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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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VAMP Adult and VAMP Plus:
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.

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

The subject Edwards Venous/Arterial Blood Management Protection (VAMP) System is a sterile, single use device that provides a safe and convenient method for the withdrawal of blood samples when attached to pressure monitoring lines. The subject device is a needleless closed blood sampling system designed to reduce infection, needle sticks, and blood waste associated with blood sampling.
The VAMP 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), arterial catheters, and umbilical catheters where the system can be flushed clear after sampling. The VAMP 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.
The collected blood can be transferred to a vacuum tube via a VAMP Blood Transfer Unit (BTU) or a VAMP Direct-Draw unit. The main purpose of the BTU is to provide a conduit (split septum membrane) in which a blood-filled syringe and blunt cannula assembly can transfer the blood sample to a vacuum tube without using a needle. The Direct-Draw Unit performs in the same fashion, except it allows for direct connection of the vacuum tube and doesn't require use of separate sampling syringe.

This document is a 510(k) summary for the Edwards Lifesciences VAMP Venous/Arterial Blood Management Protection System. It does not contain information typically found in an AI/ML device study. The device in question is a physical blood sampling system, not a software algorithm. Therefore, many of the requested categories related to AI/ML device testing (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies) are not applicable to the information provided.

However, based on the provided text, I can extract information regarding functional and safety testing that serves as the "study" demonstrating the device meets its acceptance criteria related to safety.

Here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a numerical sample size for the MRI safety testing or any other functional testing. It only states that the system "successfully passed MRI safety testing." The provenance of this data is implicitly from Edwards Lifesciences, the manufacturer. No details are given about the specific test parameters, number of units tested, or the protocol for the "MRI safety testing."

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

Not applicable. This is a physical medical device, not an AI/ML system requiring expert consensus for diagnostic ground truth. The "ground truth" for physical device performance is established through standardized engineering and safety tests.

4. Adjudication method for the test set

Not applicable for a physical device's functional and safety testing as described. "Adjudication" typically refers to resolving disagreements among experts for diagnosis, which is not relevant 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

No. This is not an AI/ML device or a diagnostic device that involves human "readers."

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

No. This is not an AI/ML algorithm.

7. The type of ground truth used

For the reported MRI safety testing, the "ground truth" would be the established safety standards and tests for medical devices in an MRI environment. The device either passed these tests or it did not.

For the other functional claims (safe, convenient, reduced infection, needle sticks, blood waste), the ground truth is implied by the device's design and mechanism of action, presumably supported by other testing (not explicitly detailed but likely part of the broader regulatory submission for a medical device).

8. The sample size for the training set

Not applicable. This is not an AI/ML device with a training set.

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

Not applicable. This is not an AI/ML device with a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The primary study mentioned directly in the provided text relates to the device's MRI safety. The document states:

• "The VAMP blood sampling system has successfully passed MRI safety testing."

This indicates that specific tests were conducted to demonstrate the device's compatibility and safety within an MRI environment, satisfying a critical safety acceptance criterion. While the details of this testing (e.g., number of units tested, specific MRI conditions, acceptance limits) are not provided in this summary, the successful completion of such testing is presented as proof that the device meets this safety criterion.

For the other performance claims (e.g., safe blood withdrawal, reduced infection, needle sticks, blood waste), the document describes them as design intentions and characteristics of the system, rather than results from a specific study detailed in this summary. These broader claims would typically be substantiated through extensive functional testing, material biocompatibility assessments, and design validation activities, which are standard for medical device development, but are not exhaustively described as individual "studies" within this 510(k) summary. The submission asserts substantial equivalence to a predicate device (K885281), implying that these performance aspects are similar to a device already cleared for market.

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