MBI FIBEROPTIC ENDO-ILLUMINATOR

K961036 · M.B. Industries, Inc. · MPA · Jul 15, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K961036
• Device Name: MBI FIBEROPTIC ENDO-ILLUMINATOR
• Applicant: M.B. Industries, Inc.
• Product Code: MPA · Gastroenterology, Urology
• Decision Date: Jul 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

illumination of the operating field during ophthalmic surgery

Device Story

MBI Fiberoptic Endo-Illuminator; single-use, sterile fiber-optic device for ophthalmic surgery. Input: light from external source. Operation: light transmitted through plastic fiber-optic filament enclosed in 20 ga. stainless steel tube; distal end emits light to illuminate surgical field. Used in OR by ophthalmic surgeons. Output: localized illumination of eye interior. Benefits: provides necessary visibility for surgeon during intraocular procedures. Device is identical to predicate; manufacturing processes and materials unchanged.

Clinical Evidence

Bench testing only. Sterility assurance level 10^-6 confirmed via ethylene oxide gas sterilization process; residual levels (EO 250 PPM, ECH 250 PPM, EG 5000 PPM) verified. Sterility confirmed by culturing spore strips.

Technological Characteristics

20 ga. stainless steel tube; plastic fiber-optic filament; proximal end plug, sheathing, and grasping point made of plastic with white colorant (non-patient contact). Sterilization: ethylene oxide gas; packaging: Tyvek/plastic envelope. Standalone device.

Indications for Use

Indicated for illumination of the operating field during ophthalmic surgery for patients undergoing such procedures.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Storz, MVS Disposable Fiberoptic Lightpipe (K854587)

Submission Summary (Full Text)

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MBI INC.

JUL 15 1996

Innovators In Medical Device Design

K961036

HOME OFFICE

MANUFACTURING CO.

William J. Buttermore

President

14240 Reelfoot Lake Drive

Chesterfield, MO 63017

[phone]

FAX [phone]

1707 Madison Avenue

Granite City, IL 62040

[phone]

Document Mail Center (HFZ-401)

March 8, 1996

Center for Devices and Radiological Health

510(k) Summary

Food and Drug Administration

9200 Corporate Boulevard

Rockville, MD 20850

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

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 post-amendment 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 captive 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 which have white color added, all components are natural with no colorants added. Those constituents having white color added are the proximal end plug that is inserted 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 predicate 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 fabric (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 $10^{6}$. 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.

Wayne C. Mosher

Chief Executive Officer