(302 days)
Tevadaptor® is a Closed System Transfer Device (CSTD) that mechanically prohibits the release of drugs, including antineoplastic and hazardous drugs, in vapor, aerosol or liquid form during preparation, compounding and administration, minimizing exposure of individuals, healthcare personnel, and the environment to hazardous drugs.
The I.V. Administration Set is single use, sterile, non-pyrogenic device used to administer intravenous solutions and/or drugs solutions from a container to a patient's vascular system.
The I.V. Administration set is comprised of various components such as: Spike, tubing, clamp, ULTRASITE® needless injection site (Y-site), 'twist-off' and Luer connection.
The I.V. Administration set is part of the Tevadaptor® closed system transfer device (CSTD) and is intended to interact with Tevadaptor® and/or Chemfort™ system's Syringe Adaptor (SA), Syringe Adaptor Lock (SAL) and Luer Lock Adaptor (LLA) components that were cleared under K192866. The Tevadaptor® and Chemfort™ CSTD are intended to protect the healthcare professional, the patient and the environment during preparation, reconstitution, compounding and administration of hazardous drugs in the form of liquid, vapor or aerosol.
The Tevadaptor® and/or Chemfort™ SA connects to the Tevadaptor® port located on the I.V. Administration set's Spike component. After the connection is made, a fluid path is opened which allows to inject of the drug to the patient's IV bag. The Tevadaptor® and/or Chemfort™ LLA connects to any female luer connection located on the I.V. Administration set to create a Tevadaptor® port connection that enables the Tevadaptor® and/or Chemfort™ SA to administer the drug directly to the patient.
The purpose of this submission is to add five new designs of I.V. Administration Sets to the Tevadaptor® and/or Chemfort™ Closed System Transfer Device (CSTD) that was cleared for sale in the US under K192866, the descriptions of the added sets, subject of this submission:
- Tevadaptor® IV Secondary Safety Set with ULTRASITE®
- Tevadaptor® IV Secondary Safety Set .
- Tevadaptor® Bag Adaptor LL ●
- Tevadaptor® Bag Adaptor LL with ULTRASITE® .
- . Tevadaptor® Bag Adaptor SP with ULTRASITE®
All of the components used in the five new I.V. Administration Sets were previously used in the predicate device cleared under K121269, except for the Spike component which has been redesigned in comparison to the predicate's Spike component that was cleared under K121269. The redesigned Spike component is substantially equivalent to the reference device, Chemfort™ Bag Adaptor SP's Spike component, which was cleared under K192866. The Spike component of both the IV Administration Set and of the reference device are identical in terms of design and raw material.
The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML medical device. Instead, it is a 510(k) premarket notification summary for an "Intravascular Administration Set" (TEVADAPTOR Bag Adaptor) that has an "ONB" product code, indicating it is a Closed System Transfer Device (CSTD).
The document mentions that the proposed device (TEVADAPTOR Bag Adaptor LL, etc.) was tested according to NIOSH guidelines and "proved to be a CSTD." This is stated as a comparison point to the predicate device, which was cleared before the NIOSH draft protocol for CSTD was issued.
Therefore, I cannot extract the requested information, such as:
- Table of acceptance criteria and reported device performance: Not present for an AI/ML device. The document lists performance tests against ISO standards for medical devices and biocompatibility.
- Sample size used for the test set and data provenance: Not mentioned.
- Number of experts used to establish ground truth and their qualifications: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- MRMC comparative effectiveness study effect size: Not mentioned.
- Standalone (algorithm only) performance: Not applicable as it's not an AI/ML device.
- Type of ground truth used: Not applicable as it's not an AI/ML device.
- Sample size for the training set: Not applicable as it's not an AI/ML device.
- How the ground truth for the training set was established: Not applicable as it's not an AI/ML device.
The document discusses the substantial equivalence of the proposed device to a predicate device (K121269) based on intended use, technological characteristics, and principles of operation, and compliance with various ISO standards for medical devices, specifically for an intravenous administration set. The key change highlighted is that the proposed device now meets the NIOSH and ISOPP definition of a CSTD.
§ 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.