(63 days)
The NHAC 16 is a local coil (receive only) and is intended to be used in conjunction with 1.5T or 3.0T magnetic resonance imaging (MRI) systems by Philips or Siemens and can be used in conjunction with the MR Diagnostics Incubator System nomag® IC. It provides MR images of the neonatal head, non-invasively and without the use of ionizing radiation.
The NHAC 16 is a 16-channel coil (receive only) and is intended to produce high resolution images of the neonate head and brain.
The NHAC 16 serves solely as a receiving coil for the reception of high frequency signals from the hydrogen nuclei. The hydrogen nuclei are induced into precession by the transmitting coil of the MRT device. The precessing magnetization induces potential differences in the NHAC 16 which are processed by the MRT system.
Used in an MR Scanner or used in the MR Diagnostics Incubator System nomag® IC and an MR Scanner, the NHAC 16 is indicated for use as a diagnostic imaging device to provide transversal, sagittal, coronal and oblique images of the internal structures of the head.
When interpreted by a trained physician, these images provide information that can be useful in the determination of a diagnosis. The excited nucleus is 1H (Hydrogen).
The signal received by the coils is dependent upon the MRI parameters (T1 or spin-lattice relaxation time, T2 or spin-spin relaxation time, density of nuclei, flow velocity and chemical shift).
I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for a medical device (NHAC 16, a neonatal head array coil for MRI) and a summary of its comparison to a predicate device.
It primarily discusses:
- The device's intended use and description.
- Comparison of its electrical, mechanical design, principles of operation, materials, and power supply to a predicate device.
- The conclusion that the modified device is substantially equivalent to the predicate device and raises no new concerns of safety or efficacy.
- A mention of "General testing was performed to ensure that functional requirements were met and that the coil executes as expected. Performance testing was conducted using phantoms and accepted imaging quality metrics." However, no specific acceptance criteria, performance metrics, or study details are provided.
- It also states that "sample clinical images of the neonatal head were not necessary to support the premarket submission."
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given text.
§ 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.