(11 days)
The intended use of the Noras MR-BI320-PA 1.5T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the female breast. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.
The included Breast Biopsy Unit Bl160-2 permits MR guided breast biopsy, wire localization of lesions that can be performed by a trained physician.
The MR-BI320-PA 1.5T is a patient rest with a immobilization- and biopsy unit and a 4-channel phased array receive only coil.
The coil is factory pre-tuned to the fixed load and no further tuning or matching is required for the patient.
The coil is divided into two spherical parts. Each half contains a 2 channel receive only arrav.
The upper coil is connected with a cable and a plug with the insertion coil. The insertion plate coil is connected to the scanner with a cable connection.
The insertion plate coil is designed to enable insertion of immobilization and biopsy system and is inserted into the patient rest.
The upper coil (patient pad coil) serves as a positioning pad for the patient at the same time.
The provided text describes a 510(k) summary for the Noras MR-BI320-PA 1.5T device, a patient rest with an immobilization- and biopsy unit and a 4-channel phased array receive-only coil for MR examination of the female breast.
However, the document does not contain information about specific acceptance criteria, a study proving the device meets these criteria, or details regarding device performance metrics (such as sensitivity, specificity, accuracy), sample sizes for test/training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies as requested in your prompt.
The document focuses on:
- Device Description: What the device is and its components.
- Intended Use: How the device is meant to be used (MR examination of the female breast, MR-guided breast biopsy and wire localization).
- Substantial Equivalence: Comparing the device to legally marketed predicate devices (MRI Devices Corporation Breast Array Coil, Noras Immobilization and Biopsy Units).
- Technological Characteristics Comparison: Highlighting improvements and capabilities compared to predicates.
- Safety and Effectiveness Concerns: Stating conformity to harmonized standards (IEC 60601-1, NEMA MS 6-2001, IEC 60601-2-33:2002) and testing on a Siemens Avanto system to ensure safety and performance with Siemens 1.5T systems.
- Conclusion of Substantial Equivalence.
The only mention of a "test protocol" is in the context of technological comparison, stating "The dedicated 4 channel 1.5T breast coil enables a MR guided biopsy under comparable picture quality as the MRI OBC coil (see Appendix C Test Protocols, due to Standard NEMA MS 6-2001)." This refers to a standard for measuring performance and safety parameters, not a specific clinical or performance study with acceptance criteria and results.
Therefore, I cannot populate the requested table or answer most of the prompt's specific questions based on the provided text. The document is a regulatory submission for substantial equivalence, not a detailed study report.
§ 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.