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The Kurin Blood Culture Collection Set is intended to obtain blood samples through the patient's vasculature via venipuncture or Peripheral IV (PIV) access. As it enters the Kurin Lock, blood initially fills a side channel then flows into the sample collection device (syringe or bottle) via an adjoining sampling channel to reduce blood culture contamination rates *.

When supplied with a pressure-rated extension set, the pressure-rated extension set is intended to be utilized separately with infusions systems to administer IV fluids, medications, blood products into the patient's vascular system and may be safely used with power injectors at pressures up to 325 psi.

*The Kurin Blood Collection System is for use as a blood collection system and its Kurin Lock allows the specimen of blood from the patient to be sidelined prior to the test sample to reduce the frequency of blood culture contamination when contaminates are present in the initial blood sample compared to blood cultures drawn using standard practice without the Kurin Lock.

The Kurin Blood Culture Collection Set is a sterile, single-use device that includes a vasculature connection (i.e., winged needle, male luer connection), flexible tubing, blood lock mechanism, and blood culture bottle holder (when supplied). The blood culture bottle holder varies between device models. Refer to the primary labeling for the compatible culture bottle.

The Subject Device is intended to be used with the adult and pediatric population. The main purpose of the Subject Device is to obtain blood samples by transferring from the patient to a culture bottle or collection container.

Venipuncture sets incorporate a needle-safe feature that covers the needle prior to disposal to aid in the prevention of needlestick injury if activated after the blood draws. Venipuncture needles include 21 and 23 gauge.

Various Peripheral IV (PIV) sets incorporate a pressure-rated extension set with slide clamp that, when detached from the blood culture collection set, can be used for infusion purposes.

The unique technology with the Subject Device is the blood lock mechanism (i.e., Kurin Lock). Upon access to the patient's vasculature, the Subject Device uses the patient's blood pressure to push an initial portion of blood that could contain bacterial contaminants (e.g., skin plugs) into the side channel. After the side channel is filled, flow stops until a collection device (i.e., blood culture bottle, vacutainer tube, syringe) is attached. The attachment of a collection device draws additional blood through the Subject Device and into the collection device. The initial portion of blood in the side channel is not isolated from this additional incoming blood, the amount of contamination reaching the collection device is dramatically reduced.

The provided text is a 510(k) Summary for the Kurin Blood Culture Collection Set with Kurin Lock Technology. It details the device's purpose, design, and a comparison to a predicate device, focusing on the justification for a blood culture contamination reduction claim.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text, structured according to your request:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion seems to be demonstrating non-inferiority or equivalent performance in reducing blood culture contamination rates compared to a predicate device.

Study Details

The primary evidence provided for the blood culture contamination reduction claim is a scientific literature review, specifically citing a particular study.

1. Sample Size and Data Provenance:

   • The cited study, "Asynchronous Testing Of 2 Specimen diversion Devices to Reduce Blood Culture Contamination: A Single-Site Product Supply Quality Improvement Project" by Monica Arenas, was conducted at the Central Texas Veterans Health Care System (CTVHCS) in the USA.
   • The study period was between November 2017 to February 2019.
   • A total of 4300 blood samples were taken, divided between a control group and two blood culture diversion devices (Device A, manufactured by Magnolia Medical Technologies, the predicate; and Device B, manufactured by Kurin, Inc., the subject device).
   • The study appears to be retrospective or a prospective quality improvement project rather than a typical randomized controlled clinical trial, given the description "Single-Site Product Supply Quality Improvement Project" and the "mean incidence of contaminated draws per month". However, the exact design (prospective/retrospective) isn't explicitly stated but inferred.

2. Number of Experts and Qualifications:

   • The document does not provide information on the number of experts used to establish ground truth or their specific qualifications for the Monica Arenas study. This information would typically be found in the full study publication rather than a 510(k) summary.

3. Adjudication Method:

   • The document does not specify any adjudication method for the test set in the Monica Arenas study. Ground truth was likely established by the bacterial culture results themselves (positive/negative for contamination).

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not conducted. This device is a blood collection system, not an AI or imaging diagnostic device that would typically involve human readers. Therefore, there is no information on how human readers improve with AI vs. without AI assistance.

5. Standalone Performance:

   • Yes, the performance tested (reduction in contamination rates) is essentially a standalone performance of the device's mechanism (the Kurin Lock) in preventing contaminants from reaching the blood collection. The "algorithm" here is the physical mechanism of diverting initial blood. The reported performance refers to the device's function directly.

6. Type of Ground Truth Used:

   • The ground truth for the contamination rate reduction claim was bacterial culture results from the collected blood samples, indicating the presence or absence of contamination.

7. Sample Size for Training Set:

   • The text does not mention a "training set" in the context of machine learning, as this is a medical device clearance focusing on its physical mechanism and clinical performance via literature review and bench testing, not an AI model.

8. How Ground Truth for Training Set was Established:

   • Not applicable, as no training set for an AI model is described. The relevant "ground truth" (bacterial culture results) was established by standard laboratory procedures in the clinical study.

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