(28 days)
The intended use for the modified device remains the same as the predicate device; for use with a pen injector device for the subcutaneous injection of insulin.
The double-pointed Type 304 stainless steel needle is epoxy bonded to a plastic hub (polypropylene) and covered with a plastic needle shield (polyethylene). This needle/hub/shield assembly is placed in a plastic outer container (polyethylene), the open end of which is sealed closed with a laminate seal for subsequent protection. Gamma irradiation sterilization will be employed and the product will meet 10 * sterility assurance levels. During use, the laminate seal is pealed away and the exposed needle hub is screwed onto the Pen injector device. This exposed needle hub will penetrate the rubber septum of an insulin containing cartridge (supplied by others). After the needle shield is removed, it is ready for a subcutaneous insulin injection. The needle assembly is a single-use disposable device.
Here's an analysis of the provided text regarding the B-D 31g x 5/16" pen needle, focusing on acceptance criteria and study information.
It's important to note that the provided text is a summary of safety and effectiveness from 1997 for a medical device (a pen needle), not a modern AI/ML medical device submission. Therefore, many of the requested fields related to AI/ML model validation (e.g., sample sizes for training/test sets, ground truth establishment methods for AI, MRMC studies, standalone AI performance) are not applicable and will be marked as such.
The provided text describes a 510(k) submission, which relies on demonstrating substantial equivalence to a predicate device, rather than proving performance against predefined acceptance criteria for a novel device through extensive clinical trials as would be common for AI/ML.
Acceptance Criteria and Device Performance for B-D 31g x 5/16" Pen Needle
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission based on substantial equivalence, explicit quantitative acceptance criteria are not stated in the document in the way they would be for a de novo device. Instead, the acceptance criterion is implied to be "functions in an equivalent manner as the predicate device" across various mechanical performance metrics.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent needle pull-out force to predicate device (B-D 30g) | "proven to function in an equivalent manner as the predicate device" |
| Equivalent penetration force to predicate device (B-D 30g) | "proven to function in an equivalent manner as the predicate device" |
| Equivalent insulin injection forces to predicate device (B-D 30g) | "proven to function in an equivalent manner as the predicate device" |
| Sterility Assurance Level | Meets 10⁻⁶ sterility assurance levels |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated. The study involved "bench testing," which implies a laboratory setting. The exact number of pen needles tested for each metric (pull-out, penetration, injection forces) is not provided.
- Data Provenance: Not specified, but given it's Becton Dickinson, it's likely internal lab testing. It is a retrospective analysis in the sense that the testing was performed on manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this device and study type. "Ground truth" in the context of expert consensus is typically relevant for interpretative tasks (e.g., radiological reads, pathology diagnosis) where human judgment defines the truth. For mechanical device performance, the "ground truth" is measured objectively by instrumentation (e.g., force gauges). No human experts were involved in establishing "ground truth" for the mechanical performance of the pen needle.
4. Adjudication method for the test set
Not applicable. As noted above, the "truth" for mechanical performance is objective measurement, 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 is a physical medical device (pen needle), not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
For the mechanical performance characteristics (needle pull-out, penetration, insulin injection forces), the ground truth was objective measurement obtained through bench testing using appropriate instrumentation. For sterility, the ground truth is established by standard microbiological testing methods to confirm the 10⁻⁶ sterility assurance level.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the 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).