SpaceOAR Vue System (SV-2101)

The SpaceOAR Vue System is an absorbable hydrogel spacer injected between the anterior rectal wall and prostate prior to radiotherapy for prostate cancer. It temporarily creates and maintains space during the entire course of radiotherapy to reduce radiation dose to the rectum, then biodegrades and is excreted from the body over time.

The subject and predicate devices are identical in principles of operation and design. Minor differences include the nominal pH of the accelerator solution, inner diameter of hypotubes in the Y-connector, luer ring color, and shelf carton color. Both deliver 10cc PEG biodegradable hydrogel formed through cross-linking of PEG-SG-TIB and Trilysine.

Not stated in this summary. The document mentions ISO 13485 and ISO 13484 in general regulatory context but does not cite specific test standards or consensus standards for device performance validation.

The modified SpaceOAR Vue System is substantially equivalent to predicate K182971 because it maintains identical principles of operation, intended use, and indications for use. Verification and usability testing confirmed the proposed device meets the same functional and performance specifications as the predicate, and the minor component changes raise no new safety or effectiveness concerns.