HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)

The HydroMARK™ Plus Breast Biopsy Site Marker is a two-component implant used to permanently mark breast biopsy sites or axillary lymph node biopsy sites. It consists of a hydrogel cylinder with an embedded titanium wire that expands upon contact with body fluids, remaining visible by ultrasound for at least 6 weeks and permanently visible by x-ray and MRI.

The subject device is substantially equivalent to the predicate in intended use, indications, performance characteristics, target population, fundamental technology, mechanism of action, marker material, sterilization method, and shelf-life. The differences are stainless steel materials in the applicator, MRI imaging compatibility enhancement versus ultrasound-only focus in the predicate, and plastic colorants.

The submission references the FDA Guidance document 'Design Control Guidance for Medical Device Manufacturers' dated March 11, 1997. Specific consensus standards (ISO, IEC, ASTM) are not cited in this summary.

Substantial equivalence is established because the subject device and predicate device share the same intended use, indications, mechanism of action, marker material composition, and performance characteristics. Performance testing confirmed marker deployment accuracy, force, size, human factors, usability, magnetic resonance safety, and biocompatibility all passed, demonstrating the device performs as safely and effectively as the legally marketed predicate.