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The Biodesign Otologic Butterfly Graft is intended for use as an implant material to aid in the natural healing process in myringoplasty and tympanoplasty procedures.

The Biodesign Otologic Butterfly Graft is a self-securing butterfly-style graft structure with the same underlay component as the predicate device, attached to an external stabilizing component with an absorbable knotted thread, all made from the same SIS (small intestinal submucosa) ECM material as that of the predicate device. This self-securing structure maintains the location and close tissue approximation of the underlay component across the tympanic membrane (TM) defect as an implant material to aid in the natural healing process in myringoplasty and tympanoplasty procedures.

The Biodesign Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. The Reinforcement may be used for buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomy, pneumoreduction) and other incisions and excisions of the lung and bronchus. The Staple Line Reinforcement can be used for the reinforcement of the gastric staple line during bariatric surgical procedures, and for reinforcement of staple lines during small bowel, mesentery, colon and colorectal procedures. The Staple Line Reinforcement may be used with anastomotic staplers or with non-anastomotic staplers.

The subject device consists of a thin multi-layer strip of SIS, pre-coated with a ready-to-use contact adhesive that eliminates the need for a separate adhesive (hydrogel), or activation of the adhesive through rehydration to affix the device to surgical stapler jaws. The single-use implant device is provided to the point of use with a protective liner covering the adhesive which has been assembled onto a foam carrier which is suspended in an alignment tray sized for the jaws of a surgical stapler. The completed device, liner, carrier, and alignment tray unit is then sealed in a foil pouch with an integrated humidity control feature and terminally E-beam sterilized. In order to accommodate a variety of commercially available surgical staplers the device is available in configurations measuring from 0.05mm to 0.6mm in thickness, and in nominal (unfolded) device lengths ranging from 76 mm to 176 mm in length and up to 12 mm wide. Upon implantation, the Biodesign® Staple Line Reinforcement device will provide mechanical reinforcement of the staple line by buttressing the soft tissue and preventing the surgical staples from tearing through the affected tissue. In addition, the Biodesign® Staple Line Reinforcement device will incorporate (remodel) into the body over time such that no graft material is left behind.

Biodesign Anal Fistula Plug: For implantation to reinforce soft tissue where a rolled configuration is required, for repair of anal, rectal and enterocutaneous fistulas. Biodesign Fistula Plug: For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Biodesign Plastic Surgery Matrix: For implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. Biodesign Tissue Graft: For implantation to reinforce soft tissue.

All four subject devices of this bundled submission are part of a family of devices manufactured by Cook Biotech Incorporated (CBI) consisting of processed porcine small intestinal submucosa (SIS), a three-dimensional, acellular, collagen-based extracellular matrix (ECM) material. SIS is manufactured by first removing the tunica mucosa from the inner intestinal surface and the serosa and tunica muscularis from the outer surface of the porcine small intestine. Further processing removes the cells and renders the material virally inactive. leaving behind a three- dimensional, decellularized, collagen-rich extracellular matrix.

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 Biodesign® Parastomal Hernia Repair Graft is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of abdominal wall defects and hernias, including but not limited to parastomal hernias.

The Biodesign® Parastomal Hernia Repair Graft is identical to the SIS Hernia Graft (i.e. same raw materials, manufacturing processes, configuration, packaging and sterilization). The devices are composed of multiple layers of porcine Small Intestinal Submucosa (SIS), a bioabsorbable, extracellular collagen matrix (ECM) that is non-crosslinked and decellularized; additionally, the device is held together with biodegradable suture to improve device handling characteristics at time of implant and is perforated to assist with fluid transfer. The single-use devices are packaged in a dried state and supplied sterile (EtO) in a sealed double pouch system.

The Biodesign® Fistula Plug is for implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.

The Biodesign® Fistula Plug is a fistula repair device made from porcine SIS, a collagen rich, bioresorbable, extracellular matrix (ECM)-based biomaterial. The device design consists of a tapered SIS cylinder (plug body) and an SIS flange/button connected together using biodegradable polyglycolic acid (PGA) surgical suture. The function of the plug body is to fill the fistula tract and the function of the flange/button is to anchor the device at the internal fistula opening. Three different size offerings (2mm, 5mm and 7mm) are available based on the diameter of the primary end of the plug.

The Biodesign® Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. The device may be used for buttressing and reinforcing staple lines during lung resection (e.g. wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomy/pneumectomy, pneumoreduction) and other incisions and excisions of the lung and bronchus. The device can be used for the reinforcement of the gastric staple line during bariatric surgical procedures of gastric bypass and gastric banding, and for reinforcement of staple lines during small bowel, mesentery, colon and colorectal procedures. The device may be used with anastomotic staplers or with non-anastomotic staplers.

