(90 days)
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures of the lower extremities.
Model 472GE-128 Quadrature Lower Extremity Coil. Compatible with GE Signa 3.0T MR Systems. Magnetic Resonance Imaging Coil.
This document describes a 510(k) premarket notification for a magnetic resonance imaging (MRI) coil, not an AI/ML device. Therefore, the specific criteria related to AI/ML device performance, such as sample sizes for test and training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI models, are not applicable to this submission.
The acceptance criteria and study information provided in this document pertain to the substantial equivalence of the new MRI coil to a legally marketed predicate device, focusing on safety and imaging performance parameters relevant to MRI coils.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are demonstrated by its substantial equivalence to a predicate device, specifically the GE Signa 1.5T MR system with its legally marketed lower extremity coil. The new device, the Model 472GE-128 Quadrature Lower Extremity Coil, is intended for use with the GE Signa 3.0T MR system. The parameters assessed for substantial equivalence fall into categories of safety and imaging performance.
Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Substantial Equivalence) | Reported Device Performance (vs. Predicate Device) |
|---|---|---|
| Safety Parameters | ||
| Maximum Static Magnetic Field | No change due to coil | No change due to coil |
| Rate of Magnetic Field Strength Change | No change due to coil | No change due to coil |
| RF Power Deposition | No change | No change |
| Acoustic Noise Levels | No change due to coil | No change due to coil |
| Biocompatibility | No change | No change |
| Imaging Performance Parameters | ||
| Specification Volume | No change | No change |
| Signal-to-Noise Ratio (SNR) | Acceptable (improved over predicate) | 2 Times Improvement over Predicate Device |
| Image Uniformity | No change | No change |
| Geometric Distortion | No change | No change |
| Slice Thickness and Gap | No change | No change |
| High Contrast Spatial Resolution | No change | No change |
Study Proving Device Meets Acceptance Criteria
The study demonstrating that the device meets the acceptance criteria is a substantial equivalence evaluation rather than a traditional clinical trial or AI model validation study. The manufacturer, IGC-Medical Advances Inc., performed an analysis and comparison against a legally marketed predicate device (a GE Signa 1.5T system with a comparable lower extremity coil).
The provided text details this comparison: "The GE Signa 3.0T MRI system, operated with the Medical Advances Quadrature Lower Extremity Coil, is substantially equivalent to the GE Signa 1.5T system operated with the legally marketed predicate device listed in section 4.0, within the Class II definition of Magnetic Resonance Diagnostic Device with respect to the safety parameter action levels" and "The GE Signa 3.0T MRI system operated with the Medical Advances Quadrature Lower Extremity Coil addressed in this PMN, has the same intended use and technological characteristics as the GE Signa 1.5T system operated with the identified legally marketed predicate device. The use of this coil does not affect the GE Signa 3.0T system safety parameter specifications."
This evaluation focuses on demonstrating that the new coil, when used with its specified MRI system, maintains the safety parameters and either maintains or improves upon the imaging performance characteristics of the predicate device. The specific improvement noted is a "2 Times Improvement over Predicate Device" in Signal-to-Noise Ratio. Other parameters are stated to have "No change," indicating they meet the equivalence standard by not degrading performance.
Information Not Applicable to This Submission:
As this is a 510(k) for an MRI coil and not an AI/ML device, the following points are not relevant and therefore not addressed in the provided document:
- Sample size used for the test set and the data provenance: Not an AI/ML device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI/ML device.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not an AI/ML device.
- 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 an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not an AI/ML device. This relates to the performance of the physical hardware (coil) in conjunction with an MRI system.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not an AI/ML device. Performance is typically assessed through phantom studies, engineering measurements, and potentially comparison of image quality in human subjects or cadavers, but not for "ground truth" as understood in AI/ML.
- The sample size for the training set: Not an AI/ML device.
- How the ground truth for the training set was established: Not an AI/ML device.
