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 Plus device is a needleless closed blood sampling system designed to reduce infection, needle sticks, and blood waste associated with blood sampling. One family of VAMP product line, the VAMP Plus blood sampling system, is the subject of this submission. The VAMP Plus Venous/Arterial Blood Management Protection System (VAMP Plus) 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 Plus 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 the 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

Here's an analysis of the provided text regarding the acceptance criteria and study for the VAMP Plus Venous/Arterial Blood Management Protection System:

This document is a 510(k) summary for a medical device cleared by the FDA. It outlines the regulatory process for the device, including its intended use, classification, and a comparison to predicate devices. However, this is NOT a study report for an AI/ML medical device. The VAMP Plus system is a physical blood sampling system, not an AI-powered one. Therefore, many of the requested categories in your prompt (such as AI-specific performance metrics, ground truth establishment, expert adjudication, MRMC studies, and training set details) are not applicable to this device or document.

The "study that proves the device meets the acceptance criteria" in this context refers to the functional and safety testing described.

1. A table of acceptance criteria and the reported device performance:

The document does not provide a table with specific quantitative acceptance criteria or detailed reported performance values for each criterion. It broadly states that the device successfully passed various tests.

Acceptance Criteria Category	Reported Device Performance
Functional and Performance Testing	Successfully passed
Packaging	Successfully passed
Shelf life	Successfully passed
Sterilization	Successfully passed
Biocompatibility	Successfully passed
Chemical Characterization	Successfully passed
Bench Testing (includes):	Successfully passed
- Overpressure leak testing	Successfully passed
- Negative leak testing	Successfully passed
- Pressure tubing pull testing	Successfully passed
- Frequency response testing	Successfully passed

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document does not specify the sample size for any of the tests. Given it's a physical device and not a data-driven model, concepts like "country of origin for data" or "retrospective/prospective" studies for data provenance are not directly applicable in the same way they would be for an AI/ML device. The testing would have been conducted in a laboratory or simulated environment, likely at the manufacturer's facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not provided. For physical device testing, "ground truth" is typically established by engineering specifications, validated test methods, and compliance with recognized standards, rather than expert human interpretation in the way it's done for diagnostic AI.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods are relevant for subjective interpretations, often in diagnostic imaging by multiple human readers. For the physical device testing described, the "passing" or "failing" of a test is based on objective measurements against pre-defined engineering criteria.

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:

Not applicable. This device is not an AI system, so an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the device's performance is established by engineering specifications, validated test methods, and compliance with relevant industry standards (e.g., for biocompatibility, sterility, leak integrity). This is not equivalent to clinical ground truth like pathology or outcomes data, which would be relevant for diagnostic devices or treatments.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable, as there is no training set for this physical device.

Summary of what the document does provide:

Device: VAMP Plus Venous/Arterial Blood Management Protection System
Intended Use: For blood withdrawal, specifically periodic withdrawal of blood samples from arterial and central line catheters, including peripherally inserted central venous catheters, attached to pressure monitoring lines.
Regulatory Pathway: 510(k) premarket notification.
Predicate Devices: K161962 (VAMP Plus) and K173586 (VAMP Adult).
Changes from Predicate:
- Change of sterilization method (Ethylene Oxide to E-beam radiation).
- Change in PVC plasticizer (DEHP to DINCH®).
- Update of product labeling.
- Introduction of an additional sampling site (Luer Activated Sampling Site) to replace the Z-site in some models.
Proof of Equivalence: The manufacturer asserts that the changes did not alter the performance and that the device successfully passed various functional and safety tests.
Testing Categories: Functional and performance, packaging, shelf life, sterilization, biocompatibility, chemical characterization, and bench testing (overpressure leak, negative leak, pressure tubing pull, frequency response).

In conclusion: The provided text describes the regulatory clearance of a physical medical device (a blood sampling system) and details the non-clinical testing performed to demonstrate its safety and effectiveness. It is not about an AI/ML medical device, and therefore, many of your specific questions related to AI acceptance criteria, ground truth, and study designs are not addressed or applicable.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

November 8, 2018

Edwards Lifesciences, LLC Ye Kim Senior Specialist, Regulatory Affairs One Edwards Way Irvine, California 92614

Re: K181684

Trade/Device Name: VAMP Plus Venous/Arterial Blood Management Protection System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: Class II Product Code: KRA Dated: October 5, 2018 Received: October 9, 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,

Michael John -S 2018.11.08 11:03:48 -05'00'

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)

K181684

Device Name

VAMP Plus Venous/Arterial Blood Management Protection System

Indications for Use (Describe)

To be used only for blood withdrawal.

Type of Use (Select one or both, as applicable)

	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
	Primary Contact	Secondary Contact
Contact Person	Ye Seul KimSenior Specialist, 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	June 25, 2018
Trade Name	VAMP Plus 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 Plus Venous/Arterial Blood Management Protection System(Cleared on November 28, 2016)
SecondaryPredicate Device	K173586: VAMP Venous/Arterial Blood Management Protection System (VAMPAdult) (Cleared on April 5, 2018)
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 Plus device is a needleless closed blood sampling system designedto reduce infection, needle sticks, and blood waste associated with bloodsampling. One family of VAMP product line, the VAMP Plus blood samplingsystem, is the subject of this submission.The VAMP Plus Venous/Arterial Blood Management Protection System (VAMPPlus) is designed for use with disposable and reusable pressure transducersand for connection to central line catheters (inclusive of peripherally insertedcentral catheters and central venous catheters) and arterial catheters where thesystem can be flushed clear after sampling. The VAMP Plus blood samplingsystem is used for the drawing and retention of heparinized/diluted blood (orclearing volume) from the catheter or cannula within the line, allowing undilutedblood samples to be drawn from an in-line sampling site. At the completion ofthe sample draw, the mixed heparin and blood solution (clearing volume) isreinfused into the patient to reduce fluid loss to the patient.
	To 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, 1, 2-cyclohexane 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 (cleared in K173586) to replace the Z-site in some of the VAMP Plusmodels. Testing was conducted to ensure that the change in sterilizationmethod and change in materials did not alter the performance of the VAMPPlus blood sampling system. The subject VAMP Plus blood sampling systemhas been shown to be substantially equivalent to the predicate devices for itsintended use in hospitals and other appropriate clinical environments.
Functional/ SafetyTesting	The VAMP Plus blood sampling system has successfully passed functional andperformance 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 Plus blood sampling system is substantially equivalent to thepredicate devices, the VAMP Plus Venous/Arterial Blood ManagementProtection Systems (K161962) and the VAMP Venous/Arterial BloodManagement Protection System (VAMP Adult) (K173586).

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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).