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The EOCVC Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring, and oxygen saturation measurements. PediaSat Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring, and oxygen saturation measurements in adults and/or pediatric patients. The pressure injectable EOCVC Oligon catheters are indicated for short term (< 30 days) hemodynamic monitoring through blood sampling, infusion of solutions, continuous monitoring of oxygen saturation measurements, pressure injection of contrast media, and central venous pressure monitoring. The suture loop and box clamp are intended to be used to facilitate the suturing the catheter at the site of insertion. The dilator, included with each catheter, is indicated for enlarging the opening in a vessel for preparation of perculancous entry of the catheter.

The Edwards Oximetry Central Venous Catheter is a non-balloon catheter that provides the means for infusion of solutions, measuring pressure, and taking blood samples through the distal lumen (terminates at the catheter tip), the proximal lumen (terminates 7 cm proximal to the tip), and the medial lumen (terminates 5 cm proximal to the tip). Edwards Oximetry Central Venous Catheter also provides the means for continuously monitoring oxygen saturation using an Edwards Lifesciences oximetry monitor or compatible bedside module. The PediaSat oximetry catheters are non-balloon catheters that provide the means for infusion of solutions, measuring pressure, and taking blood samples. These catheters also provide the means for continuously monitoring oxygen saturation using an Edwards Lifesciences oximetry monitor or compatible bedside module. The EOCVC Oligon catheter is a non-balloon catheter that provides the means for infusion of solutions measuring pressure injecting contrast media, and taking blood samples through the distal lumen (terminates 7 cm proximate to the tip), and the medial lumen (terminates 5 cm proximal to the tip). The EOCVC Oligon catheter also provides the means for continuously monitoring oxygen saturation using an Edwards Lifesciences monitor and compatible bedside module. All catheters are manufactured with a polyurethane-based Oligon polymer (containing silver, platinum, and carbon black) which has antimicrobial properties. Oxygen saturation is monitored by fiberoptic reflectance spectrophotometry. The amount of light absorbed, refracted, and reflected depends on the relative amounts of oxygenated and deoxygenated hemoglobin in the blood. The PediaSat Oximetry Catheter is a 3 lumen catheter available with a diameter of 4.5 French (F) and 8 cm in length. The EOCVC Oximetry Catheters are 3 lumen catheters available with a diameter of 8.5F and in lengths of 16 and 20 cm. EOCVC and PediaSat catheters are manufactured from polyurethane. A suture loop and a specially molded box clamp are provided with each EOCVC (Oligon and non-Oligon) and PediaSat Oximetry Catheter to facilitate suturing of the catheter at the site of insertion. The suture loop and box clamp can be placed anywhere along the catheter body at the discretion of the clinician. The dilator, included with each catheter, is indicated for enlarging the opening in a vessel for preparation of percutaneous entry of the catheter. The EOCVC (Oligon and non-Oligon) and PediaSat Kits consist of accessories previously cleared for marketing as well as accessories that are the subject of this submission. This submission is for clearance of proposed modifications to the accessories (suture loop, box clamp and dilator) for use with the previously cleared EOCVC Oligon (K160645), PreSep (now EOCVC), and PediaSat (K053609) Oximetry Catheter Kits. Additional accessories are listed on table below.

The pressure injectable PreSep Oligon Oximetry Catheters are indicated for short term (< 30 days) hemodynamic monitoring through blood sampling, infusion of solutions, continuous monitoring of oxygen saturation measurements, pressure injection of contrast media and central venous pressure monitoring. When used for pressure injection of contrast media do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with the pressure injectable PreSep Oligon Oximetry Catheter may not exceed 400psi.

