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510(k) Data Aggregation

    K Number
    K222972
    Device Name
    BioProtect Balloon Implant™ System
    Manufacturer
    BioProtect, Ltd.
    Date Cleared
    2023-08-25

    (332 days)

    Product Code
    OVB
    Regulation Number
    892.5725
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    DEN140030
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BioProtect Balloon Implant System 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 BioProtect Balloon Implant System to reduce the radiation dose delivered to the anterior rectum.

    The BioProtect Balloon Implant System is composed of a balloon made of a biodegradable material that maintains the space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.

    Device Description

    The BioProtect Balloon Implant™ System is composed of a single use, biodegradable, inflatable balloon implant, designed to act as a spacer between the prostate and the rectum. The BioProtect Balloon Implant System is supplied sterile. The balloon is implanted transperineally using transrectal ultrasound (TRUS) guidance and remains stable throughout the radiation treatment and gradually degrades over time.

    The BioProtect Balloon Implant System consists of single use components detailed below:

    1. Balloon biodegradable, inflatable balloon acts as a spacer between the prostate and rectal wall.
    2. Balloon Deployer delivery system, the balloon is mounted and folded on the deployer
    3. Delivery Kit - an applicator system used to position and deploy the balloon in the intended location. It includes an 18-gauge echogenic needle, blunt-tipped tissue dilator, and balloon introducer sheath.

    The BioProtect Balloon Implant System is for prescription use only.

    AI/ML Overview

    Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:

    Device Name: BioProtect Balloon Implant™ System

    Indications for Use: The BioProtect Balloon Implant System 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 BioProtect Balloon Implant System to reduce the radiation dose delivered to the anterior rectum. The BioProtect Balloon Implant System is composed of a biodegradable material that maintains the space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (from primary efficacy/safety endpoints)Reported Device Performance
    Efficacy Primary Endpoint: Reduction of at least 25% of the volume of the rectum receiving greater or equal to 70 Gy when compared to pre-implantation values, in 75% of the subjects assigned to the balloon group.97.9% of subjects gained rectal dose reduction >25% in rV70 post-implantation. Relative mean dose reduction of 84.8% of the rectum receiving 70Gy. Rectal radiation dose consistently reduced in all radiation levels (40Gy to 80Gy). Sign test p-values were <0.001 for all levels.
    Safety Primary Endpoint: Proportion of subjects with Grade 1 or greater rectal adverse events and implantation procedure-related adverse events with a duration of at least 2 days through the first six (6) months, demonstrating non-inferiority to the control group.Proportion of 18% in the Balloon Group vs. 23.1% in the Control Group, achieving the one-sided non-inferiority test for the Balloon Group (p < 0.001). No Serious Adverse Device Event (SADE) or Unanticipated Adverse Device Effect (UADE) occurred.
    Balloon Stability: Maintain stable distance between rectal wall and prostate throughout radiotherapy.Stable distance between rectal wall and prostate measured at last radiation treatment day (1.8 cm) compared to post-implantation (1.9 cm).
    Complete Degradation: Complete balloon degradation.Complete balloon degradation at 6 months demonstrated in 98.5% of subjects.
    Bladder Volume (Implicit, for context): Monitor bladder volume changes.Pre-implantation mean of 194.3cc (±128.51cc) and post-implantation mean of 231.5cc (±134.56cc) show a modest increase.
    Treatment Constraint Achievement (Implicit, for context): Ability to meet PTV and rectal/bladder constraints.No plan in the balloon group failed to meet all constraints. Significantly higher likelihood in achieving PTV and all rectal constraints (83.5% vs 57.7%) favoring the balloon arm, as well as all PTV and bladder constraints (70.5% vs 60.3%).

    Study Details

    The study that proves the device meets the acceptance criteria is a prospective, multi-center, randomized, double-arm, single blind, concurrently controlled clinical study (IDE G17020).

    1. Sample size used for the test set and the data provenance:

      • Sample Size: 222 subjects were enrolled and randomized.
      • Data Provenance: The study was a multi-center clinical study. The document does not specify the country of origin but refers to "IDE G17020," which is an FDA Investigational Device Exemption number, implying the study was conducted under FDA oversight, likely with sites in the US (though not explicitly stated). It was a prospective study.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

      • The document states that the primary safety endpoint was assessed by an independent Clinical Events Committee (CEC) blinded to subject assignment.
      • Qualifications of experts: Not specified in the provided text.

    3. Adjudication method for the test set:

      • The primary safety endpoint was assessed by an independent Clinical Events Committee (CEC), implying an adjudication process, but the specific method (e.g., 2+1, 3+1) is not explicitly detailed. The CEC's role suggests independent review and consensus on adverse events.

    4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

      • No, an MRMC study was not done. This study was a clinical trial comparing the device (balloon + fiducial markers) to a control (fiducial markers only) in human patients for real-world clinical outcomes related to radiation dosage and adverse events, not an imaging-based assessment by multiple readers.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

      • Not applicable. This device is a physical implant, not an AI algorithm. The performance described is the device's effectiveness in a human patient setting, not the performance of an algorithm.

    6. The type of ground truth used:

      • Clinical Outcomes Data: This includes actual measurements of rectal radiation dose reduction, recorded adverse events (evaluated by an independent CEC), and physical measurements of balloon stability and degradation within patients.

    7. The sample size for the training set:

      • Not applicable for a physical medical device. "Training set" typically refers to data used to train machine learning algorithms. This was a clinical trial for a physical implant.

    8. How the ground truth for the training set was established:

      • Not applicable. As above, this concept applies to AI/ML development, not a physical medical device clinical trial.
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