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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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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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Intended to connect to short peripheral catheter to obtain initial blood draw and when disconnected from the blood collection portion of the device, the pressure-rated extension set is intended to be utilized with infusions systems to administer IV fluids, medications, blood products to the patient's vascular system and may be safety used with power injectors at pressures up to 325 psi.

The Subject device is a sterile, single-use device that consist of a pressure-rated extension set and the blood culture collection set. The blood culture collection set incorporates a luer connection, flexible tubing, blood lock mechanism, and blood collection holder. The pressure-rated extension set is connected to the blood collection set via the luer connection. The Subject device is provided to the healthcare facility in this configuration. The Peripheral IV (PIV) catheter is connected to the pressure-rated extension set via luer connection. Blood travels through the lumen of the Subject device into the blood lock mechanism where the initial draw of blood (approximately 1ml) is diverted and sequestered. The purpose of the sequestration is to automate the discard volume method (DVM). Once the sequestered volume is diverted and retained, the blood continues travel to the blood collection holder where the blood culture sample is obtained. Once the blood draw process is completed, the blood collection set of the Subject device is disconnected from the pressure-rated extension set and discarded. The pressure-rated extension set is utilized as an infusion system to administer IV fluids, medications, blood and blood products to the patient's vascular system. The pressure-rated extension set is rated to 325 PSI. Various blood collection holders are incorporated with the Subject device to interfaces with marketed blood culture bottles and vails. These blood collection holders are cleared under K912563 (Biomerieux Shield), K950432 (BD Vacutainer), and K081229 (Short Saf-T Holder). The blood collection holder incorporates a needle that is covered by elastomer boot. The culture bottle is inserted into the blood collection holder where the needle punctures the elastomer cap and provides a pathway for the blood to traveling into the culture bottle. The vacuum of the culture bottle pulls the blood. Once completed, the culture bottle is removed and the elastomer boot covers the needle and seals to fluid path.

The provided document is a 510(k) summary for the Kurin PIV18 Blood Culture Collection Set with Kurin Lock Technology. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. While it summarizes non-clinical tests performed, it does not include acceptance criteria or a study proving that the device meets specific performance criteria related to diagnostic accuracy, sensitivity, or specificity in the way an AI/ML device study would.

The document details engineering and performance tests relevant to the device's function as a blood collection and infusion system. It confirms that these tests demonstrate substantial equivalence to predicate devices, but it does not present acceptance criteria for diagnostic performance or present a study to meet those criteria.

Therefore, the requested information specifically about acceptance criteria and a study proving achievement of those for a diagnostic device cannot be extracted from this document, as this is a physical medical device clearance, not an AI/ML diagnostic software clearance. Many of the requested fields are not applicable or cannot be found within this document.

However, I can extract information related to the non-clinical tests performed to demonstrate safety and performance of the physical device to establish substantial equivalence.

Here's an attempt to answer the questions based on the available information, noting where information is not present or not applicable for this type of device:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative table format for all tests, nor does it detail the specific reported device performance values for each test, other than qualitative statements of substantial equivalence. It lists the types of tests performed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the summary. The document describes "non-clinical tests" which typically refer to bench or lab testing, not patient-based studies. Therefore, data provenance such as country of origin or retrospective/prospective is not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as this is a physical medical device (blood collection and infusion set), not a diagnostic device requiring expert interpretation for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the type of bench and performance testing described for this physical medical device.

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

This is not applicable as this is a physical medical device, not an AI-assisted diagnostic device.

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

This is not applicable as this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" would be the engineering specifications and established performance standards that the device needs to meet (e.g., sterilization efficacy, mechanical strength, flow rates). These are not expert consensus, pathology, or outcomes data, but rather measurable physical properties.

8. The sample size for the training set

This is not applicable as this is a physical medical device, not an AI/ML device requiring a training set.

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

This is not applicable as this is a physical medical device, not an AI/ML device.

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