Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart F — Therapeutic Devices](/submissions/RA/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 892.5725](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5725) → OVB — Hydrogel Spacer

# OVB · Hydrogel Spacer

_Radiology · 21 CFR 892.5725 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/OVB

## Overview

- **Product Code:** OVB
- **Device Name:** Hydrogel Spacer
- **Regulation:** [21 CFR 892.5725](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5725)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)

## Identification

An absorbable perirectal spacer is composed of biodegradable material that temporarily positions the anterior rectal wall away from the prostate during radiotherapy for prostate cancer with the intent to reduce the radiation dose delivered to the anterior rectum. The absorbable spacer maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.

## Classification Rationale

Class II (special controls). The special controls for this device are:

## Special Controls

An absorbable perirectal spacer must comply with the following special controls: (1) The premarket notification submission must include methodology and results of the following non-clinical and clinical performance testing. For all clinical investigations used to support premarket notification submissions for this type of device, line listings of the study data must be provided. Performance bench testing must demonstrate appropriate perirectal space (i) creation and maintenance for the duration of prostate radiotherapy; Performance bench testing must demonstrate that therapeutic radiation levels (ii) do not alter the performance of the device; (iii) Performance in vivo testing must demonstrate appropriate deployment of spacer as indicated in the accompanying labeling, and demonstrate appropriate expansion and absorption characteristics in a clinically relevant environment; (iv) Clinical study must demonstrate appropriate spacer stability and lack of migration for the entire course of radiotherapy, complete absorption, and lack of long term toxicity: Sterility testing must demonstrate the sterility of the device and the effects of (v) the sterilization process on the physical characteristics of the spacer; (vi) Shelf-life testing must demonstrate the stability of the physical characteristics of the spacer throughout the shelf-life as indicated in the accompanying labeling: and. (vii) The device must be demonstrated to be biocompatible. (2) The risk management activities performed as part of the manufacturer's 21 CFR 820.30 design controls must document an appropriate end user initial training program which will be offered as part of efforts to mitigate the risk of failure to correctly operate the device, including, but not limited to, documentation of an appropriate end user initial training program on the proper spacer deployment technique. (3) The device labeling must include the following: A detailed summary of reported or observed complications related to the use (i) of the device; (ii) Appropriate warnings; Detailed instructions for system preparations and detailed implant procedure (iii) instructions; and, (iv) An expiration date that is supported by performance data as specified in subparagraph (b)(i)(vi).

*Classification.* Class II (special controls). The special controls for this device are:(1) The premarket notification submission must include methodology and results of the following non-clinical and clinical performance testing. For all clinical investigations used to support premarket notification submissions for this type of device, line listings of the study data must be provided.
(i) Performance bench testing must demonstrate appropriate perirectal space creation and maintenance for the duration of prostate radiotherapy.
(ii) Performance bench testing must demonstrate that therapeutic radiation levels do not alter the performance of the device.
(iii) Performance in vivo testing must demonstrate appropriate deployment of spacer as indicated in the accompanying labeling, and demonstrate appropriate expansion and absorption characteristics in a clinically relevant environment.
(iv) Clinical study must demonstrate appropriate spacer stability and lack of migration for the entire course of radiotherapy, complete absorption, and lack of long term toxicity.
(v) Sterility testing must demonstrate the sterility of the device and the effects of the sterilization process on the physical characteristics of the spacer.
(vi) Shelf-life testing must demonstrate the stability of the physical characteristics of the spacer throughout the shelf-life as indicated in the accompanying labeling.
(vii) The device must be demonstrated to be biocompatible.
(2) The risk management activities performed as part of the manufacturer's § 820.10(c) of this chapter design and development activities must document an appropriate end user initial training program which will be offered as part of efforts to mitigate the risk of failure to correctly operate the device, including, but not limited to, documentation of an appropriate end user initial training program on the proper spacer deployment technique.
(3) The device labeling must include the following:
(i) A detailed summary of reported or observed complications related to the use of the device;
(ii) Appropriate warnings;
(iii) Detailed instructions for system preparations and detailed implant procedure instructions; and
(iv) An expiration date that is supported by performance data as specified in paragraph (b)(1)(vi) of this section.

## Recent Cleared Devices (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K260119](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/OVB/K260119.md) | SpaceOAR Vue System (SV-2101) | Boston Scientific Corporation | Feb 10, 2026 | SESE |
| [K222972](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/OVB/K222972.md) | BioProtect Balloon Implant™ System | Bioprotect, Ltd. | Aug 25, 2023 | SESE |
| [K220641](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/OVB/K220641.md) | Barrigel Injectable Gel | Palette Life Sciences | May 26, 2022 | SESE |
| [K202224](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/OVB/K202224.md) | SpaceOAR System | Boston Scientific Corporation | Aug 28, 2020 | SESE |
| [K182971](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/OVB/K182971.md) | SpaceOAR Vue Hydrogel | Augmenix, Inc. | Jul 19, 2019 | SESE |
| [K181465](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/OVB/K181465.md) | SpaceOAR System | Augmenix, Inc. | Jun 25, 2018 | SESE |
| [DEN140030](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/OVB/DEN140030.md) | SpaceOAR System | Augmenix, Inc. | Apr 1, 2015 | DENG |

## Top Applicants

- Augmenix, Inc. — 3 clearances
- Boston Scientific Corporation — 2 clearances
- Bioprotect, Ltd. — 1 clearance
- Palette Life Sciences — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/OVB](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/OVB)

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