(115 days)
Smith & Nephew Images Digital 3-Chip Color Video Camera System, illuminators, video components and accessories are indicated for use in endoscopic surgical procedures to provide illumination and allow visualization of articular cavities, body cavities, hollow organs and canals when used in conjunction with an appropriately indicated endoscope.
Additionally, the Smith & Nephew Images Digital 3-Chip Color Video Camera System, consisting of the D-3 Camera Control Unit (REF. 7205292), PEEK Camera Head (REF. 7205208), Smith & Nephew Images Illuminator and Smith & Nephew Images liquid or fiberoptic light guide is indicated for use in endoscopic surgical procedures in the thoracic cavity when used in conjunction with an appropriately indicated thoracoscope.
The Smith & Nephew Images Digital 3-Chip Color Video Camera and Video components mate with the endoscope to allow for visualization during various surgical procedures. Smith & Nephew Images Illuminators, Light Guides and accessories are designed to supply light to the surgical site through the endoscope. The light guides mate to the endoscope and light source with instrument specific adapters.
The provided text is a 510(k) summary for the "Smith & Nephew Images Digital 3-Chip Color Video Camera, Illuminators, Video Components and Accessories". This document focuses on establishing substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a study with outcome metrics.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study to prove the device meets those criteria.
Key reasons for this conclusion are:
- Substantial Equivalence Focus: The document repeatedly emphasizes that the device is "substantially equivalent in both design and intended use" to existing predicate devices (Snowden Pencer DSP, Stryker Endoscopy, and Olympus). This means the focus is on demonstrating that the new device is as safe and effective as devices already on the market, not on proving it meets new, specific performance benchmarks.
- Lack of Performance Metrics: There are no reported performance metrics (e.g., resolution, light output, color accuracy, signal-to-noise ratio) for the Smith & Nephew device.
- Absence of Study Design: The document does not describe any study, test set, training set, ground truth establishment, expert adjudication, or MRMC studies. It mentions compliance with electrical safety standards (UL544, EN 55011, IEC 601-1, IEC 601-2-18) but these are general safety certifications, not performance studies with specific acceptance criteria as you've defined.
In summary, this 510(k) submission is a regulatory filing demonstrating equivalence, not a scientific study report with performance acceptance criteria.
§ 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.