(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.
§ 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.