(12 days)
Magnetic resonance imaging (MRI) of the musculoskeletal structures, soft tissue and vascular structures of the lower extremities.
Model 475 8 Channel T/R Phased Array Lower Extremity Coil. Compatible with GE and Siemens 1.5T and 3.0T MR Systems.
This document is a 510(k) premarket notification for a new MRI coil, the Model 475 8 Channel T/R Phased Array Lower Extremity Coil. It describes the device's characteristics and its substantial equivalence to a predicate device, focusing on safety and imaging performance parameters.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (Model 475 Coil) |
|---|---|---|
| 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 | Acceptable levels (implicit based on predicate) | Improved |
| Acoustic Noise Levels | No change due to coil | No change due to coil |
| Biocompatibility | No change | No change |
| Imaging Performance Parameters | ||
| Specification Volume (FOV) | 15-20 cm typical FOV all planes | 15-16 cm typical FOV all planes |
| Signal-to-Noise Ratio (SNR) | Baseline (predicate device performance) | 3 Times Improvement over predicate device in peripheral regions |
| 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 |
| Fast Imaging Protocol Compatible | Implicitly compatible (predicate device capability) | Yes |
Study Proving Acceptance Criteria:
The document describes premarket notification (510(k)) as the "study" that proves the device meets the acceptance criteria. This is not a clinical study in the traditional sense, but rather a submission demonstrating "substantial equivalence" to a legally marketed predicate device. The "study" here refers to the engineering and comparative analysis performed by the manufacturer, IGC-Medical Advances Inc., to show that their new coil is as safe and effective as the predicate.
The document states: "The GE and Siemens 1.5T and 3.0T MRI systems, operated with the Medical Advances 8 Channel T/R Phased Array Lower Extremity Coil, are substantially equivalent to the GE Signa 1.5T system operated with the legally marketed predicate devices 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 use of these coils does not affect the GE or Siemens 1.5T and 3.0T system safety parameter specifications."
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as this is not a clinical trial with a defined 'test set' of patient data in the typical sense. The evaluation is based on technical specifications and comparisons to the predicate device.
- Data Provenance: Not applicable. The "data" here refers to the technical specifications and performance characteristics of the new coil compared to the predicate, likely derived from internal engineering tests and simulations, rather than patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. As this is a 510(k) submission focused on technical equivalence to a predicate MRI coil, rather than a diagnostic device that interprets medical images, the establishment of "ground truth" by medical experts for a "test set" of images is not applicable in the way it would be for an AI diagnostic algorithm.
4. Adjudication Method for the Test Set:
This information is not provided and is not applicable to this type of device submission. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where multiple human readers interpret medical images and their interpretations need to be reconciled to establish a ground truth. This document pertains to the technical performance of an MRI coil, not its diagnostic interpretation by human readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. An MRMC study was not done. MRMC studies are used to evaluate the performance of diagnostic imaging devices or AI algorithms by comparing the accuracy of multiple human readers with and without the assistance of a new technology across multiple cases. This submission is for an MRI coil, which is a hardware component, not a diagnostic interpretation tool, and therefore an MRMC study is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This device is an MRI coil, a hardware component for image acquisition, not a software algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this submission.
7. The Type of Ground Truth Used:
Not applicable in the typical sense of diagnostic ground truth. The "ground truth" for this submission is established by the known, legally marketed predicate device's safety and performance characteristics. The new coil's performance is compared against these established technical benchmarks. No pathology, expert consensus on patient outcomes, or other clinical "ground truth" is used in this context. The "truth" is whether the new coil performs at least as safely and effectively as the predicate, or better in some aspects, based on engineering specifications.
8. The Sample Size for the Training Set:
Not applicable. This is a hardware component (MRI coil), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set for an AI algorithm, the concept of establishing ground truth for it does not apply.
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MAR 2 2 2004
510(k) Summary of Safety and Effectiveness
| Device Name | Model 475 8 Channel T/R Phased Array LowerExtremity Coil | |
|---|---|---|
| Applicability | Compatible with GE and Siemens 1.5T and 3.0TMR 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 475 8 Channel T/R Phased Array LowerExtremity 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. | |
| Anatomic Regions | Musculoskeletal structures, soft tissue and vascularstructures of the lower extremities. | |
| 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 |
:
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Standards
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 and Siemens 1.5T and 3.0T MRI systems, operated with the Medical Advances 8 Channel T/R Phased Array Lower Extremity Coil, are substantially equivalent to the GE Signa 1.5T system operated with the legally marketed predicate devices listed in scction 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: | Improved |
| Acoustic Noise Levels: | No change due to coil |
| Biocompatibility: | No change |
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Imaging Performance Parameters
| Specification Volume: | 15-16 cm typical FOV all planes(submitted device) vs. 15-20 cmtypical FOV all planes (predicatedevice) |
|---|---|
| Signal-to-Noise Ratio: | 3 Times Improvement over predicatedevice in peripheral regions |
| Image Uniformity: | No change |
| Geometric Distortion: | No change |
| Slice Thickness and Gap: | No change |
| High Contrast Spatial Resolution: | No change |
| Fast Imaging Protocol Compatible: | Yes |
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 and Siemens 1.5T and 3.0T MRI systems operated with the Medical Advances 8 Channel T/R Phased Array Lower Extremity Coils addressed in this Pre-Market Notification, have 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 these coils does not affect the GE or Siemens 1.5T and 3.0T system safety parameter specifications.
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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle-like emblem with three stylized lines representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 2 2004
IGC-Medical Advances, Inc. % Mr. Daniel W. Lehtonen Staff Engineer-Medical Devices Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719
Re: K040640
Trade/Device Name: Model 475: 8 Channel T/R Phased Array Lower Extremity Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: March 4, 2004 Received: March 10, 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 complics 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 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 | (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. Bugden
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
510(k) Number (if known): K C 4 0640
Model 475: 8 Channel T/R Phased Array Lower Extremity Coil Device Name:
Indications for Use:
Magnetic resonance imaging (MRI) 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 OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off) Division of Reproductive, A and Radiological Devices 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.