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The Sgarlato PainFree Pump is a single use, general purpose infusion device intended to provide continuous infusion of medication (such as local anesthetics or corticosteroids) directly into a target site for the purpose of pain relief. Infusion may be carried out via percutaneous, subcutaneous, and epidural routes. The PainFree Pump may be used to provide continuous infusion of a local anesthetic directly into an intraoperative site for postoperative management of pain following surgery. It is suitable for use as an ambulatory device. It is not intended for vascular drug delivery, hyperalimentation, or the delivery of blood or blood products.

The Sgarlato PainFree pump is mechanically the same device currently legally marketed by Sgarlato Labs for continuous infusion of liquid medication into an intraoperative site for postoperative pain management. This infusion pump is one of a multiplicity of similar general purpose devices marketed to provide continuous infusion of moderate amounts of liquid medication (100-200 ml) over an extended period of time without use of electrical power. These mechanically-driven, single-use or reusable infusion pumps are therefore suitable for ambulatory use and can provide medication infusion via catheters for extended periods ranging from a few hours to several days. The PainFree pump uses a syringe-like reservoir that compresses the plunger against a self-contained spring to apply pressure to the liquid volume in the syringe. The Sgarlato device is distributed as a single-use sterile device.

The Pain Control Infusion Pump is a single use device intended to provide continuous infusion of a local anesthetic directly into the intraoperative site for postoperative management of pain following surgery. Medication is intended to be delivered percutaneously through a catheter. The Pain Control Infusion Pump is suitable for use as an ambulatory device and is intended for use in the home environment but not limited to use in the home environment. The Pain Control Infusion Pump is not intended for epidural, subcutaneous or vascular drug delivery. It is not intended for the delivery of blood, blood products or TPN.

The proposed device, the Sgarlato Laboratories Pain Control Infusion Pump, claims substantial equivalence to a currently marketed device, the Burron Ambulatory Drug Delivery System (K896422). The Pain Control Infusion Pump is identical in design to the Burron device and will be manufactured for Sgarlato Laboratories by Burron, a division of B. Braun, Inc. The Pain Control Infusion Pump is used for the same intended purpose as the Burron Ambulatory Drug Delivery System. There is no change in design, materials, method of manufacture, or intended use and only minor name changes in the labeling from the Burron device.

The Threaded Fixation Pin is intended for patients where one of their small bones has been osteomized or fractured and the fragments are of sufficient size to place a .062 diameter threaded k-wire across to stabilize the part.

The proposed device, the Threaded Fixation Pin, claims substantial equivalence to currently marketed devices: the Orthopaedic Biosystems Limited Threaded Fixation Pin. and the Synthes Threaded Kirschner Wires. The Orthopaedic Biosystems Limited Threaded Fixation Pin, the Synthes Threaded Kirschner Wire, and the proposed device are available in Titanium Alloy. All of these devices function as internal alignment and fixation devices for small bones of the hand and foot and have no significant design differences.