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510(k) Data Aggregation

    K Number
    DEN220082

    Validate with FDA (Live)

    Device Name
    Breast Implant Removal Device (BIRD)
    Manufacturer
    Gaylord Solutions, LLC
    Date Cleared
    2023-04-20

    (150 days)

    Product Code
    QVS,OVS
    Regulation Number
    878.4675
    Type
    Direct
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Breast Implant Removal System is a single-patient, single use suction device used to assist in the removal of one intracapsular ruptured silicone breast implant.

    Not intended for en bloc removal. Not intended to remove residual silicone or be applied directly to tissue.

    Device Description

    The breast implant removal system is a two-piece bottle with a concave shaped nozzle on one end and a tapered fitting port on the opposite end that allows attachment to a vacuum source. The nozzle is placed against the shell of a ruptured implant, and once vacuum suction pressure is applied, the implant and silicone contents are drawn into the bottle.

    The tank has a tapered port for connection to vacuum tubing that interfaces with a vacuum source. The bottle is intended to be used with a standard OR wall vacuum or a portable surgical aspirator pump.

    The nozzle has a "fish-mouth" concave shaped opening to facilitate engagement between the nozzle and the implant, as well as lubricious hydrophilic coating to reduce friction in delivering the implant into the specimen bottle. External contoured features on the bottle aid in the user grip and manipulation of the container. The bottle has vent holes which must be covered to apply suction.

    After removing the bulk of the implant, any residual leaked silicone material is removed by conventional techniques such as manual removal/extraction. The tank can be opened for the purpose of implant examination or implant manufacturer return.

    AI/ML Overview

    Acceptance Criteria and Device Performance for Bateman Bottle

    This response outlines the acceptance criteria and the studies that demonstrate the Bateman Bottle meets these criteria, based on the provided text.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (from Special Controls)Reported Device Performance and Study
    (1) Animal performance testing must demonstrate that the device performs as intended and (1) will not result in tissue injury. Testing must:GLP Porcine Study: Evaluated gross and histopathologic responses of tissue to subject device explant vs. manual device explant of ruptured silicone breast implants. The study concluded: "The tissue response from the ruptured silicone implant removal with the Bateman Bottle was comparable to the tissue response from manual extraction of the ruptured silicone breast implant." This indicated no significant difference in tissue damage.
    (i) Demonstrate the ability to remove implants of the sizes and types specified in device labelingBench Testing - Implant Extraction: - Demonstrated full aspiration of the largest size implant (800cc) with high cohesivity and a 2cm rupture at 300mmHg suction. - Demonstrated full aspiration of the largest size implant (800cc) with low cohesivity and a 4cm rupture at 500mmHg suction. Labeling: The user manual includes a table with a description of the implant types, volumes, and shapes extracted in bench and animal testing, and states: "Sizes and types of implants that can be removed with the device."
    (ii) Assess tissue integrity and injury at multiple time intervals to assess tissue healing response after device use.GLP Porcine Study: Tissue conditions and responses were observed at time of implantation, time of explantation, and 28 days post-explantation. Histological tissue samples from this study showed comparable evidence of tissue injury between manual extraction and device-assisted extraction, with no significant difference in tissue damage.
    (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following:Bench Testing:
    (i) Characterization of the range of device operation, including minimum and maximum vacuum suction parametersBench Testing - Implant Extraction: Performed at worst-case conditions using lowest (300mmHg) and highest (500mmHg) recommended suction pressures. Bench Testing - Vacuum and Vent Hole Testing: Demonstrated the ability of the device to adequately achieve and maintain vacuum. Labeling: The user manual contains acceptable vacuum suction pressure ranges tested for use with the device and a summary of device specifications, including vacuum suction pressure ranges.
    (ii) Durability and integrity testingBench Testing - Bottle Testing: Demonstrated device integrity during use at or exceeding maximum recommended suction pressure (>500mmHg). Shelf Life Testing: Included visual inspection, seal strength (ASTM F88), and bubble leak testing (ASTM F2096-11) after accelerated aging, demonstrating package integrity.
    (iii) Characterization of control and variation of suction application.Bench Testing - Vacuum and Vent Hole Testing: Demonstrated the ability of the device to control and relieve vacuum as needed.
    (3) Performance testing must demonstrate the sterility of the device.Sterilization Validation: Sterilized in accordance with ISO 11137-2:2013/R2019 using gamma radiation. Validation testing substantiated a radiation sterilization dose of 25 kGy for a sterility assurance level (SAL) of 10-6.
    (4) Performance testing must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.Shelf Life Testing: Established a two-year shelf-life based on an accelerated aging study. Evaluated by visual inspection, seal strength (ASTM F88), and bubble leak testing (ASTM F2096-11). The test article met the acceptance criteria for each test. Sterilization Validation: Supported continued sterility over the shelf life.
    (5) The tissue-contacting components of the device must be demonstrated to be biocompatible.Biocompatibility Evaluation: Categorized as an external communicating device with limited (<24 hour) tissue contact. The following biocompatibility endpoints were assessed: Cytotoxicity (MEM Elution Test, ISO 10993-5:2009), Sensitization (Guinea Pig Maximization, ISO 10993-10:2010), Irritation (Intracutaneous Irritation Test, ISO 10993-10:2010), Acute Systemic Toxicity (Acute Systemic Injection Test, ISO 10993-11:2017), and Material-Mediated Pyrogenicity (Rabbit Pyrogenicity Test, ISO 10993-11:2017).
    (6) Usability testing must demonstrate that intended users can correctly use the device, based solely on reading the directions for use.Design Validation and Usability Testing (Simulated Use/Usability Testing): Intended users (plastic surgeons) performed critical tasks under simulated use conditions. The testing showed that the device was "properly used in the hands of trained professionals." This study, using an in-silico breast model, involved plastic surgeons using the device to remove varied textured and smooth implants. The study confirmed the device performed as intended: "In simulated use testing, the subject device demonstrated removal of implants without residual silicone." The risk of use error is mitigated by Usability testing.
    (7) Labeling must include the following:Labeling Section and Instructions for Use:
    (i) Summary of device specifications, including vacuum suction pressure ranges and bottle capacityThe user manual includes a description of the device technical parameters and instructions for use, explicitly stating: "The user manual contains acceptable vacuum suction pressure ranges tested for use with the device. A table is included with a description of the implant types, volumes, and shapes extracted in bench and animal testing."
    (ii) Sizes and types of implants that can be removed with the device.The user manual explicitly states: "A table is included with a description of the implant types, volumes, and shapes extracted in bench and animal testing." And the special controls state: "Sizes and types of implants that can be removed with the device."

