(190 days)
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.
The provided document is a 510(k) summary for the "MBI Illuminated Retinal Pick." It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and quantitative results. Therefore, much of the requested information cannot be directly extracted from this document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present quantitative acceptance criteria or detailed performance metrics in the way a clinical study would for a diagnostic device. The basis for acceptance is stated as substantial equivalence to predicate devices. The performance is deemed identical due to this equivalence.
| Feature / Aspect | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Intended Use | Must be identical or nearly identical to predicate devices: illumination of the operating field and/or manipulation during ophthalmic surgery. | The MBI device has the "same intended use, illumination of the operating field and/or the use of a manipulating tool during ophthalmic surgery." |
| Technological Characteristics | Materials used and methods of manufacture must be equivalent to predicate devices. | "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." "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." Design of components is based on engineering drawings, similar to predicate devices. |
| Performance | Must be identical to predicate devices. | "Performance is identical to that of the predicate devices." |
| Biocompatibility | Must be same as predicate devices (non-sterile, not non-pyrogenic). | The device "will be marketed as a non-sterile not non-pyrogenic device," which matches the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is not a study that involves a "test set" in the context of clinical data or algorithm evaluation. The "test" for this device is a comparison to predicate devices, focusing on design, materials, and intended use. No human or patient data is used in this submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. No ground truth was established by experts for a performance study. The "ground truth" here is the established safety and effectiveness of the predicate devices based on their prior 510(k) clearances.
4. Adjudication Method
Not applicable. No adjudication method was used, as there was no clinical or observational data to adjudicate.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document does not mention or present any MRMC study. The device is a surgical instrument, not an AI or diagnostic imaging device that would typically undergo such a study.
6. Standalone Performance Study (Algorithm Only)
No. This device is a physical surgical instrument, not an algorithm. Therefore, a standalone algorithm performance study is not relevant or applicable.
7. Type of Ground Truth Used
The "ground truth" in this context is the established safety and effectiveness of the predicate devices (MBI Fiberoptic Endo-illuminator K961036 and Trek 9801 Light Pipe Pick K875195) based on their prior FDA clearances. The applicant is leveraging the regulatory history of similar devices to demonstrate substantial equivalence for this new device.
8. Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
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Image /page/0/Picture/1 description: The image shows a logo with the text "MBI INC." The letters "MBI" are larger than the "INC." The text is inside of a rounded rectangle. The logo is black and white.
Innovators In Medical Device Design
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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
14240 Reelfoot Lake Drive Chesterfield, MO 63017 (314) 576-5005 FAX (314) 576-5006
HOME OFFICE
MANUFACTURING CO. 1707 Madison Avenue
Granite City, IL 62040 (618) 451-2992
March 17, 1997
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 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 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 fiberoptic 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.
son table of the technological features of this and the predicate devise is attached.
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Substantial Equivalence Comparison Chart
| MBI FiberopticEndo-illuminator | Hand HeldSurgicalInstrument | Trek 9502Light PipePick | SubmittedDevice | |
|---|---|---|---|---|
| 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 | Stainless Steel | Stainless Steel |
| ProximalEnd | Acetel | N/A | unknown | Acetel |
| FiberopticFilament | Polymethylmethacrylate | N/A | Polymethylmethacrylate | Polymethylmethacrylate |
| FilamnetSheathing | Polytetrafluoroethylene | N/A | unknown | Polytetrafluoroethylene |
| Distal End | Acetel | N/A | unknown | Acetel |
| CannulaProtector | Silicone | N/A | Silicone | Silicone |
| Adhesiveproximal end | none | N/A | unknown | none |
| Adhesivedistal end | cyanoacrylate | N/A | unknown | cyanoacrylate |
| Design ofComponents | Engineeringdrawingsattached | Instrumentdesign catalogtab "E" | VirtuallyIdentical byactualmeasurement | Engineeringdrawingsattached |
| Indicationsfor use | Lightingposteriorsegment of eye | Tool formanipulation ofelements insurgical field | Lighting ofposteriorsegment of eyeand /or tool formanipulation ofelements in eye | Lighting ofposteriorsegment of eyeand/or tool formanipulation ofelements in eye |
| Energydelivered | Cool white light | N/A | Cool white light | Cool white light |
| Biocompat-ability | not non-pyrogenic | N/A | not non-pyrogenic | not non-pyrogenic |
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Image /page/2/Figure/0 description: The image shows a diagram of an MBI Fiberoptic Endo-illuminator. The diagram labels the different parts of the device, including the fiberoptic filament, sheathing, acetel distal end, and stainless steel tubing. The diagram also includes an enlargement labeled "A". The length of the device is labeled as 3.355".
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Image /page/3/Figure/1 description: The image shows a comparison between an existing device and a submitted device, both labeled with stainless steel tubing. The existing device, labeled as "Enlargement A," features a fiberoptic filament. The submitted device is identified as the MBI Illuminated Retinal Pick. The image provides a detailed view of the components and design of both devices.
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.