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The RenaFlex™ Single-use Flexible Ureteroscope is intended to be used to visualize organs, cavities, and canals in the urinary tract (urethra. bladder, ureter, calvces and renal papillae) via transurethral or percutaneous access routes. It can also be used with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract. The Video System Center for Single Use Endoscopes is intended to provide illumination and receive, process, and output images from the compatible Olympus endoscope for diagnostics, treatment, and observation.

The RenaFlex Single-use Flexible Ureteroscope System will provide visualization and access for diagnostic and therapeutic applications, including urinary system biopsy and kidney stone treatment and removal. The RenaFlex Single-use Flexible Ureteroscope and compatible Video System Center for Single-use Endoscopes provide a means for direct visualization, diagnosis, and treatment of various diseases in the urinary tract and kidneys. The ureteroscope component of the system is intended as a single-use device that works to access the anatomy and to guide accessory devices for diagnostic and therapeutic applications in the urinary tract and kidneys. The compatible Video System Center for Singleuse Endoscopes is a reusable software-driven device that provides illumination and receives, processes, and outputs images from the endoscope using field upgradable software for diagnosis, treatment, and observation.

The POWERSEAL Sealer and Divider is a bipolar electrosurgical device intended for use in laparoscopic/minimally invasive or open surgical procedures where ligation of vessels, tissue bundles, and lymphatics is desired. POWERSEAL devices can be used on vessels (arteries and veins, pulmonary arteries, pulmonary veins) up to and including 7 mm, lymphatics, and tissue bundles. POWERSEAL devices are indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatio, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to. Nissen fundoplication, colectomy, adhesiolysis, sleeve gastrectomy, hysterectomy, oophorectomy. The POWERSEAL Sealer and Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the POWERSEAL devices for these procedures.

The POWERSEAL 5mm laparoscopic jaw sealer divider is an electrosurgical bipolar device with an integral extending cutting blade. It features a pistol grip handle and is provided in shaft lengths of 23, 37, and 44 cm. The POWERSEAL devices will be provided as sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with Olympus electrosurgical generators to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics. The jaws of the POWERSEAL are designed to seal vessels, and grasp and dissect tissue during open and minimally invasive general surgical procedures using radiofrequency (RF) energy, otherwise known as high frequency (HF) energy. A hand-actuated mechanism allows the user to open and close the instrument jaws. When the instrument jaws are correctly placed over the tissue or vessel to be sealed, the user operates a second control to initiate delivery of bipolar energy, which seals the tissue. When the sealing is complete, the user operates a separate control to activate a blade, which divides the tissue along the seal line.

The SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is intended for incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.

The SOLTIVE Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is a thulium laser. producing a pulsed beam of coherent near-infrared light (1940 nm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated LED touch screen gives the user control over the necessary laser system parameters. The SOLTIVE Laser System is equipped with a 550 nm aiming beam. The SOLTIVE Laser System is produced in two models, the SOLTIVE™ Premium SuperPulsed Laser and SOLTIVE™ Pro SuperPulsed Laser. The Premium has a maximum power output of 60 Watts and a maximum Frequency output of 2400 Hz. A secondary, foldable screen is provided. The Pro can operate at a maximum power of 35 Watts and Frequency limited to 100Hz. Both systems are operated with a wireless footswitch or wired footswitch, and both systems can utilize an auxiliary video monitor to display operating parameters. The Premium and Pro Laser must be used with a SOLTIVE Laser Fiber, offered in diameters from 150 - 940 microns. The system includes: - Laser console - Laser fibers sterile single use and reusable - Foot pedal, wireless or wired - Accessories power cord. HDMI cable, safety goggles/glasses, fiber cutter, fiber cleaver, fiber stripper and cart The devices do not incorporate medicinal substances, tissues, or blood products. The laser fibers are single-use and reusable, and both single-use and reusable are initially sterilized by Ethylene Oxide. Fibers are compatible with the Olympus endoscope models as listed on the IFU.

The Celeris System (reusable power pack and Disposable Sinus Debrider) is intended for cutting, debriding, and removal of thin bone and soft tissue in general ENT and Sinus/Rhinology procedures and applications would include: · FESS (Functional Endoscopic Sinus Surgery) – Including Endoscopic approaches for: Polypectomy, Sphenoidectomy, Maxillary Antrostomy, Uncinectomy, Frontal Sinusotomy · Turbinate Reduction / Turbinoplasty, including sub-mucosal resection.

