(266 days)
No
The description focuses on the mechanical function of a closed blood sampling system and does not mention any computational or analytical capabilities that would suggest AI/ML.
No
The device is used for blood withdrawal and sampling, not for treating a disease or condition.
No
The device is described as a blood sampling system used for the withdrawal and retention of blood samples. It does not perform any diagnostic analysis or interpretation of the collected blood samples; its function is solely for sample collection.
No
The device description clearly states it is a "sterile, single-use device" and describes physical components like a "needleless, closed blood sampling system" designed for connection to catheters and pressure monitoring lines. This indicates a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is explicitly stated as "To be used only for blood withdrawal." This describes a device used for collecting a biological sample from the body.
- Device Description: The description focuses on the mechanics of blood sampling from catheters and pressure monitoring lines. It describes a system for drawing and retaining blood, not for analyzing it or performing tests on it.
- Lack of Diagnostic Function: There is no mention of the device performing any analysis, testing, or diagnostic procedures on the collected blood. IVD devices are designed to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
This device is a blood collection system, which is a different category of medical device than 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 venous catheters, which are attached to pressure monitoring lines.
Product codes (comma separated list FDA assigned to the subject device)
KRA, FMG, FPA
Device Description
The subject Edwards Lifesciences VAMP Optima closed blood sampling system is a sterile, single-use device that provides a safe and convenient method for the withdrawal of blood samples from 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 Optima closed blood sampling system is designed for use with disposable 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 Optima closed blood sampling system is used for the drawing and retention of heparinized or non-heparinized blood 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 drawing, the blood or mixed heparin and blood
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
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 Optima closed blood sampling system has successfully passed functional and performance testing, including packaging, shelf life, sterilization, biocompatibility, chemical characterization, human factors, pre-clinical testing and bench studies. Testing was performed in accordance with the following standards: ISO 10993-1, ISO 11607-1/-2, ISO 11135, ASTM F2503-13 and FDA's 2008 device-specific guidance "Intravascular Administration Sets Premarket Notification Submissions [510(k)]."
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.
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).
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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
October 24, 2018
Edwards Lifesciences LLC Jennifer Wilbur Manager, Regulatory Affairs, Program Management One Edwards Way Irvine, California 92614
Re: K180275
Trade/Device Name: VAMP Optima closed blood sampling system Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: January 30, 2018 Received: January 31, 2018
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. 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/cdrl/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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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.
Fernando Aguel Fernando Aguel -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K180275
Device Name
VAMP Optima closed blood sampling 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.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
SECTION 5 - 510(k) SUMMARY
| 510(k) Submitter | Edwards Lifesciences, LLC | |
|---|---|---|
| Establishment | ||
| Registration | ||
| Number | 2015691 | |
| Address | One Edwards Way | |
| Irvine, CA 92614 | ||
| Phone: 949-250-2500 | ||
| Contact Person | Jennifer Wilbur | |
| Manager, Regulatory Affairs Program Management | ||
| Edwards Lifesciences | ||
| One Edwards Way | ||
| Irvine, CA 92614 | ||
| Email: Jennifer_Wilbur@edwards.com | ||
| Office: 949-756-4436 | ||
| Fax: 949-809-2984 | ||
| Date Prepared | January 30, 2018 | |
| Trade Name | VAMP Optima closed blood sampling system | |
| Common Name | Closed Blood Sampling System | |
| Classification Name | Catheter, Continuous Flush (21 CFR 870.1210) | |
| Stopcock, I.V. Set and Intravascular administration set (21 CFR 880.5440) | ||
| Regulation | ||
| Class/Product Code | Class II | |
