(6 days)
The Disetronic Penfine® Insulin Injection Pen Needles are intended for the hypodermic injection of insulin into the body when attached to an injector pen.
The Disetronic Penfine® Insulin Injection Pen Needles are the same sterile, nonpyrogenic, single use needles designed to be used with commercially available Injection Pens as the 6, 8, 10 and 12 mm Disetronic Penfine® Injection Pen Needles.
The provided document is a 510(k) summary for the Disetronic Penfine® Insulin Injection Pen Needle, seeking Over-The-Counter (OTC) use. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing extensive clinical trials with specific acceptance criteria in the same way a novel device might.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion/Requirement | Reported Device Performance (vs. Predicate) |
|---|---|
| Design Equivalency | The Disetronic Penfine® Insulin Injection Pen Needles are described as the "same sterile, nonpyrogenic, single use needles designed to be used with commercially available Injection Pens as the 6, 8, 10 and 12 mm Disetronic Penfine® Injection Pen Needles" as the predicate devices (K982399, K994197, K992399). |
| Technological Characteristics | "The technological characteristics are the same as the predicate devices." |
| Functional and Safety Testing | "Performance data has been generated in compliance with existing international standards and protocols and found equivalent to the predicate devices." |
| Indications for Use | Intended for hypodermic injection of insulin into the body when attached to an injector pen, which is assumed to be equivalent or consistent with the predicate device's indications. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of human subject testing (e.g., patient data). It refers to "Performance data... generated in compliance with existing international standards and protocols." For a device like an injection pen needle, this typically involves bench testing for aspects such as needle strength, flow rate, sterility, penetration force, and compatibility with injection pens.
- Sample Size: Not explicitly stated for bench testing, but would be determined by the relevant international standards and protocols.
- Data Provenance: Not explicitly stated (e.g., country of origin). The data would be generated from lab tests, not human data, so "retrospective or prospective" does not apply in the typical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this 510(k) submission. A 510(k) for a device like an insulin pen needle relies on engineering specifications, material properties, and performance standards, not expert consensus on human-derived data for establishing ground truth.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts when establishing ground truth on image analysis or clinical data. Since the performance data refers to bench testing against standards, human adjudication is not relevant.
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
This information is not applicable. MRMC studies are used to evaluate diagnostic imaging devices or AI tools that assist human readers in interpreting clinical data. The Disetronic Penfine® Insulin Injection Pen Needle is a mechanical medical device, not an AI or diagnostic imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This question pertains to AI algorithms. The Disetronic Penfine® Insulin Injection Pen Needle is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device would be defined by engineering specifications, material standards (e.g., for biocompatibility, sterility), and performance standards for hypodermic needles. For instance, needle sharpness might be "ground-truthed" against a specific force measurement standard, or flow rates against a volumetric standard.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of an AI algorithm or model development for this type of medical device.
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).