(266 days)
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.
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
This is a 510(k) premarket notification for the Edwards Lifesciences VAMP Optima closed blood sampling system. It is a new version of an existing device, and the submission aims to demonstrate substantial equivalence to the predicate device (VAMP Plus Venous/Arterial Blood Management Protection System, K161962).
The document does not contain acceptance criteria or a study that directly proves the device meets specific performance acceptance criteria in the traditional sense of a clinical trial for diagnostic performance metrics. Instead, this 510(k) submission focuses on demonstrating substantial equivalence through a comparison to a predicate device and extensive functional and safety testing.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned above, the document does not present a table of specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic device) and corresponding reported performance. Instead, it describes a series of functional and safety tests performed to ensure the device performs as intended and is safe.
| Test Category | Test Type | Description / Result Reporting |
|---|---|---|
| Functional/Safety | Packaging Testing | Successfully passed. (Details on criteria not provided in this summary) |
| Shelf Life Testing | Successfully passed. (Details on criteria not provided in this summary) | |
| Sterilization Testing | Successfully passed. (Details on criteria not provided in this summary) | |
| Biocompatibility Testing | Successfully passed in accordance with ISO 10993-1. (Details on specific tests and criteria not provided in this summary) | |
| Chemical Characterization | Successfully passed. (Details on criteria not provided in this summary) | |
| Human Factors Testing | Successfully passed. (Details on criteria not provided in this summary) | |
| Pre-clinical Testing | Successfully passed. (Details on criteria not provided in this summary) | |
| Bench Studies | Successfully passed. (Details on criteria not provided in this summary) | |
| Compliance to Standards | Performed in accordance with ISO 10993-1, ISO 11607-1/-2, ISO 11135, ASTM F2503-13, and FDA's 2008 guidance "Intravascular Administration Sets Premarket Notification Submissions [510(k)]." |
2. Sample Size for the Test Set and Data Provenance
The document describes "functional and performance testing," "pre-clinical testing," and "bench studies." These are not clinical studies with "test sets" in the diagnostic performance sense. Therefore, information about patient sample sizes, country of origin, or retrospective/prospective nature of a clinical test set is not applicable or provided here. These tests would involve laboratory or simulated environments.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The assessments are based on engineering, material science, and safety testing standards rather than expert clinical interpretation of data from a patient test set.
4. Adjudication Method
Not applicable, as there isn't a complex diagnostic outcome requiring adjudication by experts.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a blood sampling system, not an AI or imaging diagnostic tool that would typically involve MRMC studies or human reader improvement with AI assistance. The submission focuses on functional and safety equivalence.
6. Standalone Performance
The functional and safety tests described are effectively standalone performance assessments of the device's ability to maintain sterility, integrity, and perform its intended function of blood sampling and management. However, this is not a diagnostic algorithm standalone performance. The device is designed to be used with human operators in a clinical setting.
7. Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily established by:
- Engineering specifications and regulatory standards: The device must meet predefined specifications for material strength, leak integrity, flow rates, chemical compatibility, sterilization efficacy, etc.
- Biocompatibility standards: As per ISO 10993-1, to ensure the device does not cause adverse biological reactions.
- Safety standards: Ensuring the device prevents needle sticks, minimizes blood waste, and maintains a closed system.
There is no "expert consensus," "pathology," or "outcomes data" in the context of evaluating diagnostic accuracy for this type of device.
8. Sample Size for the Training Set
Not applicable. This device is not an AI algorithm that undergoes "training." The design and manufacturing processes are validated, not "trained."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of medical device.
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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
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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
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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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SECTION 5 - 510(k) SUMMARY
| 510(k) Submitter | Edwards Lifesciences, LLC | |
|---|---|---|
| EstablishmentRegistrationNumber | 2015691 | |
| Address | One Edwards WayIrvine, CA 92614Phone: 949-250-2500 | |
| Contact Person | Jennifer WilburManager, Regulatory Affairs Program ManagementEdwards LifesciencesOne Edwards WayIrvine, CA 92614Email: Jennifer_Wilbur@edwards.comOffice: 949-756-4436Fax: 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) | |
| RegulationClass/Product Code | Class IIKRA, FMG, FPA | |
| Predicate Device(s) | K161962: VAMP Plus Venous/Arterial Blood Management ProtectionSystem | |
| Device Description | The subject Edwards Lifesciences VAMP Optima closed blood samplingsystem is a sterile, single-use device that provides a safe andconvenient method for the withdrawal of blood samples from pressuremonitoring lines. The subject device is a needleless, closed bloodsampling system designed to reduce infection, needle sticks, and bloodwaste associated with blood sampling.The VAMP Optima closed blood sampling system is designed for usewith disposable pressure transducers and for connection to central linecatheters (inclusive of peripherally inserted central catheters and centralvenous catheters) and arterial catheters where the system can beflushed clear after sampling. The VAMP Optima closed blood samplingsystem is used for the drawing and retention of heparinized or non-heparinized blood from the catheter or cannula within the line, allowingundiluted blood samples to be drawn from an in-line sampling site. Atthe completion of sample drawing, the blood or mixed heparin and blood | |
| To be used only for blood withdrawal. | ||
| Indications forUse/Intended Use | The blood sampling system is indicated for use on patients requiringperiodic withdrawal of blood samples from arterial and central linecatheters, including peripherally inserted central catheters and centralvenous catheters, which are attached to pressure monitoring lines. | |
| Models | ModelNumber | VAMP Optima closed blood sampling system modelsModel 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 + redstriped tubing, 5-pack | |
| MHD8VZTW | FloTrac sensor + IV Set + TruWave DPT + VAMP Optima with Z-site, + COMBICAP caps + bluestriped tubing, 5-pack | |
| MHD8VLTW | FloTrac sensor + IV Set + TruWave DPT + VAMP Optima with LASS + COMBICAP caps + red stripedtubing + 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 + redstriped tubing + blue striped tubing, 5-pack |
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| ComparativeAnalysis | The modified VAMP Optima closed blood sampling system has thefollowing similarities to the predicate VAMP Plus device:has the same indications for use, intended use andcontraindications, 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 andprocesses The following proposed changes from the VAMP Plus to the VAMPOptima closed blood sampling system are the subject of this 510(k)submission. These differences are not a fundamental change inscientific technology and have no impact to the intended use orindications for use. Expansion of sampling site offerings beyond the current Z-site toinclude a needleless Luer Access Sample Site (LASS), Modification to subassembly components: Modification from a two position one-way valve to a fourposition three-way valve Modification to the reservoir from a one port to a two portsyringe body in order to align with the three-way valvedesign Dimensional and cosmetic modifications to the reservoirand 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/ SafetyTesting | The VAMP Optima closed blood sampling system has successfullypassed functional and performance testing, including packaging, shelflife, sterilization, biocompatibility, chemical characterization, humanfactors, pre-clinical testing and bench studies. Testing was performed inaccordance 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 systemhas been demonstrated to be substantially equivalent to the predicateVAMP Plus Venous/Arterial Blood Management Protection System(K161962). |
§ 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).