(15 days)
For use with a vascular access device for the administration of drugs and solutions. The Clearlink Luer Activated Valve is an in-line injection site, which can be connected to standard male Luer adapters (e.g., syringes or sets) for continuous or intermittent fluid administration or the withdrawal of fluids.
The proposed devices, which are the subject of this Special 510(k) Premarket Notification, consist of the Clearlink Luer Activated Valve, Intravenous (IV) administration and IV extension sets with the Clearlink Luer Activated Valve. They are single use disposable devices intended for use with a vascular access device for continuous or intermittent fluid administration or withdrawal of fluids. These devices are the same as the current marketed devices, previously cleared on October 19, 2000 under 510(k) premarket notification "Modification to Solution Administration Set with Capped Luer Activated Device (Clearlink)" by Baxter Healthcare Corporation (K003255).
The Clearlink Luer Activated Valve is an in-line access site and can be connected to male Luer adapters (e.g., syringes or sets) to allow needleless access to the fluid or vascular path.
The IV administration sets with the Clearlink Luer Activated Valve are used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. They contain the Clearlink Luer Activated Valve Y-Site port that can be used for the administration of secondary medication.
The IV extension sets with the Clearlink Luer Activated Valve are used for the administration and withdrawal of fluids. They consist of the Clearlink Luer Activated Valve connected to the IV extension set.
The basis for this premarket notification is a proposed minor design change to Baxter's Clearlink Luer Activated Valve Y-Site design that is integral to the IV administration sets.
This document describes a Special 510(k) Premarket Notification for a minor design change to an existing medical device, the Clearlink Luer Activated Valve and associated IV administration and extension sets. This type of submission focuses on demonstrating that the modified device remains substantially equivalent to the previously cleared predicate device, rather than proving efficacy or a new clinical benefit. Therefore, the information provided focuses on engineering and performance testing to confirm the design change does not negatively impact safety or function.
Given this context, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" will be interpreted in terms of the non-clinical bench testing performed for this 510(k) submission. Many of the requested specific points (e.g., sample size for test set, data provenance, ground truth experts, MRMC studies, standalone algorithm performance, training set details) are typically relevant for AI/ML device submissions or clinical trials, which are not applicable to this type of device and submission.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states, "All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use." However, it does not explicitly list the quantitative acceptance criteria for each test. The "reported device performance" is implicitly stated as meeting these unquantified criteria.
| Acceptance Criteria (Not explicitly quantified in the document) | Reported Device Performance |
|---|---|
| The device should demonstrate appropriate visual characteristics. | All visual inspections passed, implying device meets visual quality standards. |
| The device should maintain appropriate pressure differentials. | Testing confirmed appropriate pressure differential performance. |
| The device should be resistant to lipids. | Testing confirmed lipid resistance. |
| The device should withstand back pressure in a closed position. | Testing confirmed performance under back pressure (closed position). |
| The device should withstand back pressure with a male Luer in (open position). | Testing confirmed performance under back pressure (open position). |
| The device should prevent seepage at 6 psi low water pressure. | Testing confirmed no seepage at 6 psi low water pressure. |
| The ultrasonic weld joints should perform as expected. | Testing confirmed ultrasonic weld joint performance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size for each bench test conducted.
- Data Provenance: The tests were non-clinical bench tests conducted by Baxter Healthcare Corporation to evaluate a minor design modification. The location of the testing is not specified beyond Baxter Healthcare Corporation. The data is prospective in the sense that it was generated specifically for this regulatory submission to evaluate the new design. There is no mention of country of origin for the "data" in a clinical/patient sense, as it's bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. For bench tests of this nature, "ground truth" is typically established by engineering specifications, published standards, or validated internal test methods rather than expert clinical consensus.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The results of bench tests are typically assessed against pre-defined engineering specifications or performance standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices and AI algorithms, not for a modified IV administration set.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: Not applicable. This device is a mechanical medical device, not an AI/ML algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for the bench tests would have been established by engineering specifications, relevant industry standards (e.g., ISO, AAMI standards for IV sets), or internal validated test protocols that define acceptable performance limits for the characteristics being tested (e.g., pressure, leak rate, material integrity).
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a mechanical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment for Training Set: Not applicable. No training set was used.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.