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KC23084
DEC 1 6 2002
510(k) Summary of Safety and Effectiveness
ﺮ
| Device Name | Model 472GE-128 Quadrature Lower ExtremityCoil |
|---|---|
| Applicability | Compatible with GE Signa 3.0T MR Systems |
| Reason for 510(k) | New device |
| Classification Name | Magnetic Resonance Diagnostic Device |
| Device Classification Panel | Radiology |
| Device Classification Number | 892.1000 |
| Product Code | 90MOS |
| Common Name | Magnetic Resonance Imaging Coil |
| Proprietary Name | Model 472GE-128 Quadrature Lower ExtremityCoil |
| Establishment Registration Number | 2183683 |
| Address of MFG Facility | IGC-Medical Advances Inc.10437 Innovation DriveMilwaukee, WI 53226 |
| Point of Contact | Anthony DietzlerQuality Assurance Engineer(414) 258-3808 Ext. 255 |
| Classification | Class II |
| Intended Uses | |
| Diagnostic Uses | 2D, 3D imaging, proton density, T1 and T2weighted imaging. 2D, 3D time of flight, phasecontrast imaging. |
| Anatomic Regions | Musculoskeletal structures, soft tissue and vascularstructures of the lower extremities |
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Standards
| Performance Standards | None Established under Section 514 | |
|---|---|---|
| Voluntary Safety Standards | UL 2601-1 | Medical Electrical Equipment, Part IGeneral Requirements for Safety |
| UL 94 | Tests for Flammability of PlasticMaterials | |
| IEC 601-1 | General Safety Requirements forMedical Electrical Equipment |
Overview
The Radiology Devices Panel considered potential concerns regarding the safe and effective operation of Magnetic Resonance Diagnostic Devices when they recommended reclassification to Class II on July 27, 1987. After reclassification, the FDA's Center for Devices and Radiological Health (CDRH) released a draft guidance document for the content and review of Magnetic Resonance Diagnostic Device premarket notification submissions that offered clarification of these concerns. Due to considerable technological advances in MRDDs, CDRH issued an updated guidance document on November 14, 1998. The following is a summary of the information contained within this premarket notification that addresses these concerns:
The GE Signa 3.0T MRI system, operated with the Medical Advances Quadrature Lower Extremity Coil, is substantially equivalent to the GE Signa 1.5T system operated with the legally marketed predicate device listed in section 4.0, within the Class II definition of Magnetic Resonance Diagnostic Device with respect to the safety parameter action levels:
Safety Parameters
| Maximum Static Magnetic Field: | No change due to coil |
|---|---|
| Rate of Magnetic Field Strength Change: | No change due to coil |
| RF Power Deposition: | No change |
| Acoustic Noise Levels: | No change due to coil |
| Biocompatibility: | No change |
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Imaging Performance Parameters
| Specification Volume: | No change |
|---|---|
| Signal-to-Noise Ratio: | 2 Times Improvement over PredicateDevice |
| Image Uniformity: | No change |
| Geometric Distortion: | No change |
| Slice Thickness and Gap: | No change |
| High Contrast Spatial Resolution: | No change |
General Safety and Effectiveness Concerns
The device contains instructions for use. It includes indications for use, precautions, cautions, contraindications, warnings and quality assurance testing. This information assures safe and effective use of the device.
Substantial Equivalence Summary
The GE Signa 3.0T MRI system operated with the Medical Advances Quadrature Lower Extremity Coil addressed in this PMN, has the same intended use and technological characteristics as the GE Signa 1.5T system operated with the identified legally marketed predicate device. The use of this coil does not affect the GE Signa 3.0T system safety parameter specifications.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the caduceus symbol. The text is in all capital letters and is written in a simple, sans-serif font.
Public Health Service
C 1 6 2002
d and Drug Administration 00 Corporate Boulevard Rockville MD 20850
Mr. Anthony Dietzler Ouality Assurance Engineering IGC-Medical Advances, Inc. 10437 Innovation Drive MILWAUKEE WI 53226
Re: K023084
Trade/Device Name: Model 472GE-128: Quadrature Lower Extremity Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: September 16, 2002 Received: September 17, 2002
Dear Mr. Dietzler:
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 (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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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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" (21 CFR Part 807.97). 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. Snigdon
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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Page 1 of 1
- 510(k) Number (if known):
Model 472GE-128: Quadrature Lower Extremity Coil Device Name:
Indications for Use:
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures of the lower extremities.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
David G. Ligman
of Reproductive, Abdom Offical Davi
§ 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.