(99 days)
The Cianna Medical SGS Tissue Marker is intended to be placed percutaneously in the breast to temporarily (
Not Found
The provided document is a 510(k) summary letter from the FDA to Cianna Medical, Inc. for the SGS Tissue Marker and System. This document does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria.
Specifically, the document:
- Confirms substantial equivalence to a predicate device.
- Lists the indications for use of the device (to temporarily mark a lumpectomy site in the breast and for non-imaging detection of the marker).
- States regulatory information such as the regulation number, class, and product code.
- Provides contact information for FDA divisions.
It does not include:
- A table of acceptance criteria and reported device performance.
- Sample size, data provenance, or details of a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study, or effect size.
- Information about standalone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
To obtain this information, one would typically need to refer to the full 510(k) submission document, which often contains detailed technical and clinical study reports. The FDA 510(k) summary (which this document effectively is) summarizes the key findings but generally omits detailed study methodology and raw data.
§ 878.4670 Internal tissue marker.
(a)
Identification. An internal tissue marker is a prescription use device that is intended for use prior to or during general surgical procedures to demarcate selected sites on internal tissues.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.
(2) Performance testing must demonstrate that the device performs as intended to mark the tissue for which it is indicated.
(3) Performance data must demonstrate the sterility of the device.
(4) Performance data must support the shelf life of the device by demonstrating sterility, package integrity, device functionality, and material stability over the requested shelf life.
(5) Labeling must include:
(i) A warning that the device must not be used on a non-sterile surface prior to use internally.
(ii) An expiration date/shelf life.
(iii) Single use only labeling must be labeled directly on the device.