(62 days)
Becton Dickinson Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide.
The BD Pen Needles are designed for use with a pen injector for subcutaneous injection of a desired dose of a drug, including insulin and exenatide. The pen needle consists of a needle, hub, and shield assembly. The Becton Dickinson pen needles are offered in various gauges sizes (29G, 30G, and 31G) and lengths (5mm, 8mm, and 12.7mm). BD Pen Needles are sterile (gamma irradiation), non-toxic, and non-pyrogenic. The pen needles are disposable, single use devices.
The provided text does not contain specific acceptance criteria or details of a study that proves the device meets such criteria. Instead, it is a 510(k) summary for the BD Pen Needles, focusing on demonstrating substantial equivalence to a predicate device.
However, based on the information provided, here's what can be inferred and what is explicitly stated regarding performance and equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly Met) | Reported Device Performance (as stated in submission) |
|---|---|---|
| Technological Characteristics | Identical to predicate device | "The BD Pen Needle and the predicate device have the identical technological characteristics." |
| Performance | Equivalent to predicate device (safe and effective for intended use) | "The perform equivalent to the predicate device and is safe and effective when used as intended." |
| Intended Use | For subcutaneous injection of drugs, including insulin and exenatide. | "Becton Dickinson Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide." (The only difference noted for the new device is indication for exenatide.) |
| Sterility | Sterile (gamma irradiation) | Stated device characteristic: "BD Pen Needles are sterile (gamma irradiation)." |
| Non-pyrogenic | Non-pyrogenic | Stated device characteristic: "BD Pen Needles are non-pyrogenic." |
| Disposable | Disposable, single-use | Stated device characteristic: "The pen needles are disposable, single use devices." |
No specific quantitative or qualitative acceptance criteria (e.g., minimum tensile strength, flow rate parameters, sharpness index) are listed, nor is a study proving that these criteria were met described. The submission relies entirely on the assertion of "identical technological characteristics" and "equivalent performance" to the predicate device.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document does not describe a test set or specific testing performed for this 510(k) submission.
- Data Provenance: Not applicable, as no new clinical or performance data is presented. The submission relies on the established safety and effectiveness of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth establishment by experts is described, as no new performance data or clinical study results are provided for evaluation.
4. Adjudication method for the test set
- Not applicable. No test set or adjudication method is described.
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 medical needle, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a medical needle, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The submission is based on substantial equivalence and regulatory compliance with existing device performance standards for the predicate device, rather than new ground truth derived from a specific study for this submission.
8. The sample size for the training set
- Not applicable. No training set is mentioned as this is not an AI/ML device or a device requiring a training phase in this context.
9. How the ground truth for the training set was established
- Not applicable. No training set is mentioned.
Summary of the Study (or lack thereof) to Prove Acceptance Criteria:
The 510(k) summary primarily argues for substantial equivalence to a predicate device ("BD Pen Needles" manufactured by the same company and "Disetronic PenFine Injection Pen Needles"). The core of the submission's "proof" is the statement that:
- "The BD Pen Needle and the predicate device have the identical technological characteristics and perform equivalently."
- The "only difference between the devices is that the principal device is indicated for delivery of exenatide."
Therefore, this 510(k) package does not describe a specific study with acceptance criteria, sample sizes, experts, or ground truth generation to "prove" the device meets acceptance criteria in the way one might expect for a novel device or a device requiring new clinical evidence. Instead, it asserts that because the device is technologically identical and performs equivalently to already cleared predicate devices, it is safe and effective when used as intended. The FDA's clearance (K051899) confirms they accepted this substantial equivalence argument.
§ 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).