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The Quick-Tap® Paracentesis Kit, Tray and Needle are indicated to relieve pressure by draining fluid from the peritoneal space. The fluid may be undergo diagnostic testing to assess for chemistries, infection or abnormal cells.

Abdominal paracentesis is a procedure used to remove bodily fluid from the peritoneal cavity. Fluid can be the result of liver disease, congestive heart failure or other disease that result in "ascites" fluid. Fluid may also be in the form of blood from perforated organs due to trauma. The fluid is susceptible to infection. Abdominal paracentesis provides therapeutic relief to patients who experience bloating and difficult breathing. The procedure serves a diagnostic purpose, as well. Typically, fluid specimens are sent to a laboratory for microbiological, chemical and histological analysis. Abdominal paracentesis can be performed at bedside or in a treatment center. The patient is prepped using sterile technique and local anesthetic. The sitting position is preferred so that gravity can assist. If preferred, a skin nick is performed with a scalpel and a large bore outer cannula is introduced into the peritoneal cavity midline between the umbilicus and pubis. A syringe can be used to collect the first sample of fluid from the patient confirming a suitable puncture site. The inner needle is withdrawn and disposed of leaving the outer cannula in place. Specimen tubes stand ready for specimen collection. The large majority of fluid is drained into bags or large containers and disposed of. There are no guidelines or standard of care that define the amount or rate of ascites fluid evacuation other than to monitor for signs of hypovolemic shock. One to two liters can be evacuated at one session. After paracentesis the cannula is removed and an adhesive bandage is placed over the puncture site. The patient is then monitored briefly for signs of distress such as persistent bleeding from the puncture site, faintness, anxiety, abnormal pulse, temperature etc. Complications are rare but can include hemorrhage, perforation of abdominal organs, wound infection and hypovolemic shock. There are a variety of disposable instruments used for paracentesis. These include generic angio-introducer catheters and specific needle/cannula combinations for paracentesis. Figure A-I illustrates the Ballard, Caldwell® Paracentesis Needle/Cannula. Our proposed paracentesis needles (and thus trays and kits) are substantially equivalent in design, composition, technology and function to our present paracentesis trays (see predicate devices).

Intended to remove, by cutting, a specimen of tissue for microscopic examination from the lungs or bronchial passageways. Patient population; Any patient demonstrating an abnormality or condition indicative of malignancy or benign obstruction as noted through bronchoscopy, x-ray, MRI, etc.

Figure A-1 depicts all but a few reusable biopsy forceps designs. All operate on a 4-bar linkage arrangement as shown. Transverse motion of the control cable results in the pendulum motion of the handle consists of a slide, finger spool or finger ring arrangement and a thumb ring. The jaws are actuated by transverse motion of the finger spool that connects to the control cable is connected to the clevis. The linkages are hinged on small pins, the jaws rotate about an axle pin that is supported by the fork. With the exception of the handle, all the components are fabricated from ASTM 302, 303 or 304 stainless steel. The handle components are fabricated from a suitable material able to withstand several reprocessing cycles.

The intended use of the Lutz Needle is for the administration of single-shot epidural anesthesia. To introduce single-shot anesthetic agents into the epidural space.

The needle presented in this application is equivalent to other anesthesia conduction needles on the market that have been approved for marketing through the Premarket notification process. This is a "me too" device. The subject device has the same technological characteristics as legally marketed predicate devices. The features, specifications, and mode of action are substantially equivalent.

The MIC-KEY® G™ Low Profile Gastrostomy Replacement Kit is designed as a replacement Gastrostomy tube. It can be used in any well formed gastric tract where a low profile device is considered desirable. Gastrostomy tube feeding may be indicated for patients needing long term enteral support, including but not limited to, feeding, hydrating, medication delivery, and decompressing, secondary to a primary condition relating to the head or neck. These conditions may include: Stroke Cancer Head or neck tumors, injuries, or trauma Neurological disorders resulting in a chewing or swallowing disorder.

