(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.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three human profiles facing to the right, with flowing lines suggesting movement or transformation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 28, 2016
Edwards Lifesciences LLC Jennifer Wilbur Manager, Critical Care Regulatory Affairs, Program Management One Edwards Way Irvine, California 92614
Re: K161962
Trade/Device Name: VAMP 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 26, 2016 Received: October 27, 2016
Dear Jennifer Wilbur:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
K161962
Device Name
VAMP Venous/Arterial Blood Management Protection System
Indications for Use (Describe) 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.
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) | |
|---|---|
| ----------------------------------------------------------- | --------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
SECTION 5 – 510(k) SUMMARY
| 510(k) Submitter | Edwards Lifesciences, LLC | |
|---|---|---|
| Contact Person | Primary ContactJennifer WilburManager, Regulatory Affairs, PMJennifer_Wilbur@edwards.comOffice: 949-756-4436Cell: 508-776-4525Fax: 949-809-2984Anticipated to be on maternityleave from November 17, 2016 –February 8, 2017 | Backup ContactDeana BoushellSenior Manager, Regulatory Affairs, PMDeana_Boushell@edwards.comOffice: 949-756-4472Cell: 508-254-3289Fax: 949-809-2967 |
| Date Prepared | November 23, 2016 | |
| Trade Name | VAMP Venous/Arterial Blood Management Protection System | |
| Common Name | Closed Blood Sampling System | |
| Classification Name | Catheter, Continuous Flush (CFR 21 870.1210) | |
| RegulationClass/Product Code | Class IIKRA | |
| Predicate Device(s) | K885281: VAMP Venous/Arterial Blood Management Protection System | |
| Device Description | The subject Edwards Venous/Arterial Blood Management Protection (VAMP)System is a sterile, single use device that provides a safe and convenientmethod for the withdrawal of blood samples when attached to pressuremonitoring lines. The subject device is a needleless closed blood samplingsystem designed to reduce infection, needle sticks, and blood wasteassociated with blood sampling.The VAMP blood sampling system is designed for use with disposable andreusable pressure transducers and for connection to central line catheters(inclusive of peripherally inserted central catheters and central venouscatheters), arterial catheters, and umbilical catheters where the system can beflushed clear after sampling. The VAMP blood sampling system is used for thedrawing and retention of heparinized/diluted blood (or clearing volume) fromthe catheter or cannula within the line, allowing undiluted blood samples to bedrawn from an in-line sampling site. At the completion of sample draw, themixed heparin and blood solution (clearing volume) is reinfused into thepatient to reduce fluid loss to the patient.The collected blood can be transferred to a vacuum tube via a VAMP BloodTransfer Unit (BTU) or a VAMP Direct-Draw unit. The main purpose of theBTU is to provide a conduit (split septum membrane) in which a blood-filledsyringe and blunt cannula assembly can transfer the blood sample to avacuum tube without using a needle. The Direct-Draw Unit performs in the | |
| same fashion, except it allows for direct connection of the vacuum tube anddoesn't require use of separate sampling syringe. | ||
| VAMP Adult and VAMP Plus | ||
| Indications forUse/Intended Use | To be used only for blood withdrawal. | |
| 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. | ||
| VAMP Jr. | ||
| To be used only for blood withdrawal. | ||
| The blood sampling system is indicated for use on pediatric patients (includingneonates) requiring periodic withdrawal of blood samples from umbilical,arterial and central line catheters, including peripherally inserted centralcatheters and central venous catheters, which are attached to pressuremonitoring lines. | ||
| ComparativeAnalysis | There are no physical differences between the subject and predicate devices.The proposed changes to the predicate device include an update to theindications of VAMP Adult, VAMP Plus and VAMP Jr. to clarify that central linecatheters are inclusive of central venous catheters and peripherally insertedcentral catheters. This clarification has no impact to the intended use and isonly serving to clarify what is meant by central line catheter. | |
| Functional/ SafetyTesting | The VAMP blood sampling system has successfully passed MRI safetytesting. | |
| Conclusion | The Edwards Venous/Arterial Blood Management Protection System and itsaccessories have been demonstrated to be substantially equivalent to thepredicate Venous/Arterial Blood Management Protection System and itsaccessories (K885281). |
{4}------------------------------------------------
§ 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).