Who is the manufacturer of MBI ILLUMINATED RETINAL PICK?

M.B. Industries, Inc. filed the 510(k) submission for MBI ILLUMINATED RETINAL PICK (K964405).

What is the FDA product code for MBI ILLUMINATED RETINAL PICK?

MPA. It is classified under 21 CFR 876.1500 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for MBI ILLUMINATED RETINAL PICK?

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

What are the predicate devices for MBI ILLUMINATED RETINAL PICK?

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

Who can help prepare an FDA 510(k) submission like MBI ILLUMINATED RETINAL PICK?

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.

MBI ILLUMINATED RETINAL PICK

K964405 · M.B. Industries, Inc. · MPA · May 13, 1997 · Gastroenterology, Urology

Device Facts

Record ID	K964405
Device Name	MBI 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

Lighting of posterior segment of eye and/or tool for manipulation of elements in eye

Device Story

MBI Illuminated Retinal Pick is a handheld surgical instrument combining fiberoptic illumination with a manipulation tool. Device consists of a 20-gauge stainless steel tube enclosing a polymethyl methacrylate fiber-optic filament. Distal end of tube extends past fiberoptic element to function as a surgical pick. Device connects to an external light source to deliver cool white light to the surgical field. Used by ophthalmic surgeons during eye surgery to visualize and manipulate ocular tissues. Benefits include simultaneous illumination and manipulation, reducing need for multiple instruments. Device is non-sterile and non-pyrogenic upon distribution.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence established through design comparison, material analysis, and performance characteristics identical to predicate devices.

Technological Characteristics

Materials: 20 ga. stainless steel tube, polymethyl methacrylate fiber-optic filament, polytetrafluoroethylene sheathing, acetel proximal/distal ends, silicone cannula protector. Energy: External cool white light source. Form factor: Handheld surgical instrument. Sterilization: Non-sterile. No software or electronic components.

Indications for Use

Indicated for use during ophthalmic surgery for illumination of the operating field and/or manipulation of elements within the eye.

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

Storz Inst. Co. MVS 1011 (K896549)

Related Devices

K964553 — MBI CO-AXIAL ILLUMINATED RETINAL PICK · M.B. Industries, Inc. · May 13, 1997
K972506 — INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR · Infinitech, Inc. · Oct 1, 1997
K973290 — SYNTEC TRUE LIGHT ENDOILLUMIINATOR WITH PICK · Vaughan Weeks · Nov 14, 1997
K971338 — SYNTEC, INC. DISPOSABLE BARE END FIBER · Syntec, Inc. · May 6, 1997
K982462 — FIBER OPTIC ENDOILLUMINATION PROBE · Microvision, Inc. · Sep 14, 1998

Submission Summary (Full Text)

{0} MBI INC. K964405 # Innovators In Medical Device Design HOMÉ OFFICE 14240 Reelfoot Lake Drive Chesterfield, MO 63017 (314) 576-5005 FAX (314) 576-5006 MANUFACTURING CO. 1707 Madison Avenue Granite City, IL 62040 (618) 451-2992 March 17, 1997 William J. Buttermore President Document Mail Center (HFZ-401) Center for Devices and Radiological Health Food and Drug Administration 9200 Corporate Boulevard Rockville, MD 20850 ## 510(k) Summary 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 Illuminated Retinal Pick". 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 equivalent to the MBI Fiberoptic Endo-illuminator K961036 combined with a hand held surgical instrument. It is virtually identical 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 during ophthalmic surgery, and the same technological characteristics (materials used and methods of manufacture). The applicant has been manufacturing light pipes for Storz Instrument Co. for the past six years and the submitted devise is but a small modification to the existing device. 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 20 ga. 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. Just as in the predicate devices, except for the 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 color is added will come into contact with the patient. There are no changes from the color additives used in the predicate devices. 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 {1} Substantial Equivalence Comparison Chart | | MBI Fiberoptic Endo-illuminator | Hand Held Surgical Instrument | Trek 9502 Light PipePick | Submitted Device | | --- | --- | --- | --- | --- | | 510(k) No. | K961036 | Not Applicable | K875195 | K 964405 | | 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 | | Filamnet 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 | N/A | unknown | cyanoacrylate | | Design of Components | Engineering drawings attached | Instrument design catalog tab "E" | Virtually Identical by actual measurement | Engineering drawings attached | | Indications for use | Lighting posterior segment of eye | Tool for manipulation of elements in surgical field | 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 | | 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 | {2} ![img-0.jpeg](img-0.jpeg) MBI Fiberoptic Endo-illuminator K961036 Storz Inst. Co. MVS 1011 K896549 {3} ![img-1.jpeg](img-1.jpeg) (1) Fiberoptic Filament - Stainless Steel Tubing - Stainless Steel Tubing Submitted Device MBI Illuminated Retinal Pick ![img-2.jpeg](img-2.jpeg)