(43 days)
Model A & B Subcutaneous Infusion Set is intended to be used to administer insulin and medications under the skin.
The MSR Model A and Model B Subcutaneous Infusion Sets connect at the female luer connection to a reservoir containing insulin or other medications delivered by an infusion pump. The 28 gauge AISI 304 stainless steel introducer needle and 25 gauge soft cannula connected to the hub is inserted into the subcutaneous tissue . The introducer needle is removed and the hub and soft cannula remains in place. The Model B Subcutaneous Infusion Set has a 28 gauge AIS1 needle connected to a hub is inserted directly into the subcutaneous tissue. The cannula hub are affixed by an acrylic medical grade adhesive. The tubing is polvethylene lined polyurethane has a female Luer on one end and a connector that attaches to the hub on the other end. The tubing set portion can be removed and capped off when the pump is not in use while the hub and cannula remain in place.
The provided text is a 510(k) summary for the MSR Model A & B Subcutaneous Infusion Sets. This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a predicate device already legally marketed. It primarily focuses on comparing technical features and intended use.
Crucially, this document does NOT contain information about acceptance criteria or a study proving device performance against such criteria in the context of diagnostic accuracy, sensitivity, or specificity for AI/ML devices.
The document describes a medical device (subcutaneous infusion sets) that delivers insulin and medications. It does not relate to an AI/ML-driven diagnostic or analytical device that would typically have acceptance criteria for performance metrics like sensitivity, specificity, or accuracy. Therefore, the specific information requested in the prompt related to AI/ML device studies (sample sizes, expert ground truth, MRMC studies, standalone performance, training sets) is not present in this document.
Therefore, I cannot fulfill the request to provide the acceptance criteria and study details as they are not described in this 510(k) summary.
The 510(k) process for this type of medical device involves demonstrating substantial equivalence to a predicate device, which typically includes:
- Comparison of Technical Features: As detailed in the document, MSR compares its device's materials, insertion angles, needle lengths, and tubing dimensions to the predicate device (Disetronic Tender Set K9972135).
- Intended Use: Showing the intended use is the same as the predicate device.
- Performance Testing (Non-Clinical): For infusion sets, this would typically involve bench testing for things like flow rates, leakage, material compatibility, strength, and sterility, but these specific test results and their acceptance criteria are not detailed in this summary.
- Biocompatibility: Confirmation that materials are biocompatible.
The document states: "No significant technological differences exist between the MSR Model A and Model B Infusion Sets and the predicate device" and "These differences do not affect the safety and effectiveness of the device." This is the core "proof" in a 510(k) submission: demonstrating that any differences do not raise new questions of safety or effectiveness.
§ 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.