(133 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| MRI Safety | The VAMP blood sampling system has successfully passed MRI safety testing. |
| Functionality (Blood Withdrawal) | "safe and convenient method for the withdrawal of blood samples" |
| Reduced Infection | "designed to reduce infection" |
| Reduced Needle sticks | "designed to reduce ... needle sticks" |
| Reduced Blood Waste | "designed to reduce ... blood waste associated with blood sampling." |
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.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).