The Celeris DSD handpiece is a single-use disposable debrider handle and blade permanently combined with a built-in motor that plugs into a reusable power pack that contains a power supply for motor control. The power pack is also part of the subject system. The power supply is able to auto-adapt to any voltage via the universal power cord connection. Motor control requires software on a controller board inside the power pack. The handpiece incorporates a rotatable blade and attached RF cable for bipolar models. The blades are either standard, bipolar, or malleable. The bipolar function requires a separate electrosurgical generator (not part of this system), connected via a cable. The cutting performance is equivalent to the current Gyrus ACMI predicate models. A trigger style button on the DSD handle, or analog footswitch (sold separately) connected to the power pack, activates the blade oscillation and a standard electrosurgical unit footswitch (sold separately) powers the binolar effect for bipolar blades. The electrosurgical generator and footswitch alone will control the RF energy delivery. A nosecone on the DSD handpiece allows the blade cutting window to rotate left or right. The blades are offered in 2mm and 4mm variants, either straight or malleable, and standard or bipolar. The malleable blade angle is flexible, and the design allows the blade to be bent with the provided bending fixture up to 60° at the user's discretion. A standard suction tube (sold separately) is attached to the DSD handpiece proximal suction port and a clip attaches the tubing to the power cable. The handpiece power cable plugs directly into the power pack. The non-sterile power pack plugs into a standard power outlet and only provides power to the connected DSD handpiece. When the handpiece is activated power is sent to the motor which oscillates a gear which in turn oscillates the inner blade. For bipolar models, the energy lead from the cable is connected directly to the blade and energy is provided by the separate electrosurgical generator footswitch. For bipolar models, insulation around the cutting window limits energy delivery to the surgical site.

1. The PK Needle is indicated for resection of soft tissue in laparoscopic and general surgical procedures. 2. The PK Spatula is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures. 3. The PK J-Hook is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures.

The Olympus PK Electrosurgical Instruments: PK Needle, PK Spatula, and PK J-Hook are bipolar electrosurgical instruments with the capability to resect, cut, and coagulate soft tissue and blood vessels in laparoscopic and general surgical procedures. They pass through a 5mm cannula or operating laparoscope working channel of 5mm or larger diameter. The devices are activated via buttons on the handle or by a foot pedal and plug into compatible Olympus generators (ESG-400 and ESG-410). The generator and device make up a medical electrical system.

The SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is intended for incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery. Urology: · Ablation of Benign Prostatic Hypertrophy) [BPH]• Laser Resection of the Prostrate (LRP)• Laser Enucleation of the Prostate (LEP) · Laser Ablation of the Prostate (LAP) · Transurethral Incision of the Prostate (TUIP) · Condylomas · Urethral strictures · Lesions of external genitalia · Bladder neck incisions (BN) · Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors Endoscopic fragmentation of ureteral, bladder, and renal calculi• Treatment of distal impacted fragments remaining in the ureters following lithotripsy Lithotripsy and Percutaneous Urinary Lithotripsy Indications: · Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones • Endoscopic fragmentation of calculi • Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed Gastroenterology: Open and endoscopic gastroenterology surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) including: · Appendectomy · Angiodysplasia · Polyps · Colorectal cancer · Biopsy · Telangiectasias • Gall Bladder calculi • Telangiectasias of the Osler-Weber-Renu disease • Biliary/Bile duct calculi • Vascular Malformation . Ulcers . Gastric ulcers . Esophagitis . Duodenal ulcers . Esophageal ulcers . Non Bleeding Ulcers · Varices · Pancreatitis · Colitis · Haemorrhoids · Mallory-Weiss tear · Cholecystectomy · Gastric Erosions • Benign and Malignant Neoplasm Gynecology: Open and laparoscopic gynecological surgery (incision, excision, ablation, vaporization, coagulation and hemostasis) of soft tissue

The SOLTIVE Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is a thulium laser, producing a pulsed beam of coherent near-infrared light (1940 nm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated LED touch screen gives the user control over the necessary laser system parameters. The SOLTIVE Laser System is equipped with a 550 nm aiming beam. The SOLTIVE Laser System is produced in two models, the SOLTIVE™ Premium SuperPulsed Laser and SOLTIVE™ Pro SuperPulsed Laser. The Premium has a maximum power output of 60 Watts and a maximum Frequency output of 2400 Hz. A secondary, foldable screen is provided. The Pro can operate at a maximum power of 35 Watts and Frequency limited to 100Hz. Both systems are operated with a wireless footswitch or wired footswitch, and both systems can utilize an auxiliary video monitor to display operating parameters. The Premium and Pro Laser must be used with a SOLTIVE Laser Fiber, offered in diameters from 150 - 940 microns. The system includes: - Laser console ● - Laser fibers sterile single use and reusable ● - Foot pedal, wireless or wired ● - Accessories power cord, HDMI cable, safety goggles/glasses, fiber cutter, . - fiber cleaver, fiber gripper, sterilization trav, cart . The devices do not incorporate medicinal substances, tissues, or blood products. The laser fibers are single-use and reusable, and both single-use and reusable are initially sterilized by Ethylene Oxide. Fibers are compatible with the Olympus endoscope models as listed on the IFU.

