(242 days)
The SteadiSet Infusion Set is indicated for the subcutaneous infusion of insulin administered by an external pump. The infusion set is indicated for single use.
The subject device, Capillary Biomedical, Inc. SteadiSet Infusion Set, is a sterile, non-pyrogenic, intravascular administration set device used to administer insulin from a reservoir cartridge to a patient subcutaneously through a cannula. The infusion set administers insulin by means of a compatible external pump.
The infusion set consists of an inserter, tube set, and disconnect cover. The inserter consists of a housing, insertion buttons, an infusion set hub (with cannula) and adhesive patch with protective liner. The inserter facilitates insertion of the cannula subcutaneously. The cannula is a soft medical-grade polymer extruded over a stainless-steel coil.
The tube set provides the insulin pathway between the hub's indwelling cannula and an external insulin pump cartridge. The tube set consists of infusion set tubing with a reservoir connector (proximal end) and hub connector (distal end).
The disconnect cover can be connected to the hub to provide cover when the infusion set tubing is disconnected from the hub.
The device is sterilized by Ethylene Oxide (ETO) and is a single-patient, single-use device.
The provided FDA 510(k) Clearance Letter for the SteadiSet Infusion Set does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria. This document primarily focuses on demonstrating substantial equivalence to a predicate device based on similar design, materials, and intended use, rather than presenting detailed performance study results against specific acceptance criteria.
The "Non-Clinical Performance Data" section lists various tests performed (e.g., Insertion Force and Depth, Strength of Materials, Biocompatibility, Sterility), but it does not provide:
- Specific acceptance criteria values for each test (e.g., "Insertion force must be less than X N").
- Reported device performance values (e.g., "Observed insertion force was Y N").
- Details about the study methodology for these performance characteristics (e.g., sample size, ground truth establishment, expert involvement).
Therefore, I cannot fulfill most of the request based solely on the provided text. The questions asking about sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment (especially for training sets) are all related to robust clinical or non-clinical performance studies that are not described in this clearance letter.
This type of FDA letter confirms clearance based on a submission, but the detailed study reports themselves are typically much more extensive and are not usually part of the publicly available clearance letter.
Here's a breakdown of what can be inferred or stated based on the provided document, and what is missing:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided definitively from this document. The document lists types of tests performed (e.g., "Insertion Force and Depth", "Strength of Materials, Joints, and Connectors"), but it does not specify the quantitative acceptance criteria for these tests nor the measured performance values of the SteadiSet Infusion Set against those criteria. For example, it lists "Insertion Force and Depth" as a test, but doesn't say "Acceptance Criteria: Insertion Force
§ 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.