(81 days)
The Leo III Tx/Rx Quadrature Knee Coil is a transmit-receive quadrature RF coil, used for obtaining diagnostic images of the knee and surrounding anatomy in Magnetic Resonance Imaging Systems. The Leo III Tx/Rx Quadrature Knee Coil is designed for use with the Magnetom Trio 3.0T MRI system manufactured by Siemens Medical Solutions, Inc. The indications for use are the same as for standard MR Imaging.
The Alpha III Tx/Rx Quadrature Wrist Coil is a transmit-receive quadrature RF coil, used for obtaining diagnostic images of the wrist and hand in Magnetic Resonance Imaging Systems. The Alpha III T/R Quadrature Wrist Coil is designed for use with the Magnetom Trio 3.0T MRI system manufactured by Siemens Medical Solutions, Inc. The indications for use are the same as for standard MR Imaging.
The Leo III Tx/Rx Quadrature Knee Coil is designed to provide Magnetic Resonance Images of the knee and surrounding anatomy. The Alpha III Tx/Rx Quadrature Wrist Coil is designed to provide Magnetic Resonance Images of the wrist and hand. The Leo III Tx/Rx Quadrature Knee Coil and the Alpha III Tx/Rx Quadrature Wrist Coil are designed for use with the Siemens Magnetom Trio 3.0T scanner manufactured by Siemens Medical Solutions.
The indications for use are the same as for standard imaging:
The 3.0T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images vield information that can be useful in the determination of a diagnosis.
The Leo III Tx/Rx Quadrature Knee Coil is a multi-element quadrature transmit-receive coil. The coil has a split top design with a latching device and a large open viewing window on the top. The open, patient friendly design eases patient handling and positioning and maximizes patient comfort. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and has a high impact and tensile strength.
The Alpha III T/R Quadrature Wrist Coil is a multi-element quadrature transmit-receive coil. The coil has a rigid enclosure with windows on top to facilitate patient handling. The open, patient friendly design eases patient handling and positioning and maximizes patient comfort. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and has a high impact and tensile strength.
The provided document describes the safety and effectiveness of two medical devices: the Leo III Tx/Rx Quadrature Knee Coil and the Alpha III Tx/Rx Quadrature Wrist Coil. This document is a 510(k) premarket notification, which establishes substantial equivalence to existing predicate devices rather than conducting a de novo study with acceptance criteria and clinical performance data in the way a novel AI/software medical device would.
Therefore, many of the typical sections for AI/software medical device studies (like acceptance criteria, sample sizes for training/test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) are not applicable or detailed in this type of submission.
Summary of Device Features and Comparison to Predicate Devices (serving as the basis for demonstrating safety and effectiveness):
| Feature/Acceptance Criteria | Leo III Tx/Rx Quadrature Knee Coil Performance | Alpha III Tx/Rx Quadrature Wrist Coil Performance |
|---|---|---|
| Intended Use | Imaging of the knee and surrounding anatomy. | Imaging of the wrist and hand. |
| Indications for Use | Identical to routine MRI imaging. | Identical to routine MRI imaging. |
| Coil Enclosure Material | Flame Retardant Polyurethane, Polycarbonate, Kydex Acrylic/PVC, Delrin Acetal | Flame Retardant Polyurethane, Polycarbonate, Kydex Acrylic/PVC, Delrin Acetal |
| Coil Design | 12 z-inductor transmit receive quadrature coil. | 2 element saddle transmit receive quadrature coil. |
| Decoupling | Transmit/Receive Switch actively switched during transmit and receive modes. | Transmit/Receive Switch actively switched during transmit and receive modes. |
| Prevention of RF Burns | Uses pin diodes to isolate receive channel from transmit channel; elements/circuitry enclosed in non-conductive housing. | Uses pin diodes to isolate receive channel from transmit channel; elements/circuitry enclosed in non-conductive housing. |
| Radio Frequency Absorption | Power deposition limited by SAR algorithm. | Power deposition limited by SAR algorithm. |
| Formation of Resonant Loop | Active diodes and fast RF blowing fuses isolate coil elements; cable length and stiffness prevent looping. | Active diodes and fast RF blowing fuses isolate coil elements; cable length and stiffness prevent looping. |
Study Information (Based on a 510(k) Substantial Equivalence Submission):
- Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical study of the device's diagnostic performance involving a test set, but rather a submission for substantial equivalence to predicate devices based on design and technical characteristics.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring ground truth established by experts is mentioned.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This device is an MRI accessory (coil), not an AI/software medical device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an MRI accessory (coil), not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The demonstration of safety and effectiveness relies on comparison to predicate devices, engineering documentation, and adherence to safety principles, not a ground truth for diagnostic accuracy.
- 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.
- How the ground truth for the training set was established: Not applicable.
Explanation of the Study and its findings:
The provided document is a 510(k) Premarket Notification to the FDA for the Leo III Tx/Rx Quadrature Knee Coil and the Alpha III Tx/Rx Quadrature Wrist Coil. This type of submission aims to demonstrate that the new device is "substantially equivalent" to one or more legally marketed predicate devices, meaning it has the same intended use and the same technological characteristics as the predicate devices, or has different technological characteristics but does not raise different questions of safety and effectiveness, and the information submitted demonstrates that the device is as safe and effective as the legally marketed device.
Key Findings from the Submission:
- Substantial Equivalence: The FDA determined that both the Leo III Tx/Rx Quadrature Knee Coil and the Alpha III Tx/Rx Quadrature Wrist Coil are substantially equivalent to legally marketed predicate devices.
- Predicate Devices:
- For the Leo III Tx/Rx Quadrature Knee Coil, predicate devices include the Allegra 3.0Tesla TxRx Head coil (K002179) and the Leo 7000 Knee Coil (K971246), both manufactured by USA Instruments, Inc. The Hi-Res 9000 Phased Array Carotid Coil (K001210) by USA Instruments, Inc. was also referenced for enclosure material.
- For the Alpha III Tx/Rx Quadrature Wrist Coil, predicate devices include the Alpha 7000 Wrist Coil (K972205) and the Allegra 3.0Tesla TxRx Head coil (K002179), both manufactured by USA Instruments, Inc. The Hi-Res 9000 Phased Array Carotid Coil (K001210) by USA Instruments, Inc. was also referenced for enclosure material.
- Basis for Equivalence: The submission details various product features (Intended Use, Indications for Use, Coil Enclosure Material, Coil Design, Decoupling, Prevention of RF Burns, Radio Frequency Absorption, Formation of Resonant Loop) and explicitly compares them to the features of the identified predicate devices. The arguments for safety and effectiveness are based on these comparisons, asserting that the new coils share fundamental technology and safety features with already cleared devices.
- No Clinical Trials for Diagnostic Accuracy: This type of submission, for an MRI accessory, typically does not involve a clinical study to assess diagnostic accuracy or create a "ground truth" test set for diagnostic performance. Instead, the focus is on engineering specifications, material safety, electrical safety, RF safety, and ensuring performance similar to existing coils for image acquisition. The indications for use are stated to be "the same as for standard MR Imaging," meaning the device is intended to enable the existing, established diagnostic capabilities of an MRI system for specific anatomies.
§ 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.