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The HydroCision Spinelet System is indicated for surgical procedures where the cutting and removal of soft tissue and the ablation and removal of hard tissue or bone is required. Specific functions include cutting, ablation and shaping of soft tissue, and decorticating and smoothing of bone, cartilage and other bone related tissue in open and minimally invasive in spinal surgeries.

The HydroCision SpineJet System comprises of (i) sterile disposable tubing assembly- SpineJet device and (ii) reusable console unit- HydroCision Console. The components of SpineJet device consists of a pump cartridge, handpiece and tubing assembly (also known as disposable hose). The SpineJet device is provided sterile, via ethylene oxide sterilization. The reusable HydroCision Console are packaged and sold separately. The SpineJet device is designed to be used in combination with the HydroCision console as a SpineJet system. The SpineJet system is connected with a foot pedal, a sterile bag of saline, and a waste container prior to operation. The SpineJet device pump cartridge plugs into the front of the HydroCision Console. This connection provides power to the SpineJet device and pressurizes the saline to deliver to the tip of the SpineJet handpiece through high pressure saline tube. The SpineJet handpiece consists of a plastic handle and a two-lumen needle: high pressure tube lumen and evacuation tube lumen, which are welded together in the handle. As the high-pressure saline passes from one lumen nozzle to another lumen nozzle, the targeted tissues are cut, debrided and removed into the evacuation tube lumen, passing into the waste container. The SpineJet tubing assembly (also known as disposable hose) consists of three tubes: (i) Clear saline supply tube (fluid supply hose) - which delivers saline from saline bag to pump cartridge (ii) High pressure saline tube- which delivers pressurized saline from the pump cartridge to the tip of Spinelet handpiece and (iii) Evacuation tube (waste hose) - which removes debrided tissue, along with saline from tip of the handpiece and delivers it to waste container, which is provided by the facility. The Hydrocision Console (K190804) is an electrically powered device. It provides the power to pressurize sterile saline fluid, which is delivered to the distal tip of the SpineJet handpiece. The HydroCision console includes the software functionality to provide touch-screen LCD display and graphical user interface. To perform an open or minimally invasive spinal procedure, the SpineJet handpiece needle is inserted into the spine through cannula access set and guided toward the targeted diseased tissue under fluoroscopic guidance. Once the Spinelet handpiece needle is in position, the surgeon activates the high-pressure saline of Spinelet device using the Hydrocision console and foot pedal. Using fluoroscopic guidance, the surgeon uses the Spinelet handpiece to cut and remove the targeted diseased tissue. When the procedure is complete, the handpiece is withdrawn, and the incision is closed using steri-strips for a closed, minimally invasive procedure. The Spinelet device is provided sterile, via ethylene oxide sterilization.

HydroCision TenJet Device is indicated for orthopedic surgical procedures where the cutting, debridement and removal of soft and hard tissue is required in a variety of open, arthroscopic, and minimally invasive surgical procedures.

The TenJet device is a single use disposable device intended for use in orthopedic surgical procedures where the cutting, debridement and removal of soft and hard tissue is required in a variety of open, arthroscopic, and minimally invasive surgical procedures. The TenJet device is constructed from various biocompatible materials. The TenJet device is designed to be used in combination with HydroCision Console and Foot Pedal, which are sold and package separately. The Accessory Kit, also known as supply kit is packaged along with each HydroCision TenJet Device. The supply kit contains sterile packaged, single use, OEM surgical supply items for use in the surgical site preparation and closure. The itemized contents of the kit with their manufacturer and regulatory information are provided in section 11.7.3 of this 510(k). The components of TenJet device consists of a pump cartridge, handpiece and tubing assembly, which is used in combination with HydroCision Console. The TenJet device pump cartridge plugs into the front of the HydroCision Console. This connection provides power to the TenJet device and pressurizes the saline to deliver to the tip of the TenJet handpiece through high pressure saline tube. The TenJet handpiece consists of a plastic handle and a two-lumen needle: high pressure tube lumen and evacuation tube lumen, which are welded together in the handle. As the high-pressure saline passes from one lumen nozzle to another lumen nozzle, the targeted tissues are cut, debrided and removed into the evacuation tube lumen, passing into the waste container. The TenJet tubing assembly (also known as disposable hose) consists of three tubes: (i) Clear saline supply tube (fluid supply hose) - which delivers saline bag to pump cartridge (ii) High pressure saline tube- which delivers pressurized saline from the pump cartridge to the tip of TenJet handpiece and (iii) Evacuation tube (waste hose) - which removes debrided tissue, along with saline from tip of the handpiece and delivers it to waste container, which is provided by the facility. The Hydrocision Console is an electrically powered device. It provides the power to pressurize sterile saline fluid, which is delivered to the distal tip of the TenJet handpiece. The HydroCision console includes the software functionality to provide touch-screen LCD display and graphical user interface. The detailed software description and associated documentation is included in Section 16 of the TenJet 510(k). To perform an open, arthroscopic or minimally invasive surgical procedure, the TenJet handpiece needle is inserted into the body through a small incision and guided toward the targeted diseased tissue under ultrasound visualization. Once the Tenlet handpiece needle is in position, the surgeon activates the high-pressure saline of TenJet device using the Hydrocision console and foot pedal. Using ultrasound visual guidance, the surgeon uses the TenJet handpiece to cut, debride and remove the targeted diseased tissue. When the procedure is complete, the handpiece is withdrawn and the incision is closed using steri-strips for a closed, minimally invasive, ultrasound guided procedure. The TenJet device is provided sterile, via ethylene oxide sterilization.

