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The Biodesign® Diaphragmatic Hernia Graft is intended for implantation to reinforce soft tissues where weakness exists including the repair of diaphragmatic/hiatal hernias.

The graft is supplied sterile and is intended for one time use only.

The Biodesign® Diaphragmatic Hernia Graft, the subject device, has the same indications for use and is physically identical to the predicate device (K133011) with the same name. The only difference between the subject device and the predicate device is the rehydration fluid options described in the devices' instructions for use (IFU).

Both the subject and predicate devices are part of a family of implant devices manufactured from porcine small intestine that have been processed to remove the tunica mucosa from the inner intestinal surface and the serosa and tunica muscularis from the outer intestinal surface. After further disinfection to ensure the material is virally inactive, the resulting layer is a three dimensional, acellular, collagen-rich extracellular matrix (ECM) that is termed small intestinal submucosa (SIS). Both the subject and predicate devices are multilayered SIS sheets configured in two shapes: rectangular shape (7 x 10 cm) and the U-cut shape (7 x 10 cm with U-shaped notch). Both devices are perforated and have polyglycolic acid (PGA) suture stitched across the device and around the perimeter. The purpose of the suture stitching is to prevent delamination due to device handling during implantation. Both devices are provided in a double Tyvek® pouch and are ethylene oxide (EO) sterilized.

Prior to implantation, the Biodesign® Diaphragmatic Hernia Graft, the subject device, can be rehydrated with sterile saline or autologous body fluids (e.g., blood, bone marrow aspirate, or blood concentrates such as platelet concentrate).

Upon implantation, the Biodesign® Diaphragmatic Hernia Graft (both subject and predicate device) will provide mechanical reinforcement of soft tissue in the repair of diaphragmatic/hiatal hernias. Over time, the device will incorporate (remodel) into the body such that no graft material is left behind.

The provided document is a 510(k) summary for a medical device called the Biodesign® Diaphragmatic Hernia Graft. It describes the device, its intended use, and why it is considered substantially equivalent to a predicate device.

However, the document does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device, which is what your detailed questions are tailored to. The device in focus (a surgical mesh) is a physical implant, not a software or AI-driven diagnostic or therapeutic tool.

Therefore, I cannot answer questions 1 through 9 directly from the provided text, as they pertain to the evaluation of an AI/ML system's performance and validation.

The document's "Performance Data" section discusses non-clinical testing (mechanical properties, tensile strength, suture retention strength, hydration time, and simulated use/handling properties) to show that a new rehydration fluid option does not significantly change the device's properties compared to the predicate device. This is a very different type of "performance data" than what would be generated for an AI/ML medical device.

In summary, the provided text does not contain the information required to answer your specific questions.

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