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The AURORA Surgiscope System is intended for use in neurosurgery and endoscopic neurosurgery and pure neuroendoscopy (i.e. ventriculoscopy) for visualization, diagnostic, and/or therapeutic procedures, such as ventriculostomies, biopsies and removal of cysts, tumors, and other obstructions.

The Aurora Surgiscope System consists of two components: (1) a sterile, single use, Sheath with integrated illumination LEDs and camera, with an Obturator, and (2) a non-sterile, reusable control unit, Image Control Box (ICB). The Sheath is intended to provide access to the surgical site by acting as the insertable portion of the device, as well as the instrument channel to accommodate other surgical tools. Depth markers are present along the length of the Sheath for user reference. The proximal end of the Sheath also incorporates a Tab, which serves as the location for fixation arm to hold the device. At the proximal end of the Sheath is the Imager, which comprises the following components: LEDs (light emitting diodes), camera (and optical components), and focus knob. - The LEDs provide illumination to the surgical field by directing light down the Sheath, along the working channel. - The camera captures videos of the surgical field. - The focus knob allows the user to adjust the focus of the camera to obtain the desired image quality. To facilitate insertion of the Sheath into the surgical site, an Obturator is provided with the device. During device insertion, the Obturator is fully inserted into the Sheath, and the entire AURORA Surgiscope is advanced to the desired surgical location. The distal end of the Obturator is conical in shape to minimize tissue damage during device insertion. In addition, the proximal handle of the Obturator is designed to accommodate various stereotactic instruments for neuronavigation, which can further aid in device placement. The Obturator is removed after insertion. The ICB is a non-sterile device that provides three main functions in the AURORA Surgiscope System: - To power the LEDs and camera of the AURORA Surgiscope. - To relay the video feed captured by the AURORA Surgiscope camera to a connected Medical Grade Surgical Monitor for real-time image visualization. - To allow the user to make adjustments to the displayed video feed (e.g., contrast, brightness), and to vary the light output of the LEDs. The user interface is a membrane keypad with buttons located on the ICB that can be depressed for image adjustment, such as zoom, contrast, and brightness. The connection ports to the AURORA Surgiscope, Medical Grade Surgical Display Monitor, and Power are located on the side of the ICB, along with the ON/OFF switch.

The CUSA® Clarity Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable. The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in: Plastic and Reconstructive surgery, Orthopedic Surgery and Thoracic Surgery and the following specific uses: Neurosurgery - including removal of primary and secondary malignant and spinal tumors, including but not limited to meningiomas and gliomas Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy Urological surgery- including removal of renal parenchyma during nephrectomy or partial nephrectomy General Surgery - including removal of benign or malignant tumors or other unwanted soft or hard tissue in open or minimally invasive general surgical procedures Laparoscopic Surgery - including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy Gynecological Surgery - including removal of dysplastic genital epithelial tissue including vulvar and vaginal intraepithelial neoplasia, removal of condyloma, debulking of metastatic uterine, ovarian, fallopian tube or primary peritoneal carcinoma, and open or laparoscopic excision of tissue and adhesions associated with endometriosis

The CUSA Clarity Ultrasonic Surgical Aspirator System (CUSA Clarity) is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective dissection of target tissue while preserving vessels, ducts and other delicate structures. The CUSA Clarity consists of a console that provides power and control of the ultrasonic, aspiration and irrigation functions, two surgical handpieces that provide ultrasonic mechanical energy (23 kHz and 36 kHz), a footswitch to allow user control over the ultrasonics, titanium surgical tips (variety of models), irrigation flues, suction/irrigation system (manifold tubing and vacuum canister) and accessories used for assembly/disassembly and reprocessing. The CUSA Clarity may also be optionally used with the CUSA Electrosurgical Modules which provide optional electrosurgical capability.

