MBI CO-AXIAL ILLUMINATED RETINAL PICK

K964553 · M.B. Industries, Inc. · MPA · May 13, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K964553
• Device Name: MBI CO-AXIAL ILLUMINATED RETINAL PICK
• Applicant: M.B. Industries, Inc.
• Product Code: MPA · Gastroenterology, Urology
• Decision Date: May 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MBI Coaxial Illuminated Retinal Pick is intended for the illumination of the operating field and/or the use of a manipulating tool and/or use of irrigation or aspiration during ophthalmic surgery.

Device Story

Device is a coaxial illuminated retinal pick used in ophthalmic surgery. It combines fiberoptic illumination with a surgical manipulation tool. Input is light energy delivered via polymethyl methacrylate fiberoptic filaments. Device transforms light into a focused beam at the distal end while providing a stainless steel tool for tissue manipulation, irrigation, or aspiration. Operated by surgeons in a clinical/surgical setting. Output is illumination of the posterior segment of the eye and physical manipulation of ocular structures. Benefits include simultaneous visualization and surgical access to the posterior segment. Device is non-sterile and non-pyrogenic upon marketing.

Clinical Evidence

Bench testing only. Performance is stated to be identical to predicate devices. No clinical data provided.

Technological Characteristics

Materials: Stainless steel cannula, polymethyl methacrylate fiberoptic filaments, polytetrafluoroethylene sheathing, acetel proximal/distal ends, silicone cannula protector, and Helioseal (K813015) adhesive. Energy source: Cool white light delivered via fiberoptics. Design: Coaxial configuration with central lumen for irrigation/aspiration. Non-sterile, non-pyrogenic.

Indications for Use

Indicated for lighting the posterior segment of the eye and/or manipulation of elements within the eye, or aspiration and irrigation within the eye during ophthalmic surgery.

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

• MBI Fiberoptic Endo-illuminator (K961036)
• Trek 9801 Light Pipe Pick (K875195)

Reference Devices

• Helioseal (K813015)
• Storz Inst. Co. MVS 1011 (K896549)

Submission Summary (Full Text)

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MBI INC.

K964553

Innovators In Medical Device Design

MAY 13 1997

HOME OFFICE
14240 Reelfoot Lake Drive
Chesterfield, MO 63017
[phone]
FAX [phone]

MANUFACTURING CO.
1707 Madison Avenue
Granite City, IL 62040
[phone]

March 17, 1997
510(k) Summary

William J. Buttermore
Document Mail Center (HFZ-401)
Center for Devices and Radiological Health
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 Coaxial Illuminated Retinal Pick". The classification name of the device is Illuminator, Fiberoptic, Surgical Field. It is classified ad Illuminator, Fiberoptic, Surgical Field - HBI Reg 878.4580. There are no standards applying to it.

The device is equivalent to the MBI Fiberoptic Endo-illuminator K961036 combined with a hand held surgical instrument. It is very similar to the Trek 9801 Light Pipe Pick K875195. The MBI device has the same intended use, illumination of the operating field and/or the use of a manipulating tool and/or use of irrigation or aspiration during ophthalmic surgery, and the same technological characteristics (materials, except for Helioseal" K813015, used and methods of manufacture). The applicant has been manufacturing light pipes (K961036) for Storz Instrument Co. for the past six years and the submitted devise has but three small modification to the existing device as follows:
1. The one large fiberoptic filament is replaced with six smaller filaments of the same material.
2. The tool which in the 9801 Trek pick comes from the bottom of the stainless steel tubing now comes from the center of the instrument, and has a lumen that can accomplish aspiration or irrigation during surgery.
3. Where there was no sealant at the distal end of the fibers there is now a small amount of "Helioseal" (K813015) to position and prevent leakage between the fibers and the tool.

Performance is identical to that of the predicate devices. 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 stainless steel tube enclosing a plastic fiber-optic filament whose flat end surface will give off the light needed by the surgeon. A small portion of the stainless steel tube is fashioned into a surgical instrument that extends past the fiberoptic element. All materials are identical to those used in the predicate devices, except for the "Helioseal" as noted. No parts to which color has been added will come in contact with the eye.

The device will be marketed as a non-sterile not non-pyrogenic device.

A comparison table of the technological features of this and the predicate devise is attached.

Bill Buttermore

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Substantial Equivalence Comparison Chart

| | MBI Fiberoptic Endo-illuminator | Hand Held Surgical Instrument | Trek 9502 Light Pipe Pick | Submitted Device: Coaxial Illuminated Retinal Pick |
| --- | --- | --- | --- | --- |
| 510(k) No. | K961036 | Not Applicable | K875195 | K964553 |
| Cannula (tube) | Stainless Steel | N/A | Stainless Steel | Stainless Steel |
| Surgical Tool | | Stainless Steel | | Stainless Steel |
| Proximal End | Acetel | N/A | unknown | Acetel |
| Fiberoptic Filament | Polymethyl methacrylate | N/A | Polymethyl methacrylate | Polymethyl methacrylate |
| Filament Sheathing | Polytetra fluoroethylene | N/A | unknown | Polytetra fluoroethylene |
| Distal End | Acetel | N/A | unknown | Acetel |
| Cannula Protector | Silicone | N/A | Silicone | Silicone |
| Adhesive proximal end | none | N/A | unknown | none |
| Adhesive distal end | cyanoacrylate between the fiber and the tubing but at the proximal end of the tubing not entering the eye. | N/A | unknown | cyanoacrylate or "Helioseal" (K813015) between the tubing and the fibers on the proximal tubing end. "Helioseal" at the distal end that enters the eye. |
| Design of Components | Engineering drawings attached | Instrument design catalog tab "E" | Virtually Identical by actual measurement | Engineering drawings attached |

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| Continued | MBI Fiberoptic Endo-illuminator | Hand Held Surgical Instrument | Trek 9502 Light Pipe Pick | Submitted Device : Coaxial Illuminated Pick |
| --- | --- | --- | --- | --- |
| Indications for use | Lighting posterior segment of eye | Tool for manipulation of elements in surgical field or providing aspiration or irrigation within the eye. | Lighting of posterior segment of eye and /or tool for manipulation of elements in eye | Lighting of posterior segment of eye and/or tool for manipulation of elements in eye or aspiration and irrigation within the eye. |
| Energy delivered | Cool white light | N/A | Cool white light | Cool white light |
| Biocompatibility | not non-purogenic | N/A | not non-pyrogenic | not non-pyrogenic |

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MBI Fiberoptic Endo-illuminator
K961036
Storz Inst. Co. MVS 1011
K896549

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Enlargement "A" - Existing Device
approved K961036

MBI Illuminated Retinal Pick - not yet
approved. Identical to Trek 9802
approved K875195

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MBI Illuminated Retinal Pick submitted but not yet approved - identical to Trek 9802 (K875195)


MBI Coaxial Illuminated Retinal Pick - This submission