(63 days)
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures of the lower extremities.
Model 473SI-42D Quadrature Lower Extremity Coil. Compatible with Siemens 1.0T Magnetom Impact MRI systems. Magnetic Resonance Imaging Coil.
The provided text is a 510(k) summary for the Model 473SI-42D Quadrature Lower Extremity Coil, a Magnetic Resonance Imaging (MRI) coil. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results in the way one might for a novel diagnostic algorithm.
Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not present in this type of regulatory submission for this device. This document is for a physical device (an MRI coil) whose safety and effectiveness are established by showing it performs comparably to an existing, legally marketed device and does not alter the fundamental safety parameters of the MRI system it's used with.
Here's an attempt to answer your questions based on the provided text, primarily noting what is not available due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
The device is claiming substantial equivalence to a predicate device. The "acceptance criteria" are effectively that the new device does not change the safety or imaging performance characteristics of the established MRI system when compared to the predicate device. The performance is reported as "No change" for these parameters.
| Safety Parameter / Imaging Performance Parameter | Acceptance Criteria (Implicitly: "No change from predicate") | Reported Device Performance |
|---|---|---|
| Maximum Static Magnetic Field | No change | No change |
| Rate of Magnetic Field Strength Change | No change | No change |
| RF Power Deposition | No change | No change |
| Acoustic Noise Levels | No change | No change |
| 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 the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. Given that this is a physical MRI coil demonstrating substantial equivalence, formal clinical "test sets" with patient data (in the sense of a diagnostic AI algorithm) are typically not required unless there are significant changes to the intended use or technology that would introduce new safety or efficacy questions. The testing would likely involve technical bench testing and phantom imaging to ensure the "no change" assertions are met.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/not provided. The "ground truth" in this context is established by the technical specifications and performance of the Siemens 1.0T Magnetom Impact MRI system when used with the legally marketed predicate device. The goal is to show the new coil does not change these established characteristics, not to diagnose conditions from a dataset.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods are typically used for clinical endpoints or diagnostic interpretations, which are not the focus of this 510(k) for an MRI coil.
5. 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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI or imaging systems that assist human readers in making diagnoses. This submission is for an MRI coil, a hardware component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This device is an MRI coil, a hardware component, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to the established safety parameters and imaging performance characteristics of the Siemens 1.0T Magnetom Impact MRI system when used with the predicate device. This is based on technical specifications, engineering measurements, and established regulatory standards for MRI equipment, rather than clinical expert consensus or pathology on patient data.
8. The sample size for the training set
This information is not applicable/not provided. This device is an MRI coil, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided. This device is an MRI coil, not an AI algorithm.
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510(k) Summary of Safety and Effectiveness
1
| Device Name | Model 473SI-42D Quadrature Lower Extremity Coil | |
|---|---|---|
| Applicability | Compatible with Siemens 1.0T Magnetom Impact MRIsystems | |
| Reason for 510(k) | New device | |
| Classification Name | Magnetic Resonance Diagnostic Device | |
| Device Classification Panel | Radiology | |
| Device Classification Number | 892.1000 | |
| Product Code | 90LNH | |
| Common Name | Magnetic Resonance Imaging Coil | |
| Proprietary Name | Model 473SI-42D Quadrature Lower Extremity Coil | |
| Establishment Registration Number | 2183683 | |
| Address of MFG Facility | Medical Advances, Inc.10437 Innovation DriveMilwaukee, WI 53226 | |
| Point of Contact | Thomas E. TynesVice President - Operations(414) 258-3808 Ext. 407 | |
| Classification | Class II | |
| Intended Uses | ||
| Diagnostic Uses | 2D, 3D imaging, proton density, T1 and T2 weightedimaging. 2D, 3D time of flight, phase contrastimaging. | |
| Anatomic Regions | Musculoskeletal structures, soft tissue and vascularstructures of the lower extremities | |
| Performance Standards | None Established under Section 514 | |
| Voluntary Safety Standards | UL 544 | Medical and Dental Equipment |
| 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 released a draft guidance document for the content and review of Magnetic Resonance Diagnostic Device premarket notification submissions that offered clarification of these concerns. The following is a summary of the information contained within this premarket notification that addresses these concerns:
The Siemens 1.0T Magnetom Impact MRI system operated with the Medical Advances Quadrature Lower Extremity Coil is substantially equivalent to the same 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 |
|---|---|
| Rate of Magnetic Field Strength Change: | No change |
| RF Power Deposition: | No change |
| Acoustic Noise Levels: | No change |
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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 Siemens 1.0T Magnetom Impact 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 same system operated with the identified legally marketed predicate device. The use of this coil does not affect the Siemens Magnetom Impact system safety parameter specifications.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the edge. Inside the circle is a stylized image of an eagle. The eagle is drawn with simple, curved lines, giving it a modern and abstract appearance. The seal is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 8 1998
Thomas E. Tynes Vice President - Operations Medical Advances, Inc. 10437 Innovation Drive Milwaukee, WI 53226
Re:
K982496 Model 473SI - 42D Quadrature Lower Extremity Coil Dated: July 14, 1998 Received: July 17, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS
Dear Mr. Tynes:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation vou might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdch/dsmadsmam.html".
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health …
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ___ Model 473SI Series: Quadrature Lower Extremity Coil
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)
Elind h. Segmon
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devic 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use ______
(Optional Format 1-2-96)
§ 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.