(34 days)
The Autoject 2 is a hand held mechanical device intended for a self-administered automated subcutaneous injection of FDA approved drugs. The device is designed for use with a 1ml glass fixed needle syringe, for use in the home by the patient or care-giver to aid and support a recommended treatment regime.
The Autoject 2 O.T.C is a hand held non-sterile semi-automatic device using pre-filled 1ml glass syringes capable of a subcutaneous injection of FDA approved drugs. The devices are designed for re-usable use to aid and support patient/ care-giver use in the home with a treatment regime.
The provided text describes a medical device, the Autoject 2, and indicates that a 510(k) premarket notification was submitted and found substantially equivalent to a predicate device. However, the document does not contain details about specific acceptance criteria, comprehensive study designs, or detailed performance metrics that would typically be found in a robust study report proving a device meets acceptance criteria.
The information primarily focuses on the device's description, intended use, and a list of tests performed. It mentions "User Trials" but provides no specifics on their methodology or results beyond a general statement of "success."
Therefore, I cannot populate all the requested sections with specific, quantitative data. I will extract what is available and clearly state what information is not present in the provided text.
Here's an attempt to answer based solely on the provided text, highlighting the absence of detailed information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from tests performed) | Reported Device Performance (as stated in document) |
|---|---|
| Performance during 1 Meter Drop Test | Correct action (pass, no quantitative data available) |
| Force to Load | Correct action (pass, no quantitative data available) |
| Force to Fire | Correct action (pass, no quantitative data available) |
| Force to Remove RNS | Correct action (pass, no quantitative data available) |
| Force to Adjust Depth Adjuster | Correct action (pass, no quantitative data available) |
| Load and Fire Test | Correct action (pass, no quantitative data available) |
| Dry Firing | Correct action (pass, no quantitative data available) |
| Environmental Test | Correct action (pass, no quantitative data available) |
| Dose Efficiency Testing | Correct action (pass, no quantitative data available) |
| Handling a variety of drugs | Capable (pass, details under section 6, not provided) |
| User/Caregiver preference (User Trials) | Clearly indicates success (pass, no quantitative data available, user demographics or study details not provided) |
Note: The document only lists tests and states "proving the correct action" or "clearly indicates the success." It does not provide specific acceptance criterion values (e.g., "Force to Fire
§ 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).