GE PROPELLER IMAGING OPTION FOR MRI

• K Number: K031230
• Device Name: GE PROPELLER IMAGING OPTION FOR MRI
• Manufacturer: GE MEDICAL SYSTEMS
• Date Cleared: 2003-05-02 ( 14 days)
• Product Code: LNH
• Regulation Number: 892.1000

Intended Use

Propeller Imaging Option is a Fast Spin Echo (FSE) based sequence which employs a alternate k-space trajectory. 1. 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. 2. 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.

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.

Predicate Devices

K972990, K944979

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on a specific MRI pulse sequence (Propeller) and its technical advantages (improved signal/contrast, motion artifact reduction, diffusion imaging). There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies.

Therapeutic

No
The device is described as an "Imaging Option" or "pulse sequence" for an MRI system, intended to improve image quality and aid visualization for diagnostic purposes, not for direct treatment or therapy.

Diagnostic

Yes

The device aids the trained physician in the visualization of pathology, areas with reduced signal and image contrast, or areas obscured by motion artifacts, which are all diagnostic tasks. The "Intended Use / Indications for Use" section explicitly states that the device "may aid the trained physician in the visualization of pathology".

SaMD (Software as a Medical Device)

No

The device is described as a "pulse sequence" for an MRI system, which is a component of the MRI hardware that controls the timing and strength of the magnetic fields and radiofrequency pulses. While it is software that controls the hardware, it is intrinsically linked to and operates the MRI hardware itself, making it more than just standalone software.

IVD (In Vitro Diagnostic)

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 examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
• Device Function: The Propeller Imaging Option is a pulse sequence for Magnetic Resonance Imaging (MRI). It is used to acquire images of the human body in vivo (within the living organism). It does not analyze samples taken from the body.
• Intended Use: The intended use describes aiding physicians in visualizing pathology and anatomical structures through improved image quality and reduced artifacts. This is a function of an imaging device, not an IVD.
• Device Description: The description clearly states it's a pulse sequence for MRI, focusing on image acquisition and quality.
• Input Imaging Modality: The input is Magnetic Resonance Imaging (MRI), which is an in vivo imaging technique.

Therefore, the Propeller Imaging Option falls under the category of medical imaging devices, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

• 1. 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.
• 2. 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.

Product codes

90 LNH

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

MRI

Anatomical Site

inferior brain areas such as cerebellum, internal auditory canal, vertebrae and orthopedic areas.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained physician

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K972990, K944979

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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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,

1

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	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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.

• 1. 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.
• 2. 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.

(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 _