(127 days)
The devices are used to administer solutions to a surgically implanted port.
The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to administer solutions to a surgically implanted port. This device is designed utilizing a non-coring Huber needle to access the implanted port. The K-Shield Advantage PAIS has an integral safety device intended to protect against accidental needle stick injuries and infection caused by blood borne pathogens. Upon removal from the port, the Anti- Needlestick Protector (ANSP) covers the needle tip protecting against accidental needle stick injuries. The devices are disposable ethylene oxide sterilized medical devices which are constructed from non-coring needle (Huber needle), wing, tubing (either micro bore or standard bore), clamp, female conical fitting and locking cap. The device has optional injection site (needle injection, needleless access connector (NAC), or no injection site) and/or anti-needlestick protector (ANSP).
The provided 510(k) summary for the K-Shield Advantage Port Access Infusion Set (K123344) does not contain the specific acceptance criteria or a detailed study proving the device meets those criteria in the format requested.
The summary describes the device, its intended use, and states that "Bench testing was performed and confirms that the device meets design requirements and specifications." It also mentions compliance with EN ISO 8536-4:2007. However, it does not provide a table of quantitative acceptance criteria, detailed performance metrics, or the specifics of the bench testing study (like sample size, ground truth establishment, or expert involvement) that would allow for a complete answer to your request.
Therefore, I cannot extract the information required to populate the table and answer the specific questions about the study design, sample sizes, expert involvement, or adjudication methods, as this level of detail is not present in the provided text.
Based solely on the provided text, here's what information can be gleaned, though it is limited:
Summary of Available Information Regarding Performance and Testing:
- Acceptance Criteria/Performance: The document broadly states that the device "meets design requirements and specifications" and "complies with the International standard EN ISO 8536-4: 2007-Infusion equipment for medical use -Part 4: Infusion sets for single use, gravity feed mainly". No specific quantitative acceptance criteria or performance metrics are listed in a table.
- Study Type: "Bench testing was performed."
- Safety Feature: The device includes an "Anti-Needlestick Protector (ANSP)" intended to "protect against accidental needle stick injuries." While this is a key safety feature, the document doesn't provide performance data for it (e.g., efficacy rates of the ANSP).
- Biocompatibility: Materials are evaluated per ISO 10993-1:2009 and "have been determined to be biocompatible."
- Sterilization: Validation was conducted per EN ISO 11135-1:2007.
Missing Information:
All the specific points you requested (Table of acceptance criteria and reported device performance, sample size for test set, data provenance, number of experts, adjudication method, MRMC study details, standalone study details, type of ground truth, training set sample size, ground truth for training set) are not present in the provided 510(k) summary. These details are typically part of a more extensive test report that would be submitted to the FDA but are often summarized or omitted from the public 510(k) summary document itself.
§ 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.