(90 days)
Not Found
Not Found
No
The summary describes an MRI coil, which is a hardware component, and does not mention any software or algorithms that would incorporate AI/ML. The performance studies focus on hardware-related imaging parameters.
No.
The device is an MRI coil used for imaging and diagnosis, not for treating a condition or disease.
Yes
This device is an MRI coil, which is a component of an MRI system. MRI systems are used to produce images of the body's internal structures, which are then interpreted by healthcare professionals to diagnose various medical conditions. Therefore, the device facilitates diagnostic imaging.
No
The device description explicitly states it is a "Magnetic Resonance Imaging Coil," which is a hardware component used in MRI systems.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a Magnetic Resonance Imaging (MRI) Coil. MRI coils are components of an MRI system used to generate and receive radiofrequency signals to create images of the inside of the body. This is an in vivo imaging technique, meaning it is performed on a living organism.
- Intended Use: The intended use is for "Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures of the lower extremities." This describes an imaging procedure performed directly on the patient, not a test on a sample taken from the patient.
Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
90MOS
Device Description
Compatible with GE Signa 3.0T MR Systems. A Magnetic Resonance Imaging Coil. Model 472GE-128 Quadrature Lower Extremity Coil.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI) and Magnetic Resonance Angiography (MRA)
Anatomical Site
musculoskeletal structures, soft tissue and vascular structures of the lower extremities
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Imaging Performance Parameters:
Signal-to-Noise Ratio: 2 Times Improvement over Predicate Device
Other parameters (Specification Volume, Image Uniformity, Geometric Distortion, Slice Thickness and Gap, High Contrast Spatial Resolution) show No change.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Signal-to-Noise Ratio: 2 Times Improvement over Predicate Device
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
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
KC23084
DEC 1 6 2002
510(k) Summary of Safety and Effectiveness
ﺮ
| Device Name | Model 472GE-128 Quadrature Lower Extremity
Coil |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------|
| 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 Extremity
Coil |
| Establishment Registration Number | 2183683 |
| Address of MFG Facility | IGC-Medical Advances Inc.
10437 Innovation Drive
Milwaukee, WI 53226 |
| Point of Contact | Anthony Dietzler
Quality Assurance Engineer
(414) 258-3808 Ext. 255 |
| Classification | Class II |
| Intended Uses | |
| Diagnostic Uses | 2D, 3D imaging, proton density, T1 and T2
weighted imaging. 2D, 3D time of flight, phase
contrast imaging. |
| Anatomic Regions | Musculoskeletal structures, soft tissue and vascular
structures of the lower extremities |
1
Standards
| Performance Standards | None Established under Section 514 | |
|---|---|---|
| Voluntary Safety Standards | UL 2601-1 | Medical Electrical Equipment, Part I |
| General Requirements for Safety | ||
| UL 94 | Tests for Flammability of Plastic | |
| Materials | ||
| IEC 601-1 | General Safety Requirements for | |
| Medical 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 |
2
Imaging Performance Parameters
| Specification Volume: | No change |
|---|---|
| Signal-to-Noise Ratio: | 2 Times Improvement over Predicate |
| Device | |
| 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.
3
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.
4
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
5
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