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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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The Kurin Blood Culture Collection Set is a winged blood collection needle with flexible tubing intended for venipuncture to obtain blood samples. It is provided with a safety shield for covering the used venipuncture needle prior to disposal to aid in the prevention of needlestick injury if manually activated after the blood collection, the set also includes a blood collection holder for connection to vacuum-based collection vials.

The Subject Device is a sterile, single-use blood culture collection set. The blood collection set incorporates a venipuncture needle assembly that is connected with flexible tubing to a blood lock mechanism that is connected by flexible tubing to a blood collection holder. Blood collection is accomplished by inserting the venipuncture needle into the patient's peripheral vascular system. Blood will travel up the lumen into the blood lock mechanism where the initial draw of blood (approximately 0.15 ml) is held in a side chamber. The purpose of the side chamber is to automate the initial specimen diversion volume method (ISDVM). Once the side chamber volume is retained, the blood upon connection to a vacuum bottle continues to travel up the lumen to the blood collection holder into the attached blood culture bottle/vial.

The Subject Device's venipuncture needle assembly incorporates an active, semi-automatic needlestick safety design where the safety mechanism is activated via a button on the needle hub. When the safety mechanism is activated, a protective shield is deployed. It advances distally to cover the entire length, including the distal tip, of the venipuncture needle. The protective shield is locked in this position protecting the clinician/patient from needlestick injuries. Silicone coating is applied to the outside of the venipuncture needle, which aids in the insertion into the peripheral vascular system.

The Subject Device incorporates various blood collection holders to interact with various types of vacuum-based collection vials.

The Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle, has undergone various evaluations to demonstrate its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't present a formal table of specific, quantified acceptance criteria for each test. Instead, it lists the types of evaluations performed and implies that the performance met acceptable standards for demonstrating substantial equivalence. The "Reported Device Performance" column below is based on the conclusion stated in the document that the device "has demonstrated it is substantially equivalent... based on the intended use and performance testing conducted."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes (number of devices or tests performed) for each individual test conducted to support the 510(k) submission. It broadly states that "evaluations were conducted."

The data provenance is implicit: the tests were conducted by Kurin, Inc. to support their premarket notification. Therefore, this would be considered prospective data collected specifically for regulatory submission. There is no information provided about the country of origin for the data collection, but given the company's address in San Diego, California, it is reasonable to infer the testing was likely conducted in the United States or under conditions compliant with U.S. regulatory standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This type of information (number and qualifications of experts for ground truth establishment) is typically not applicable to the evaluation of mechanical or material performance of a blood collection device, which relies on standardized engineering and biological tests rather than expert interpretation of complex clinical data. The "ground truth" for these tests is defined by the passing criteria of the relevant ISO standards and FDA guidance documents.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are usually relevant for studies involving human interpretation or clinical outcomes where discrepancies need to be resolved. For the types of performance and material tests described for this device, which are objective and quantitative, an adjudication method is not applicable. The results are typically pass/fail based on pre-defined criteria from recognized standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or mentioned in the provided text. MRMC studies are typically employed for diagnostic imaging devices or algorithms where the performance of human readers (with and without AI assistance) is compared. This device is a blood specimen collection device, not an imaging or diagnostic AI tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone (algorithm only) performance study was not done or mentioned. This device is a physical medical device for blood collection, not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for the various evaluations conducted for this device was established based on recognized industrial standards, international standards (ISO), and FDA guidance documents.

Examples of ground truth sources include:

• AAMI TIR 28 for sterilization.
• ISO 10993-1:2018 for biocompatibility.
• ISO 1135-3:2016 for blood-taking sets.
• ISO 7864:2016 and ISO 9626:2016 for sterile hypodermic needles.
• ISO 23908:2011 for sharps injury protection.
• ISO 11135:2014 for ethylene oxide sterilization.
• ISO 11607-1:2006 for packaging integrity.
• FDA Guidance documents (e.g., Medical Devices with Sharps Injury Prevention Features).

The outcomes of these tests are objective measurements against the specified criteria within these standards.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable to the evaluation of this medical device. Training sets are used in machine learning and AI development. The evaluations performed here are for a physical product and its constituent materials and mechanisms.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for this type of device evaluation, this question is not applicable.

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The Kurin Blood Culture Collection Set is a winged blood collection needle with flexible tubing intended for venipuncture to obtain blood samples. It is provided with a safety shield for covering the used venipuncture needle prior to disposal to aid in the prevention of needlestick injury if manually activated after the blood collection, the set also includes a safety shield and apparatus for connection to vacuum based collection vials.

The Kurin device is a sterile, single use blood culture collection set. The Kurin includes a winged needle with flexible tubing and an attached vial adapter intended for venipuncture to obtain blood culture samples. Kurin is identical in every way to existing sets used to collect blood culture samples except for the insertion into the tubing of the Kurin blood capture chamber. The Kurin blood capture device sequesters the initial draw of blood upon initial venipuncture. The set is provided with a safety shield for covering the used needle prior to disposal. The amount of blood diverted is very small, estimated at a fraction of 1 ml.

The provided document is a 510(k) premarket notification for a medical device called the "Kurin Blood Culture Collection Set." This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing rather than proving performance against specific acceptance criteria for diagnostic accuracy or effectiveness in a clinical context. Therefore, the information typically found in acceptance criteria and detailed study descriptions for AI/ML medical devices (like sensitivity, specificity, F1 score, sample size for test sets, expert qualifications, etc.) is not present in this document.

However, I can extract the non-clinical testing performed and present them as "acceptance criteria" and "reported performance" based on how they are described in the document as meeting specifications.

Here's the analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document describes non-clinical engineering and bench testing, not a clinical test set with patient data. No specific sample sizes for these tests (e.g., number of devices tested for flow rate, leakage, etc.) are provided in the summary. Data provenance is not applicable in the context of clinical populations as it's not a clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable as this document describes non-clinical, bench testing, and engineering verification, not a study evaluating expert performance or ground truth established by experts. The "ground truth" here is determined by the specifications of the standards (e.g., ISO, ASTM) and the physical properties of the device.

4. Adjudication method for the test set

Not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not described here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a blood collection set, not an AI/ML diagnostic tool, and no MRMC studies are mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device, not an algorithm, and its performance is assessed via non-clinical testing.

7. The type of ground truth used

The "ground truth" for the non-clinical tests described in this document is based on engineering specifications, compliance with international standards (ISO, ASTM), and predefined performance benchmarks (e.g., no leakage, specific flow rates, successful sterilization).

8. The sample size for the training set

Not applicable. As this is not an AI/ML device, there is no training set.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this type of device.

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