(8 days)
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the Musculoskeletal structures, soft tissue and vascular structures of the torso, pelvis, and abdomen.
Model 558GE-64 Torso Array Coil. Compatible with GE Signa EXCITE 1.5T MR Systems.
The provided text describes a 510(k) premarket notification for the "Model 558GE-64 Torso Array Coil" for Magnetic Resonance Diagnostic Devices. This submission focuses on establishing substantial equivalence to a predicate device, rather than performing a novel clinical study for the device itself. Therefore, many of the requested elements for a study proving device performance are not applicable or cannot be extracted from this document as it is a submission for a new coil for an existing MRI system, not a new diagnostic algorithm or AI device.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this device (an MRI coil), the "acceptance criteria" and "reported device performance" are framed in terms of maintaining the performance and safety characteristics of the MRI system when the new coil is used, and demonstrating equivalence to a predicate device.
| Acceptance Criteria (Stated Goal / Claim) | Reported Device Performance (as stated in the submission) |
|---|---|
| Safety Parameters: | |
| Maximum Static Magnetic Field: No change | No change due to coil |
| Rate of Magnetic Field Strength Change: No change | No change due to coil |
| RF Power Deposition: No change | No change |
| Acoustic Noise Levels: No change | No change due to coil |
| Biocompatibility: No change | No change |
| Imaging Performance Parameters: | |
| Specification Volume: No change | No change |
| Signal-to-Noise Ratio: No change | No change |
| 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 |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical study with a "test set" of patient data in the way an AI/diagnostic algorithm would. The evaluation seems to be based on technical specifications and comparison to a predicate device. Therefore, no information on sample size or data provenance in this context can be extracted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. As this is not a diagnostic device with a "ground truth" to be established by experts on a test set, this information is not present.
4. Adjudication Method for the Test Set
Not applicable. There is no test set or adjudication method described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document is for an MRI coil, not an AI-assisted diagnostic tool. No MRMC study or AI performance evaluation is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm, but a hardware component (MRI coil).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For a hardware component like an MRI coil, "ground truth" would relate to its physical and electromagnetic properties, not diagnostic accuracy in the clinical sense. The "ground truth" here is the established safety and performance of the MRI system with the new coil, which is shown by physical measurements and adherence to technical specifications, along with the substantial equivalence argument.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
Summary of the Study/Evidence Provided (for the MRI coil):
The submission for the "Model 558GE-64 Torso Array Coil" is a technical and substantial equivalence declaration, not a clinical efficacy study. The "study" implicitly referenced is the technical evaluation demonstrating that the new coil, when used with the GE Signa EXCITE 1.5T MR Systems, does not change the safety parameters (Maximum Static Magnetic Field, Rate of Magnetic Field Strength Change, RF Power Deposition, Acoustic Noise Levels, Biocompatibility) or the imaging performance parameters (Specification Volume, Signal-to-Noise Ratio, Image Uniformity, Geometric Distortion, Slice Thickness and Gap, High Contrast Spatial Resolution) compared to the MRI system without the new coil or compared to the predicate device.
The main "proof" is the argument of substantial equivalence to a legally marketed predicate device (Hitachi AIRIS-Elite 0.3T system operated with the identified predicate coil), based on:
- Same intended use.
- Similar technological characteristics (with the implication that the new coil maintains or does not degrade the established performance of the MR system it's compatible with).
- Demonstration that the coil does not affect the system's safety and imaging performance specifications.
The document states that a draft guidance document for MRDDs (issued Nov 14, 1998) clarifies concerns, and the submission summarizes information addressing these concerns, focusing on the lack of change in safety and performance parameters. The device also includes instructions for use, indications, precautions, cautions, contraindications, warnings, and quality assurance testing to assure safe and effective use.
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MAY 1 4 2004
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510(k) Summary of Safety and Effectiveness
| Device Name | Model 558GE-64 Torso Array Coil |
|---|---|
| Applicability | Compatible with GE Signa EXCITE 1.5T MRSystems |
| 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 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, parallel-imaging compatibility. |
| Anatomic Regions | From the chest to the pelvic region - including, butnot limited to the liver, spleen, pancreas,gallbladder, peritoneum, renal/adrenal structures,torso vasculature, bladder, uterus, ovaries, andprostate. |
| 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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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.
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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
§ 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.