected by acute stroke.
Diffusion Weighted EPI is more accurate than conventional MRI pulse sequence (ie Fast FLAIR and Fast Spin Echo) in identifying the occurrence of acute stroke.
-
0 Comparison with Predicate
The Diffusion Weighted EPI Imaging Option is substantially equivalent to the currently marketed Siemens Medical System Diffusion Weighted MR Imaging Option (510k #K971055). -
o Summary of Studies
The Diffusion Weighted EPI Imaging Option was evaluated to the IEC 601-2-33 International medical equipment safety standard for Magnetic Resonance Systems. Evaluation testing confirmed accuracy statements in the User Manual. -
o Conclusions
It is the opinion of GE that the Diffusion Weighted EPI Imaging Option does not result in any new potential hazards.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle. The logo is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Larry Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical System PO Box 414, W-709 Milwaukee, WI 53201
Re:
K972990 Diffusion Weighted EPI Imaging Option Dated: November 20, 1997 Received: November 21, 1997 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH
FEB - 5 1998
Dear Dr. Kroger:
We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (30) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html":. -------------------------------------------------------------------------------------------
Sincerely vours,
h. liau Yi
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Device Name: Diffusion Weighted EPI Imaging Option
Indications For Use:
- ﺬ-
Diffusion Weighted EPI imaging produces magnetic resonance (MR) images whose contrast is dependent on the local diffusion coefficient of water. Diffusion Weighted EPI can be useful in visualizing the apparent loss of diffusion (mobility) by water molecules in brain tissues affected by acute stroke.
Diffusion Weighted EPI is more accurate than conventional MRI pulse sequence (ie Fast FLAIR and Fast Spin Echo) in identifying the occurrence of acute stroke.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Wint le Seymon
on of Reproductive, Abdominal, E d Radiological De
510(k) Number K972990
OR
Prescription Use
(Per 21 CFR 801.109) ✓
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________