(8 days)
Not Found
Not Found
No
The 510(k) summary describes a passive MRI coil and does not mention any software or processing capabilities, let alone AI/ML.
No
Explanation: The device is described as an array coil for MRI, used for imaging and angiography, not for treatment or therapy.
Yes
The device is a coil used for MRI/MRA, which are imaging modalities explicitly used to visualize internal structures for the purpose of diagnosis (e.g., of musculoskeletal, soft tissue, and vascular structures). While the device itself doesn't make a diagnosis, it is an essential component of a diagnostic imaging system.
No
The device description explicitly states "Model 558GE-64 Torso Array Coil," which is a hardware component used in MRI systems. The summary also details performance studies related to imaging parameters of this hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for Magnetic Resonance Imaging (MRI) and Magnetic Resonance Angiography (MRA) of anatomical structures. This is an imaging modality used to visualize internal body structures, not to perform tests on samples taken from the body (like blood, urine, or tissue).
- Device Description: The device is a "Torso Array Coil" for an MRI system. This is a component of an imaging machine, not a device used to analyze biological samples.
- Anatomical Site: The device is used to image specific anatomical regions within the body. IVDs are used to analyze samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device is clearly an imaging component used in vivo (within the living body).
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 torso, pelvis, and abdomen.
Product codes (comma separated list FDA assigned to the subject device)
90MOS
Device Description
Model 558GE-64 Torso Array Coil
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
From the chest to the pelvic region - including, but not limited to the liver, spleen, pancreas, gallbladder, peritoneum, renal/adrenal structures, torso vasculature, bladder, uterus, ovaries, and prostate. Additionally, Musculoskeletal structures, soft tissue and vascular structures of the torso, pelvis, and abdomen.
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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.
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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).
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§ 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.
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MAY 1 4 2004
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Page 1 of 3
510(k) Summary of Safety and Effectiveness
| Device Name | Model 558GE-64 Torso Array Coil |
|---|---|
| Applicability | Compatible with GE Signa EXCITE 1.5T 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 558GE-64 Torso Array 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, parallel-imaging compatibility. | |
| Anatomic Regions | From the chest to the pelvic region - including, but |
| not limited to the liver, spleen, pancreas, | |
| gallbladder, peritoneum, renal/adrenal structures, | |
| torso vasculature, bladder, uterus, ovaries, and | |
| prostate. | |
| 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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Koy1185
Page 2 of 3
Standards
Performance Standards
Voluntary Safety Standards
None Established under Section 514
UL 60601-1 Medical Electrical Equipment, Part I: General Requirements for Safety
- Tests for Flammability of Plastic UL 94 Materials
- General Safety Requirements for IEC 601-1 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 EXCITE 1.5T MRI system, operated with the Medical Advances Torso Array Coil, is substantially equivalent to the Hitachi AIRIS-Elite 0.3T 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
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Page 3 of 3
Imaging Performance Parameters
| Specification Volume: | No change |
|---|---|
| Signal-to-Noise Ratio: | No change |
| 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 EXCITE 1.5T MRI system operated with the Medical Advances Torso Array Coil addressed in this PMN, has the same intended use and technological characteristics as the Hitachi AIRIS-Elite 0.3T system operated with the identified legally marketed predicate device. The use of this coil does not affect the GE Signa EXCITE 1.5T system safety parameter specifications.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The text is in all caps and is smaller than the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevaid Rockville MD 20850
MAY 1 4 2004
IGC Medical Advances % Mr. Daniel W. Lehtonen Staff Engineer-Medical Devices Intertek Testing Services 70 Codman Hill Road BOXBOROUGH MA 01719
Re: K041185 Trade/Device Name: Model 558GE-64: Torso Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: May 3, 2004 Received: May 6, 2004
Dear Mr. Lehtonen:
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 such 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 clectronic 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 Section 510(k) I mis lotter natification. The FDA finding of substantial equivalence of your device to a legally promance motively 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 11 you accure 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. Broughton
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 of ﻠﺴ
Ko4 1185 510(k) Number (if known):
Model 558GE-64: Torso Array 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 torso, pelvis, and abdomen.
(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) the text in the image is:
and Radiological Dev 510(k) Number