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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 subject Edwards Lifesciences VAMP Optima closed blood sampling system is a sterile, single-use device that provides a safe and convenient method for the withdrawal of blood samples from 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 Optima closed blood sampling system is designed for use with disposable 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 Optima closed blood sampling system is used for the drawing and retention of heparinized or non-heparinized blood 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 drawing, the blood or mixed heparin and blood

This is a 510(k) premarket notification for the Edwards Lifesciences VAMP Optima closed blood sampling system. It is a new version of an existing device, and the submission aims to demonstrate substantial equivalence to the predicate device (VAMP Plus Venous/Arterial Blood Management Protection System, K161962).

The document does not contain acceptance criteria or a study that directly proves the device meets specific performance acceptance criteria in the traditional sense of a clinical trial for diagnostic performance metrics. Instead, this 510(k) submission focuses on demonstrating substantial equivalence through a comparison to a predicate device and extensive functional and safety testing.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned above, the document does not present a table of specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic device) and corresponding reported performance. Instead, it describes a series of functional and safety tests performed to ensure the device performs as intended and is safe.

2. Sample Size for the Test Set and Data Provenance

The document describes "functional and performance testing," "pre-clinical testing," and "bench studies." These are not clinical studies with "test sets" in the diagnostic performance sense. Therefore, information about patient sample sizes, country of origin, or retrospective/prospective nature of a clinical test set is not applicable or provided here. These tests would involve laboratory or simulated environments.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The assessments are based on engineering, material science, and safety testing standards rather than expert clinical interpretation of data from a patient test set.

4. Adjudication Method

Not applicable, as there isn't a complex diagnostic outcome requiring adjudication by experts.

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

Not applicable. This device is a blood sampling system, not an AI or imaging diagnostic tool that would typically involve MRMC studies or human reader improvement with AI assistance. The submission focuses on functional and safety equivalence.

6. Standalone Performance

The functional and safety tests described are effectively standalone performance assessments of the device's ability to maintain sterility, integrity, and perform its intended function of blood sampling and management. However, this is not a diagnostic algorithm standalone performance. The device is designed to be used with human operators in a clinical setting.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily established by:

• Engineering specifications and regulatory standards: The device must meet predefined specifications for material strength, leak integrity, flow rates, chemical compatibility, sterilization efficacy, etc.
• Biocompatibility standards: As per ISO 10993-1, to ensure the device does not cause adverse biological reactions.
• Safety standards: Ensuring the device prevents needle sticks, minimizes blood waste, and maintains a closed system.

There is no "expert consensus," "pathology," or "outcomes data" in the context of evaluating diagnostic accuracy for this type of device.

8. Sample Size for the Training Set

Not applicable. This device is not an AI algorithm that undergoes "training." The design and manufacturing processes are validated, not "trained."

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

Not applicable, as there is no training set for this type of medical device.

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