(39 days)
This instrument has been designed to be used with an Olympus endoscope for washing, and spraying contrast media or medicine (e.g. anesthetics) within the airway, including tracheobronchial tree.
Spray Catheter PW-6C-1 has been designed to be used with an Olympus endoscope to perform washing, and spraying of contrast media or medicine (e.g. anesthetics) within the airway, including the tracheobronchial tree. PW-6C-1 is used in combination with an way, mologing the spray fluid continuously. Both PW-6C-1 and MAI-929 are non-sterile, reusable.
The provided text does not contain information about acceptance criteria or a study proving device performance against such criteria. The document is a 510(k) summary for a medical device (Spray Catheter PW-6C-1), which primarily addresses substantial equivalence to a predicate device for market clearance. It does not include specific performance studies, statistical analyses, or details on ground truth establishment for a test set.
Therefore, I cannot populate the requested table or provide details for points 1-9 based on the given text.
§ 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.