(331 days)
The safety pen needle is intended for use with pen injector devices for subcutaneous injection of fluids and FDA-approved drugs.
HE Model: Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.
HS Model: Additionally, the product has two safety shields, which lock in place after use (patient end) and upon removal of the needle from the pen (pen connection end). The locked shields help reduce the occurrence of needle sticks from both ends of the needle.
The proposed device, Safety Pen Needle, is a sterile, non-pyrogenic, single-use device, which is intended for use with pen injector devices for subcutaneous injection of fluids and FDA-approved drugs. It incorporates a sharps injury prevention feature, which can reduce the occurrence of accidental needle sticks.
The proposed device is provided with two models, i.e. HE Model and HS Model. HE Model has an attached safety shield, which can automatically lock in place and reduce the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection. HS Model has two safety shields, which lock in place after use (patient end) and upon removal of the needle from the pen (pen connection-end). The locked shields help reduce the occurrence of accidental needle sticks from both ends of the needle.
Both of HE Model and HS Model contain main body, needle tube, front shield, rear shield, big spring, turning tube, container (outer cap) and peel tab (sealing paper). Both ends of the needle tube (i.e. the patient end and the pen connection end) is lubricated by silicone oil. The needle tube and the needle hub are bonded by glue. The container sealed with the peel tab constitutes the sterile barrier system. The common components of both models are almost the same in materials and structure and size, and the only difference is the structure of the rear shield. The biggest difference between the two models is that HS Model contains a small spring additionally and has a relatively more complex structure.
The provided text is a 510(k) summary for a medical device (Safety Pen Needle). It describes the device, its intended use, comparison to a predicate device, and non-clinical testing conducted to demonstrate substantial equivalence.
However, the text does not contain the detailed information required to answer the specific questions about acceptance criteria and a study proving the device meets those criteria, particularly for a software-based AI/ML device. The document pertains to a physical medical device (pen needle) and relies on standard performance testing and simulated clinical use for safety features, not AI/ML performance metrics.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance (for AI/ML metrics like sensitivity, specificity, AUC). The document lists "Requirements" (standards) and "Results" (Pass/Fail) for various physical and biological tests, but these are not the AI/ML performance metrics you asked for.
- Sample size used for the test set and data provenance (for AI/ML). The document mentions 500 subject devices for a "simulated clinical use study" of the safety feature, but this is not an AI/ML test set.
- Number of experts used to establish ground truth and their qualifications. This is not relevant to a physical pen needle's mechanical testing.
- Adjudication method for the test set. Not relevant.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done. Not relevant, as this is for a physical device, not an AI assisting human readers.
- If a standalone (algorithm only) performance study was done. Not relevant.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.). The "ground truth" for the physical device's safety feature was a lack of needle-stick injuries and protective feature failure in a simulated environment.
- The sample size for the training set. Not applicable for a physical device.
- How the ground truth for the training set was established. Not applicable.
In summary, the provided document describes the regulatory submission for a physical medical device and does not contain the information requested about the acceptance criteria and study for an AI/ML powered device.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).