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illumination of the operating field and/or the use of a manipulating tool during ophthalmic surgery

The device is a hand held surgical instrument that combines a fiberoptic illuminator with a manipulating tool. It consists of a 20 ga. stainless steel tube enclosing a plastic fiberoptic filament. The distal end of the tube is fashioned into a surgical instrument that extends past the fiberoptic element. The device is intended to be used during ophthalmic surgery to provide light to the operating field and/or to manipulate elements in the surgical field.

Lighting posterior segment of eye and/or tool for manipulation of elements in eye or aspiration and irrigation within the eye.

The device is a Coaxial Illuminated Retinal Pick. It is a hand held surgical instrument that combines a fiberoptic illuminator with a manipulating tool and has a lumen for aspiration or irrigation. It consists of a stainless steel tube enclosing six smaller fiberoptic filaments made of polymethyl methacrylate with polytetra fluoroethylene sheathing. The distal end has a small amount of "Helioseal" to position and prevent leakage between the fibers and the tool. The device will be marketed as non-sterile not non-pyrogenic.

illumination of the operating field during ophthalmic surgery

The trade name of the device for which the determination of substantial equivalence is being sought is "MBI Fiberoptic Endo-Illuminator". The classification name of the device is Illuminator, Fiberoptic, Surgical Field. It is classified as Illuminator, Fiberoptic, Surgical Field - HBI Reg 878.4580. There are no standards applying to it. The device is identical to the Storz, MVS Disposable Fiberoptic Lightpipe marketed as a class II postamendment device by Storz Ophthalmics, Inc. under 510(k) marketing clearance issued by FDA as document control number K854587. The MBI device has the same intended use (illumination of the operating field during ophthalmic surgery) and the same technological characteristics (materials used and methods of manufacture). The applicant has been functioning as a capive manufacturing site producing. the predicate device for Storz and now intends to produce and sell to other customers the same device it has been manufacturing for Storz. Performance is identical to that of the predicate device. When in use during ophthalmic surgery, part of the device will come into contact with the eye of the patient. The distal end that will contact the patient is a 20 ga. stainless steel tube enclosing a plastic fiber-optic filament whose flat end surface will give off the light needed by the surgeon. All materials are identical to those used in the predicate device. Just as in the predicate device, except for three plastic constituents white color added, all components are natural with no colorants added. Those constituents having white color added are the proximal end plug. that is insected into the light source device which is away from the patient, the sheathing for the fiber-optic filament, and the surgeon's grasping point that holds the distal tube that is inserted into the patient's eye during surgery. The colorant is in the plastic material of which the components are made. No constituent to which colorant is added will come into contact with the patient. There are no changes from the color additives used in the predicate device. The device will be marketed as a single-use, sterile device. As with the prodicate device, sterility will be obtained by packaging the device in a clean, sealed envelope having a clear plastic window as one side and gas-permeable non-woven plastic (Tyvek) as the other side. In a process identical to that used for the predicate device, sealed envelopes containing the device will be sterilized by ethylene oxide gas which will penetrate the gas-permeable non-woven plastic fabric killing all pathogens on the device. Maximum residual levels of ethylene oxide, ethylene chlorohydrin, and ethylene glycol on the device are 250 PPM, 250 PPM, and 5000 PPM respectively. Successful sterilization will be confirmed by culturing spoor strips embedded in the lot to be sterilized. The device will meet sterility assurance level 10°. The constituents of the envelope are impenetrable by pathogens ensuring that sterility is maintained as long as package integrity is not compromised. The device is not considered non-pyrogenic.