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VAMP Adult blood sampling system: To be used only for blood withdrawal. The blood sampling system is indicated for use on patients requiring periodic withdrawal of blood samples from arterial and central line catheters, including peripherally inserted central venous catheters, which are attached to pressure monitoring lines.

The Edwards Venous/Arterial Blood Management Protection (VAMP) Systems are sterile, single use devices that provide a safe and convenient method for the withdrawal of blood samples when attached to pressure monitoring lines. The VAMP devices are needleless closed blood sampling systems designed to reduce infection, needle sticks, and blood waste associated with blood sampling. One family of VAMP product line, the VAMP Adult blood sampling system, is the subject of this submission. The VAMP Adult blood sampling system is designed for use with disposable and reusable pressure transducers and for connection to central line catheters (inclusive of peripherally inserted central catheters and central venous catheters) and arterial catheters where the system can be flushed clear after sampling. The VAMP Adult blood sampling system is used for the drawing and retention of heparinized/diluted blood (or clearing volume) from the catheter or cannula within the line, allowing undiluted blood samples to be drawn from an in-line sampling site. At the completion of sample draw, the mixed heparin and blood solution (clearing volume) is reinfused into the patient to reduce fluid loss to the patient.

This document is a 510(k) premarket notification for the VAMP Venous/Arterial Blood Management Protection System (VAMP Adult). This type of submission is used to demonstrate that a device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through clinical trials, which would be required for a novel device or a PMA.

Therefore, the information typically found in an AI/imaging device submission regarding acceptance criteria, training/test set sample sizes, expert adjudication, MRMC studies, and standalone performance is not applicable to this document. This submission focuses on chemical and mechanical testing to demonstrate substantial equivalence following changes to materials and sterilization methods.

Here's an analysis of what is provided and why common AI/ML and imaging study criteria aren't present:

What is provided in this document:

• Device Name: VAMP Venous/Arterial Blood Management Protection System (VAMP Adult)
• Regulation Number/Name: 21 CFR 870.1210, Continuous flush catheter (Class II)
• Product Code: KRA
• Indications for Use: To be used only for blood withdrawal. Indicated for use on patients requiring periodic withdrawal of blood samples from arterial and central line catheters, including peripherally inserted central venous catheters, which are attached to pressure monitoring lines.
• Predicate Devices:
  • K161962: VAMP Venous/Arterial Blood Management Protection System (cleared on Nov 28, 2016)
  • K171996: TruWave™ Disposable Pressure Transducer and associated kits (cleared on Oct 23, 2017)
• Changes to the Device:
  • Change of sterilization method (100% Ethylene Oxide to E-beam radiation)
  • Change in the PVC plasticizer from DEHP to the non-phthalate plasticizer, Cyclohexane-1, 2-dicarboxylic acid diisononyl ester (DINCH®) for the tubing.
  • Update of product labeling to reflect changes.
  • Introduction of an additional sampling site, Luer Activated Sampling Site (K060231), to replace the z-site in some VAMP Adult models.
• Testing Conducted: "Testing was conducted to ensure that the change in sterilization method and change in materials did not alter the performance of the VAMP Adult blood sampling system." This included:
  • Functional and performance testing
  • Packaging
  • Shelf life
  • Sterilization
  • Biocompatibility
  • Chemical characterization
  • Bench testing (overpressure leak testing, negative leak testing, pressure tubing pull testing, frequency response testing).

Why the requested information (related to AI/imaging device studies) is not in this document:

This submission does not concern an AI/ML device or an imaging device. It is for a mechanical medical device (a blood sampling system) where the primary evaluation is for functional performance, material compatibility, and sterilization efficacy, rather than diagnostic accuracy or algorithmic performance. Therefore, the questions related to:

1. A table of acceptance criteria and reported device performance (for AI/ML/imaging metrics): Not applicable. The acceptance criteria would be for specific physical and chemical properties and functional tests (e.g., flow rate, leak rates, material extractables), not diagnostic accuracy metrics like sensitivity, specificity, AUC, etc.
2. Sample sizes used for the test set and data provenance (e.g., country of origin, retrospective/prospective): Not applicable in the context of imaging/clinical data. Bench testing involves specific numbers of units tested, but not "patient data" as you'd find in an AI study.
3. Number of experts used to establish ground truth, qualifications: Not applicable, as there's no diagnostic ground truth being established.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This device does not involve human interpretation of images or data that an AI might assist with.
6. Standalone (algorithm-only) performance: Not applicable. There is no algorithm.
7. Type of ground truth used (expert consensus, pathology, outcomes data): Not applicable, as there's no diagnostic task. "Ground truth" for this device would refer to measured physical properties meeting predefined specifications.
8. Sample size for the training set: Not applicable, as there is no AI/ML model to train.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission successfully demonstrated substantial equivalence of the modified VAMP Adult system to its predicate devices through a series of non-clinical (bench) tests and material characterizations, not through human-in-the-loop or standalone AI performance studies.

