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The Steripath® Micro Blood Collection System is a system to draw blood for in vitro diagnostic testing. The Steripath® Micro Blood Collection System is indicated for use as a blood collection system that diverts and sequesters the initial specimen prior to collection of a subsequent test sample to reduce the frequency of blood culture contamination when contaminants are present in the initial blood cultures drawn with standard procedure without manual diversion. Additionally, components of the system may be used for infusion following sample collection after discomection of the Initial Specimen Diversion Device® (ISDD®).

The device, Steripath® Micro Blood Collection System, is a system to draw blood for in vitro diagnostic testing. The purpose of this submission is to expand the product line to include inlet components with the BD Venipuncture® UltraTouch™ Push Button Needle, outlet components with a transfer adapter, and universal models with no inlet component. The Steripath® Micro Blood Collection System is indicated for use as a blood collection system that diverts and sequesters the initial specimen prior to collection of a subsequent test sample to reduce the frequency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion. The device sequesters and diverts 0.5 - 1.0 mL of the initial specimen of blood (potentially contaminated) into a diversion chamber. Once diversion is complete, a subsequent blood sample flows through a second pathway within the device and is collected either directly into a culture bottle (not provided by Magnolia Medical Technologies), or into a syringe that is used to inoculate culture bottles. Additionally, components of the system may be used for infusion after disconnection of the Initial Specimen Diversion Device® (ISDD®). The Steripath® Micro Blood Collection System, needle configurations, for the subject device are manufactured using non-sterile BD UltraTouch® needles, which are equivalent to the commercially available BD UltraTouch® Push Button™ Blood Collection Set (K212724), except for the sterilization step. The Steripath® Micro Blood Collection System and UltraTouch® needles have the same intended use. Incorporation of the needle with the ISDD® functions on the same technological characteristics and principles of operation with the difference that the subject device leverages the Initial Specimen Diversion Technology® (ISDT) and mechanically sequesters the initial specimen of blood. Inclusion of this technology does not raise any added questions of safety or effectiveness. The different configurations of the Steripath® Micro Blood Collection System are made available by using different combinations of the inlet and outlet accessories. Proposed configurations are listed in Table 5.1.

The Steripath® Micro Blood Collection System is a system to draw blood for in vitro diagnostic testing. The Steripath® Micro Blood Collection System is indicated for use as a blood collection system that diverts and sequesters the initial specimen prior to collection of a subsequent test sample to reduce the frequency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion. Additionally, components of the system may be used for infusion following sample collection after disconnection of the Initial Specimen Diversion Device® (ISDD®).

The Steripath® Micro Blood Collection System diverts and sequesters the initial portion of the blood specimen (potentially contaminated blood) in the diversion reservoir. When diversion is complete, a subsequent blood sample flows through a second pathway within the device. The subsequent blood sample is collected into a syringe that is used to inoculate culture bottles. Upon removal of the Initial Specimen Diversion Device®, ISDD®, components of the system can be used for infusion per the included manufacturer's instructions for use. The subject device incorporates multiple syringe oulet accessory configurations that include and three sizes of syringes that are previously cleared as referenced below. The Steripath® Micro Blood Collection System are available: | Steripath®<br>Micro Kit<br>Model<br>Number | ISDD® | Inlet Accessory | Outlet Accessory | |--------------------------------------------|--------|----------------------------------------------------------------------|--------------------------------------------------------------| | 4005-EN | P00353 | Luer Extension, 7"<br>ICU Medical, Inc.<br>Model B1754-NS<br>K964435 | Syringe, 5ml<br>Becton Dickinson<br>Model 301027<br>K980987 | | 4010-EN | P00353 | Luer Extension, 7"<br>ICU Medical, Inc.<br>Model B1754-NS<br>K964435 | Syringe, 10ml<br>Becton Dickinson<br>Model 301029<br>K980987 | | 4020-EN | P00353 | Luer Extension, 7"<br>ICU Medical, Inc.<br>Model B1754-NS<br>K964435 | Syringe, 20ml<br>Becton Dickinson<br>Model 301031<br>K980987 |

The Steripath® Gen2 Blood Collection System is a system to draw blood for in vitro diagnostic testing. The Steripath® Gen2 Blood Collection is indicated for use as a blood collection system that diverts and sequesters the initial specimen prior to collection of a subsequent test sample to requency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion. Additionally, components of the system may be used for infusion following sample collection after disconnection of the Initial Specimen Diversion Device® (ISDD®). Venipuncture needles are indicated for short term infusion (less than 2 hours).

The Steripath® Gen2 Blood Collection System diverts and sequesters the initial portion of the blood specimen (potentially contaminated blood) in the diversion reservoir. When diversion is complete, a subsequent blood sample flows through a second pathway within the device. The subsequent blood sample is collected either directly into a culture bottle (not provided by Magnolia Medical Technologies), or into a syringe that is used to inoculate culture bottles. Upon removal of the ISDD®, components of the system can be used for infusion per the included manufacturer's instructions for use (note: infusion with butterfly needles is limited to less than 2hrs). The subject device incorporates multiple configurations that include various inlet and outlet accessories that are previously cleared as referenced below. The Steripath® Gen2 Blood Collection System is a single use, sterile, mechanical device that diverts and sequesters the initial 1.5mL to 2.0mL of blood from the patient. The system consists of an Initial Specimen Diversion Device® (ISDD®) made of injection molded, medical grade plastics. Off-the-Shelf (OTS) components provide the interface to the patient vasculature, and to the culture bottle or syringe for subsequent sample collection. Upon removal of the ISDD®, components of the system can be used for infusion per the included manufacturer's instructions for use (note: infusion with butterfly needles is limited to less than 2hrs).