(29 days)
To administer fluids from a container into the patient's vascular system through a vascular access device.
The proposed devices, which are the subject of this Special 510(k) Premarket Notification, consist of a stand-alone stopcock, stopcock manifold gangs, Intravenous (I.V.) administration sets with stopcock(s), and I.V. extension sets with stopcock(s). They are single use disposable devices intended for use for continuous or intermittent fluid administration or withdrawal of fluids. These devices are the same as the current marketed devices, previously cleared under 510(k) premarket notifications K962581 (cleared August 28, 1996), K961225 (cleared June 21, 1996) and K022895 (Elcam Plastic, cleared October 18, 2002).
The stand-alone stopcock 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. It is used to control the fluid flow pathway by rotating the flow control handle.
The stopcock manifold gangs consist of individual stopcocks assembled in series through common Luer fittings to form a manifold or gang. These pre-assembled stopcock gangs provide multiple access sites into a common fluid path for the administration of drugs and solutions. The Luer connectors on either end of the stopcock gang allow connection to an administration or extension set for fluid administration through an indwelling intravascular catheter.
The I.V. administration sets with stopcock(s) (i.e. solution sets, secondary medication sets, Continu-Flo sets) 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 stopcock(s) that can be used for the administration of secondary medication.
The I.V. extension sets with stopcock(s) are used for the administration and withdrawal of fluids. They consist of the stopcock connected to the extension set.
Currently, Baxter uses three stopcock designs in the stopcock system. The basis for this premarket notification is the standardization to one stopcock design. No new materials of construction are being introduced into Baxter's stopcock system as part of this change. This change does not impact the intended use or the fundamental scientific technology of the device. The product labels are also being updated to add the indications for use statement of the device and clarify their use to comply with Baxter's labeling standards.
The provided document describes a Special 510(k) Premarket Notification for "Stopcock and I.V. Solution Administration Sets with Stopcocks." This submission is for a device modification, specifically the standardization to one stopcock design, and not for a new device requiring extensive clinical trials for performance evaluation against acceptance criteria as is common for AI/ML devices. Therefore, much of the requested information regarding AI/ML device studies (e.g., sample size for test sets, expert qualifications, HRMC studies, standalone performance) is not applicable or present in this document.
However, the document does list acceptance criteria in the form of bench tests that were conducted and states that "All test results meet the acceptance criteria."
Here's the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide specific quantitative acceptance criteria values for each test, nor does it give specific reported device performance values. Instead, it makes a general statement that all tests met the acceptance criteria.
| Acceptance Criteria (Test Name) | Reported Device Performance |
|---|---|
| Visual inspection | All test results meet the acceptance criteria and support that the devices are appropriately designed for the intended use. |
| Inner diameter assessment | All test results meet the acceptance criteria and support that the devices are appropriately designed for the intended use. |
| High pressure test | All test results meet the acceptance criteria and support that the devices are appropriately designed for the intended use. |
| Long duration pressure test | All test results meet the acceptance criteria and support that the devices are appropriately designed for the intended use. |
| ISO Luer tests on female and male Luer lock connectors | All test results meet the acceptance criteria and support that the devices are appropriately designed for the intended use. |
| Plug torque test | All test results meet the acceptance criteria and support that the devices are appropriately designed for the intended use. |
| Lipid resistance test | All test results meet the acceptance criteria and support that the devices are appropriately designed for the intended use. |
| Rigid bond flex test | All test results meet the acceptance criteria and support that the devices are appropriately designed for the intended use. |
| Rigid bond water pressure test | All test results meet the acceptance criteria and support that the devices are appropriately designed for the intended use. |
| Rigid bond air pressure test | All test results meet the acceptance criteria and support that the devices are appropriately designed for the intended use. |
| Rigid bond torque test | All test results meet the acceptance criteria and support that the devices are appropriately designed for the intended use. |
| Tubing bond pressure test | All test results meet the acceptance criteria and support that the devices are appropriately designed for the intended use. |
| Tubing bond tensile test | All test results meet the acceptance criteria and support that the devices are appropriately designed for the intended use. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for each bench test or the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device modification submission based on bench testing, not an AI/ML diagnostic or prognostic device requiring expert consensus for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Bench tests do not typically involve human adjudication in the same way clinical studies or image interpretation studies do.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-assisted device.
7. The type of ground truth used
The ground truth for the performance evaluation was established through bench test specifications and internal risk analyses. The tests were designed to evaluate the functional performance of the device against predefined engineering and safety standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set. The "training" in this context refers to manufacturing and design verification processes, not machine learning model training.
9. How the ground truth for the training set was established
Not applicable. As noted above, this is not an AI/ML device. For traditional device manufacturing, "ground truth" for design and testing is established through established engineering standards, risk analyses, and regulatory requirements.
§ 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.