(52 days)
The Transbronchial Needle Aspiration Cytology Procedural Kit is intended to retrieve and handle specimens and to prepare them for proper cytopathic examination.
The Transbronchial Needle Aspiration Cytology Procedural Kit contains items for obtaining and handling of cytologic specimens in the context of a transbronchial aspirating needle procedure.
The provided text describes a 510(k) summary for a "TBNA Cytology Procedural Kit." This document is a premarket notification for a medical device to demonstrate its substantial equivalence to a legally marketed predicate device.
Crucially, the provided text does NOT contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.
The document primarily focuses on:
- Identifying the submitter, contact, and proprietary name of the device.
- Stating the common name, classification name, and providing a statement of equivalence.
- Listing the components of the kit, their 510(k) status, and classification.
- Describing the device and its intended use.
- Asserting that the technological characteristics of the kit components do not vary from those used individually.
- An official FDA letter granting substantial equivalence.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, study details, and performance metrics as this information is not present in the provided document. This type of regulatory submission (510(k)) for a kit often relies on the established safety and effectiveness of its individual components rather than requiring a new clinical performance study for the assembled kit itself, especially if the components are already cleared or exempt.
§ 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.