(25 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the breast and axillary tissues that can be interpreted by a trained physician.
Magnetic Resonance Specialty Coil, Model OBC-300 Breast Array Coil
This is a 510(k) clearance letter and an Indications for Use statement for a Magnetic Resonance Specialty Coil (Model OBC-300 Breast Array Coil). This type of document typically does not contain acceptance criteria or details about a study to prove device performance in the way a clinical trial report would.
510(k) clearances are primarily based on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. The focus is usually on comparing technical specifications and performance characteristics rather than extensive clinical efficacy studies to meet specific performance criteria against a disease.
Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in the provided text.
Based on the nature of the documents, I can provide the following:
Device Description: Magnetic Resonance Specialty Coil (Model OBC-300 Breast Array Coil)
Intended Use: To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the breast and axillary tissues that can be interpreted by a trained physician.
Regulatory Class: II
Procode: 90 MOS
To answer the detailed questions, one would need to access the full 510(k) submission (K993776), which is not available in the provided snippets.
§ 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.