OVB · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.5725
Classification
FDA Product Code
OVB
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 892.5725
Review panel
RA
Medical specialty
Radiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
The perirectal spacer is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of the perirectal spacer to reduce the radiation dose delivered to the anterior rectum. The perirectal spacer is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patients body over time.