(129 days)
The Disposable Pen Injector Assembly is a disposable pen injector designed for single patient use by diabetics for the subcutaneous self-injection of a desired dose insulin. The disposable pen injector assembly uses 3 mL cartridge of HUMALOGTM (U-100, insulin lispro for injection), and a single use detachable and disposable insulin pen needle (supplied separately). The pen injector allows the user to dial the desired dose up to 80 units in 1 unit increments. It is intended for general population.
The Disposable Pen Injector Assembly is a disposable single-patient use pen injector capable of injecting a dose of up to 80 units of insulin in 1 unit increments. The pen injector is intended for use with 3mL insulin cartridges and single-use, disposable insulin pen needles (supplied separately). After the intended insulin cartridge is used up, the Disposable Pen Injector Assembly should be disposed. The Disposable Pen Injector Assembly is intended for single user only and provided non-sterile.
This document describes the FDA's decision regarding the 510(k) premarket notification for the "Disposable Pen Injector Assembly" from Wuxi NEST Biotechnology Co., Ltd. It outlines the device's characteristics, comparison to a predicate device, and performance data used to establish substantial equivalence.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Disposable Pen Injector Assembly are primarily based on meeting the requirements of ISO 11608-1:2022 Needle-based injection systems for medical use - Requirement and test methods - Part 1: Needle-based injection systems.
| Acceptance Criteria / Performance Aspect | Standard / Requirement | Reported Device Performance |
|---|---|---|
| Dose Accuracy | ISO 11608-1:2022 requirements | Meets ISO 11608-1:2022 requirements. Performance test with FDA-cleared insulin cartridges (3mL) demonstrated compliance. |
| Biocompatibility | ISO 10993-1: Evaluation and testing within a risk management process | |
| ISO 10993-5:2009: Test for in vitro cytotoxicity | ||
| ISO 10993-10:2021: Tests for skin sensitization | ||
| ISO 10993-23:2021: Tests for irritation | Biocompatibility tests were conducted and verified that the proposed devices are safe for contacting human skin. The device is categorized for skin contact, duration A-limited ( |
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).