← Product Code [MPA](/productcode/MPA) · K964405 # MBI ILLUMINATED RETINAL PICK (K964405) _M.B. Industries, Inc. · MPA · May 13, 1997 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K964405 ## Device Facts - **Applicant:** M.B. Industries, Inc. - **Product Code:** [MPA](/productcode/MPA.md) - **Decision Date:** May 13, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for 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. ## Regulatory 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. In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period. ## Predicate Devices - MBI Fiberoptic Endo-illuminator ([K961036](/device/K961036.md)) - Trek 9801 Light Pipe Pick ([K875195](/device/K875195.md)) ## Reference Devices - Storz Inst. Co. MVS 1011 ([K896549](/device/K896549.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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) --- **Source:** [https://fda-staging.innolitics.com/device/K964405](https://fda-staging.innolitics.com/device/K964405) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com