(136 days)
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:
- 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:
- 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.
- 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.
- Number of experts used to establish ground truth, qualifications: Not applicable, as there's no diagnostic ground truth being established.
- Adjudication method: Not applicable.
- 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.
- Standalone (algorithm-only) performance: Not applicable. There is no algorithm.
- 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.
- Sample size for the training set: Not applicable, as there is no AI/ML model to train.
- 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.
§ 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).