The PreSep Oligon Oximetry Catheter is a pressure injectable antimicrobrial catheter intended to provide the means for infusion of solutions, measuring pressure, delivering contrast media and taking blood samples through the distal, proximal and medial lumens. The PreSep Oligon Oximetry Catheter also provides the means for continuously monitoring oxygen saturation using an Edwards Lifesciences oximetry monitor. The PreSep Oligon Oximetry Catheter is a 3 lumen catheter available in 8.5 French, 16 and 20cm lengths. The lumens exit at the tip of the catheter for the distal; medial and proximal exit at the ports. The catheter is manufactured from a base material of barium sulfate-filled polyurethane. Barium sulfate makes the material more radiopaque. Carbon, silver, and platinum are added to the base material. The silver and platinum render the polymer antimicrobial, by oligodynamic iontophoresis. The antimicrobial agent is silver, which is ionized and electrochemically released from the inside and outside surfaces of the catheter material into the lumens and subcutaneous space. The Oligon polymer technology provides antimicrobial protection on both the inside and outside of the catheter. With the use of the Oligon material, the catheter has demonstrated significant antimicrobial activity, within 48 hours after inoculation, against the following organisms: Staphylococcus epidermidis, Staphylococcus aureus, Enterococcus faecalis, Candida albicans, Escherichia coli, Serratia marcescens, Acinetobacter calcoaceticus, Corynebacterium diptheriae, Enterobacter aerogenes, Klebsiella pneumoniae, Staphylococcus aureus Gentamicin and Methicillin resistant (GMRSa), Pseudomonas aeruginosa, Candida glabrata, and VRE (Enterococcus faecium)

The Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter (PICCOx), is indicated for access to the central venous system for continuous in vivo measurement of the oxyhemoglobin saturation of blood (ScvO2), intravenous therapy, blood sampling, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the PICCOx may not exceed 300 psi.

The Peripherally Inserted, Pressure Injectable Central Venous Oximetry Catheter (PICCOx) is a single or multi-lumen catheter capable of intravenous infusion including pressure infusion up to 300psig, central venous pressure monitoring, venous blood sampling, and allows for continuous measurement of central venous oxygen saturation (ScvO2) in the superior vena cava. The device includes fiber optics in a dedicated lumen for light transmission and single or multiple fluid lumens. Constructed of barium sulfate filled polyurethane, these catheters are radiopaque enabling the use of fluoroscopy or X-ray, to guide insertion and verify position. The maximum recommended infusion rate for the pressure injectable lumen is 5 mL/sec. Distance markings on the catheters provide a visual indication of insertion depth. Every 5cm the insertion depth is printed with an actual number and in between the numbers are black dots which are printed every 1cm. The catheter is non-trimmable, and offered in usable lengths of 40cm, 45cm, 50cm, and 55cm. Individual lumen hubs are ISO standard female luers which are adaptable to NeedleFree Connectors, syringes or IV tubing compliant with the ISO standard. The fiber optic lumen which is terminated in a housing, can be plugged into a compatible Optical Module. PICCOx is intended to be used with a user defined convenience kit. These "kits" are cleared under 510(k) K052865. All kits are terminally sterilized. The contents of the kit are sterile, medical devices intended for single patient use only with fluid path and invasive surfaces non-pyrogenic (or as indicated on the labeling of internal component packaging.)

The PreSep Oligon Oximetry Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring and oxygen saturation measurements.

The PreSep Oligon Oximetry Catheters (K060093) are used with Edwards oximetry monitors to continuously measure oxygen saturation. The catheters also provide the means for infusion of solutions, measuring pressure and taking blood samples. The PreSep Oligon Oximetry Catheters can be used with an uncoated stainless steel guidewire or a PTFE-coated Nitinol core guidewire, which are included in kits or as separately packaged components.

Hospira Advanced Sensor Catheters: Indicated for the assessment of the hemodynamic status of a patient, including but not restricted to the following: Venous Pressures, Cardiac Output. Oxyhemoglobin Saturation, and Venous Blood Sampling. A secondary indication is for the therapeutic infusion of solutions. Hospira Critical Care Catheters; Indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients including the following : acute heart failure; differentiating ruptured ventricular septum form mitral regurgitation; diagnosis of tamponate; severe hypovolemia; complex circulatory situations (e.g., fluid management with acute burn patients); medical emergencies; adult respiratory distress syndrome; gram negative sepsis; drug intoxication; acute renal failure; hemorrhagic pancreatitis; intra- and postoperative management of high risk patients; history of pulmonary or cardiac disease; fluid shifts (such as extensive intra-abdominal operations); management of high risk obstetrical patients; known cardiac disease; toxemia; premature separation of the placenta; cardiac output determination by thermodilution method; and blood sampling. Additional indication for Hospira Critical Care Pacing Lead Catheters: Indicated for temporary transluminal ventricular pacing using a temporary ventricular lead.