| KRA, FMG, FPA | ||
| Predicate Device(s) | K161962: VAMP Plus Venous/Arterial Blood Management Protection | |
| System | ||
| Device Description | The subject Edwards Lifesciences VAMP Optima closed blood sampling | |
| system is a sterile, single-use device that provides a safe and | ||
| convenient method for the withdrawal of blood samples from 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 Optima closed blood sampling system is designed for use | ||
| with disposable 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 Optima closed blood sampling | ||
| system is used for the drawing and retention of heparinized or non- | ||
| heparinized blood 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 drawing, the blood or mixed heparin and blood | ||
| 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. | ||
| Models | Model | |
| Number | VAMP Optima closed blood sampling system models | |
| Model Description | ||
| VOPTIMA | VAMP Optima with Z-site + COMBICAP caps, 10-pack | |
| VOPTIMAL | VAMP Optima with LASS + COMBICAP caps, 10-pack | |
| MHD8VZ | FloTrac sensor + IV Set + VAMP Optima with Z-site + COMBICAP caps, single pack | |
| MHD8VZ5 | FloTrac sensor + IV Set + VAMP Optima with Z-site + COMBICAP caps, 5-pack | |
| MHD8VRL | FloTrac sensor + IV Set + VAMP Optima with LASS + COMBICAP caps + red striped tubing, single pack | |
| MHD8VRL5 | FloTrac sensor + IV Set + VAMP Optima with LASS + COMBICAP caps + red stopcock inserts + red | |
| striped tubing, 5-pack | ||
| MHD8VZTW | FloTrac sensor + IV Set + TruWave DPT + VAMP Optima with Z-site, + COMBICAP caps + blue | |
| striped tubing, 5-pack | ||
| MHD8VLTW | FloTrac sensor + IV Set + TruWave DPT + VAMP Optima with LASS + COMBICAP caps + red striped | |
| tubing + blue striped tubing, 5-pack | ||
| MHDQ8VZ | FloTrac IQ sensor + IV Set + VAMP Optima with Z-site + COMBICAP caps, single pack | |
| MHDQ8VZ5 | FloTrac IQ sensor + IV Set + VAMP Optima with Z-site + COMBICAP caps, 5-pack | |
| MHDQ8VRL | FloTrac IQ sensor + IV Set + VAMP Optima with LASS + COMBICAP caps + red striped tubing, | |
| single pack | ||
| MHDQ8VRL5 | FloTrac IQ sensor + IV Set + VAMP Optima with LASS + COMBICAP caps + red striped tubing, 5- | |
| pack | ||
| MHDQ8VZTW | FloTrac IQ sensor + IV Set + TruWave DPT + VAMP Optima with Z-site + COMBICAP caps + | |
| blue striped tubing, 5-pack | ||
| MHDQ8VLTW | FloTrac IQ sensor + IV Set + TruWave DPT + VAMP Optima with LASS + COMBICAP caps + red | |
| striped tubing + blue striped tubing, 5-pack |
4
5
| Comparative
Analysis | The modified VAMP Optima closed blood sampling system has the
following similarities to the predicate VAMP Plus device:
has the same indications for use, intended use and
contraindications, uses the same operating principle, has similar technological characteristics, built from the same type of components, incorporates the same basic reservoir design, utilizes many of the same materials, includes the option for a Z-site sample site, is MR Conditional, contains an IV set, compatible with a TruWave disposable pressure transducer
(K142749), is packaged and sterilized using the same materials and
processes The following proposed changes from the VAMP Plus to the VAMP
Optima closed blood sampling system are the subject of this 510(k)
submission. These differences are not a fundamental change in
scientific technology and have no impact to the intended use or
indications for use. Expansion of sampling site offerings beyond the current Z-site to
include a needleless Luer Access Sample Site (LASS), Modification to subassembly components: Modification from a two position one-way valve to a four
position three-way valve Modification to the reservoir from a one port to a two port
syringe body in order to align with the three-way valve
design Dimensional and cosmetic modifications to the reservoir
and reservoir bracket Pressure tubing, IV Set and adhesive material changes, Male luer lock connector change, Designed to be compatible with a FloTrac sensor (K152980) |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Functional/ Safety
Testing | The VAMP Optima closed blood sampling system has successfully
passed functional and performance testing, including packaging, shelf
life, sterilization, biocompatibility, chemical characterization, human
factors, pre-clinical testing and bench studies. Testing was performed in
accordance with the following standards: ISO 10993-1, ISO 11607-1/-2,
ISO 11135, ASTM F2503-13 and FDA's 2008 device-specific guidance
"Intravascular Administration Sets Premarket Notification Submissions
[510(k)]." |
| Conclusion | The Edwards Lifesciences VAMP Optima closed blood sampling system
has been demonstrated to be substantially equivalent to the predicate
VAMP Plus Venous/Arterial Blood Management Protection System
(K161962). |