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The Aquamantys single-use disposable Malleable Bipolar Sealer with Light is a sterile, bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of RF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to orthopaedic, spine, thoracic, and open abdominal surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

The Aquamantys Malleable Bipolar Sealer is similar to the Aquamantys 6.0 Bipolar Sealer, cleared via K#052859, in that they are comprised of a pencil-grip handle which houses an electrode terminating at the distal tip. The Aquamantys Malleable Bipolar Sealer is constructed of the same medical device grade materials as the Aquamantys 6.0 except for the LED light circuit and over molded shaft. All biocompatibility data is on file at TissueLink Medical, Inc. A summary is included in Section 5 of this submission. The manufacture of both devices is similar, consisting of an electrode tip/shaft assembly extending out of an ergonomically designed clamshell body. Both devices have two parallel (along the axis of symmetry) electrodes stemming from the handle that are approximately 4-6 millimeters apart. Both devices are electrically insulated, leaving only the tip of each shaft electrically active. Like the Aquamantys 6.0 Bipolar Sealer, each tip of the Aquamantys Malleable is a smooth stainle cylinder with a hemispherical end. Each tip is set at a downward angle between 0° - 45° along the long axis of the device. The Aquamantys 6.0 device has a slot located on each tip oriented lateral to the handle towards the outside of the device, allowing saline to flow from the inner lumen of the hypotube to the electrode. The Aquamantys Malleable device incorporates a hole instead of a slot, similarly oriented lateral to the handle towards the outside of the device. The saline wets the outer surface of the stainless steel electrode tip in a manner identical to the Aquamantys 6.0 Bipolar Sealer. The device is not intended for use without saline. Ten (10) feet of saline tubing and electrical cord are routed distally from the handle. The distal end of the disposable electrical cord contains a standard three (3) prong paddle plug for connection to the Aquamantys Pump Generator System. The saline tubing is connected to an I.V. pump segment. The L.V. pump segment contains a 6" pump tubing portion for loading into the Aquamantys Pump portion of the Aquamantys Pump Generator System and a Drip Chamber/spike set for connection to the saline delivery source. The simultaneous application of saline irrigation and radio-frequency energy allows coagulation of bleeding tissue at much lower temperatures than conventional dry radiofrequency coagulation. This prevents the formation of surface eschar. Most conventional electrosurgical devices create a surface eschar that is hard and scab-like. The Aquamantys Malleable Bipolar Sealer has an optional illumination provided by a LED light positioned between the electrodes at the distal end of the device. It can be switched on or off with a button located on the handpiece and is used to illuminate the surgical site if needed. The Aquamantys Malleable Bipolar Sealer also incorporates a malleable shaft that can be bent by the user into various positions, while maintaining the functionality as identified in the product specifications.

The TissueLink SS4.0 bipolar sealer is a sterile, single-use bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of RF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for but not limited to orthopaedic, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein-sealling during surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization.)

Aquamantys SS4.0 Bipolar Sealer

The Aquamantys™ Bipolar Pump Generator is an electrosurgical generator with a rotary peristaltic pump which is intended for hemostatic sealing of soft tissue and bone at the operative site. It is intended for, but not limited to, use in orthopaedic, spine and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization). For use only by qualified medical personnel properly trained in the use of electrosurgical equipment, technology and techniques.

The Aquamantys Pump Generator is a shelf top unit consisting of a sheet metal housing, front control panel and side mounted pump. Within the housing resides a main circuit board, a display board and a power supply. The software integrates the flow to the desired power setting and flow level selected. The pump generator can be set from 20 to 200 watts and has high, medium and low flow rate settings. The Aquamantys system includes the pump generator, cart and specified Aquamantys disposable devices. The Aquamantys BPS 6.0 and the Aquamantys BPS 2.3 are hand held "wand" like devices that consist of a plastic handle with two needle electrodes at one end that interface with the operative site. The other end of the handle has a cable that plugs into the pump generator and have a section of pump tubing that clamps into the peristaltic pump. Compared to most conventional electrosurgical devices and generators, TissueLink bipolar devices are unique in that they provide simultaneous fluid delivery, as well as the treatment of tissue that is based on simultaneous irrigation and low power density RF energy delivery to tissue that is oozing blood at a slow but steady rate.

The TissueLink BPS bipolar sealer is a sterile, single use electrosurgery device intended to be used in conjunction with an electrosurgical generator for delivery of radiofrequency current and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to, endoscopic and open abdominal, orthopaedic, spine and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

TissueLink Bipolar Sealer 2.3 (Bipolar Floating Ball) device

The TissueLink Sealing Forceps (Bipolar Forceps) is a sterile, single use bipolar electrosurgical device intended to be used in general and thoracic electrosurgical applications for coagulating, sealing and transecting tissue. It is intended for, but not limited to abdominal and thoracic surgery, laparoscopic procedures, endoscopic procedures and thoracoscopic procedures. The device is not intended for contraceptive tubal coagulation (permanent female sterilization.)

TissueLink Sealing Forceps, Model 1 21-202-1

The TissueLink Bipolar Floating Ball device is a sterile, single use electrosurgery device intended to be used in conjunction with an electrosurgical generator for delivery of radiofrequency current and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to, endoscopic and open abdominal, orthopaedic, spine and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

TissueLink Bipolar Floating Ball device

The TissueLink Bipolar Floating Ball device is a sterile, single use bipolar electrosurgery device intended to be used in conjunction with an electrosurgical generator for delivery of mention to be asou in colligation for hemostatio sealing and coagulation of soft tissue at the operative site. It is intended for, but not limited to, endoscopic and open abdominal, general and operaire surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

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The TissueLink Solid Cylinder monopolar device is a sterile, single use electrosurgery device intended to be used in conjunction with an electrosurgical generator for delivery of radio frequency current and saline for blunt dissection, hemostation of soft tissue at the operative site. It is intended for, but not limited to, endoscopic and open abdominal and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

TissueLink Solid Cylinder monopolar device