The Biodesign® Staple Line Reinforcement device is part of a family of implant devices manufactured from porcine small intestine that are disinfected and processed to remove the tunica mucosa from the inner intestinal surface and tunica muscularis from the outer intestinal surface. The resulting membrane is a three dimensional, acellular, collagen-rich extracellular matrix (ECM) that is termed small intestinal submucosa (SIS). Biodesign® Staple Line Reinforcement consists of a thin multi-layer strip of SIS, pre-coated with an adhesive that eliminates the need for a separate adhesive (e.g. hydrogel) to affix the device to surgical stapler jaws. The single-use device is provided on a foam applicator and suspended in a form-fitting tray before being sealed in a foil pouch and sterilized (E-beam). The material composition, general manufacturing processes, packaging configuration and sterilization method of the subject device are identical to the predicate, SURGISIS® SLRTM Staple Line Reinforcement (K070405). Upon implantation, the Biodesign® Staple Line Reinforcement device will provide mechanical reinforcement of the staple line by buttressing the soft tissue and preventing the surgical staples from tearing through the affected tissue. In addition, the Biodesign® Staple Line Reinforcement device will incorporate (remodel) into the body over time such that no graft material is left behind.

DynaMatrix is intended for use in guided tissue regeneration and bone regeneration procedures. It may be used for bone regeneration and healing of periodontal defects, for gingival augmentation, to enhance alveolar ridges, or to contain or prevent migration of graft material. The device is supplied sterile and intended for one-time use.

DynaMatrix consists of layered sheets of bioabsorbable extracellular collagen membrane matrix derived from porcine Small Intestinal Submucosa (SIS). These sheets are lyophilized, packaged in a Tyvek pouch, and sterilized using ethylene oxide to an SAL of 10°. The device is available in sheets ranging from 2 cm to 12 cm2, and can be trimmed or shaped to the appropriate size to fit the defect to be treated. When hydrated, the membrane maintains suture tear resistance. It is considered to be a permanent contact implanted device, and is fully biocompatible. DynaMatrix is available by prescription only and is intended for use in an oral surgery setting for guided tissue regeneration and bone regeneration procedures. It may be used for bone regeneration and healing of periodontal defects, for gingival augmentation, to maintain or enhance alveolar ridges, or to contain or prevent migration of graft material. Dynamatrix achieves its intended use by providing a passive, resorbable scaffold to guide epithelial tissue ingrowth and angiogenesis of the epithelial layer in order to maintain space around the bony defect, prevent epithelial down-growth, and allow for new bone formation.

The Nerve Cuff is intended for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity. The device is supplied sterile and is intended for one-time use.

The Nerve Cuff is composed of a bioabsorbable, extracellular collagen matrix (Small Intestinal Submucosa, SIS). The SIS material that comprises the Nerve Cuff is identical to that of its predicate (Surgisis Nerve Cuff, K031069), and reference device (Nerve Cuff, K132660). Both the predicate and reference devices are also manufactured by Cook Biotech Incorporated. The Nerve Cuff is implanted around an injured nerve to provide a scaffold which becomes infiltrated by the patient's cells and is remodeled into native tissue. In addition, the Nerve Cuff protects the damaged or severed nerve while the nerve heals. The device is packaged in a dried state and supplied sterile in a clamshell container inside a sealed pouch.

The Flowable Wound Matrix is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, 2nd degree burns, skin tears) and draining wounds.

The Flowable Wound Matrix is a wound management device consisting of particulate Porcine Small Intestinal Submucosa (SIS) and fructose, a natural carrier. The device is an addition to the family of SIS-based wound management devices (Oasis Wound Matrix (K061711) and Cook ECM Powder (K152033)) already manufactured by Cook Biotech Incorporated. The device is supplied dry, rehydrated with saline at the time of application, and delivered topically to the wound through a pre-supplied syringe. SIS, which composes the majority of the device, is the same base material as that of the predicate device Oasis Wound Matrix (K061711) and reference device Cook ECM Powder (K152033). In addition to SIS, the device also contains fructose, a carrier added only to facilitate the preparation and delivery of the device. Fructose is a sugar naturally found in the body and is readily metabolized. The Flowable Wound Matrix is meant to be employed by the user to manage wounds of the types outlined in the intended use of the device. The device achieves its intended use by providing a scaffold for cellular invasion and capillary growth, and maintaining a supportive environment for wound management.