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The Medisystems Hemodialysis Fistula Needle Securement Device, SiteGuard, is intended for use to secure the fistula needle to the patient's skin. The SiteGuard needle securement device has the following features: a. It allows the needle to be held at a consistent angle during treatment; b. It secures wing/hub to the patient's skin and helps prevent movement and/or dislodgement of the needle during use; and, c. It helps to immobilize the patient's vein or access during cannulation so that it is not necessary for caregivers to hold the vein or access with their fingers.

The subject of this 510(k) is a removable, rigid plastic securement device that is attached to the AVF needle set by the care giver. The SiteGuard securement device will be included in the unit packaging pouch with the Medisystems AVF needle set and also will be available for purchase as an individually packaged accessory. Because the tape, the AVF wing, and the patient's skin are flexible, the needle may dislodge or move within the patient's access during treatment due to this inherent flexibility. The securement device adds a rigid structure to increase the ability of the tape to prevent the needle from accidentally dislodging or moving within the patient's vascular access. This accessory also will immobilize the patient's vein during insertion of the cannula so that it is not necessary for caregivers to hold the vein or access with their fingers. The channel along the bottom of the securement device is designed to immobilize the patient's vein during insertion. This feature is especially helpful for patients who have newly created fistulas or implanted grafts because new accesses tend to move during cannulation.

Medisystems Blood Tubing Set Accessories are indicated for use as a part of an extracorporeal blood circuit for hemodialysis. The specific indications for use each accessory are as follows: a. The Reverso™ is indicated for use as an access flow reversing valve to reverse the blood flow to and from the arterial and venous access devices during hemodialysis procedures without the need to clamp and disconnect bloodlines. b. The Recirculation Connector is indicated for use as a male to male Luer adaptor. c. The Parallel Dialyzer Connector is indicated for use to interconnect two hemodialyzers in parallel as prescribed by the physician as part of the extracorporeal blood system. d. The Series Dialyzer Connector is indicated for use to interconnect two hemodialyzers in series as prescribed by the physician as part of the extracorporeal blood system.

A series of blood tubing set accessories to be used as part of the extracorporeal circuit. A. Medisystems Blood Tubing Set Accessory, Access Flow Reversing Valve, (Reverso): The technical characteristics of the device consist of a manually operated valve with a gasket to prevent leakage. The device is also equipped with tubing and Luer connectors to allow it to interconnect between the blood tubing set and the blood access devices. The device allows reversal to the arterial and venous blood access without the need to disconnect the blood tubing set from the access devices. The reversal of the arterial and venous accesses is necessary to facilitate certain common diagnostic procedures and can be used to reverse flow in central venous or femoral catheters that have patency problems. B. Medisystems Blood Tubing Set Accessory, Recirculation Connector: The device is a singly packed recirculation connector (male-to male Luer adaptor) used to interconnect the arterial and venous bloodlines. C. Medisystems Blood Tubing Set Accessory, Parallel Dialyzer Interconnector: The device is used with a standard blood tubing set to provide a means to connect two dialyzers in parallel into the extracorporeal circuit. D. Medisystems Blood Tubing Set Accessory, Series Dialyzer Interconnector: The device is used with a standard blood tubing set to provide a means to connect two dialyzers in series into the extracorporeal circuit.

Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site or "buttonhole" method of needle insertion.

The Medisystems Buttonhole Needle Set consists of a hollow, rigid needle/cannula, a flexible tube, and locking connector to provide access through the skin at a constant or "buttonhole" site. Different degrees of point sharpness are offered to accommodate creation of the buttonhole site and cannulation through an established buttonhole site.

Medisystems Transducer Protectors are indicated for use as protective devices for pressure monitors on hemodialysis machines as well as to help protect the sterility of the blood tubing fluid pathway. The filter helps prevent cross-contamination by viruses, bacteria, and other particulate matter while preventing the flow of fluids to the hemodialysis machine's pressure transducer.

Medisystems Transducer Protectors are designed to be used as protective devices for pressure monitors as well as to help maintain the sterility of the blood tubing fluid pathway. The 0.2 um hydrophobic filter helps prevent cross-contamination by viruses, bacteria and particulate matter while preventing the flow of fluids to the hemodialysis machine pressure monitor. The technical characteristics of the device consist of a filter housing that contains a 0.2 um hydrophobic filter. The combination of the pore size and hydrophobic nature of the filter also prevents the flow of fluids, viruses, bacteria, and particulate matter into the pressure monitor at pressures lower than the rated pressure of the device.

The proposed Dialysis Priming Sets are indicated for use to provide a means to deliver rie proposed promote from a collapsible container or vented bottle into a patient's. vascular system during dialysis procedures.

The Medisystems Dialysis Priming Sets provide a means of delivering fluids and medicaments from a collapsible container or vented bottle into a patient's vascular system during dialysis procedures. The set consists of a flexible drip chamber with a spike for attachment to the solution container, an adjustable clamp that regulates flow, a flexible delivery tube with a two port connector. This connector will allow connection of the set to devices with compatible female luer connectors. The set will also allow connection of a separate device with compatible male luer to the set's female luer connector.

Medisystems Peritoneal Dialysis Set product line is indicated for use in compatible peritoneal dialysis procedures. Specific codes are indicated respectively for Continuous Ambulatory Peritoneal Dialysis (CAPD) and Cycler Peritoneal Dialysis.

The Medisystems' Peritoneal Dialysis Sets comprise a number of codes to facilitate peritoneal dialysis procedures. The Medisystems' Peritoneal Dialysis Sets consist of tubing and componentry to allow connection between a container of dialysate solution and the patient's indwelling catheter for instillation into and retention of the dialysate in the peritoneal cavity. The Peritoneal Dialysis Sets then allow exchange of fresh dialysate by providing a means to aseptically drain the used dialysate from the peritoneal cavity into a collection bag for disposal.

Medisystems Transducer Protectors are single use, disposable prescription devices intended for use as protective devices for pressure monitors and to help protect the sterility of the fluid pathway.

Medisystems Transducer Protectors are designed to be used as protective devices for pressure monitors as well as to help maintain the sterility of the blood tubing fluid pathway. The 0.2 µm hydrophobic filter helps prevent cross-contamination by bacteria and particulate matter while preventing the flow of fluids to the machine pressure monitor at pressures less than 600 mmHg.

The blood tubing sets are intended for use with a blood access device and a medically approved flowthrough treatment device.

Medisystems blood tubing sets are used during extracorporeal procedures by providing a means to connect blood access devices to flow-through treatment device(s) (e.g. a hemodialyzer).