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.

Device Description

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.

AI/ML Overview

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:

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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.

April 5, 2018

Edwards Lifesciences, LLC Ye Kim Specialist, Regulatory Affairs One Edwards Way Irvine, California 92618

Re: K173586

Trade/Device Name: VAMP Venous/Arterial Blood Management Protection System (VAMP Adult) Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: Class II Product Code: KRA Dated: March 2, 2018 Received: March 5, 2018

Dear Ye Kim:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2 - Ye Kim

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kenneth J. Cavanaugh -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173586

Device Name

VAMP Venous/Arterial Blood Management Protection System

Indications for Use (Describe) 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.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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SECTION 5 - 510(k) SUMMARY

510(k) Submitter	Edwards Lifesciences, LLC
Contact Person	Primary Contact	Secondary Contact
	Ye Seul KimSpecialist, Regulatory AffairsEdwards LifesciencesOne Edwards WayIrvine, CA 92614Tel: (949) 250 - 2445Fax: (949) 809 – 5425Email: yeseul_kim@edwards.com	Renate MacLarenSenior Manager, Regulatory AffairsEdwards LifesciencesOne Edwards WayIrvine, CA 92614Tel: (949) 250 - 5783Fax: (949) 809 – 2941Email: renate_maclaren@edwards.com
Date Prepared	April 5, 2018
Trade Name	VAMP Venous/Arterial Blood Management Protection System
Common Name	Closed Blood Sampling System
ClassificationName	Catheter, Continuous Flush (21 CFR 870.1210)
RegulationClass/ProductCode	Class IIKRA
Primary PredicateDevice	K161962: VAMP Venous/Arterial Blood Management Protection System(Cleared on November 28, 2016)
SecondaryPredicate Device	K171996: TruWave™ Disposable Pressure Transducer and associated kits(Cleared on October 23, 2017)
Device Description	The Edwards Venous/Arterial Blood Management Protection (VAMP) Systemsare sterile, single use devices that provide a safe and convenient method forthe withdrawal of blood samples when attached to pressure monitoring lines.The VAMP devices are needleless closed blood sampling systems designed toreduce infection, needle sticks, and blood waste associated with bloodsampling. One family of VAMP product line, the VAMP Adult blood samplingsystem, is the subject of this submission.The VAMP Adult blood sampling system is designed for use with disposableand reusable pressure transducers and for connection to central line catheters(inclusive of peripherally inserted central catheters and central venouscatheters) and arterial catheters where the system can be flushed clear aftersampling. The VAMP Adult blood sampling system is used for the drawing andretention of heparinized/diluted blood (or clearing volume) from the catheter orcannula within the line, allowing undiluted blood samples to be drawn from anin-line sampling site. At the completion of sample draw, the mixed heparin andblood solution (clearing volume) is reinfused into the patient to reduce fluid lossto the patient.
	VAMP AdultTo be used only for blood withdrawal.
Indications forUse/Intended Use	The blood sampling system is indicated for use on patients requiring periodicwithdrawal of blood samples from arterial and central line catheters, includingperipherally inserted central catheters and central venous catheters, which areattached to pressure monitoring lines.
ComparativeAnalysis	The subject device is identical to the predicate devices in terms of intendeduse/ indications for use, and technology. The proposed changes to the deviceinclude a change of sterilization method (100% Ethylene Oxide to E-beamradiation); change in the PVC plasticizer from DEHP to the non-phthalateplasticizer, Cyclohexane-1, 2-dicarboxylic acid diisononyl ester (DINCH®) forthe tubing; update of product labeling to reflect changes in sterilization method(from EO to E-beam radiation) and removal of phthalate symbol on all levels ofpackaging; introduction of an additional sampling site, Luer Activated SamplingSite (K060231) to replace the z-site in some of the VAMP Adult models. Testingwas conducted to ensure that the change in sterilization method and change inmaterials did not alter the performance of the VAMP Adult blood samplingsystem. The subject VAMP Adult blood sampling system has been shown to besubstantially equivalent to the predicate devices for its intended use in hospitalsand other appropriate clinical environments.
Functional/ SafetyTesting	The VAMP Adult blood sampling system has successfully passed functionaland performance testing, including packaging, shelf life, sterilization,biocompatibility, chemical characterization and bench testing that includesoverpressure leak testing, negative leak testing, pressure tubing pull testing andfrequency response testing.
Conclusion	The VAMP Adult blood sampling system is substantially equivalent to thepredicate devices, the Venous/Arterial Blood Management Protection Systems(K161962) and the TruWave™ Disposable Pressure Transducer andassociated kits (K171996).

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Regulation Number and Section

§ 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).