(242 days)
Becton Dickinson Pen Needle is intended for use with pen injector devices for subcutaneous injection of drugs.
The BD Pen Needle has the same intended use/indications for use, technological characteristics, and principles of operation as the predicate device cleared under K162516. The pen needle assembly consists of a double-ended cannula that is assembled into an injection-molded hub using adhesive. The hub has internal threads, which allow it to be screwed onto the pen-injector device. This allows the Non-Patient (NP) end of the cannula to penetrate through the rubber septum of the pen injector cartridge. The Patient and NP ends of the cannula are lubricated using silicone-based lubes for ease of injection and rubber septum penetration. An injection-molded inner shield is assembled over the Patient end of the cannula to protect the point from damage and accidental needle sticks. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peel-away (tear drop) label to provide a sterile barrier and tamper evidence. The outer cover is also used to remove the hub and cannula from the pen. The peel-away tear-drop label is pre-printed with information, which includes the lot number and needle gauge / length. The BD Pen Needle is a single-use disposable device and is provided sterile (gamma irradiation sterilization). It is non-toxic and non-pyrogenic.
This document is an FDA 510(k) summary for a Becton Dickinson (BD) Pen Needle (K213478). It describes the device, its intended use, and comparative testing against a predicate device (K162516) to demonstrate substantial equivalence.
Based on the provided text, the device in question is a BD Pen Needle, a medical device used with pen injector devices for the subcutaneous injection of drugs. The information focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets specific acceptance criteria as an AI/ML-driven diagnostic or treatment device with performance metrics like sensitivity, specificity, etc.
Therefore, the requested information regarding AI/ML acceptance criteria, study design (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), training set details, and specific metrics (sensitivity, specificity, AUC) is not applicable to this document.
This 510(k) summary demonstrates substantial equivalence by:**
- Comparing Indications for Use: The subject device has the identical indication for use to the predicate device.
- Comparing Technological Characteristics: The devices share the same fundamental scientific technology (single lumen needle).
- Demonstrating Performance Testing: Non-clinical tests were conducted based on ISO standards and BD internal requirements to show that the design, materials, and manufacturing process changes do not raise new questions of safety or effectiveness.
Here's a breakdown of the relevant information provided in the document:
1. A table of acceptance criteria and the reported device performance:
The document does not present acceptance criteria in the form of specific performance metrics (e.g., sensitivity, specificity, F1-score) and reported performance values as would be typical for an AI-driven device. Instead, it relies on demonstrating equivalence through adherence to relevant standards and direct comparison with a predicate device.
The "acceptance criteria" are implied by the standards and internal test requirements met, and the "reported device performance" is the successful compliance with these tests.
| Characteristic / Test | Implied Acceptance (Met if not stated otherwise) | Reported Device Performance |
|---|---|---|
| Functional Performance (ISO 11608-2:2012, ISO 9626:2016, BD internal tests) | Compliance with standards and internal requirements. | Validated design; supporting evidence provided. |
| Biocompatibility (ISO 10993-1:2018) | Compliance with ISO 10993-1:2018 (e.g., Cytotoxicity, Sensitization, Intracutaneous reactivity, Irritation, Material Mediated Pyrogenicity, Genotoxicity, Implantation and Particulate Analysis, Chemical Characterization, Toxicological Risk Assessment). | Testing conducted according to standard; results are presumed to have met criteria (not explicitly listed). |
| Particulate Matter (USP) | Meet USP acceptance criteria. | Met the USP acceptance criteria. |
| Sterility (ISO 11137-2:2013) | Minimum SAL of 10^-6. | Validated gamma irradiation; SAL of 10^-6 achieved. |
| Endotoxin (LAL assay) | Meet endotoxin limit requirement. | Requirement met; product is non-Pyrogenic. |
| Sterile barrier testing (Tear drop label) | Successful performance of tear drop label removal force and seal integrity. | Testing performed; presumed to meet criteria. |
| Packaging Integrity (ASTM D4169-16) | Meet requirements for product protection and sterility maintenance. | All packaging deemed acceptable. |
| Shelf-life / Stability | Support 5-year shelf-life (sterility and performance). | Accelerated stability testing conducted to validate 5-year shelf-life. |
| Intended Use | Identical to predicate. | Identical to predicate. |
| Sterilization Method | Identical to predicate. | Identical to predicate (gamma irradiation). |
| SAL 10^-6 | Identical to predicate. | Identical to predicate (YES). |
| Tamper Evident Feature | Identical to predicate. | Identical to predicate (YES, tear-drop label). |
| Non-pyrogenic and Endotoxin Free | Identical to predicate. | Identical to predicate (YES). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not detail specific sample sizes for "test sets" in the context of diagnostic performance evaluation. The "testing" mentioned refers to engineering, functional, and biocompatibility tests on the physical device components and assembled product, adhering to industrial standards. Data provenance (country of origin, retrospective/prospective) is not applicable or specified for these types of tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not an AI/ML diagnostic device requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML diagnostic device requiring adjudication of expert interpretations.
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 not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of device, "ground truth" is defined by adherence to engineering specifications, material properties, and biological safety standards rather than diagnostic accuracy against a clinical reference.
8. The sample size for the training set
Not applicable. This is not an AI/ML algorithm that has a "training set."
9. How the ground truth for the training set was established
Not applicable.
§ 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).