Device Dossier

Intraoperative tumour margin analysis probe

Device Dossier for Intraoperative tumour margin analysis probe (Intraoperative tumour margin analysis probe, Class IIa, sponsor Vicki Partridge). ARTG…

Intended purpose

The MarginProbe is indicated for use as an intraoperative probe in breast lumpectomy procedures for intraoperative margin assessment and to aid in the selection of tissue abnormalities for excision. MarginProbe is an adjunct to current methods of margin assessment and is designed only for intraoperative assessment of the margins. Use of the device does not eliminate the need for complete postoperative pathological assessment. The device is sterile, intended for single use.

TGA Public Summary