(33 days)
The ICU Medical Clave Stopcock is a device used to administer or withdraw fluids that flow from a container to a patient's vascular system through a needle or catheter inserted into a vein or artery. This device is a four-way stopcock with an integral CLAVE side-port for closed, needleless access to the patient tubing or other fluid container.
The Clave® Stopcock is a device that incorporates the functionality of needleless connectivity with the 4-way flow valve of a stopcock. The fluid path has three positions: Flush Position; Flow Position; and Port Access Position. The proprietary technology of the Clave enables the device to have a needleless port for administration of medications or other IV fluids as directed by the physician.
The provided document is a 510(k) summary for the Clave® Stopcock, a physical medical device. It describes the device's components, intended use, and substantial equivalence to predicate devices, focusing on materials and operational characteristics.
This type of submission focuses on demonstrating safety and effectiveness by showing substantial equivalence to existing legally marketed devices, rather than through a traditional clinical study with detailed performance metrics and acceptance criteria in the way new AI/software as a medical device (SaMD) clearances would.
Therefore, the requested information, such as specific acceptance criteria for a device's performance, the details of a study proving those criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment, is not applicable to this submission. These elements are typically found in regulatory submissions for AI/ML-based devices or devices requiring extensive clinical trials to establish efficacy and performance de novo.
The document states:
- Safety and Performance: "ICU Medical Clave Stopcock conform to the requirements of published international standards as well as those FDA recognized standards and/or published guidelines prior to marketing the device." This indicates compliance with established industry standards for mechanical devices, not performance metrics derived from a study comparing algorithms or human readers.
- Rationale for SE: "This submission is a combination of two devices that have been in the field for more than 15 years. These two devices are regarded highly within the industry and valued by our customers. This device will integrate the spike portion of the Clave into the molded portion of the Stopcock... There are no functional differences between any of the predicate devices or the proposed devices in terms of use." This is the core argument for substantial equivalence, implying that the combined device's performance is assumed to be equivalent to its well-established components.
- Conclusion: "The materials, performance, and operational features of both the submitted device and the predicate devices are substantially equivalent and safe and effective for their intended use." This states the conclusion of the 510(k) review process based on the comparison to predicate devices and adherence to standards, not on a new performance study.
In summary, none of the requested specific acceptance criteria or study details are present because the submission is for a physical device demonstrating substantial equivalence, not an AI/ML-based device requiring detailed performance metric studies.
§ 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.