(107 days)
The GE Sterile Disposable Equipment Cover is intended to protect equipment from fluids. Specifically, a coil used in the GE Magnetic Resonance Imaging (MRI) System.
An MRI system requires the use of a remote transmitting coil to generate the localized images. The coil is placed on the area of the patient where the operating incision is made. The coil itself resembles a window frame. These coils are very suspectible to damage caused by various fluids that may be release during an invasive procedure. To protect these coils, a Sterile Disposable Equipment Cover is used to seal the coil inside a wrapper preventing it from fluid contamination. The Sterile Disposable Equipment Cover is made from PVC Film and the strap is polynap of 100% nylon fabric with polyester foam core and nylon tricot backing.
I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) summary for a medical device (Sterile Disposable Equipment Coil Cover) and primarily focuses on its description, intended use, and comparison to a predicate device for regulatory clearance. It does not include acceptance criteria, performance studies, sample sizes, expert involvement, or any details about AI algorithms or ground truth establishment.
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JAN 30 1997
813-942-3828
510(K) SUMMARY (as required by 807.92(c))
Requlatory & Marketing Services, Inc. (RMS) Submitter of 510(k): 40178 U.S. 19 North Tarpon Springs, FL 34689 813-942-3908 Phone:
Contact Person: Edward H. Ransom
Date of Summary:
Trade Name: GE Sterile Disposable Equipment Coil Cover
October 4, 1996
Sterile Disposable Equipment Cover Classification Name:
Fax:
Predicate Device: Contour Fabricators Inc. Bandbag, Wrap, Sterile, Disposable Fluoroscope and General Equipment Cover. K782155
Device Description/ An MRI system requires the use of a remote transmitting coil to generate the localized images. The coil is placed on the area of the patient where the operating incision is made. The coil itself resembles a window frame.
These coils are very suspectible to damage caused by various fluids that may be release during an invasive procedure. To protect these coils, a Sterile Disposable Equipment Cover is used to seal the coil inside a wrapper preventing it from fluid contamination. The Sterile Disposable Equipment Cover is made from PVC Film and the strap is polynap of 100% nylon fabric with polyester foam core and nylon tricot backing.
| Materials | Contour Fabricators | Contour Fabricators K782155 |
|---|---|---|
| Cover | PVC Film | Polyethylene |
| Strap | Foam | Rubber Band |
| Packaging | Tyvek/Mylar Pouch | Tyvek/Mylar Pouch |
| Sterilization | ETO | ETO |
Intended Use:
The GE Sterile Disposable Equipment Cover is intended to protect equipment from fluids. Specifically, a coil used in the GE Magnetic Resonance Imaging (MRI) System.
§ 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.