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The DANA 3cc Syringe Insulin Reservoir is an accessory to the DANA Diabecare® Insulin Pumps. The DANA 3cc Syringe Insulin Reservoir is intended for the delivery of insulin from the DANA Diabecare® Insulin Pumps using specified insulin administration sets. The DANA 3cc Syringe Insulin Reservoir is intended exclusively for use with the DANA Diabecare® Insulin Pumps. The DANA Diabecare® Insulin Pumps are external programmable syringe infusion pumps used for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. The pumps are not intended for use with blood or blood products.

The DANA 3cc Syringe Insulin Reservoir is a sterile, single-use, non-pyrogenic, syringe that is designed for use with all versions of the DANA Diabcare® Insulin pump that have been cleared for marketing in the U.S. (K001604, K022317, and K063126). The syringe reservoir is a 3 ml polypropylene syringe with a 300 unit insulin capacity that is supplied with a 22 gauge, 12.7 mm straight needle. The reservoir is filled similarly to filling an insulin syringe. Once filled and inspected for entrapped air, the needle is removed and the syringe reservoir is inserted into the distal end for attachment to the linking screw that connects the syringe reservoir to the DANA Diabecare® Insulin pump. The syringe has groves cut into the distal end for attachment to the linking screw that connects the syringe reservoir to the DANA Diabecare® Insulin Pump. The proposed DANA 3cc Syringe Insulin Reservoir is a modification of the insulin reservoir accessory described in K001604, the original 510(k) premarket notification for the DANA Diabecare® Insulin Pump. The modification was limited to a change in the gasket configuration and material. The proposed DANA 3cc Syringe Insulin Reservoir has a ring shape gasket that is manufactured from silicone.

The DANA Diabecare® IIS is an external programmable syringe infusion pump used for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. The pump is not intended for use with blood or blood products. The DANA Diabecare® IIS insulin pump is an external digitally controlled syringe pump that is intended for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. It is not intended for use with blood or blood products.

The DANA Diabecare® IIS insulin pump is a modification of the device described in K022317, the DANA Diabecare® II Insulin Pump. The DANA Diabecare® IIS insulin pump is a digitally controlled syringe pump that provides precise insulin delivery and monitoring of device functions. The DANA Diabecare® IIS insulin pump has two insulin delivery modes, the basal infusion rate and meal bolus injections. The user can program up to 24 basal infusion dosages in one-hour increments and three bolus injections daily. The basal infusion rate can be temporarily increased or reduced to accommodate changes in activity levels. The DANA Diabecare® IIS insulin pump is battery powered, water resistant, compact, and lightweight. The pump is equipped with safety systems, acoustic signals, and an LCD display that reads "SE" for a system error. The data that can be stored and retrieved from the DANA Diabecare® IIS insulin pump software includes the following: 100 alarms, 500 bolus doses, 500 daily insulin dosages, and 500 prime histories. The pump also has an error log. DANA Diabecare® IIS is intended to be used with a proprietary insulin reservoir and the infusion set. The insulin reservoir is a 3mL plastic syringe with a 300-unit insulin capacity. Accessories for the device include the SUPERLINE, SUPERLINE-Easy Release, Soft-Release-R and Soft-Release-ST, which are identical to those included with the DANA Diabecare® II Insulin Pump, and consist of a 55cm/(70cm)/110cm length of tubing with a luer-lock connector on the proximal end for attachment to the insulin syringe and a 27G needle on the distal end. Additional accessories necessary for operation and maintenance of the pump, syringe, and infusion set are provided with the DANA Diabecare® IIS pump.

The DANA Diabecare® II external programmable syringe infusion pump and the SUPERLINE-EasyRelease, Soft-Release-ST, and Soft-Release-R Infusion Sets are indicated for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. The pump and administration sets are not intended for use with blood or blood products.

The DANA Diabecare® II insulin pump, SUPERLINE-EasyRelease (EasyRelease) Infusion Set, and Soft-Release Infusion Sets are modifications of the DANA Diabecare® insulin pump and SUPERLINE infusion set that were described in K001604, the 510(k) premarket notification for the DANA Diabecare® insulin infusion pump. The modifications made to the parent DANA Diabecare® insulin pump to produce the modified DANA Diabecare® II Insulin Pump were limited to software modifications including changes to the basal and bolus insulin delivery modes. features accessed via the password-protected (lock-out) mode, and the addition of alarms, a fail-safe function, and the ability to store and retrieve information (alarm, bolus dose, daily insulin dose). The overall design of the proposed EasyRelease, Soft-Release-ST, and Soft-Release-R Infusion Sets is identical to the design of the parent SUPERLINE Infusion Set. The design modifications are limited to the following: - Addition of a site for disconnecting the insulin pump from the infusion set . without removing the needle from the abdomen - Replacement of the infusion needle with an indwelling soft cannula (Soft-. Release-R and Soft-Release-ST only) The two versions of the Soft-Release Infusion Sets differ in the design of the detachment site and cannula assembly. The Soft-Release-R Infusion Set has a sliding lock detachment site and a "rectangular" cannula oriented perpendicular to the infusion tubing axis. The Soft-Release-ST has a turning screw lock detachment site that uses a conical fitting and a straight cannula oriented parallel to the infusion tubing axis. There are minor differences in the materials used for the construction of the proposed EasyRelease, Soft-Release-ST, and Soft-Release-R Infusion Sets as compared to the parent SUPERLINE.