(160 days)
Top Fine® Pen Needle is intended for use with pen injector device for the subcutaneous injection of insulin.
Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G, 32G, 33G and 34G) and lengths (4mm, 5mm, 6mm, 8mm, 12mm). Top Fine® Pen Needles are sterile (EO gas sterilization), non-toxic and non-pyrogenic.
Top Fine® Pen Needle assembly consists of hub, needle cap, sterile cap and sterile paper.
The document provided describes the Top Fine® Pen Needle and its equivalence to a predicate device (Feel Fine Insulin Pen Needle). The acceptance criteria are based on bench testing to demonstrate equivalent performance to the predicate device.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria Study | Standard/Method | Reported Device Performance (Top Fine® Pen Needle) |
|---|---|---|
| Inside and outside dimensions of needles | Not specified | Compliant (implied by overall conclusion of equivalence) |
| Size designation | Not specified | Compliant (implied by overall conclusion of equivalence) |
| Elasticity of the needle tube | ISO 11608-2:2012 | Conforms to standard |
| The flexural rigidity | ISO 11608-2:2012 | Conforms to standard |
| Pull (referring to needle pull-out force) | ISO 11608-2:2012 | Conforms to standard |
| Lubricant (presence/effectiveness) | ISO 7864:1993 | Conforms to standard |
| Compatibility test (with pen injectors) | Not specified (Specific compatible pens listed) | Compatible with listed pens (BD Pen, FlexPen, HumalogPen, etc.) |
| Needle dose accuracy | Not specified | Compliant (implied by overall conclusion of equivalence) |
| Needle hub torque removal | Not specified | Compliant (implied by overall conclusion of equivalence) |
| Endotoxin Test | USP 39: Bacterial Endotoxin test and KP 11: Endotoxin Test Method | Compliant (implied by overall conclusion of equivalence) |
| Sterilization | ISO 11135: 2007 (EO Gas sterilization) | Conforms to standard |
Notes:
- The document explicitly states that the "principal device demonstrated equivalent performance to the predicate devices during bench testing" and that "The bench tests of Needles with 32G, 33G, 34G demonstrated conformances to ISO 11608-2 and ISO 7864." The general conclusion statement also implies compliance for other aspects.
- For several criteria, specific numerical acceptance limits are not provided in the document, but compliance with the standards (ISO 11608-2, ISO 7864, ISO 11135, USP 39, KP 11) serves as the acceptance criteria.
2. Sample size used for the test set and the data provenance
- Sample size for the test set: The document does not specify the exact sample sizes for each bench test conducted. It generally refers to "bench tests" being conducted.
- Data provenance: The tests were conducted by MedExel Co., Ltd. in Korea (company address listed as "252, Geumgwangosan-ro, Geumgwang-myeon, Anseong-si, Gyeonggi-do, Korea"). The nature of bench testing implies the data would be prospective for the device being tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for a medical device like a pen needle typically refers to its physical and functional performance against established engineering and medical standards, not expert opinions or diagnoses. The "bench tests" are designed to objectively measure these parameters.
4. Adjudication method for the test set
Not applicable. As described above, the evaluation relies on objective measurements against engineering and medical standards, not subjective expert judgment requiring adjudication.
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
Not applicable. This device is a hypodermic single lumen needle, not an AI-powered diagnostic tool. Therefore, MRMC effectiveness studies with human readers and AI assistance are not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument, not an algorithm. Its performance is evaluated through physical and functional bench tests.
7. The type of ground truth used
The ground truth used is based on established engineering and medical device standards and objective physical and functional performance measurements. Specifically, the document mentions:
- ISO 11608-2:2012 (Needle systems for medical use - Part 2: Needles for pen injectors)
- ISO 7864:1993 (Sterile hypodermic needles for single use)
- ISO 11135: 2007 (Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices)
- USP 39: Bacterial Endotoxin test
- KP 11: Endotoxin Test Method
8. The sample size for the training set
Not applicable. This device is a physical medical instrument, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of 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).