The Hospira Critical Care and Advanced Sensor Catheters have multi-lumens that incorporate some or all of the following components and features: a distal balloon for positioning the catheter tip via blood flow within the pulmonary artery, a heater coil for determining continuous cardiac output, a thermistor for monitoring core temperature and cardiac output, fiber optics for monitoring mixed venous oxygen saturation (SvQ2), and access ports for drug delivery or blood sampling. In addition, the Hospira Critical Care Pacing Lead Catheters include an access port for use with Transluminal Right Ventricular Pacing Leads. The catheters also incorporate insertion distance markings and are provided with a syringe for inflating the balloon.

The OPTICATH® Central Venous Oximetry Probe with Fluidic Seal (Heparin Coated) is intended for measuring the oxygen saturation of blood. The OPTICATH® Central Venous Oximetry Probe with Fluidic Seal (Heparin Coated) is indicated for the continuous in vivo measurement of the oxyhemoglobin saturation of blood in the central venous system (ScvO2) for monitoring hemodynamic status during metabolic, respiratory, cardiovascular, and/or other physiological system(s) compromise in accordance with hospital protocols or current Clinical Standards of Practice. The probe with fluidic seal is also indicated for pressure monitoring, and infusion of fluids.

The Central Venous Oximetry Probes (Heparin Coated) are non-pyrogenic, sterile, single patient use, disposable oxygenation monitoring sets for use with central venous catheters for continuous monitoring of central venous oxygen saturation. The probes are manufactured from medical-grade polymers and incorporate a closed-ended fiber optic lumen at the tip to measure central venous oxygen saturation. The exterior of the proposed device is coated with Heparin using the same Heparin agent and coating method used on Oximetry Catheters being marketed by Hospira today. The method of operation is the same as the predicate OPTICATH® Central Venous Oximetry Probe with Fluidic Seal. The Fluidic Seal is a non-pyrogenic, sterile, single patient use device that facilitates the introduction of a Central Venous Oximetry Probe into any size-compatible central venous catheter. The Fluidic Seal also maintains the relative insertion of the oximetry probe within the central venous catheter. The Fluidic Seal consists of a lateral flush port for the administration of fluids and/or for pressure monitoring. The subject devices are modifications of the predicate OPTICATH® Central Venous Oximetry Probe with Fluidic Seal. The modification is to add Heparin coating to the probe and change the lead tubing material to a PE-lined polyvinyl chloride. Both the predicate and the proposed devices can be used with marketed central venous catheters for obtaining critical cardiac performance parameters.

The OPTICATH® Central Venous Oximetry Catheter is indicated for central venous pressure monitoring, drug and fluid administration, vascular access, venous blood sampling and the continuous in vivo measurement of the oxyhemoglobin saturation of blood in the central venous system (ScvO2) for monitoring hemodynamic status during metabolic, respiratory, cardiovascular, and/or other physiological system(s) compromise in accordance with hospital protocols or current Clinical Standards of Practice.. The OPTICATH® Central Venous Oximetry Catheter is intended for onetime use.

The OPTICATH® Central Venous Oximetry Catheter is a disposable single use central venous catheter with integrated fiber optics for measurement of blood oxyhemoglobin levels. It is compatible with existing Oximetrix 3, Q2 or Q2 Plus SO₂ oxylicmographili lovols: 1015 computactured by Philips, GE Medical and Spacelabs. The Central Venous Oximetry – Integrated Catheter is a component within a Hospira Central Venous Catheter (CVC) kit.