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Elcam Antimicrobial Closed Stopcocks (DSS and TSS) are indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.

Both configurations have a feature of an antimicrobial agent using a compound containing silver.

The inclusion of an antimicrobial agent into the material formulation is intended to prevent/reduce the growth of contaminants on the device.

The device is NOT intended to be used as a treatment for patient infections.

Elcam Medical's Antimicrobial Closed Stopcocks (DSS and TSS) are a similar version of Elcam legally marketed stopcocks, cleared under 510(k) numbers K053405 and K060231, as identified in paragraph number 3 above. Our Antimicrobial DSS and TSS combine two or three features of our legally marketed devices into one product contains these two or three protection lines as following described:

The Double Safe Stopcock (DSS) consists of our antimicrobial stopcock combined with our closed swabable luer-activated valve stopcock.

The closed swabable valve functions as a microbial barrier and the antimicrobial agent, impregnated in the stopcock body acts to prevent/reduce the growth of contaminants.

This configuration presents a stopcock with two protection lines; (1) impregnated antimicrobial agent; (2) closed swabable valve.

The Triple Safe Stopcock (TSS) consists of the same platform of the antimicrobial stopcock together with our legally marketed MRVLS (Minimal Residual Volume Luer-activated Swabable stopcock) design. The two protection lines described above for the DSS exist in the TSS yet, the TSS has a third protection line which is the unique design of the MRVLS handle enables fluid flow around the handle and thus enables more thorough and continuous flushing of the entire stopcock fluid path. This configuration presents a stopcock with three protetion lines:

(1) impregnated antimicrobial agent; (2) closed swabable valve; (3) MRVLS handle unique design.

The provided text describes a Special 510(k) summary for Elcam Medical's Antimicrobial Closed Stopcocks (DSS and TSS). This is a regulatory submission, not a research study, and therefore it does not contain the information typically found in a study proving device performance against acceptance criteria relating to diagnostic accuracy for AI/ML devices.

The document states that the modified device was tested in accordance with Elcam's legally marketed device specifications and "all acceptance criteria were met." However, it does not detail what those specific acceptance criteria were, nor does it provide a full study report with data to prove meeting them.

Here's a breakdown of the requested information based on the provided text, and where the information is not available because this is not a diagnostic AI/ML study:

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

A table of specific acceptance criteria and reported device performance is not provided in the document. The text states:

• "Design verification tests results are supporting all labeling claims and substantial equivalency."
• "The modified device was tested with accordance to Elcam's legally marketed device specification and all acceptance criteria were met."

However, the actual criteria and results are not detailed.

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

Not applicable/Not provided. This document describes a medical device in the context of a 510(k) submission, not an AI/ML algorithm or a diagnostic test involving patient data. The "tests" mentioned are likely performance tests for fluid flow, antimicrobial properties, material compatibility, and structural integrity, not a test set of patient cases.

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)

Not applicable/Not provided. As this is not an AI/ML diagnostic study, there is no "test set" requiring expert ground truth establishment.

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

Not applicable/Not provided. There is no test set or adjudication process described.

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/Not provided. This is not a study involving human readers or AI assistance.

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

Not applicable/Not provided. Elcam's Antimicrobial Closed Stopcocks are physical medical devices, not an AI/ML algorithm.

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

Not applicable/Not provided. For the types of tests indicated (biocompatibility, chemical, material characterization, risk assessment, and device specifications), the "ground truth" would be established by relevant industry standards, material properties, and engineering specifications, not by medical expert consensus or patient outcomes in the context of a diagnostic test.

8. The sample size for the training set

Not applicable/Not provided. This is not an AI/ML algorithm that requires a training set.

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

Not applicable/Not provided. This is not an AI/ML algorithm that requires a training set with established ground truth.

In summary, the provided document is a regulatory submission for a physical medical device (stopcocks), not a study demonstrating the performance of an AI/ML diagnostic device. Therefore, most of the requested information regarding acceptance criteria and study details for AI/ML performance is not present. The document broadly states that "all acceptance criteria were met" for design verification tests, but does not provide the specifics of these tests or criteria.

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