(97 days)
The Modified Easy-Ject Automatic Injector Device (also known as EZ-Ject) is an automatic injection device with a cooling mechanism for injection and needle withdrawal.
The Modified Easy-Ject Automatic Injector is a hand held device that performs automates a disk shaped cooling element that cools the skin prior to the needle injection. The Modified Easy-Ject Automatic Injector Device is an automatic injection device with a cooling mechanism for injection and needle withdrawal.
The provided text is a 510(k) summary for the EZ-JECT Automatic Injector Device. It describes the device, its intended use, and its comparison to a predicate device. However, it does not include information about acceptance criteria or a study proving the device meets acceptance criteria in the format requested.
The document is purely a regulatory submission, focusing on establishing substantial equivalence to a predicate device, rather than providing performance data against specific acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
To answer your request, I would need a document that includes:
- A section explicitly defining acceptance criteria (e.g., "The device must achieve X performance metric with Y confidence").
- A study report detailing the methodology, results, and conclusions regarding those acceptance criteria.
§ 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).