(21 days)
SpaceOAR System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this the intent of SpaceOAR System to reduce the radiation dose delivered to the anterior rectum.
The SpaceOAR System is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.
The SpaceOAR Hydrogel System consists of components for the preparation of a synthetic, absorbable hydrogel spacer and a delivery mechanism provided in a sterile, single use package. The SpaceOAR hydrogel is a synthetic, absorbable polyethylene glycol (PEG)based hydrogel that upon injection creates a space that temporarily positions 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. SpaceOAR hydrogel is completely synthetic with no animal or human derived components. It is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment (approximately 3 months) and is completely absorbed by the patient's body over time (approximately 6 months).
This submission describes a modification to an already cleared device (SpaceOAR Hydrogel System), not a new device requiring a full de novo clearance or a new 510(k) for a substantially different device. Therefore, the "acceptance criteria" and "study" described are focused on demonstrating that the modified device performs equivalently to the predicate device and does not introduce new safety or effectiveness concerns, rather than establishing efficacy of the device from scratch.
Here's a breakdown of the requested information based on the provided text, recognizing the context of a device modification:
Description of Acceptance Criteria and the Study Proving Device Meets Acceptance Criteria
The acceptance criteria for the modified SpaceOAR System are implicitly defined as demonstrating that the changes do not negatively impact the device's functional and performance specifications compared to the predicate device and that it remains biologically safe.
The study described is a series of design verification tests and assessments conducted to confirm that the modified device continues to function as intended and is substantially equivalent to the previously cleared SpaceOAR System (K181465).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functional and Performance Equivalence to Predicate Device | Verified through repetition of design verification tests, confirming the modified device meets the same functional and performance specifications as the predicate. |
| - Sterilization Validation | "Sterilization Validation" was repeated and confirmed. |
| - Shelf Life Testing | "Shelf Life Testing" was repeated and confirmed. |
| - System Needle to Hub Tensile Strength | "System Needle to Hub Tensile Strength" was repeated and confirmed. |
| - Fluid Connection | "Fluid Connection" was repeated and confirmed. |
| - SpaceOAR Hydrogel System Prep and Assembly Time | "SpaceOAR Hydrogel System Prep and Assembly Time" was repeated and confirmed. |
| - PEG Vial Puncture Force | "PEG Vial Puncture Force" was repeated and confirmed. |
| - Packaging Performance Testing | "Packaging Performance Testing" was repeated and confirmed. |
| Biological Safety Equivalence | "A risk-based biocompatibility assessment of these limited changes indicates that no new biocompatibility testing is required to assess the proposed device change. The proposed SpaceOAR System is biologically safe for its intended use." This implies the acceptance criterion of not introducing new biocompatibility risks was met. |
| No New Issues of Safety or Effectiveness | "The conclusion of the assessments demonstrates that the modified device continues to function as intended in a manner equivalent to the predicate device. The modified device raises no new issues of safety or effectiveness compared to the predicate." This is the overarching conclusion related to meeting general safety and effectiveness acceptance criteria for device modifications. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the specific sample sizes for each of the repeated design verification tests (e.g., number of units tested for tensile strength, shelf life, etc.). It only mentions that the tests were "repeated."
Data Provenance: The testing appears to be internal design verification and validation testing conducted by Boston Scientific Corporation. The provenance is internal company data, not clinical data from external sources.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device modification submission relies on engineering design verification and validation testing to demonstrate equivalence, not on expert-adjudicated clinical ground truth for a test set. Clinical data and expert ground truth were not used for this specific submission given the "limited changes to device components, packaging and labeling."
4. Adjudication Method for the Test Set
Not applicable. As noted in point 3, this was not a clinical study requiring expert adjudication of a test set. The assessment relied on a risk analysis to determine the necessary verification tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. The SpaceOAR System is a medical device (hydrogel spacer), not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done
Not applicable. The SpaceOAR System is a physical medical device, not an algorithm, so standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
For this specific submission (device modification), the "ground truth" is essentially the established performance specifications and safety profile of the predicate device (K181465). The "study" aims to verify that the modified device continues to meet these same engineering specifications and does not introduce new safety concerns.
8. The Sample Size for the Training Set
Not applicable. This submission concerns a physical medical device and its manufacturing/component changes, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted in point 8, there is no training set for a machine learning model in this submission.
§ 892.5725 Absorbable perirectal spacer.
(a)
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.(b)
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 § 820.30 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:
(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.