(14 days)
Propeller Imaging Option is a Fast Spin Echo (FSE) based sequence which employs a alternate k-space trajectory.
- When used with diffusion sensitizing gradients on a minimum of 3 axes, it will augment the standard Echo Planar Imaging (EPI) based diffusion imaging by providing improved image quality in areas of high susceptibility. This may aid the trained physician in the visualization of pathology in areas traditionally obscured by susceptibility artifacts.
It is intended for use in anatomical regions where significant susceptibility differences exist between adjacent structures (e.g. tissue/air and tissue/bone). This includes, but is not limited to, inferior brain areas such as cerebellum, internal auditory canal, vertebrae and orthopedic areas. Other high susceptibility regions include tissue in the presence of MRI compatible metallic implants, artificial joint, etc. - When used in the place of high resolution FSE, it will yield improved contrast-tonoise and signal-to-noise with comparable resolution and overall scan time, or improved contrast-to-noise and signal-to-noise with minimal in-plane motion-induced artifact. This may aid the trained physician in visualization of areas with reduced signal and image contrast or areas obscured by motion artifacts.
It is intended for use in high-resolution anatomical regions where FSE is traditionally used, particularly in neurological imaging, where improved contrast-to-noise and signalto-noise is needed.
The Propeller Imaging Option is a Fast Spin Echo (FSE) based pulse sequence that provides improved signal to noise and contrast to noise compared to traditional FSE with comparable resolution and scan time, and may be used to reduce motioninduced artifacts. With the addition of Diffusion gradients, Propeller may be used to differentiate tissues with restricted diffusion from tissues with normal diffusion, similar to Diffusion Weighted EPI.
The provided text describes a 510(k) premarket notification for the GE Propeller Imaging Option for MRI. This document outlines the device's description, indications for use, and a comparison with predicate devices. However, it does not contain details about specific acceptance criteria, a dedicated study proving performance against those criteria, or the methodology (including sample sizes, expert involvement, and ground truth establishment) for such a study.
The "Summary of Studies" section only states that the device was evaluated against certain international medical equipment safety standards (IEC60601-1-4 and IEC 60601-2-33), indicating a focus on safety rather than clinical performance or diagnostic accuracy. The conclusion also emphasizes safety ("does not result in any new potential hazards").
Therefore, based on the provided text, the requested information cannot be fully extracted.
Here's an attempt to answer the questions based on the absence of detailed performance study information in the given document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
| The document focuses on compliance with safety standards (IEC60601-1-4, IEC 60601-2-33) and substantial equivalence to predicate devices (K972990, K944979). It mentions "improved signal to noise and contrast to noise compared to traditional FSE with comparable resolution and scan time, and may be used to reduce motion-induced artifacts," and "improved image quality in areas of high susceptibility," but these are descriptions of expected benefits/capabilities rather than quantified performance metrics against explicit acceptance criteria. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The document does not describe any specific clinical or image-based test set used for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth establishment for a test set is described.
4. Adjudication method for the test set
- Not applicable. No test set or adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not specified. There is no mention of an MRMC study or an AI component in the context of human reader improvement. The device described is an "Imaging Option" (pulse sequence) for MRI, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The document does not describe an algorithm with standalone performance metrics. The device is a technical imaging sequence enhancement.
7. The type of ground truth used
- Not applicable. No ground truth for image or diagnostic performance is described. The "indications for use" speak to aiding physicians in "visualization of pathology" and "visualization of areas with reduced signal," implying a qualitative improvement for human interpretation rather than a direct diagnostic output that would require a ground truth for validation.
8. The sample size for the training set
- Not applicable. The document does not describe a machine learning algorithm that would require a training set.
9. How the ground truth for the training set was established
- Not applicable.
Summary of the Document's Scope:
The provided 510(k) summary focuses on the technical aspects, indications for use, and safety compliance of the Propeller Imaging Option for MRI, establishing its substantial equivalence to previously cleared predicate devices. It describes the capabilities of the imaging option (e.g., improved SNR, CNR, reduced motion artifacts, improved image quality in high susceptibility areas) rather than presenting quantitative clinical performance data from a specific study designed to meet diagnostic acceptance criteria. The approval is based on safety standards and equivalence, not necessarily on a full-scale clinical performance study with defined acceptance criteria and ground truth.
