(139 days)
The DISPOSABLE BALLOON CATHETER B5-2C has been designed to be used for injection into bronchi, saline injection associated with bronchoalveolar lavage, and bronchial hemostasis (tamponade).
The DISPOSABLE BALLOON CATHETER B5-2C has been designed to be used for injection into bronchi, saline injection associated with bronchoalveolar lavage, and bronchial hemostasis (tamponade). The Balloon Catheter is inserted into the instrument channel of compatible bronchoscopes and advanced to the target area, where medical fluid or saline solution are injected, or the balloon is inflated to allow for hemostasis (tamponade). When the procedure is completed, the balloon is deflated, and the catheter is removed from the patient.
The Balloon Catheter is provided sterile and is constructed of a natural rubber latex inflatable balloon, polyethylene tube, branch, irrigation port, air feed cap, and stopcock. The inflatable balloon has a maximum diameter of O 11 mm after inflation.
The provided document is a 510(k) clearance letter and summary for a medical device (Disposable Balloon Catheter B5-2C). It does not contain any information about acceptance criteria and associated study results for an AI/ML powered device.
The document describes the device, its intended use, comparison to a predicate device, and various performance testing. However, these tests are standard for a physical medical device (biocompatibility, bench testing for physical properties like balloon diameter, strength, etc.) and do not involve AI/ML performance metrics such as sensitivity, specificity, or the involvement of expert readers for ground truth establishment.
Therefore, I cannot provide accurate answers to the questions based on the provided text, as the information regarding acceptance criteria and studies for an AI-powered device is not present.
§ 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.