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 Delive
| Device Type ID | 5417 |
| Device Name | Hydrogel Spacer |
| Physical State | Synthetic, Absorbable Polyethylene Glycol (PEG)-based Hydrogel Supplied In A Single Use Tray |
| Technical Method | Injected In Tissue Found Between The Rectum And Prostate. The Injected Liquid Solidifies Creating A Space Between The Rectum And Prostate During Radiation Therapy To Protect Vulnerable Tissue. It Gradually Liquifies And Is Absorbed. |
| Target Area | Between The Prostate And The Rectum |
| Regulation Description | Absorbable Perirectal Spacer. |
| Regulation Medical Specialty | Radiology |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 892.5725 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OVB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5417 |
| Device | Hydrogel Spacer |
| Product Code | OVB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Absorbable Perirectal Spacer. |
| CFR Regulation Number | 892.5725 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AUGMENIX , INC. | ||
GRANTED | 1 | |
AUGMENIX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Improper Or Incorrect Procedure Or Method | 6 |
Use Of Device Problem | 6 |
Adverse Event Without Identified Device Or Use Problem | 5 |
Contamination / Decontamination Problem | 2 |
Contamination During Use | 2 |
Insufficient Information | 2 |
Missing Value Reason | 1 |
Inadequate Or Insufficient Training | 1 |
Device Handling Problem | 1 |
| Total Device Problems | 26 |