(84 days)
The CLC 2000 is a single use, sterile, non-pyrogenic, swab-able, bi-directional valve intended for use as an accessory to Intravascular administration set. The CLC 2000 provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein or artery). The CLC 2000 also provides access for the withdrawal of fluids from a patient's vascular system.
The CLC 2000 is a single use, sterile, non-pyrogenic, swab-able, bi-directional valve intended for use as an accessory to Intravascular administration set.
The provided text is a 510(k) summary for the ICU Medical CLC 2000 Intravascular Administration Set, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way new drug or novel medical device approvals might.
Therefore, the document does not contain the acceptance criteria and the study that proves the device meets those criteria in the format requested. Instead, it focuses on comparing the new device's characteristics (labeling, intended use, design, materials) to those of predicate devices (B. Braun V2 Ultrasite Injection Site and ICU Medical CLAVE Connector) to establish substantial equivalence.
Here's why the requested information is not available in the provided text:
- Acceptance Criteria Table: This document does not define specific performance metrics or thresholds for the CLC 2000. The comparison is qualitative against predicate devices.
- Sample Size, Data Provenance, Experts for Ground Truth, Adjudication, MRMC Study, Standalone Performance, Type of Ground Truth, Training Set Size, and Training Set Ground Truth: These details are typically associated with clinical trials or analytical performance studies that are designed to measure a device's performance against predefined endpoints. The 510(k) summary provided here is a premarket notification, which relies on demonstrating equivalence rather than such detailed performance studies. While the manufacturer would have performed internal testing (e.g., biocompatibility, sterility, flow rates, durability), the specifics of those tests and any "acceptance criteria" for them are not detailed in this public summary.
The document's purpose is to satisfy the regulatory requirement of demonstrating that the CLC 2000 is "substantially equivalent" to existing, legally marketed devices, thus allowing it to proceed to market without requiring a full Premarket Approval (PMA) application, which would involve more extensive clinical data.
In summary, based on the provided text, I cannot provide the requested information because the document is a 510(k) summary focused on substantial equivalence rather than a detailed performance study with defined acceptance criteria.
§ 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.