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SUMMARY OF SAFETY AND EFFECTIVENESS
- . This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
- . ldentification of Submitter Larry A. Kroger, Ph.D.,
MAY - 2 2003
-
. Phone:
262-5443464 -
. Fax:
262-548-4768 -
Date Prepared:
March 21, 2003 -
. Identification of the Product Propeller Imaging Option for MRI
Manufactured by: GE Medical Systems 3200 N Grandview Blvd. Waukesha, WI 53188 -
. Common Name Propeller Imaging Option for MRI
-
. Classification Name Magnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-LNH
-
. Device Description
The Propeller Imaging Option is a Fast Spin Echo (FSE) based pulse sequence that provides improved signal to noise and contrast to noise compared to traditional FSE with comparable resolution and scan time, and may be used to reduce motioninduced artifacts. With the addition of Diffusion gradients, Propeller may be used to differentiate tissues with restricted diffusion from tissues with normal diffusion, similar to Diffusion Weighted EPI.
- . Indications for Use
When used with diffusion sensitizing gradients on a minimum of 3 axes, it will augment the standard EPI-based diffusion imaging by providing improved image quality in areas of high susceptibility. This may aid the trained physician in the visualization of pathology in areas traditionally obscured by susceptibility artifacts.
It is intended for use in anatomical regions where significant susceptibility differences exist between adjacent structures (e.g. tissue/air and tissue/bone). This includes, but is not limited to, inferior brain areas such as cerebellum, internal auditory canal,
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vertebrae and orthopedic areas. Other high susceptibility regions include tissue in the presence of MRI compatible metallic implants, artificial joints, etc.
When used in the place of high resolution FSE, it will yield improved contrast-tonoise and signal-to-noise with comparable resolution and overall scan time, or improved contrast-to-noise and signal-to-noise with minimal in-plane motion-induced artifact. This may aid the trained physician in visualization of areas with reduced signal and image contrast or areas obscured by motion artifacts.
It is intended for use in high-resolution anatomical regions where FSE is traditionally used, particularly in neurological imaging, where improved contrast-to-noise and signal-to-noise is needed.
. Comparison with Predicate
The Propeller Imaging Option is substantially equivalent to the features currently marketed GE Medical System Diffusion Weighted EPI Imaging Option (510k #K972990), and Echo Planar Imaging Option including FSE (K944979).
Summary of Studies .
The Propeller Imaging Option was evaluated to thelEC60601-1-4, the Programmable Electrical Medical Systems standard, and IEC 60601-2-33 International medical equipment safety standard for Magnetic Resonance Systems.
. Conclusions
It is the opinion of GE that the Propeller Imaging Option for MRI does not result in any new potential hazards.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
GE Medical Systems % Mr. Heinz-Joerg Steneberg Division Manager, Medical Department TUV Rheinland of North America 12 Commerce Road NEWTON CT 06470
Re: K031230
MAY = 2 2003
Trade/Device Name: GE Propeller Imaging Option for MRI Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: April 17, 2003 Received: April 18, 2003
Dear Mr. Steneberg:
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); good manufacturing practice requirements as set forth in the quality systems (OS) 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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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K� 3 |2 ]0
Device Name: GE Propeller Imaging Option for MRI
Indications For Use:
Propeller Imaging Option is a Fast Spin Echo (FSE) based sequence which employs a alternate k-space trajectory.
-
- When used with diffusion sensitizing gradients on a minimum of 3 axes, it will augment the standard Echo Planar Imaging (EPI) based diffusion imaging by providing improved image quality in areas of high susceptibility. This may aid the trained physician in the visualization of pathology in areas traditionally obscured by susceptibility artifacts.
It is intended for use in anatomical regions where significant susceptibility differences exist between adjacent structures (e.g. tissue/air and tissue/bone). This includes, but is not limited to, inferior brain areas such as cerebellum, internal auditory canal, vertebrae and orthopedic areas. Other high susceptibility regions include tissue in the presence of MRI compatible metallic implants, artificial joint, etc.
- When used with diffusion sensitizing gradients on a minimum of 3 axes, it will augment the standard Echo Planar Imaging (EPI) based diffusion imaging by providing improved image quality in areas of high susceptibility. This may aid the trained physician in the visualization of pathology in areas traditionally obscured by susceptibility artifacts.
-
- When used in the place of high resolution FSE, it will yield improved contrast-tonoise and signal-to-noise with comparable resolution and overall scan time, or improved contrast-to-noise and signal-to-noise with minimal in-plane motion-induced artifact. This may aid the trained physician in visualization of areas with reduced signal and image contrast or areas obscured by motion artifacts.
It is intended for use in high-resolution anatomical regions where FSE is traditionally used, particularly in neurological imaging, where improved contrast-to-noise and signalto-noise is needed.
- When used in the place of high resolution FSE, it will yield improved contrast-tonoise and signal-to-noise with comparable resolution and overall scan time, or improved contrast-to-noise and signal-to-noise with minimal in-plane motion-induced artifact. This may aid the trained physician in visualization of areas with reduced signal and image contrast or areas obscured by motion artifacts.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) for NB
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K031230
Prescription Use _
(Per 21 CFR 801.109)
OR Over-The-Counter Use _
§ 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.