(14 days)
For use with a 1.5T Siemens Avanto/Espree or 3T Siemens Trio a TIM/Verio magnetic resonance scanner to produce diagnostic images of the head that can be interpreted by a trained physician.
The 1.5T and 3T CP Head Coils are circularly polarized (CP) transmit and receive coils designed for magnetic resonance imaging of the head. The coils are designed for use with the Siemens MAGNETOM 1.5T Avanto/Espree and Siemens MAGNETOM 3T Trio a TIM/Verio systems respectively. The coil elements are enclosed in a rigid plastic housing (polycarbonate) which is fire-rated and has impact and tensile strength (material data provided). The coils have a split-top mechanical design with a system cable on the posterior half of the coil. The inner cross section is shaped to fit the head anatomy. The coils include the following accessories: a mirror to reduce patient anxiety/claustrophobia and foam pads also to aid positioning and enhance patient comfort.
This submission (K091114) is for an MRI head coil, specifically the TxRx 1.5T CP Head Coil and TxRx 3T CP Head Coil, and not for an AI/ML device. Therefore, the provided document does not contain information regarding various aspects typically associated with AI/ML device evaluations. As such the questions are not applicable to the provided document.
Here's why and what information is available in the document:
Why the questions are not applicable (and the information is missing):
- No AI/ML Device: The device is a magnetic resonance (MR) head coil, a hardware component for MRI scanners. It does not perform any Al/ML functions like image interpretation, anomaly detection, or diagnostic assistance.
- No 'Performance' in the AI/ML Sense: The "performance" of an MR coil is typically evaluated based on signal-to-noise ratio, image uniformity, specific absorption rate (SAR), and other physical/electrical characteristics, not diagnostic accuracy metrics (like sensitivity, specificity, AUC) that would be established against a medical ground truth.
- No Clinical Study for Diagnostic Efficacy: The 510(k) summary indicates substantial equivalence to predicate devices (other MR head coils). This usually means that the new device performs similarly in terms of image quality and safety, and does not require a new clinical study demonstrating diagnostic performance against a ground truth.
Information that is available from the document:
- Device Description: The TxRx 1.5T and 3T CP Head Coils are circularly polarized transmit and receive coils designed for magnetic resonance imaging of the head. They are intended for use with specific Siemens MAGNETOM 1.5T Avanto/Espree and 3T Trio a TIM/Verio MRI systems, respectively.
- Intended Use: "For use with a 1.5T Siemens Avanto/Espree or 3T Siemens Trio a TIM/Verio magnetic resonance scanner to produce diagnostic images of the head that can be interpreted by a trained physician."
- Substantial Equivalence: The submission concludes that the new coils are substantially equivalent to legally marketed predicate devices (MAGNETOM Symphony Head Coil and MAGNETOM Trio Head Coil from USA Instruments) because they have similar designs, are constructed of similar materials, and their use does not result in any new potential hazards.
Therefore, I cannot provide answers to the questions because the provided document does not pertain to an AI/ML device or a study evaluating diagnostic performance against a ground truth.
§ 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.