The HydroCision ArthroJet System with Cautery, TurboBurr, and Curette is indicated for orthopedic surgical procedures where the cutting and removal of soft tissue and the ablation and removal of hard tissue or bone is required, with control of bleeding during those procedures as needed. Specific functions include cutting, ablation and shaping of soft tissue, and drilling, reaming, decorticating and smoothing of bone, cartilage and other bone related tissue in a variety of surgical procedures including open and minimally invasive spinal surgeries and small and large joint arthroscopic procedures.

The HydroCision ArthroJet System with Cautery, TurboBurr and Curette employs two basic system components to achieve its mechanism of action: - the reusable power console unit - the sterile, disposable pump cartridge, handpiece and tubing assembly. The handpiece component of the sterile, disposable assembly is comprised of two principal components: - a high pressure fluid conduit with integral fluidjet nozzle. - a low pressure collection tube. The high pressure conduit consists of a hollow stainless steel tube with a nozzle at the distal end. The collection tube incorporates an opening at its distal end such that the fluidjet is directed into the opening when in use. Because of the hydrodynamic design of the fluidjet/collection tube combination, the orifice serves to pull excised tissue fragments and other debris into the collection tube. Controls on the front panel allows the user to adjust the pressure, from zero to a factory pre-set limit of 15,000 psi.

The HydroCision ArthroJet System with Cautery, TurboBurr and Curette is indicated for orthopedic surgical procedures where the cutting and removal of soft tissue and the ablation and removal of hard tissue or bone is required, with control of bleeding during those procedures as needed. Specific functions include cutting, ablation and shaping of soft tissue, and drilling, reaming, decorticating and smoothing of bone, cartilage and other bone related tissue in a variety of surgical procedures including open and minimally invasive spinal surgeries and small and large joint arthroscopic procedures.

The HydroCision ArthroJet System with Cautery, TurboBurr, and Curette consists of the reusable power control unit; a sterile, disposable pump cartridge and tubing assembly; and sterile, disposable handpieces with curette. It provides the same functions as the predicate upon which it is based. The handpiece includes the rotating burr, which is driven by a fluidjet driven rotor.

The intended use of the HydroCision General Surgery FluidJet System is for the tangential cutting, resection and removal of soft tissue or fluid from the body. HydroCision General Surgery FluidJet System is not intended for use in suction lipoplasty procedures.

The HydroCision General Surgery FluidJet System uses a pressurized stream of sterile saline to lavage and clean wounds. The stream of saline simultaneously washes the tissue surface and vacuums away foreign material, including contamination and infected and necrotic tissue from the wound. The system employs two basic system components to achieve this purpose: the reusable power console unit and the sterile, disposable pump cartridge, handpiece and tubing assembly.

The HydroCision ArthroJet System with Cautery and TurboBurr is indicated for orthopedic surgical procedures where the cutting and removal of soft tissue and the ablation and removal of hard tissue or bone is required, with control of bleeding during those procedures as needed. Specific functions include cutting, ablation and shaping of soft tissue, and drilling, reaming, decorticating and smoothing of bone, cartilage and other bone related tissue in a variety of surgical procedures including open and arthroscopic spinal surgeries and small and large joint arthroscopic procedures.

The HydroCision ArthroJet System with Cautery and TurboBurr consists of the reusable power control unit; a sterile, disposable pump cartridge and tubing assembly; and sterile, disposable handpieces. It provides the same functions as the predicate upon which it is based. The handpiece includes the rotating burr, which is driven by a fluidjet driven rotor.

The HydroCision. Inc. Debridement System is intended for wound debridement, soft tissue debridement, and cleansing of the surgical site in applications in which, in the physicians judgement, would require the use of a pulse lavage device with sharp debridement. This device is not intended to be used on burns.

The HydroCision Debridement System uses a pressurized stream of sterile saline to lavage and clean wounds. The stream of saline simultaneously washes the tissue surface and vacuums away foreign material, including contamination and infected and necrotic tissue from the wound. The svstem employs two basic system components to achieve this purpose: the reusable power console unit and the sterile, disposable pump cartridge, handpiece and tubing assembly.

The HydroCision, Inc. Debridement System is intended for wound debridement, soft tissue debridement, and cleansing of the surgical site in applications in which, in the physicians judgement, would require the use of a pulse lavage device with sharp debridement. This device is not intended to be used on burns.

The HydroCision Debridement System uses pressurized streams of sterile saline to lavage and clean wounds. The streams of saline simultaneously wash the tissue surface and vacuum away foreign material, including contamination and infected and necrotic tissue from the wound. The system employs two basic system components to achieve this purpose: the reusable power console unit and the sterile, disposable pump cartridge, handpiece and tubing assembly.

The intended use of the HydroCision ArthroJet System with Cautery is to resect damaged tissue, remove extraneous matter, and control bleeding in surgical applications of articular body cavities.

The HydroCision ArthroJet System with Cautery is a surgical device which provides cutting, tissue removal, and electrocauterization in the same tool. The HydroCision ArthroJet System with Cautery uses the same system as the FDA approved HydroCision ArthroJet System (K982266) with the addition of a bipolar cauterization function at the distal tip of the handpiece. The ArthroJet System with Cautery is compatible with standard RF generators which provide bipolar energy output (with a voltage of less than or equal to 1.000 volts p-p). The ArthroJet System with Cautery operates in a saline or Ringer's Lactate environment. The bipolar cables used in the ArthroJet System with Cautery are available in two types, reusable and single use.