(71 days)
The Intercept™ Internal MR Coils are recommended for high-resolution Magnetic Resonance Imaging of internal anatomical structures. The single use, disposable coils were designed to be inserted into body orifices of the patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the coil. The unique coil shapes facilitate orientation of the coils to the anatomy. These products are to be used with a 1.5T Philips MRI system.
The Intercept™ Urethral Internal MR Coil is recommended for high-resolution Magnetic Resonance Imaging of the male and female urethra and surrounding tissue. The single use, disposable coil was designed to be inserted in the urethra of a patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the urethra and including the prostate in males. The flexible coil facilitates placement of the coil in the anatomy, This product is to be used with a 1.5T Philips MRI system. The signals picked up by the coil are conducted through a small coaxial cable to a connection with the standard surface coil connector for MRI systems. The coil and cable are completely sealed inside the insulating layer.
The Intercept™ Vascular Internal MR Coil is recommended for high-resolution Magnetic Resonance Imaging of the peripheral vasculature. The single use, disposable coil is designed for insertion into an artery or vein of a patient during MRI scans in order to obtain improved image quality in the peripheral vasculature. The flexible coil facilitates placement of the coil in the peripheral vascular anatomy. The coil would most commonly be used through femoral artery access similar to .035" guidewires currently in use. The handling characteristics of this device are familiar to vascular interventionalists thereby facilitating integration into their practices. This product is to be used with a 1.5T Philips MRI system.
The Intercept™ Internal MR Coils are intracavitary specialty coils for use in MR imaging of the anatomical regions surrounding a body cavity. The signals picked up by the coil are conducted through a small coaxial cable and interfacing network to a connection with the standard surface coil connector for MRI systems. The coil is insulated with polymeric housing that protects is from contact from body fluids.
This 510(k) summary describes a device that is essentially an accessory to an MRI system (internal MR coils). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are focused on demonstrating that the new device (Philips compatible version of existing coils) is substantially equivalent to legally marketed predicate devices, particularly regarding safety and compatibility with the new MRI system.
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Study Type |
|---|---|---|
| Possibility of excess RF heating: No excess heating, temperature change within acceptable range ( |
§ 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.