(27 days)
The Biopsy Sciences, LLC., Lung Biopsy Site Marker is intended to provide accuracy in marking a biopsy location for visualization during surgical resection.
Biopsy Sciences Lung Biopsy Site Markers are made of resorbable FocalSeal-L Surgical Sealant, an FDA approved hydrogel used on the surgical site during lung surgery. The FocalSeal-L hydrogel material degrades in a manner similar to absorbable sutures, via hydrolysis. The Site Markers mark the site of the biopsy tissue sample, which provides accurate visualization during surgical resection of the tumor. Lung biopsy procedures are performed by fine needle aspiration through a coaxial needle. When the fine needle aspiration device is removed, the delivery system is mated to the coaxial needle. The plunger of the delivery system is depressed, which accurately places the Site Marker in the biopsy tract.
The provided text is a 510(k) premarket notification for a medical device and does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is primarily focused on seeking FDA clearance by demonstrating substantial equivalence to predicate devices, rather than presenting detailed performance study results.
Therefore, I cannot extract the requested information.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.