(281 days)
The Sanarus Indica Marker System is indicated for use to attach to soft tissue, including breast tissue, following an open surgical or percutaneous biopsy procedure and to radiographically and radiologically mark the location of the biopsy procedure.
The Sanarus Indica Marker System consists of a delivery device (applier), introducer cannula and non-absorbable tissue marker that is clearly visible on standard radiographs and ultrasound.
This document is a 510(k) premarket notification for the Sanarus Indica Marker System. It outlines the device description, indications for use, and claims substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document states:
- "Biocompatibility and bench testing have demonstrated that the device is safe and effective and that its performance is equivalent to the predicate devices."
This is a general statement about testing, but it does not provide specific acceptance criteria, performance metrics, study designs, sample sizes, or details about ground truth or expert involvement as requested.
Therefore, I cannot provide the requested table and information because the provided text does not contain the necessary details about specific acceptance criteria and a study to prove they were met.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.