(309 days)
The Intubation Endoscope and Introducer Sheath are used in the direct visualization in the trachea and lungs during fiberoptically assisted intubation and airway management.
UROHEALTH Intubation Endoscope Introducer Sheath is a device that consists a malleable or nonmalleable introducer sheath that houses a channel for insufflation of oxygen or fluid delivery, a deflecting mechanism for the distal tip, a channel for scope insertion, and a distal window. The reusable fiber optic imaging and illumination system consists of a focusing ocular lens, a distal objective lens, and a connection for a fiber optic light cable.
The provided 510(k) summary for K970107, the UROHEALTH Intubation Endoscope and Introducer Sheath, describes performance testing but does not present specific acceptance criteria or detailed study results in a quantitative manner as typically expected for device performance. It outlines the types of tests to be conducted rather than reporting the outcomes against defined metrics.
Here's a breakdown based on the provided text, addressing your points:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, specific quantitative acceptance criteria and reported device performance are not available. The summary states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Integrity of sterile barrier under normal usage conditions | "will be tested to ensure integrity of the sterile barrier under normal usage conditions." (No specific results or metrics provided). |
| Integrity of all bonded joints based on appropriate ASTM procedure | "All bonded joints will tested according to the appropriate ASTM procedure." (No specific results or metrics provided). |
| Biocompatibility (cytotoxicity, sensitization, irritation) in accordance with EN 30993 for medical devices with mucosal membrane contact ( |
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.