(121 days)
Sharpsite™ AC Rigid Endoscope: The Sharpsite™ AC Rigid Endoscopes are intended for use in surgical imaging in otolaryngology and Head and Neck procedures. including thinology and endoscopic plastic and reconstructive surgery.
Sharpsite™ AC Sterilization Tray: Sharpsite™ AC Endoscope Sterilization Tray is intended to provide a specific configuration to hold, organize and protect Sharpsite™ AC Rigid Endoscope during their transport, storage and sterilization prior to use in surgical procedures.
The Sharpsite™ AC endoscopes are rigid rod lens endoscopes for imaging and are available in diameters from 2.7 mm to 4.0 mm and in angles of view of 0, 30, 45 and 70 degrees. These endoscopes are reusable, autoclavable instruments and are provided non-sterile.
The Sharpsite™ Rigid Ear, Nose and Throat (ENT) endoscopes provide access and allow observation during otolaryngology and head and neck procedures. The device consists of rigid rod inserted into body orifice. The endoscope includes an optical system to visualize the image by direct view or with use of a camera. The endoscopes are provided non-sterile and can be reused by multiple methods as mentioned in the IFU. Each Sharpsite™ endoscope is fitted with a commercially available removable light port adapter for use with different manufacturers light cables.
Sharpsite™ AC Endoscopic sterilization tray is a container which is a reusable device that includes a base and lid. It is a single level thermoplastic instrument case designed to hold Sharpsite™ AC Rigid Endoscopes. The Sharpsite™ tray is specifically configured to organize, store, protect, transport and sterilize Sharpsite™ AC Rigid Endoscopes for use in surgical procedures.
The provided text is a 510(k) summary for the Medtronic Sharpsite™ AC Rigid Endoscope and Sharpsite™ AC Endoscope Sterilization Tray. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results for device performance in the context of an AI/ML-driven medical device.
The information requested in the prompt, specifically regarding acceptance criteria for device performance and the study proving it, is typically associated with AI/ML-based diagnostic or prognostic devices, or devices with complex functional output that requires rigorous validation against ground truth.
The device described here, the Sharpsite™ AC Rigid Endoscope, is a rigid rod lens endoscope used for surgical imaging. Its primary function is to provide visualization. The "testing" section (page 7) refers to cleaning and sterilization validations, biocompatibility assessment, and states that "Additional bench, animal or clinical testing was not required to establish substantial equivalence." This indicates that the substantial equivalence argument relies on the similarity of the device's technological characteristics and intended use to a previously cleared predicate device (K965233).
Therefore, I cannot extract the requested information from the provided text because it does not describe an AI/ML-driven device's performance validation. The document is about establishing substantial equivalence for a non-AI/ML optical imaging tool and its sterilization tray.
If this were an AI/ML device, the acceptance criteria and study details would be presented very differently, focusing on metrics like sensitivity, specificity, AUC, human reader agreement, and the methodology for establishing ground truth for AI model training and testing.
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.