(118 days)
Provide access, illumination and allow observation or manipulation of body cavities, hollow organs and canals. The device(s) consist of various rigid or flexible instruments inserted into these spaces and includes an optical system for conveying an image to the users eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the device.
The SOPRO 61D is a high resolution, digital processing camera system utilizing a CCD image sensor. It provides high quality images with excellent resolution and colour contrast. This makes the camera a multidiciplinary tool.
The provided text does not contain any information about acceptance criteria, device performance, a study to prove acceptance, or details regarding ground truth, expert opinions, or sample sizes.
The document is a 510(k) summary for the SOPRO 61D camera, detailing its submission to the FDA for market clearance. It primarily focuses on:
- Submitter and Device Information: Company contact, device name (SOPRO 61D), classification name (Laparoscope and Accessories, General & Plastic Surgery).
- Predicate Device: Smith & Nephew Dyonics cameras (K936071) and SOPRO 51D (K000424).
- Device Description: High-resolution digital processing camera system utilizing a CCD image sensor, providing high-quality images with excellent resolution and color contrast.
- Intended Use: "Provide access, illumination and allow observation or manipulation of body cavities, hollow organs and canals. The device(s) consist of various rigid or flexible instruments inserted into these spaces and includes an optical system for conveying an image to the users eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the device."
- Substantial Equivalence: Claims virtual identity to the SOPRO 51D and other existing camera systems in terms of intended use, composition, safety, and effectiveness.
- FDA Clearance Letter: Confirms substantial equivalence to legally marketed predicate devices.
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, ground truth, or expert involvement because this information is not present in the provided text.
§ 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.