(12 days)
The Animas ezSerter™ Infusion Set Inserter is intended to aid in the insertion of the Animas ezSet™ infusion sets. This device is intended for home use and is a prescription device.
The Animas ezSerter™ Infusion Set Inserter is a simple device for automatically inserting the cannula of the Animas ezSef™ angled infusion sets subcutaneously. The inserter is composed of several molded plastic pieces and stainless steel springs. An elongated molded plastic housing acts as a handle and a quide for an internally mounted spring-loaded carrier. An opening in the proximal end of the carrier accepts and retains the handle of the introducer needle hub.
This document, K021700, is a 510(k) summary for the Animas ezSerter™ Infusion Set Inserter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and expert-read ground truth.
Therefore, the requested information regarding acceptance criteria, study data, sample sizes, expert qualifications, and ground truth establishment is not available in this document.
The 510(k) summary describes:
- Device Name: Animas ezSerter™ Infusion Set Inserter
- Intended Use: To aid in the insertion of Animas ezSet™ infusion sets.
- Predicate Device: MiniMed Sil-Serter™ Infusion Set Insertion System
- Comparison of Technical Features: Both are spring-loaded devices where the user loads the infusion set, compresses a spring, and activates the device. The 510(k) states that "The differences between the new device and the predicate devices do not affect the safety or effectiveness of the device." This statement implies that the device's performance is considered to be on par with the predicate, but specific performance data or acceptance criteria are not detailed in this summary.
In summary, this document is a regulatory submission for substantial equivalence and does not contain the kind of detailed performance study results, acceptance criteria, or ground truth methodology typically found in clinical validation reports for AI/diagnostic devices.
§ 880.6920 Syringe needle introducer.
(a)
Identification. A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.(b)
Classification. Class II (performance standards).