(63 days)
The Dyonics Vision 337 Autoclavable Camera Head and Camera Coupler 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 Dyonics Vision 337 Autoclavable Camera Head and Camera Coupler are indicated for use in endoscopic surgical procedures in the thoracic cavitity when used in conjunction with an appropriately indicated thoracoscope.
The proposed Dyonics Vision 337 Autoclavable Camera Coupler can be used in conjunction with any direct-view endoscope or appropriate video-endoscope, control unit, light source, and monitor to allow illumination and visualization of articular cavities, body cavities, hollow cavities and canals. The camera head acts to transmits real time video images of the surgical site to the camera control unit. It then processes and displays the image to a viewing system or recording media.
The camera head attaches to the endoscope by means of a camera coupler.
The camera head and the camera coupler are hermetically sealed to allow for autoclavability.
I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is primarily a 510(k) premarket notification letter and summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and study results.
The document states:
- "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent..."
- "The proposed Dyonics Vision 337 Autoclavable Camera Coupler are substantially equivalent in design, materials of construction, and function and intended use as to the Smith & Nephew Images Digital 3-Chip Color Video Camera and Dyonics Camera Coupler."
This type of submission typically compares the new device to existing legally marketed predicate devices to show they are equally safe and effective, rather than conducting new performance studies against specific acceptance criteria for novel claims. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication methods, and MRMC/standalone studies is not present in this document.
§ 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.