The CUSA® Clarity Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable. The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in: Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses: Neurosurgery - including removal of primary and secondary malignant and benign brain and spinal tumors, including but not limited to meningiomas and gliomas Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy Urological surgery- including removal of renal parenchyma during nephrectomy or partial nephrectomy General Surgery - including removal of benign or malignant tumors or other unwanted soft or hard tissue in open or minimally invasive general surgical procedures Laparoscopic Surgery - including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy

The device within the scope of this premarket notification is the optional CUSA® Electrosurgery Module (CEM) accessory that is intended to be used with the 23 kHz components of the CUSA® Clarity Ultrasonic Surgical Aspirator System. The purpose of this submission is to modify the CEM nosecone accessory currently offered with CUSA Clarity to allow for connection with additional electrosurgical generators, to continue to provide electrosurgical capabilities to the user. The additional electrosurgical generators that the modified CEM Nosecone may be used with include the Medtronic FT10 (K191601), Medtronic FX8 (K181389), Erbe VIO 300D (K083452), and Erbe VIO 3 (K190823). Compatibility with the Medtronic Force FX (K143161) will be maintained as well. The CUSA Clarity 23kHz Expanded CEM Nosecone has the same intended use and technological characteristics as the predicate CUSA Clarity 23 kHz CEM Nosecone (K190180). The subject CEM nosecone will continue to allow the surgeon to apply immediate electrosurgical coagulation to bleeding tissue at the surgical site, with the same handpiece assembly that is removing unwanted tissue.

The CUSA® Clarity Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable. The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in: Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses: Neurosurgery - including removal of primary and secondary malignant and benign brain and spinal tumors, including but not limited to meningiomas and gliomas Gastrointestinal and Affiliated Organ Surgery – including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy Urological surgery- including removal of renal parenchyma during nephrectomy or partial nephrectomy General Surgery – including removal of benign or malignant tumors or other unwanted soft or hard tissue in open or minimally invasive general surgical procedures Laparoscopic Surgery - including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy

The device within the scope of this premarket notification is the CUSA® Clarity 23kHz Single-Sided Bone Tip Pack that is intended to be used with the 23 kHz Handpiece of the CUSA® Clarity Ultrasonic Surgical Aspirator System. The CUSA® Clarity Ultrasonic Surgical Aspirator System is the newest device that was added to the Integra Lifesciences Corporation family of tissue ablation products. All CUSA systems are surgical aspirators that use ultrasonics and cavitation with irrigation and aspiration, to fragment, emulsify and remove unwanted tissue. It allows for the selective dissection of target tissue while preserving vessels, ducts, and other delicate structures. The CUSA Clarity 23kHz Single-Sided Bone Tip Pack has the same intended use and technological characteristics as the predicate CUSA Clarity system, including all predicate tip pack accessories. A bone tip is currently cleared with the predicate CUSA Clarity system (CUSA Clarity 23 kHz Bone Tip). The primary modification of the CUSA Clarity 23 kHz Single-Sided Bone Tip Pack when compared to the currently cleared CUSA Clarity bone tip is that the subject device has a limited abrasive fragmentation surface at the distal end of the tip when compared to the existing bone tip.

The CUSA® Clarity Ultrasonic System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable. The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in: Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses: Neurosurgery - including removal of primary and secondary main and spinal tumors, including but not limited to meningiomas and gliomas Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy Urological surgery- including removal of renal parenchyma during nephrectomy or partial nephrectomy General Surgery - including removal of beingn or malignant tumors or other unwanted soft or hard tissue in open or minimally invasive general surgical procedures Laparoscopic Surgery - including removal of hepatic parenchyma in lapatic resection, lobectomy or trisegmentectony, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy

The devices within the scope of this premarket notification are the CUSA® Clarity 23kHz Laparoscopic Tip Packs that are intended to be used with the 23 kHz Handpiece of the CUSA® Clarity Ultrasonic Surgical Aspirator System. The CUSA® Clarity Ultrasonic Surgical Aspirator System is the newest device that was added to the Integra Lifesciences Corporation family of tissue ablation products. There are three (3) systems currently marketed in the United States: CUSA Clarity Ultrasonic Surgical Aspirator System (CUSA Clarity), CUSA® Excel+ Ultrasonic Surgical Aspirator System (CUSA Excel+) and CUSA® NXT Ultrasonic Tissue Ablation System (CUSA NXT). All CUSA systems are surgical aspirators that use ultrasonics and cavitation, in combination with irrigation and aspiration, to fragment, emulsify and remove unwanted tissue. It allows for the selective dissection of target tissue while preserving vessels, ducts, and other delicate structures. The CUSA Clarity 23kHz Laparoscopic Tip Packs have the same intended use and technological characteristics as the predicate CUSA Clarity and CUSA Excel+ systems, including the predicate tip pack accessories. The primary modification of the subject tips compared to the predicate devices is that they are longer, in order to provide an alternate tip design suited for laparoscopic surgery to the CUSA Clarity portfolio. CUSA Clarity is already indicated for laparoscopic surgery. The purpose of the subject tips is to continue to fill out the CUSA Clarity Tip portfolio to align with that of the legacy CUSA Excel+ system and meet user needs; the CUSA Excel+ system has a tip design very similar to the subject tips. Additionally, testing confirmed that the modifications reduce the frictional force between a trocar and the flue as compared to the predicate CUSA Excel+ Laparoscopic Tip, making the device easier to insert and retract from the trocar during surgical use.

