(135 days)
Not Found
No
The device description and performance studies focus on mechanical and fluid management aspects of blood sampling, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is used for blood withdrawal and sampling, which is a diagnostic or monitoring function, not a therapeutic intervention.
No
This device is designed for blood withdrawal and sampling, which is a procedure to collect biological samples, but it does not perform any diagnostic analysis itself. Its purpose is to facilitate the collection of blood samples, which may then be used for diagnostic testing by other means.
No
The device description clearly states it is a sterile, single-use device that provides a method for blood withdrawal and is designed to reduce infection, needle sticks, and blood waste. It describes physical components like tubing and sampling sites, and the performance studies focus on physical characteristics and functionality, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To be used only for blood withdrawal." While blood is being withdrawn, the device itself is not performing any diagnostic testing on the blood in vitro (outside the body).
- Device Description: The description focuses on the mechanics of blood withdrawal, sampling, and reinfusion. It describes a system for managing blood flow and obtaining samples, not for analyzing the blood.
- Lack of Diagnostic Function: There is no mention of the device analyzing blood components, detecting biomarkers, or providing any diagnostic information based on the blood sample. The blood sample is intended to be taken for potential diagnostic testing, but the device itself is not performing that test.
- Performance Studies: The performance studies mentioned are related to the functional and physical integrity of the device (leak testing, pull testing, frequency response), not the accuracy or performance of a diagnostic test.
In summary, this device is a tool for obtaining a blood sample, which may then be used for in vitro diagnostic testing, but the device itself is not an IVD.
N/A
Intended Use / Indications for Use
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 catheters and central venous catheters, which are attached to pressure monitoring lines.
Product codes (comma separated list FDA assigned to the subject device)
KRA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals and other appropriate clinical environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The VAMP Plus blood sampling system has successfully passed functional and performance testing, including packaging, shelf life, sterilization, biocompatibility, chemical characterization and bench testing that includes overpressure leak testing, negative leak testing, pressure tubing pull testing and frequency response testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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
1
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.
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)
| 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 Kim | |
| Senior Specialist, Regulatory Affairs | ||
| Edwards Lifesciences | ||
| One Edwards Way | ||
| Irvine, CA 92614 | ||
| Tel: (949) 250 - 2445 | ||
| Fax: (949) 809 – 5425 | ||
| Email: yeseul_kim@edwards.com | Renate MacLaren | |
| Senior Manager, Regulatory Affairs | ||
| Edwards Lifesciences | ||
| One Edwards Way | ||
| Irvine, CA 92614 | ||
| Tel: (949) 250 - 5783 | ||
| Fax: (949) 809 - 2941 | ||
| Email: 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 | |
| Classification | ||
| Name | Catheter, Continuous Flush (21 CFR 870.1210) | |
| Regulation | ||
| Class/Product | ||
| Code | Class II | |
| KRA | ||
| Primary Predicate | ||
| Device | K161962: VAMP Plus Venous/Arterial Blood Management Protection System | |
| (Cleared on November 28, 2016) | ||
| Secondary | ||
| Predicate Device | K173586: VAMP Venous/Arterial Blood Management Protection System (VAMP | |
| Adult) (Cleared on April 5, 2018) | ||
| 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. | ||
| To be used only for blood withdrawal. | ||
| Indications for | ||
| Use/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. | ||
| Comparative | ||
| Analysis | The subject device is identical to the predicate devices in terms of intended | |
| use/ indications for use, and technology. The proposed changes to the device | ||
| include a change of sterilization method (100% Ethylene Oxide to E-beam | ||
| radiation); change in the PVC plasticizer from DEHP to the non-phthalate | ||
| plasticizer, 1, 2-cyclohexane dicarboxylic acid diisononyl ester (DINCH®) for | ||
| the 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 of | ||
| packaging; introduction of an additional sampling site, Luer Activated Sampling | ||
| Site (cleared in K173586) to replace the Z-site in some of the VAMP Plus | ||
| models. Testing was conducted to ensure that the change in sterilization | ||
| method and change in materials did not alter the performance of the VAMP | ||
| Plus blood sampling system. The subject VAMP Plus blood sampling system | ||
| has been shown to be substantially equivalent to the predicate devices for its | ||
| intended use in hospitals and other appropriate clinical environments. | ||
| Functional/ Safety | ||
| Testing | The VAMP Plus blood sampling system has successfully passed functional and | |
| performance testing, including packaging, shelf life, sterilization, | ||
| biocompatibility, chemical characterization and bench testing that includes | ||
| overpressure leak testing, negative leak testing, pressure tubing pull testing and | ||
| frequency response testing. | ||
| Conclusion | The VAMP Plus blood sampling system is substantially equivalent to the | |
| predicate devices, the VAMP Plus Venous/Arterial Blood Management | ||
| Protection Systems (K161962) and the VAMP Venous/Arterial Blood | ||
| Management Protection System (VAMP Adult) (K173586). |
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