(64 days)
These disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes.
Feel Fine Insulin Pen Needle consists of a sterile cap, needle cap needle hub, which can be fixed with needle and blister paper. The sterile cap functions to maintain the sterility of the needle because sterile cap covers the needle hub and needle cap with blister paper sealed on the opening hole of sterile cap. The needle hub can be connected with pen. The necdle cap covers intended to provide physical protection to the needle tube. They are supplied with a sterile fluid path, (EO), nontoxic, and non pyrogenic, for single use only, disposable. The devices operate on the principles of common piston syringes.
This response is based on the provided text only and does not include external information.
The document describes the Feel Fine Insulin Pen Needle and its substantial equivalence to a predicate device, the B.Braun "one.clickTM needle" (K033575). It does not provide detailed acceptance criteria with specific numerical performance metrics or a comprehensive study report with quantitative results for the Feel Fine Insulin Pen Needle. Instead, it indicates that the device's safety and effectiveness were demonstrated through bench tests.
Here's an analysis of the information available against your requested criteria:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Demonstrated in bench tests, indicating the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device. |
| Mechanical Testing | Demonstrated in bench tests, indicating the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device. |
| Sterility Testing (including EO residues) | Demonstrated in bench tests, indicating the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device. The device is EO sterilized. |
| Technological Characteristics | Identical to the predicate device. |
| Performance (general) | Performs the same way as common piston syringes. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for any of the bench tests (biocompatibility, mechanical, sterility). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective) for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The document refers to "bench tests" for performance evaluation, not clinical studies involving expert assessment of outcomes or images for establishing ground truth in the context of diagnostic devices.
4. Adjudication method for the test set
This information is not provided. As the tests are described as "bench tests" for engineering and material properties, an adjudication method in the context of clinical interpretation would likely not be applicable.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not conducted. This device is an insulin pen needle, a physical medical device for injection, not an AI-assisted diagnostic or interpretative tool. Therefore, the concept of human readers improving with AI assistance is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The Feel Fine Insulin Pen Needle is a physical medical device, not an algorithm.
7. The type of ground truth used
The ground truth for the "performance" of the pen needle was established through "bench tests" for properties like biocompatibility, mechanical integrity, and sterility. These are typically assessed against pre-defined engineering and material standards, rather than expert consensus, pathology, or outcomes data in a clinical trial setting. The "ground truth" here refers to compliance with these standards and equivalence to the predicate device's established performance.
8. The sample size for the training set
This information is not applicable. The device is a physical medical device, not a machine learning algorithm, and therefore does not have a "training set" in the AI context.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
§ 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).