(150 days)
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.
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.
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 labeling | Bench 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 parameters | Bench 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 testing | Bench 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 ( |
N/A