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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).

Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device's performance, structured as requested.

The provided document describes a 510(k) premarket notification for the "Steripath® Gen2 Blood Collection System." This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving enhanced effectiveness through a primary clinical endpoint study as might be required for a PMA. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are geared towards showing functional equivalence, safety, and a reasonable expectation of effectiveness, rather than a direct clinical performance study against a defined clinical endpoint for de novo approval.

The primary claim of effectiveness for the Steripath® Gen2 is its ability to reduce the frequency of blood culture contamination. While clinical studies are summarized, the core of the FDA's acceptance for a 510(k) clearance hinges on functional and performance testing, and the demonstration that the new feature (initial specimen diversion) does not raise new questions of safety or effectiveness.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for the device are largely derived from its functional requirements and safety standards. The reported device performance indicates that the device passed all these verification tests.

1. Table of Acceptance Criteria and the Reported Device Performance:

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