(139 days)
The SC Profi Fine pen needle is intended for use with insulin pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.
The SC Profi Fine pen needles are comprised of a stainless steel needle pointed at both ends from 28 gauge to 31gauge. The double-pointed needle is attached to a plastic hub, which screws on to a compatible pen injector (not supplied with this device). It is designed to fit Type A universal insulin pen injectors. The exposed patient-end needle lengths are 3/16"(5mm), 5/16"(8mm), and 1/2"(12.7mm). The needle tip is covered by a colored plastic protective cap, which is covered by a transparent outer plastic cap. Just prior to use, the outer plastic cap is removed and retained for recapping once the injection is complete. The colored cap is then removed to expose the needle and the injection administered. After the injection, the user inserts the used needle into the open end of the outer cap so it can be safely removed from the pen injector and disposed of immediately. This pen needle device is individually packaged and ETO sterilized. It is a disposable device intended for single use only.
The ShinChang Medical Co., Ltd SC Profi Fine Pen Needle is not an AI/ML device. The provided text is a 510(k) summary for a medical device that does not use artificial intelligence or machine learning. Therefore, an analysis of acceptance criteria and a study proving device performance using AI/ML metrics is not applicable.
The submission focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and conformance to established standards for pen needles.
However, I can extract information related to the performance testing described:
Acceptance Criteria and Reported Device Performance (as far as discernible from the text):
The device was tested according to established harmonized standards for pen needles. The acceptance criteria would be successful conformance to these standards (i.e., meeting the requirements outlined within them).
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ISO 11608-2:2000, Pen-injectors for Medical Use-Part2: Needles- Requirements and Test Methods | Tested in accordance with this standard. (Implies conformance to its requirements for various needle characteristics) |
| ISO 9626, Stainless Steel Needle Tubing for Manufacture of Medical Devices | Meets this standard. (Implies conformance to material and manufacturing specifications) |
| ISO 7864, Sterile Hypodermic Needles for Single Use | Meets this standard. (Implies conformance to sterility, design, and performance for single-use hypodermic needles) |
| Needle pull-out resistance | Testing reports attached (Implies acceptable performance, as no new safety issues were identified) |
| Injection force | Testing reports attached (Implies acceptable performance, as no new safety issues were identified) |
| Penetration resistance | Testing reports attached (Implies acceptable performance, as no new safety issues were identified) |
Details related to the study that proves the device meets the acceptance criteria (based on the provided text):
- Sample size used for the test set and data provenance: Not specified in the provided summary. The summary mentions "testing reports are attached," which would contain this information.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This type of testing for pen needles generally relies on objective, quantifiable physical and mechanical measurements rather than expert human interpretation.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable for this type of device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, not applicable as this is not an AI/ML device.
- The type of ground truth used: The "ground truth" for this device's performance is defined by the objective physical and mechanical requirements specified in the ISO standards (e.g., tensile strength for pull-out, measured force for injection/penetration, material composition, sterility assurance levels).
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
Additional Information from the Summary:
- The device explicitly states it "meets the following standards" (ISO 11608-2, ISO 9626, ISO 7864), and performance testing was conducted accordingly.
- A risk analysis was conducted, and no new or different issues of safety and effectiveness were identified.
- The primary method of demonstrating effectiveness is through substantial equivalence to legally marketed predicate devices.
§ 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).