The MIC-KEY® "G"™ Low Profile Gastrostomy Replacement Kit is intended to be used for patients requiring enteral support or decompression via a gastrostomy and is designed to be a balloon - secured replacement gastrostomy tube. A tapered distal tip eases insertion through the gastric tract and the balloon is then inflated to assure secure placement. The tapered tip makes the tube less traumatic to place than skin level tubes with mushroom type tips. Device modification: The modification to this device is a change in balloon material formulation. The device is packaged sterile and is marketed with a number of accessories; reference page 19 - Kit Certification, "Special" 510(k) Premarket Notification.

The Ballard Medical Products® Faciletome™ Bow String Papillotome(s) is intended to be used for patients requiring transendoscopic cannulation and sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi.

The bow string papillotome is one of the most commonly used E.R.C.P. (Endoscopic Retrograde Colangio-Pancreatography) devices and has been established in the industry for several years. It has evolved into several variations on one general theme, facilitating entrance into the biliary tree. It performs this by housing a stainless steel mono-filament or stranded wire that is to be the active wire when monopolar, surgical power is introduced into the device handle connection. A sheath runs the length of the wire and allows only that portion of the wire that is needed to cut be exposed and insulates the remainder from the patient. The bow geometry and wire tension aid in cutting the tissue at the precise location. The wire is attached to a handle, that when manipulated, allows the operator to apply tension forming a " bow" at the distal end. The Ballard Medical Products® Faciletome™ Bow String Papillotome is placed under direct vision of a duodenscope, with or without fluoroscopic aid. The single lumen, double lumen and triple lumen designs have a variety of cutting wire lengths as well as a variety of precurved tip configurations in the precurved model type.

The MIC-KEY® G™ Low Profile Gastrostomy Replacement Kit is designed as a replacement Gastrostomy tube. It can be used in any well formed gastric tract where a low profile device is considered desirable. Gastrostomy tube feeding may be indicated for patients needing long term enteral support, including but not limited to, feeding, hydrating, medication delivery, and decompressing, secondary to a primary condition relating to the head or neck. These conditions include: Stroke Cancer Head or neck tumors, injuries, or trauma Neurological disorders resulting in a chewing or swallowing disorder.

The MIC-KEY® "G"™ Low Profile Gastrostomy Replacement Kit is intended to be used for patients requiring enteral support or decompression via a gastrostomy, and is designed to be a balloon - secured replacement gastrostomy tube. A tapered distal tip eases insertion through the gastric tract and the balloon is then inflated to assure secure placement. The tapered tip makes the tube less traumatic to place than skin level tubes with obturator placed mushroom type tips. The balloon in this device is mounted (distal cuff) to the distal inner lumen of the feeding tube, the proximal cuff is mounted to the outer diameter of the feeding tube. While the balloon length is equivalent to the predicate MIC-KEY, the overall length of the device has been decreased to facilitate the balloon, when inflated, to surround the device distal tip. The device is packaged sterile and is marketed with a number of accessories; reference Section 11 - Kit Certification, "Special" 510(k) Premarket Notification.

As with the great majority of other ET suction catheters, the indication for endotracheal suctioning is to provide a patent airway by removing excess fluids, secretions, exudate and transudate through the artificial airway. These include patients with indwelling oral or nasal endotracheal tubes, and tracheostomy tubes. This system applies to intubated patients requiring a full range of respiration and ventilatory support. They may be spontaneously breathing, on mechanical ventilation, or partially supported by mechanical devices. The TRACH CARE® closed suction system, as well as other suction catheters, can also be used for saline lavage and surfactant delivery to the distal airway. The closed system device allows for multiple suction episodes utilizing the same catheter. The protective sleeve of the closed system isolates the flora from the patient's secretions, thus reducing the risk of cross-contamination to health care providers and other patients.

5 French through 18 French TRACH CARE® Closed Suction Endotracheal Suction Catheters with MICROBAN® and various airway connectors.