(88 days)
These disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes
The Pen Needle consists of a sterile cap, needle cap needle hub, which can be fixed with needle and protected by 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 to the pen. The needle cap cover is 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.
The Easy.Touch Pen Needle (K112789) is a relabeled version of the Feel Fine insulin pen needle (K080904) and is claimed to be substantially equivalent to it and Becton Dickenson Pen Needles (K100005, K051899). The submission provided a summary of performance testing to support this claim of substantial equivalence.
Here's an breakdown of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that "Bench testing included biocompatibility, compatibility with ISO Type A pens, mechanical testing, sterility testing including EO residues. The tests demonstrated that the device is as effective, and performs in a substantially equivalent manner to the previous predicate devices."
However, specific acceptance criteria values (e.g., minimum tensile strength, maximum leakage rate) and the precise reported device performance values are not detailed in the provided text. The claim is general, stating that the device "is as effective, and performs in a substantially equivalent manner."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Met, showed substantial equivalence to predicate devices |
| Compatibility with ISO Type A Pens | Met, showed substantial equivalence to predicate devices |
| Mechanical Testing | Met, showed substantial equivalence to predicate devices |
| Sterility (including EO residues) | Met, showed substantial equivalence to predicate devices (Sterility Assurance Level 10^-6) |
2. Sample Sizes and Data Provenance:
- Test Set Sample Size: Not specified. The document states "Bench tests were performed," but does not provide the number of units tested for each type of bench test.
- Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing by MHC Medical Products or its contracted labs, likely performed in the USA given the company's address. The data is retrospective in the sense that it's based on completed bench tests submitted for regulatory review.
3. Number of Experts and Qualifications for Ground Truth:
- This information is not applicable as the provided documentation describes a medical device, specifically a pen needle. The "ground truth" for such a device is established through objective physical, chemical, and biological performance testing (bench tests) against recognized standards and predicate device performance, not through expert consensus on interpretations like with diagnostic imaging.
4. Adjudication Method for the Test Set:
- Not applicable. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done. This type of study is typically performed for AI-powered diagnostic systems or decision support tools where human interpretation is involved. The Easy.Touch Pen Needle is a mechanical device, not a diagnostic or AI-assisted tool.
6. Standalone (Algorithm Only) Performance Study:
- No, a standalone algorithm study was not done. This is not an AI/algorithm-driven device. The performance refers to the physical and biological characteristics of the pen needle itself.
7. Type of Ground Truth Used:
- The ground truth used for evaluating the device's performance was based on objective bench test results against established engineering specifications, ISO standards (e.g., for ISO Type A pens), and the performance characteristics of legally marketed predicate devices. This includes measurements for mechanical integrity, material biocompatibility, and sterility.
8. Sample Size for the Training Set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI. Its design and manufacturing are based on established engineering principles and standards, not data training.
9. How Ground Truth for the Training Set Was Established:
- Not applicable. See 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).