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1. The ON-Q Pump is intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous and epidural. 2. The ON-Q Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to or around surgical wound sites or close proximity to nerves when compared with narcotic only pain management.

The ON-Q Pump consists of an elastomeric pressure source with an integrated administration line. Fill volumes range from 50 to 770 ml. Flow rates range from 0.5 to 250 ml/hr. The administration line typically consists of fixed flow rate control tubing or orifice but may contain any of the following optional features: • Select-A-Flow component that provides a range of flow rates that may be dialed depending on the needs of the healthcare professional. • Bolus component (e.g. OnDemand) that provides basal and/or bolus delivery. • Y-adapter component that may split the administration line into two or more delivery sites. The Y-adapter component may also be used to provide a combination of options (such as both the Select-A-Flow and OnDemand components) for one delivery site. • Air and particulate eliminating filter. The pump may be sold as a kit with additional medical devices or accessories such as the following: • Catheter, introducer needle, Tunneler, syringe, dressing, filling extension set, carry case, E-clip, nerve block accessories, etc.

The ON-Q Introducers are intended for the percutaneous introduction and placement of catheters into or around surgical wound sites and/or close proximity to nerves. Introducers with a luer hub may be used to aspirate or inject a bolus of fluid or medication prior to placing the catheters.

The ON-Q Introducers consist of the following two components: The first component is a stainless steel shaft (trocar) with a handle or luer hub. The trocar diameter ranges from 11 to 17 GA and the length ranges from 3.25 to 12 inches. The trocar may have a sharp, beveled tip or a blunt, rounded tip. The second component is a peelable (split T-Handle) plastic sheath that is designed to fit over the trocar. The model configurations are designated as follows: Models with a blunt tip are called ON-Q Tunnelers. The sheaths may be sold separately and are single use only. Some versions of the ON-Q Tunnelers may be reusable. Models with a sharp tip are called ON-Q Introducers Needles which are single use only. The ON-Q Introducers are intended for the percutaneous introduction and placement of catheters into or around surgical wound sites and/or close proximity to nerves. Introducers with a luer hub may be used to aspirate or inject a bolus of fluid or medication prior to placing the catheters.

The ON-Q SilverSoaker Catheter is intended to provide continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for perioperative and postoperative pain management. The ON-Q SilverSoaker Catheter is contraindicated for the epidural space and in neonatal populations. The ON-Q SilverSoaker Catheter contains an antimicrobial agent which may destroy or inhibit the growth of microorganisms on both the inner and outer surfaces of the catheter. The antimicrobial agent is intended to reduce the possibility that the catheter may become microbially compromised. The antimicrobial agent is not intended to be used as a treatment for existing infections.

The ON-Q SilverSoaker Catheter consists of two design options: Fenestrated Catheter: a modified epidural catheter with multiple holes at the distal end up to a 10 inch infusion segment Soaker Catheter: a modified epidural catheter with multiple holes at the distal end up to a 10 inch infusion segment. This version of the ON-Q SilverSoaker Catheter contains a hollow fiber along the inner lumen of the catheter to provide even distribution of medication along the infusion segment. This 510(k) adds an antimicrobial agent which may destroy or inhibit the growth of microorganisms on both the inner and outer surfaces of the catheter. The antimicrobial agent is intended to reduce the possibility that the catheter may become microbially compromised. The antimicrobial agent is not intended to be used as a treatment for existing infections.

1. The I-Flow Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, intra-arterial, subcutaneous, intramuscular and epidural. 2. The 1-Flow Elastomeric Pump is also intended for continuous and/or intermittent delivery of local anesthetics or narcotics to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia. Routes of administration may be intraoperative, perineural or percutaneous. 3. The I-Flow Elastomeric Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.

The I-Flow Elastomeric Pump consists of an elastomeric pressure source with an integrated administration line. The current device has an optional Y-adapter that splits the administration line into two delivery sites. This special 510(k) proposes a multi-Y adapter that can provide 3 or more integrated administration lines for multi-site delivery.

With I-Flow Corporation's ON-Q, PainBuster and C-bloc pain management kits; and As a stand alone device to provide continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves. Routes of administration may be intraoperative, percutaneous, perineural. The Soaker version of the I-Flow Catheter is contraindicated for the epidural space.

The I-Flow Catheter consists of three design options which can utilize infusion segments ranging from epidural to 10 inches (same as the predicate devices with the exception of the 10 inch infusion segment): Standard epidural catheter: 3 radial holes at the distal end with an approximate 0.5 inch infusion segment. Fenestrated Catheter: a modified epidural catheter with multiple holes at the distal end up to a 10 inch infusion segment Soaker Catheter: a modified epidural catheter with multiple holes at the distal end up to a 10 inch infusion segment. This version of the I-Flow Catheter contains a hollow fiber along the inner lumen or along the outside diameter of the distal end of the catheter to provide even distribution of medication along the infusion segment.

1. The I-Flow Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, intra-arterial, subcutaneous, intramuscular and epidural. 2. The I-Flow Elastomeric Pump is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural or percutaneous. 3. The I-Flow Elastomeric Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.

The current package labeling of the I-Flow Elastomeric Pump does not reference specific types of surgeries or potential benefits. This 510(k) proposes a labeling change that would reference the specific type(s) of surgery and potential benefits that are supported by published clinical studies.

1. The I-Flow Variable Rate Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, intraarterial, subcutaneous, intramuscular and epidural. 2. The I-Flow Variable Rate Elastomeric Pump is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves for preoperative and postoperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural or percutaneous.

The I-Flow Variable Rate Elastomeric Pump consists of an elastomeric pressure source with an integrated administration line. This special 510(k) proposes a labeling change to the existing device submitted under K020660 for the variable flow rate component.

1. The Paragon Infusion System with Bolus is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, subcutaneous, intramuscular and epidural. 2. The Paragon Infusion System with Bolus is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous.

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- 1. The I-Flow Elastomeric Pump with Bolus is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, subcutaneous, intramuscular and epidural. - 2. The I-Flow Elastomeric Pump with Bolus is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/c close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural or percutaneous.

This special 510(k) proposes a new optional component for the I-Flow Elastomeric Pump that incorporates a bolus component. The bolus component offers the additional ability to deliver fixed bolus volumes of medication at fixed time intervals instead of just a continuous infusion rate.

- With I-Flow Corporation's PainBuster, ON-Q and Nerve Block pain management kits; and 1. - As a stand alone device to provide continuous or intermittent delivery of local anesthetics 2. or narcotics to surgical wound sites and/or close proximity to nerves outside of the epidural space. Routes of administration may be intraoperative, percutaneous or perineural.

The Soaker Catheter has a closed end tip with multiple holes arranged radially along the lateral surface along the infusion segment at the distal end of the device. A membrane in the inner diameter of the catheter promotes even distribution along the infusion segment. This special 510(k) proposes a slight design change that has the membrane along the outside diameter of the catheter instead of the inside diameter.