(37 days)
The ACHIEVA , INTERA and PANORAMA 1.0T Release 2-series are magnetic resonance diagnostic devices that produce cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis.
The ACHIEVA , INTERA and PANORAMA 1.0T Release 2-series are the successor of the predicate devices ACHIEVA, INTERA and PANORAMA 1.0T release 1-series. The Release 2-series introduces the new functionalities:
- Fiber Tracking .
Diffusion Tensor Imaging (DTI) extends the functionality of Diffusion Weighted Imaging (DWI) to measure the directional dependence of the diffusion coefficient in tissue. With Fiber Tracking the directional dependency can be used to visualize the white matter structure in the brain. - Smart Scan .
SmartScan enables automatic planning of geometries and acquisition. When needed the user can control and confirm the automatically planned acquisition. The ExamCard provides the fully automated process of data acquisition.
Regional Perfusion Imaging (Arterial Spin Labeling)
Regional Perfusion Imaging with Arterial Spin Labeling provides a noninvasive acquisition method for selectively mapping of the flow territories and to determine the regional perfusion in the human brain. - kt-BLAST and kt-SENSE. .
Kt-BLAST (Broad-use Linear Acquisition Speed-up Technique) reduces scan time of dynamic and multi-phase studies by also using k-space data from other dynamics / phases. Kt-SENSE combines kt-BLAST with SENSE parallel imaging. Kt-blast and kt-SENSE can be applied to reduce scan time or improve temporal resolution of dynamic or multi-phase studies.
The ACHIEVA, INTERA and PANORAMA 1.0T Release 2-series are the successors of the predicate devices ACHIEVA , INTERA and PANORAMA 1.0T Release 1-series. The design of the Release 2-series are based on the same software platform and hardware technology as their predicate devices.
The provided text describes a 510(k) submission for Philips Medical Systems' ACHIEVA, INTERA, and PANORAMA 1.0T Release 2-series of Magnetic Resonance Diagnostic Devices (MRDD). However, the document does not contain specific information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Instead, the submission focuses on demonstrating substantial equivalence to their predicate devices (Release 1-series, K043147, K041602). The key argument for substantial equivalence is that the Release 2-series introduces new functionalities (Fiber Tracking, Smart Scan, Regional Perfusion Imaging, kt-BLAST, kt-SENSE) but does not induce any other risks than already indicated for their predicate devices with the same safety and effectiveness. This implies that the safety and effectiveness of the new features are considered to be within the established parameters of the predicate devices.
Therefore, I cannot populate the requested table or answer the specific questions about the study that proves the device meets acceptance criteria, as this information is not present in the provided document. The document essentially states that because the new device is a technological update that does not introduce new safety or effectiveness risks compared to its predecessor, specific new performance studies for acceptance criteria are not detailed in this submission.
§ 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.