Who is the manufacturer of GE STERILE DISPOSABLE EQUIPMENT COIL COVER?

Contour Fabricators, Inc. filed the 510(k) submission for GE STERILE DISPOSABLE EQUIPMENT COIL COVER (K964141).

What is the FDA product code for GE STERILE DISPOSABLE EQUIPMENT COIL COVER?

MOS. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for GE STERILE DISPOSABLE EQUIPMENT COIL COVER?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like GE STERILE DISPOSABLE EQUIPMENT COIL COVER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

GE STERILE DISPOSABLE EQUIPMENT COIL COVER

K964141 · Contour Fabricators, Inc. · MOS · Jan 30, 1997 · Radiology

Device Facts

Record ID	K964141
Device Name	GE STERILE DISPOSABLE EQUIPMENT COIL COVER
Applicant	Contour Fabricators, Inc.
Product Code	MOS · Radiology
Decision Date	Jan 30, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2

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.

Device Story

Sterile disposable equipment cover; protects MRI remote transmitting coils from fluid contamination during invasive procedures. Device consists of PVC film wrapper and polynap strap (nylon fabric, polyester foam core, nylon tricot backing). Coil placed inside cover; sealed to prevent fluid ingress. Used in clinical MRI settings; operated by healthcare personnel. Benefits patient/facility by preventing damage to sensitive imaging hardware during procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: PVC film cover; polynap strap (100% nylon fabric, polyester foam core, nylon tricot backing). Sterilization: ETO. Form factor: Disposable wrapper/cover for MRI coils.

Indications for Use

Indicated for use as a protective barrier for MRI remote transmitting coils against fluid contamination during invasive procedures.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

Contour Fabricators Inc. Bandbag, Wrap, Sterile, Disposable Fluoroscope and General Equipment Cover (K782155)

Related Devices

K993682 — MRI EQUIPMENT COVER · Image-Guided Neurologics, Inc. · Jan 20, 2000
K052395 — STERILE EQUIPMENT COVERS · Volcano Corporation · Dec 1, 2005
K101350 — RADSCAN EQUIPMENT SLICKER · Radscan Medical Equipment, Inc. · Jan 4, 2011
K970185 — STERILE DISPOSABLE EQUIPMENT MAGNET COVER · Contour Fabricators, Inc. · Apr 10, 1997
K981406 — CERVIX COIL LATEX SHEATH · Philips Medical Systems (Cleveland), Inc. · Jul 16, 1998

Submission Summary (Full Text)

{0} JAN 30 1997 # 510(K) SUMMARY K964141 (as required by 807.92(c)) ## Submitter of 510(k): Regulatory & Marketing Services, Inc. (RMS) 40178 U.S. 19 North Tarpon Springs, FL 34689 Phone: 813-942-3908 Fax: 813-942-3828 ## Contact Person: Edward H. Ransom ## Date of Summary: October 4, 1996 ## Trade Name: GE Sterile Disposable Equipment Coil Cover ## Classification Name: Sterile Disposable Equipment Cover ## 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 susceptible 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. ## Comparison: | 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.