    2. Sample Size Used for the Test Set and Data Provenance

    • Bench Testing (Implant Extraction and Usability):
      • Implants: Includes "the largest size implant (800cc)" with both "high cohesivity and a 2cm rupture" and "low cohesivity and a 4cm rupture." "800cc implants of various silicone cohesivity that were ruptured with 2 cm and 4 cm cuts." Also "various textured and smooth implants of various sizes." (Specific number of implants tested not explicitly stated but covers a range of worst-case scenarios).
      • Data Provenance: Retrospective (bench testing simulating real-world use) conducted under controlled laboratory conditions.
    • Animal Study (GLP Porcine Study):
      • Animals: Seven (7) pigs (Yorkshire Cross).
      • Implants: Each pig was implanted with 3 pairs of implants (6 total implants per model), for a total of 42 implants across the 7 pigs. "Small, 200cc volume" implants were used as a "worst case ruptured implant" scenario.
      • Data Provenance: Prospective animal study (live animal model).

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    • Usability Testing: "Plastic surgeons" were used as "intended users." The exact number of plastic surgeons is not specified, nor are their specific years of experience or other qualifications beyond being "trained professionals."
    • Animal Study: The study provided gross and histopathologic responses. This implies evaluation by veterinarians and potentially veterinary pathologists. No specific number or qualifications are provided.

    4. Adjudication Method for the Test Set

    • Usability Testing: Not explicitly stated, but the process involved plastic surgeons performing critical tasks. The "results" section implies a consensus or clear outcome regarding correct device use.
    • Animal Study (Histopathology): Not explicitly stated, but histopathologic evaluation typically involves expert review, potentially with consensus if discrepancies arise.

    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

    • No MRMC comparative effectiveness study was done. The device in question (Bateman Bottle) is a physical suction retrieval system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, this question is not applicable to this device submission.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    • Not applicable. The Bateman Bottle is a physical device that requires human-in-the-loop operation. It is not an algorithm or software-only device.

    7. The Type of Ground Truth Used

    • Bench Testing (Implant Extraction):
      • Quantitative measurements: "Residual silicone is measured by the difference in weights of the implant and bottle after extraction and before implantation." This provides a direct, objective ground truth for extraction efficacy.
      • Qualitative observations: "Design verification to verify device dimensional parameters conformed to specification." "Bottle access testing to ensure the bottle can be opened following implant extraction." "Vacuum and vent hole testing to demonstrate the ability of the device to adequately achieve and maintain vacuum."
    • Animal Study:
      • Histopathology: "The tissue response from the ruptured silicone implant removal with the Bateman Bottle was comparable to the tissue response from manual extraction of the ruptured silicone breast implant." This forms the ground truth for tissue injury comparison.
      • Gross observation: "Peri-implant tissue conditions and responses were observed."
    • Usability Testing:
      • Expert consensus/direct observation: Evaluation of whether "intended users can correctly use the device, based solely on reading the directions for use." This is often a qualitative assessment by observers during the simulated use.

    8. The Sample Size for the Training Set

    • Not applicable. The provided document describes device performance testing for regulatory approval. It does not mention any "training set" in the context of machine learning. The studies are primarily for verification and validation of a physical device.

    9. How the Ground Truth for the Training Set Was Established

    • Not applicable. As no training set for machine learning was mentioned, the method for establishing its ground truth is irrelevant to this submission.
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