(25 days)
The PoleStar N-20 is a Magnetic Resonance Diagnostic Device intended to produce transverse, sagittal, coronal, and oblique 2D and 3D images of the extremities and selected sections of the head. The images produced by the PoleStar N-20 reflect the spatial distribution of protons (Hydrogen Nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and T2*.
Anatomical regions: extremities and selected sections of the head.
Nuclei excited: H-1
Diagnostic uses: T1, T2, T2* and density weighted imaging.
The PoleStar N-20 is intended to be used intraoperatively in a standard operating room. When interpreted by trained physicians, the MR images provide information that can be useful in determining a diagnosis.
The PoleStar N-20 utilizes a permanent magnet to acquire 2D single-slice, multi slice, and 3d volume images. A wide variety of pulse sequences are provided to the operator, including spin echo, gradient echo, fast spin echo, and steady state free precession acquisitions. The PoleStar N-20 is a widely open and compact Intraoperative MRI unit intended to be used in a typical pre-existing operating room. The PoleStar N-20 can be moved within the room between procedures, from the operating table to its Magnet Storage Cabinet, thus allowing the operating room to be used for any type of surgery.
This document is a 510(k) summary for the Odin Medical Technologies PoleStar N-20, an intraoperative MRI device. The primary claim for substantial equivalence is based on a comparison to the predicate device, Odin's PoleStar N-10. This filing does not describe a study to prove acceptance criteria for device performance. Instead, it focuses on demonstrating that the PoleStar N-20 is substantially equivalent to an existing device (the PoleStar N-10) based on similar technical specifications and identical intended use.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and statistical analysis is not present in the provided text.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide explicit "acceptance criteria" for performance that would typically be seen in a clinical validation study for a new diagnostic device. Instead, it offers a "Substantial Equivalence Comparison Table" that lists technical specifications of the new device (PoleStar N-20) against its predicate (PoleStar N-10). The "performance" in this context refers to these specifications matching or being comparable to the predicate.
| Parameter | PoleStar N-10 (Predicate, K010850) | PoleStar N-20 (New Device) | Performance/Comparison |
|---|---|---|---|
| Clinical application | Extremities and selected sections of the head | Extremities and selected sections of the head | Identical |
| Magnet type | Permanent | Permanent | Identical |
| Field strength | 0.12T | 0.13T | Slight increase, deemed comparable |
| 5 gauss fringe field (radial/axial, m) | 1.5 | 2.2 | Minor difference, likely considered acceptable for similar use |
| Shimming | Passive, active | Passive, active | Identical |
| Gradient subsystem Strength mT/m | 25 | 22 | Minor difference, likely considered acceptable |
| Gradient subsystem Rise time to 10mT/m msec |
§ 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.