VAMP Venous/Arterial Blood Management Protection System

K173586 · Edwards Lifesciences, LLC · KRA · Apr 5, 2018 · Cardiovascular

Device Facts

• Record ID: K173586
• Device Name: VAMP Venous/Arterial Blood Management Protection System
• Applicant: Edwards Lifesciences, LLC
• Product Code: KRA · Cardiovascular
• Decision Date: Apr 5, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2

Intended Use

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 catheters and central venous catheters, which are attached to pressure monitoring lines.

Device Story

VAMP Adult is a sterile, single-use, needleless closed blood sampling system; connects to arterial and central line catheters via pressure monitoring lines. Device facilitates withdrawal of blood samples; draws and retains heparinized/diluted blood (clearing volume) from catheter; allows collection of undiluted blood from in-line sampling site. Post-sampling, clearing volume is reinfused to patient to minimize fluid loss. Used in hospital/clinical settings by healthcare providers. Reduces infection risk, needle sticks, and blood waste. Subject of this 510(k) includes transition to E-beam sterilization and adoption of DINCH plasticizer for tubing.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included packaging, shelf life, sterilization validation, biocompatibility, chemical characterization, overpressure leak testing, negative leak testing, pressure tubing pull testing, and frequency response testing.

Technological Characteristics

Sterile, single-use closed blood sampling system. Materials include PVC tubing with DINCH (Cyclohexane-1, 2-dicarboxylic acid diisononyl ester) plasticizer. Connectivity: interfaces with pressure monitoring lines and catheters. Sterilization: E-beam radiation. Mechanical design includes Luer Activated Sampling Site.

Indications for Use

Indicated for patients requiring periodic blood sampling from arterial or central venous catheters (including PICCs) attached to pressure monitoring lines.

Regulatory Classification

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.

Predicate Devices

• VAMP Venous/Arterial Blood Management Protection System (K161962)
• TruWave™ Disposable Pressure Transducer and associated kits (K171996)

Reference Devices

• Luer Activated Sampling Site (K060231)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 Kim<br>Specialist, Regulatory Affairs<br>Edwards Lifesciences<br>One Edwards Way<br>Irvine, CA 92614<br>Tel: (949) 250 - 2445<br>Fax: (949) 809 – 5425<br>Email: [e-mail] | Renate MacLaren<br>Senior Manager, Regulatory Affairs<br>Edwards Lifesciences<br>One Edwards Way<br>Irvine, CA 92614<br>Tel: (949) 250 - 5783<br>Fax: (949) 809 – 2941<br>Email: [e-mail] |
| Date Prepared | April 5, 2018 | |
| Trade Name | VAMP Venous/Arterial Blood Management Protection System | |
| Common Name | Closed Blood Sampling System | |
| Classification<br>Name | Catheter, Continuous Flush (21 CFR 870.1210) | |
| Regulation<br>Class/Product<br>Code | Class II<br>KRA | |
| Primary Predicate<br>Device | K161962: VAMP Venous/Arterial Blood Management Protection System<br>(Cleared on November 28, 2016) | |
| Secondary<br>Predicate Device | K171996: TruWave™ Disposable Pressure Transducer and associated kits<br>(Cleared on October 23, 2017) | |
| Device Description | The Edwards Venous/Arterial Blood Management Protection (VAMP) Systems<br>are sterile, single use devices that provide a safe and convenient method for<br>the withdrawal of blood samples when attached to pressure monitoring lines.<br>The VAMP devices are needleless closed blood sampling systems designed to<br>reduce infection, needle sticks, and blood waste associated with blood<br>sampling. One family of VAMP product line, the VAMP Adult blood sampling<br>system, is the subject of this submission.<br><br>The VAMP Adult blood sampling system is designed for use with disposable<br>and reusable pressure transducers and for connection to central line catheters<br>(inclusive of peripherally inserted central catheters and central venous<br>catheters) and arterial catheters where the system can be flushed clear after<br>sampling. The VAMP Adult blood sampling system is used for the drawing and<br>retention of heparinized/diluted blood (or clearing volume) from the catheter or<br>cannula within the line, allowing undiluted blood samples to be drawn from an<br>in-line sampling site. At the completion of sample draw, the mixed heparin and<br>blood solution (clearing volume) is reinfused into the patient to reduce fluid loss<br>to the patient. | |
| | VAMP Adult<br>To be used only for blood withdrawal. | |
| Indications for<br>Use/Intended Use | The blood sampling system is indicated for use on patients requiring periodic<br>withdrawal of blood samples from arterial and central line catheters, including<br>peripherally inserted central catheters and central venous catheters, which are<br>attached to pressure monitoring lines. | |
| Comparative<br>Analysis | The subject device is identical to the predicate devices in terms of intended<br>use/ indications for use, and technology. The proposed changes to the device<br>include a change of sterilization method (100% Ethylene Oxide to E-beam<br>radiation); change in the PVC plasticizer from DEHP to the non-phthalate<br>plasticizer, Cyclohexane-1, 2-dicarboxylic acid diisononyl ester (DINCH®) for<br>the tubing; update of product labeling to reflect changes in sterilization method<br>(from EO to E-beam radiation) and removal of phthalate symbol on all levels of<br>packaging; introduction of an additional sampling site, Luer Activated Sampling<br>Site (K060231) to replace the z-site in some of the VAMP Adult models. Testing<br>was conducted to ensure that the change in sterilization method and change in<br>materials did not alter the performance of the VAMP Adult blood sampling<br>system. The subject VAMP Adult blood sampling system has been shown to be<br>substantially equivalent to the predicate devices for its intended use in hospitals<br>and other appropriate clinical environments. | |
| Functional/ Safety<br>Testing | The VAMP Adult blood sampling system has successfully passed functional<br>and performance testing, including packaging, shelf life, sterilization,<br>biocompatibility, chemical characterization and bench testing that includes<br>overpressure leak testing, negative leak testing, pressure tubing pull testing and<br>frequency response testing. | |
| Conclusion | The VAMP Adult blood sampling system is substantially equivalent to the<br>predicate devices, the Venous/Arterial Blood Management Protection Systems<br>(K161962) and the TruWave™ Disposable Pressure Transducer and<br>associated kits (K171996). | |

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