(133 days)
No
The device description and intended use focus on mechanical blood sampling and management, with no mention of AI or ML capabilities.
No.
The device is used for blood withdrawal and sampling, which are diagnostic and monitoring functions, not therapeutic interventions. While it may reduce infection and fluid loss, its primary purpose is not to treat a condition.
No.
The device is described as a blood sampling system for withdrawing blood samples from catheters and is explicit about its purpose being only for blood withdrawal. There is no mention of analysis, diagnosis, or interpretation of the blood samples by the device itself.
No
The device description clearly outlines a sterile, single-use physical system with components like catheters, pressure monitoring lines, and blood transfer units, indicating it is a hardware device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The primary intended use is for the withdrawal of blood samples from catheters. While the collected blood can be used for diagnostic testing, the device itself is focused on the collection process, not the analysis of the blood.
- Device Description: The description details a system for safely and conveniently obtaining blood samples and managing the clearing volume. It describes the mechanism for drawing and transferring blood, but not any components or processes for analyzing the blood's properties or composition.
- Lack of Diagnostic Function: There is no mention of the device performing any tests, measurements, or analyses on the blood sample itself. It's a tool for obtaining the sample, which is then presumably sent to a laboratory for IVD testing.
In summary, the VAMP system is a blood collection device, not a device that performs diagnostic testing on the collected blood.
N/A
Intended Use / Indications for Use
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.
Product codes
KRA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arterial, Central line catheters (including peripherally inserted central venous catheters, and central venous catheters), Umbilical (for pediatric patients).
Indicated Patient Age Range
Patients (including pediatric patients and neonates)
Intended User / Care Setting
Not Found
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 blood sampling system has successfully passed MRI safety testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
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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.
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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
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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) | |
|---|---|
| ----------------------------------------------------------- | --------------- |
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SECTION 5 – 510(k) SUMMARY
| 510(k) Submitter | Edwards Lifesciences, LLC | |
|---|---|---|
| Contact Person | Primary Contact | |
| Jennifer Wilbur | ||
| Manager, Regulatory Affairs, PM | ||
| Jennifer_Wilbur@edwards.com | ||
| Office: 949-756-4436 | ||
| Cell: 508-776-4525 | ||
| Fax: 949-809-2984 | ||
| Anticipated to be on maternity | ||
| leave from November 17, 2016 – | ||
| February 8, 2017 | Backup Contact | |
| Deana Boushell | ||
| Senior Manager, Regulatory Affairs, PM | ||
| Deana_Boushell@edwards.com | ||
| Office: 949-756-4472 | ||
| Cell: 508-254-3289 | ||
| Fax: 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) | |
| Regulation | ||
| Class/Product Code | Class II | |
| KRA | ||
| 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 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. | ||
| VAMP Adult and VAMP Plus | ||
| Indications for | ||
| Use/Intended 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. | ||
| 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. | ||
| Comparative | ||
| Analysis | There are no physical differences between the subject and predicate devices. | |
| The proposed changes to the predicate device include an update to the | ||
| indications of VAMP Adult, VAMP Plus and VAMP Jr. to clarify that central line | ||
| catheters are inclusive of central venous catheters and peripherally inserted | ||
| central catheters. This clarification has no impact to the intended use and is | ||
| only serving to clarify what is meant by central line catheter. | ||
| Functional/ Safety | ||
| Testing | The VAMP blood sampling system has successfully passed MRI safety | |
| testing. | ||
| Conclusion | The Edwards Venous/Arterial Blood Management Protection System and its | |
| accessories have been demonstrated to be substantially equivalent to the | ||
| predicate Venous/Arterial Blood Management Protection System and its | ||
| accessories (K885281). |
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