(106 days)
The Top Fine® disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes.
Top Fine® insulin pen needle consists of a sterile cap, a needle cap, and a needle hub which holds the needle. Blister papers the cap. The sterile cap maintains sterility the 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 screwed onto the pen. The needle cap cover is intended to provide physical protection to the needle tube. The device is for single patient single time use. The pens come in three sizes, 29 gauge, 30 gauge, and 31 gauge. They are ETO sterilized, non toxic and nonpyrogenic.
The provided text is a 510(k) summary for the Top Fine® Insulin Pen. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a comprehensive study report for novel performance. As such, some of the requested information (e.g., specific performance metrics, sample sizes for training/test sets, expert details for ground truth) is not explicitly present in the document.
However, based on the available information, here's an attempt to structure the response:
Device: Top Fine® Insulin Pen (Insulin syringe)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | "Results were satisfactory" |
| Mechanical Testing | "Results were satisfactory" |
| Sterility Testing | "Results were satisfactory" |
| EO Residues | "Results were satisfactory" |
| Instructions for Use Adequacy | "Results were satisfactory" |
| Range of Patient Population Use | "Results were satisfactory" |
| Performance Characteristics | "Results were satisfactory" |
| Reliability | "Results were satisfactory" |
| Safety | "No concerns over safety as compared to predicate devices" |
| Effectiveness | "No concerns over effectiveness as compared to predicate devices" |
| Substantial Equivalence | "The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device." |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact sample size for the bench or clinical tests. It generally states that "Both bench and clinical tests were performed."
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given the manufacturer is based in Korea, it's plausible the studies were conducted there, but this is not confirmed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- The document does not provide details on the number of experts or their qualifications used to establish ground truth. The evaluation likely relied on standard industry practices and regulatory guidelines for medical device testing.
4. Adjudication Method for the Test Set
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none). The "satisfactory" outcomes imply a straightforward assessment against pre-defined benchmarks, usually without complex expert adjudication in this type of submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or interpretative AI systems, which is not applicable to an insulin pen needle. The comparison was primarily for substantial equivalence of physical and functional characteristics against predicate devices.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is a physical medical device (insulin pen needle), not an algorithm or AI system. Its performance is evaluated through physical and biological testing, not computational analysis.
7. The Type of Ground Truth Used
- For this type of device, "ground truth" would be established by:
- Validated laboratory methods: For biocompatibility (e.g., ISO standards), sterility (e.g., USP methods), and EO residue testing.
- Mechanical testing standards: For needle integrity, strength, and flow rates.
- Clinical observation and qualitative assessment: For adequacy of instructions for use, patient population range, and general reliability in a clinical setting (though the extent of "clinical testing" here appears to be focused on usage and general performance rather than specific clinical outcomes).
- Comparison to predicate devices: The "ground truth" for substantial equivalence is often the performance profile of the legally marketed predicate devices.
8. The Sample Size for the Training Set
- This question is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- This question is not applicable, as there is no "training set" for this type of device.
Summary of the Study:
The study described is a submission for substantial equivalence for the Top Fine® Insulin Pen needles to existing legally marketed predicate devices (B.Braun "one.click™ needle", Terumo® Micro tapered Pen Needle, BD Pen Needles).
The study involved:
- Bench testing: Covered biocompatibility, mechanical testing, sterility testing (including EO residues).
- Clinical testing: Focused on determining the adequacy of instructions for use, the range of patient population, general performance characteristics, and reliability.
The results of both bench and clinical tests were reported as "satisfactory" and indicated "no concerns over safety and effectiveness as compared to predicate devices." The conclusion was that the device is "as safe, as effective, and performs in a substantially equivalent manner to the predicate device."
It is important to note that a 510(k) summary provides a high-level overview and does not typically delve into the granular details of study protocols, specific performance metrics with numerical thresholds, or detailed statistical analysis that would be found in a full study report or PMA submission.
§ 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).