ClearTip TBNA Type

The ClearTip TBNA Type is a manually operated endoscopic needle aspiration instrument designed to obtain tissue specimens from the tracheobronchial tree. It is inserted through a bronchoscope's working channel and is used for ultrasonically guided fine needle aspiration (FNA) of submucosal and extraluminal lesions. The device is supplied sterile for single-patient use only.

The subject device features a modified handle design (similar to the primary predicate K190239), offers needle gauges of 19 and 22 gauge (compared to 25 gauge in the primary predicate), adjustable needle length of 0–5 cm, sheath lengths of 746.5–774.5 mm, and total needle lengths of 915–955 mm. Patient-contacting materials include PEEK, Nitinol, and PTFE. The minimum accessory channel diameter is 2.2 mm.

Not stated in this summary. The document references ISO 13485 quality management requirements in the regulatory letter but does not cite specific consensus standards for performance testing in the 510(k) summary.

The subject device is substantially equivalent because differences from the predicate devices are limited to handle shape, the addition of a 19-gauge needle option, sheath length, and total needle length. Comparative performance testing demonstrated the subject device performs comparably to the predicate and meets identical acceptance criteria. The modified handle design mirrors the primary predicate K190239, and the device maintains the same indication for use, principle of operation, materials, sterility method, and single-use designation.