(367 days)
Insignis® Subcutaneous Needle Sets are intended for the delivery of medication to the subcutaneous tissue for use not to exceed 24 hours.
The Insignis® Subcutaneous Needle Sets are sterile, single use, packaged subcutaneous needle sets. Each Subcutaneous Needle Set has a luer lock at one end and a 90-degree 26G (0.46mm) needle mounted to a closing wing-stabilizer (or butterfly wings) at the distal end of one or more needles. The needles are available in four different lengths: 6mm, 9mm, 12mm, and 14mm. Each set has a slide clamp to stop the flow immediately as well as a butterfly wing that can be closed around the needle upon completion of the infusion. The Insignis® Subcutaneous Needle Sets is available as a single set, as well as a two, three and four needles sets.
The Insignis® Subcutaneous Needle Sets is designed to be used for less than 24 hours
This document is a 510(k) Premarket Notification from the FDA regarding the "Insignis Subcutaneous Needle Sets." It is a regulatory document to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than a clinical study evaluating the performance of an AI-powered diagnostic device.
Therefore, the information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert ground truth adjudication, MRMC studies, standalone algorithm performance, and training set details for an AI/diagnostic device is not present in this document.
This document describes a medical device (subcutaneous needle sets) and its equivalence to a predicate device based on physical characteristics, intended use, and conformance to various industry standards for manufacturing, materials, sterility, and biocompatibility.
To directly answer your request based only on the provided text, and noting the mismatch between the prompt's focus on AI/diagnostic acceptance criteria and the document's content:
Based on the provided FDA 510(k) document (K202279) for Insignis Subcutaneous Needle Sets:
The document describes the acceptance criteria and proof of device performance in the context of demonstrating substantial equivalence to a predicate device, as required for a 510(k) submission, not for an AI-powered diagnostic device. The performance claimed is related to the physical and functional attributes of the needle sets for medication delivery.
Here's an attempt to map the prompt's questions to the available information, while explicitly stating where the information is not applicable or present for an AI/diagnostic device:
1. Table of acceptance criteria and the reported device performance:
The acceptance criteria are implicitly met by conformance to recognized industry standards and comparison to a predicate device. The "performance" is demonstrating that the device functions as intended and is safe and effective when used as described.
| Acceptance Criteria (Implicitly from Standards & Equivalence) | Reported Device Performance (Summary from Document) |
|---|---|
| Intended Use Equivalence: | Insignis Subcutaneous Needle Sets are intended for the delivery of medication to the subcutaneous tissue for use not to exceed 24 hours. This is "Same" as the predicate device (RMS Subcutaneous Needle Set, K102512). |
| Biocompatibility: | The device meets ISO 10993-1 and specific parts (5, 6, 10, 11) for biocompatibility (cytotoxicity, local effect after implantation, irritation, skin sensitization, systemic toxicity). Classified as Externally communicating device, Blood Path indirect, Limited Contact ( |
§ 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.