UltraCor™ Twirl™ Breast Tissue Marker

The UltraCor™ Twirl™ Breast Tissue Marker (Curls and Clover) is a disposable beveled needle applicator containing a Nitinol radiographic marker designed for long-term marking of breast tissue biopsy sites. The marker is deployed from a 17-gauge needle tip into soft breast tissue, including axillary lymph nodes, to enable radiographic localization during subsequent clinical procedures.

The subject device is substantially equivalent to the predicate (Ring shape marker, K180061) in intended use, indications, performance characteristics, target population, fundamental scientific technology, operating principle, Nitinol wireform material, sterilization method, shelf-life, and packaging. The devices differ only in marker shapes (Curls and Clover versus Ring) and applicator handle overmold colorants.

Not stated in this summary. The document references FDA Guidance on Design Control (March 11, 1997) but does not cite specific consensus standards (ISO, IEC, ASTM, etc.).

The subject device performs identical clinical functions to the predicate using the same fundamental technology, materials, sterilization, and deployment mechanism. Comprehensive biocompatibility testing (cytotoxicity, sensitization, irritation, acute toxicity, subchronic toxicity, genotoxicity, implantation studies) and performance testing (visibility, retention, deployment accuracy and force, corrosion resistance) demonstrate the Curls and Clover marker shapes perform as safely and effectively as the Ring shape predicate. The only differences—cosmetic marker shapes and handle colorants—do not affect the device's safety or effectiveness in radiographic marking.