(136 days)
No
The description focuses on the mechanical function of a blood sampling system and does not mention any computational or analytical capabilities that would suggest AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is used for blood withdrawal and sampling from existing catheter lines for diagnostic purposes, not for treating a disease or condition. Its function is to facilitate safe and efficient blood collection, not to provide therapeutic intervention.
No
The device is described as a blood sampling system for withdrawing blood samples, not for diagnosing conditions. It facilitates the process of obtaining samples but does not perform diagnostic analysis itself.
No
The device description clearly states it is a sterile, single-use device with physical components like tubing and sampling sites, indicating it is a hardware-based medical device.
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." This describes a process of obtaining a sample, not analyzing it.
- Device Description: The description focuses on the mechanics of blood sampling, reducing infection, needle sticks, and blood waste. It describes how the system manages blood flow and allows for sample collection, but not how the collected blood is analyzed or used for diagnostic purposes.
- Lack of Diagnostic Function: There is no mention of the device performing any tests, measurements, or analysis on the blood sample itself to provide diagnostic information about a patient's health.
- No Mention of Diagnostic Output: The description doesn't mention any output related to a diagnosis, disease state, or other health condition.
The VAMP Adult blood sampling system is a device used to collect blood samples, which are then likely sent to a laboratory for in vitro diagnostic testing. The VAMP system facilitates the collection process but does not perform the diagnostic analysis itself.
N/A
Intended Use / Indications for Use
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.
Product codes
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 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.
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
Adult
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 Adult 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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
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
2
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 | ||
| 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 | April 5, 2018 | |
| Trade Name | VAMP 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 Venous/Arterial Blood Management Protection System | |
| (Cleared on November 28, 2016) | ||
| Secondary | ||
| Predicate Device | K171996: TruWave™ Disposable Pressure Transducer and associated kits | |
| (Cleared on October 23, 2017) | ||
| 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. | |
| | VAMP Adult
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, Cyclohexane-1, 2-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 (K060231) to replace the z-site in some of the VAMP Adult models. 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. The subject VAMP Adult 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 Adult 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 Adult blood sampling system is substantially equivalent to the
predicate devices, the Venous/Arterial Blood Management Protection Systems
(K161962) and the TruWave™ Disposable Pressure Transducer and
associated kits (K171996). | |
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