(191 days)
The coil is indicated for use on the order of a physician, in conjunction with Philips 1.5T and 3.0T MR scanners as an accessory to produce images of the hip, knee, foot/ankie, shoulder and elbow regions, as an aid to diagnosis.
The design of the 1.5T and 3.0T 8-channel Medium General Purpose (GP) Flex Coils are based on design features of the predicate device, 1.5T and 3.0T 8-channel General Purpose Flex Coil. The Medium GP Flex Coils are designed as receive only for high resolution diagnostic imaging of regional structures of the musculoskeletal hip, knee, foot/ankie, shoulder, and elbow. The Medium GP Flex Coils are manufactured of materials that are similar to those used to manufacture the predicate devices.
This is a traditional 510(k) for an MRI coil, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth types for AI/ML performance evaluation is not applicable and cannot be extracted from the provided text.
The document describes the device, its intended use, and its substantial equivalence to a predicate device. The review process for such a device focuses on its physical characteristics, safety, and imaging capabilities rather than AI/ML performance metrics.
Summary of available information:
- Device Name: 1.5T and 3.0T 8-Channel Medium General Purpose Flex Coils
- Manufacturer: Invivo Corporation
- Device Type: Magnetic Resonance (MR) Specialty Coil
- Indication for Use: To produce images of the hip, knee, foot/ankle, shoulder, and elbow regions, as an aid to diagnosis, in conjunction with Philips 1.5T and 3.0T MR scanners.
- Substantial Equivalence: Based on similarities in design features, overall indications for use, and technological characteristics to the predicate device (1.5T and 3.0T 8-channel General Purpose Flex Coil - K093842).
§ 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.