INTEGRA® Wound Matrix (Macro-Channels) is indicated for the management of wounds including: partial and full-thickness wounds, pressure 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, partial thickness burns, skin tears) and draining wounds. The device is intended for one-time use.

INTEGRA® Wound Matrix (Macro-Channels) is a collagen-glycosaminoglycan wound dressing that maintains and supports a healing environment for wound management. INTEGRA® Wound Matrix (Macro-Channels) has macro-channels to facilitate drainage of wound exudate. INTEGRA® Wound Matrix (Macro-Channels) is supplied sterile and is intended for one-time use.

The intended use/indications for use of the predicate devices identified remain the same as previously cleared in their respective 510(k)s. The respective 510(k)s for the devices can be referenced in the predicate device section above.

The purpose of this submission is the addition of MR Conditional information to the labeling for the predicate devices. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions, packaging or sterilization.

The surgical patties and surgical strips are indicated for the use including brain and other tissues of the central nervous system, during surgery.

The Codman Surgical Patties and Strips are single use, sterile devices indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery. The Surgical Patties are comprised of 3 main components: Cottonoid Material, String and X-ray detectable monofilament. The Strips are comprised of 2 main parts: Cottonoid Material and X-ray detectable monofilament.

The Cadence Total Ankle System is designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. The Cadence Total Ankle System is indicated for use to treat: - Systemic arthritis of the ankle (e.g. rheumatoid arthritis, hemochromatosis) - Primary arthritis (e.g. degenerative disease) - Secondary arthritis (e.g. post-traumatic, avascular necrosis, if minimally 2/3 of the talus is preserved) Cadence Total Ankle System is also indicated for revision surgeries following failed total ankle replacement and non-union/mal-union of ankle arthrodesis. Provided sufficient bone stock is present. Note - In the United States, this device is intended for cemented use only. Note - Outside the United States, this device is intended for cemented or cementless use.

The Cadence Total Ankle System is a prosthesis composed of a tibial tray, a talar dome and an insert. The tibial tray and talar dome are secured to patient anatomy. The insert is rigidly fixed to the tibial tray intra-operatively. The insert acts as a bearing along the talar dome, enabling flexion and extension movement at the replaced joint. Each of the three components is available in a variety of sizes and design configurations intended for both primary and revision surgery applications. The Cadence System also consists of various instrumentation to allow for appropriate implantation of the Cadence Prosthesis. The scope of the Cadence System is being extended to include additional options for the talar domes. The new talar dome option features a flat cut design in comparison to the currently commercialized talar dome chamfer cut design. New instrumentation will also be introduced to aid in the implantation of the new flat cut talar dome design.

The CUSA Clarity Ultrasonic System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable. The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in: Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses: Neurosurgery - including removal of primary and secondary main and spinal tumors, including but not limited to meningiomas and gliomas Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy Urological surgery- including removal of renal parenchyma during nephrectomy or partial nephrectomy General Surgery - including removal of benign or malignant tumors or other unwanted soft or hard tissue in open or minimally invasive general surgical procedures Laparoscopic Surgery - including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy

The CUSA Clarity Ultrasonic Surgical Aspirator System (CUSA Clarity) is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective dissection of target tissue while preserving vessels, ducts and other delicate structures. The CUSA Clarity consists of a console that provides power and control of the ultrasonic, aspiration and irrigation functions, two surgical handpieces that provide ultrasonic mechanical energy (23 kHz and 36 kHz), a footswitch to allow user control over the ultrasonics, titanium surgical tips (variety of models), irrigation flues, suction/irrigation system (manifold tubing and vacuum canister) and accessories used for assembly/disassembly and reprocessing.