Indicated for use in patients undergoing nasal/sinus surgery as a space occupying hemostat/splint to: - Separate tissue or structures compromised by surgical trauma - Separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity - Help control minimal bleeding following surgery or trauma - Help control minimal bleeding following surgery or nasal trauma by tamponade effect blood absorption and platelet aggregation - Act as an adjunct to aid in the natural healing process Indicated for use as a nasal hemostat to treat epistaxis. Intended for use under the direction of a licensed healthcare provider.

Intranasal splints are utilized to stop nasal hemorrhage and for the prevention of tissue adhesion in the nasal and/or sinus cavities. It is often used after FESS, nasal/sinus surgery, or surgical trauma in the event of excessive epistaxis. Splints are gently inserted into the nasal cavity. The device is designed to swell within the nasal cavity in order to exert pressure on the bleeding sites. The splint material is dissolvable. Splints can also be used following sinus surgery in order to hold cartilage and membranes in their proper places during healing following surgerv. The Chitosan Intranasal Splint is made from Carboxymethyl Chitosan, mixed with Methyl Cellulose, and Hydroxyethyl Cellulose to make an absorbent porous sponge that is flexible and dissolvable. The device acts as a nasal splint and temporary spacer.

The Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheters are in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.

Both the predicate and proposed Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheters consist of a semi-compliant nylon blow molded balloon; and, a shaft that communicates a fluid passage for expansion and collapse of the balloon portion, operated by an inflation device. Like the predicate, the EZDilate Wire Guided Balloon is designed to be used with a 0.035 in. (0.89mm) guidewire and has a wire lumen sized appropriately. Each balloon catheter is packaged with a soft tip 0.035 in. (0.89mm) guidewire pre-loaded into the guidewire lumen. The guidewire is manufactured by Lake Region Medical; and, is cleared under K935198, Gastroenterology and Urology Guidewire Modifications. All wire-guided balloons with have lengths of 5.5cm and a catheter length of 240cm. The balloon is inflated with a 60cc inflation device, which will be sold separately. The suggested inflation device is manufactured by Atrion (K032840). The Gyrus ACMI EZDilate 3-StageWire Guided Balloon Dilatation Catheter is a reinforced catheter attached to a distal dilatation balloon. The semi-compliant balloon allows for a progressive radial expansion through three target sizes using one balloon. A silicone coating applied to the balloon increases ease of insertion, positioning of the balloon within the alimentary tract, and device removal.

For rapid transcervical aspiration of the uterine cavity.

The Berkeley VC-10 Vacuum Curettage System uses aspiration to remove uterine contents through the cervix. The system includes the vacuum pump, collection containers, connection tubing, and patient contacting vacurettes. The vacuum pump is electrically powered and generates suction through vacuum pressure. The vacuum pump console is not provided sterile and is a multi-use device. The patient contacting vacurettes of the VC-10 system are provided as sterile, single use disposable devices. Similar to the predicate device VC-10, the modified Berkeley VC-10 includes a high capacity. double diaphragm pump and motor, enclosed in a stainless steel cabinet. Collection canisters sit on top of the cabinet, and a large vacuum gauge and vacuum control knob are easily accessed on the top of the cabinet. A vacurette (available in various shapes and sizes) is attached to a collection set (includes a plastic swivel handle with a slip ring to control the vacuum and PVC tubing) and is attached to the patient port of the first collection container. Two accessories, which can be used to collect tissue, include a tissue trap, which is connected to the collection tubing and the collection container, or a gauze sack, which is placed inside the collection container. The modified VC-10 offers the same foot actuator pedal for vacuum supply.

The PK AIM is indicated for open, general surgery (including plastic and re-constructive) or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping and dissection is performed. The device has been designed to seal and cut vessels (up to and including 3 mm in diameter), tissue bundles, and lymphatics when used with the Olympus ESG-400 Generator. This device is not intended to be used for tubal ligation or female sterilization.

Both predicate PK AIM and proposed PK AIM devices can be described as 2 in 1 devices with a pencil type handle that combines the technologies of a monopolar pencil and a bipolar forceps. The device has buttons that allow hand activation and a sliding toggle switch to allow the surgeon to switch between a forceps, and a pencil device. Foot pedals connected to the generator are also available to allow for foot pedal activation of the device. Both predicates (Olympus OFJ and Olympus PK AIM connect/plug into the Olympus ESG-400 generator (K141225). The generator and subject device make up a medical electrical system. The PK AIM instrument is to be used only with the Olympus ESG-400 Generator. The proposed device is comprised of a mixture of plastics, metals heatshrink and epoxy.