MammoSTAR Biopsy Site Identifier

MammoSTAR Biopsy Site Identifier is a sterile, single-use tissue marker made of pyrolytic carbon-coated zirconium oxide embedded in lyophilized beta-glucan gel. It is placed into soft tissue during surgical procedures to radiographically mark a surgical location and is visible on X-ray, CT, mammography, ultrasound, and MRI.

The device is identical to the predicate in all technological respects: same pyrolytic carbon-coated zirconium oxide marker material, same lyophilized beta-glucan carrier composition, same sterilization method (gamma irradiation at 25.0–35.0 kGy), same visualization modalities, and same MR-conditional safety profile. The only change is an added contraindication regarding infection.

Not stated in this summary.

The device is substantially equivalent because it remains physically and functionally identical to the predicate device K100994 in design, materials, manufacturing, and sterilization. Both are single-use implantable tissue markers with identical marker material, carrier composition, and performance characteristics. The addition of a contraindication regarding infection does not alter the device itself or its fundamental function. Since there is no change to the device, no new testing data is required to establish substantial equivalence.