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Standard Staple-Line Reinforcement is indicated for use in bariatric procedures in which gastric tissue transection and resection with staple line reinforcement is needed.

The Standard Staple-Line Reinforcement (SSLR23) is an implantable device designed to be used with Standard Bariatrics' TITAN SGS23R device (K210278) during laparoscopic surgery to position, clamp, staple, and resect long planes of soft flat tissue and organs, such as the stomach. The SSLR23 device consists of 2 (two) sheets of GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material, configured to be used only with TITAN SGS23R and which provides a continuous sheet of Staple-Line Reinforcement for the entire length of the staple-line, up to 23cm in length. The device contains an applicator to aid in the installation of the SSLR23 on the TITAN SGS23R jaws. The SSLR23 device is single-use and supplied sterile.

ECHELON ENDOPATH Staple Line Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. ECHELON ENDOPATH Staple Line Reinforcement can be used for reinforcement of staple lines during lung resection and bariatric surgical procedures. The device can also be used for reinforcement of staple lines during gastric, small bowel, and colorectal procedures.

Echelon Endopath Staple Line Reinforcement is a staple line reinforcement, also known as a buttress, for use in the surgical environment for the purpose of reinforcing a staple line. The Subject Device of this 510(k) is the same as the Predicate Device with a modification to the labeling to include the addition of the Intuitive Surgical SureForm™ 60 mm Blue, Green and Black Reloads and SureForm™ 60 mm Stapler 510(k) Cleared K173721 as compatible devices. The Predicate Device is compatible with the Echelon Flex™ 60 mm Powered Plus Articulating Endoscopic Linear Cutters with Echelon Endopath 60 mm Endoscopic Linear Cutter Reloads with Gripping Surface Technology, (510k cleared K202665, K183435). There are no design or manufacturing changes associated with this submission. The Subject Device is to be used with surgical stapling devices. Surgical stapling devices place staggered rows of staples with a reinforcement material, and simultaneously divide the tissue and the reinforcement material between the stapled rows. The Subject Device is an absorbable staple line reinforcement material which is secured to both the stapler anvil and reload with a synthetic attachment material. The product consists of an applicator which includes the implantable device, one for each of the upper and lower stapler jaws. The implantable material consists of 3 materials: the Vicryl material, the Polydioxanone film and the attachment adhesive material. Echelon Endopath Staple Line Reinforcement is an implanted material which works as an adjunct to surgical staples after transection, to provide support to soft tissue during the healing process. There are no modifications to the predicate device; and the materials of the Subject Device and Predicate Device are the same. Each unit is packaged sterile in separate pouch.

NEOVEIL® Staple Line Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. NEOVEIL® Staple Line Reinforcement of staple lines during lung resection, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, and small bowel procedures.

NEOVEIL® Staple Line Reinforcement is composed of a biodegradable synthetic polymer, polyglycolic acid (PGA) and is offered as a nonwoven surgical mesh configured into sleeves. The device is applied to the surgical site via a mechanical stapler with two jaws, where one piece of the sleeve is slid over each jaw of the stapler. This is accomplished by attaching a similar-sized piece of nonabsorbable elastic knit to the PGA felt that is held together by means of PGA tacking threads. After deployment of the tube type reinforcement material, the non-degradable elastic knits, comprised of polyurethane and nylon, are removed and discarded along with the PGA tacking sutures. The PGA material is dyed with D&C Green No.6.

ECHELON ENDOPATH Staple Line Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. ECHELON ENDOPATH Staple Line Reinforcement can be used for reinforcement of staple lines during lung resection and bariatric surgical procedures. The device can also be used for reinforcement of staple lines during gastric, small bowel and colorectal procedures.

Echelon Endopath Staple Line Reinforcement is a staple line reinforcement, also known as a buttress, for use in the surgical environment for the purpose of reinforcing a staple line. The Subject Device is to be used Echelon Endopath GST 60 mm reloads in conjunction with the Echelon family of 60 mm endoscopic linear cutters. The Echelon 60 mm Stapler in conjunction with the Echelon Endopath GST60 mm reload places staggered rows of titanium staples with a reinforcement material, and simultaneously divide the tissue and the reinforcement material between the stapled rows. The Subject Device is an absorbable staple line reinforcement material which is secured to the stapler anvil and reload with a synthetic attachment material. The Subject Device contains an applicator and the implantable device which consists of 3 materials: the Vicryl material, the Polydioxanone film and the attachment material. Echelon Endopath Staple Line Reinforcement is an implanted material which works as an adjunct to surgical staples after transection, to provide support to soft tissue during the healing process. Echelon Endopath Staple Line Reinforcement is composed of undyed multifilament fibers identical to those used in Vicryl surgical sutures. The polyglactin 910 implant is knitted by a process which interlocks each fiber juncture to prevent unraveling. The implanted material consists of a Vicryl layer laminated with a PDO film on each side, and a Buttress Attachment Material which is a synthetic material applied to the top outer surface of each implant. The staple line reinforcement is used as a buttress to provide support during the healing process. Both Subject and Predicate materials are hydrolyzed by body fluids and absorbed after serving the intended function. The subject Device absorption is essentially complete at 120 days. The primary difference between the Subject and Predicate Devices is the feature for loading and delivery of the device to the implantation site. A thin layer of bioabsorbable adhesive is coated onto one surface of the implantable device and is composed of a synthetic polymer/poloxamer blend to attach the Subject Device to the stapler. Whereas the Predicate Device utilized a sleeve construction and suture pullcord to secure the reinforcement material on the stapler.

GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. It can be used for reinforcement of staple lines during hysterectomy, lung resection, bladder reconstruction, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, small bowel, and spleen procedures. It is also intended to be used for remforcement of suture lines and staple lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.

The subject of this 510(k) pre-market notification is a modification to the GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material Configured for Endoscopic Surgical Staplers (EBSG, also referred to as the predicate) to include altered bioabsorbable sheet geometries, tailored lattice stitching, and inner dimension geometry for both the cartridge and anvil devices. The cartridge and anvil devices were specifically designed to fit the geometry of the Intuitive SureForm 60™ mm staplers (K173721 cleared July 5, 2018) Black, Green and Blue cartridge reloads. GORE® SEAMGUARD® Reinforcement Bioabsorbable Staple Line Reinforcement Configured for Intuitive Surgical® Robotic Endoscopic Surgical Staplers (EBSG-R, also referred to as the modified device) possesses the same fundamental scientific technology as the predicate. No other physical modifications were made to the predicate device, and the implantable materials of the modified device and predicate are the same synthetic bioabsorbable poly (glycolide: trimethylene carbonate) copolymer (PGA:TMC).

GORE® SEAMGUARD® Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. GORE® SEAMGUARD® Reinforcement can be used for reinforcement of staple lines during hysterectomy, lung resection, liver resection, bladder reconstruction, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, small bowel, and spleen procedures. GORE® SEAMGUARD® Reinforcement is also intended to be used for reinforcement of staple lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.

The modified GORE® SEAMGUARD® Reinforcement possesses the same indications for use and fundamental scientific technology as the predicate GORE® SEAMGUARD® Reinforcement. The implantable device and loading carriers of the predicate GORE® SEAMGUARD® Reinforcement are being modified to permit the reinforcement material to be loaded onto the stapler and attach via adhesive-coated tabs that wrap around the side/back of the cartridge/anvil jaws of a surgical stapling device, in lieu of attaching a fully-coated device surface to the top surfaces of the cartridge/anvil jaws, to minimize the impact of the surface topography of surgical staplers in establishing compatible device fit. The implantable materials of the modified GORE® SEAMGUARD® Reinforcement and predicate GORE® SEAMGUARD® Reinforcement are the same bioabsorbable PGA:TMC. Both utilize the same bioabsorbable PLA:TMC adhesive to secure the device onto the jaws of a surgical stapler.

NEOVEIL™ is indicated for use in surgical procedures in which soft tissue transection or resection with suture or staple line reinforcement is needed. NEOVEIL™ can be used for reinforcement of suture or staple lines during lung resection, liver resection, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, and small bowel procedures.

As packaged, NEOVEIL™ is a suture- and staple-reinforcement product composed of 100% bioabsorbable polyglycolic acid (PGA). This nonwoven product is dyed with D&C Green No.6 in order to make it readily visible to the surgeon. Two forms of NEOVEIL TM are provided. The Tube type model constitutes of pre-formed porous bio-absorbable nonwoven sheets and is intended for staple-line reinforcement. The Tube type model is provided in the form of sleeves, one for the cartridge and one for the anvil on a corresponding stapler. After deployment of the tube type reinforcement material, the non-degradable elastic knits, comprised of polyurethane and nylon, are removed and discarded along with the PGA tacking sutures. The Sheet type model is simply a porous fibrous bio-absorbable sheet which is intended for suture-line reinforcement. The thickness of the bioabsorbable NEOVEIL™ staple line reinforcement ranges from 0.1 mm to 0.85 mm. Mesh weave characteristics and pore size are not applicable since NEOVEIL™ is nonwoven material. Average basis weight of the NEOVEIL model ranges from 35 to 225 (g/m²).

GORE® SEAMGUARD® Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. GORE® SEAMGUARD® Reinforcement can be used for reinforcement of staple lines during hysterectomy, lung resection, liver resection, bladder reconstruction, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, small bowel, and spleen procedures. GORE® SEAMGUARD® Reinforcement is also intended to be used for reinforcement of staple lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.

The subject GORE® SEAMGUARD® Reinforcement device is an assembly of three components: 1) the implantable device, 2) two (2) loading carriers (for anvil & cartridge side of stapling device), and 3) a protective cover. The implantable device consists of three layers - Web, Film, and Adhesive. The Web and Film layers are comprised of synthetic bioabsorbable polyglycolide (PGA) and trimethylene carbonate (TMC). A thin layer of bioabsorbable adhesive is coated onto one surface of the implantable device, and is composed of a synthetic bioabsorbable polylactide and trimethylene copolymer. The adhesive's function is to affix the device onto the surgical stapler for delivery to the implant site. The bioabsorbable copolymers degrade via a combination of hydrolytic and enzymatic pathways. The device is supplied sterile for single use only.