Hospira Latex-Free Advanced Sensor Catheters: Indicated for the assessment of the hemodynamic status of a patient, including but not restricted to the following: Venous Pressures, Cardiac Output, Oxyhemoglobin Saturation, and Venous Blood Sampling, A secondary indication is for the therapeutic infusion of solutions. Hospira Latex-Free Critical Care Catheters: Indicated for the assessment of hemodynamic status through right ventricular, and pulmonary artery and / or wedge pressure monitoring for patients including the following: acute heart failure; differentiating ruptured ventricular septum from mitral regurgitation; diagnosis of tamponade; severe hypovolemia; complex circulatory situations (e.g., fluid management with acute burn patients); medical emergencies; adult respiratory distress syndrome; gram negative sepsis; drug intoxication; acute renal failure; hemorrhagic pancreatitis; intra- and postoperative management of high risk patients; history of pulmonary or cardiac disease; fluid shifts (such as extensive intra-abdominal operations); management of high risk obstetrical patients; known cardiac disease; toxemia; premature separation of placenta; cardiac output determination by thermodilution method; and blood sampling. Additional indication for Hospira Latex-Free Critical Care Pacing Lead Catheters: Indicated for temporary transluminal ventricular pacing a temporary ventricular pacing lead.

The HOSPIRA Latex-Free Critical Care and Advanced Sensor Catheters have multi-Iumens that incorporate some or all of the following components and features: a distal balloon for positioning the catheter tip via blood flow within the pulmonary artery, a heater coil for determining continuous cardiac output, a thermistor for monitoring core temperature and cardiac output, fiber optics for monitoring mixed venous oxygen saturation (SvO2), and access ports for drug delivery or blood sampling. In addition, the HOSPIRA Latex-Free Critical Care Pacing Lead Catheters include an access port for use with Transluminal Right Ventricular Pacing Leads. The catheters also incorporate insertion distance markings and are provided with a syringe for inflating the latex-free balloon.

The OPTICATH® Central Venous Oximetry Probe with Fluidic Seal is intended for measuring the oxygen saturation of blood. The OPTICATH® Central Venous Oximetry Probe with Fluidic Seal is indicated for the continuous in vivo measurement of the oxyhemoglobin saturation of blood in the central venous system (ScvO2) for monitoring hemodynamic status during metabolic, respiratory, cardiovascular, and/or other physiological system(s) compromise in accordance with hospital protocols or current Clinical Standards of Practice. The probe with fluidic seal is also indicated for pressure monitoring and infusion of fluids.

The OPTICATH® Central Venous Oximetry Probe is a sterile, non-pyrogenic, single use, disposable probe for use with compatible optical modules/oximeters and central venous catheters. The probe incorporates optic fibers that enable continuous in vivo monitoring of oxyhemoglobin saturation within circulating blood using the principle of reflection spectrophotometry. The Fluidic Seal is a non-pyrogenic, sterile, single use accessory to the OPTICATH® Probe that facilitates the introduction of the Probe into any sizecompatible central venous catheter and maintains the insertion position of the probe tip. The Fluidic Seal has a lateral flush port for pressure monitoring or for infusion of fluids. The subject device is a modification of the predicate OPTICATH® Oximetry Catheter (K820674). The modifications include: 1) reducing the usable length of the probe and removing the guiding balloon since the probe is intended to monitor the oxyhemoglobin saturation of blood in the superior vena cava (central venous oxygen). (i.e., the additional length and balloon that facilitate placement of the predicate catheter into the pulmonary artery are not required) and 2) addition of a Fluidic Seal, which is an accessory to the OPTICATH® Probe, that facilitates placement of the probe into a previously-inserted central catheter and maintains the position of the probe tip.

The PreSep Oligon Oximetry Catheters are intended to provide the means for infusion of solutions, measuring pressure and taking blood samples through the distal, proximal and medial lumens. The PreSep Oligon Oximetry Catheters also provide the means for continuously monitoring oxygen saturation using an Edwards Lifesciences oximetry monitor. The PreSep Oligon Oximetry Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring and oxygen saturation measurements.

The PreSep Oligon Oximetry Catheters are used with Edwards oximetry monitors to continuously measure oxygen saturation. These catheters also provide the means for infusion of solutions, measuring pressure and taking blood samples.