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510(k) Data Aggregation
(69 days)
MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE
Becton Dickinson Pen Needle is intended for use with pen injector device for the subcutaneous injection of insulin.
The Becton Dickinson Ultra-Fine™ Pen Needle is designed for use with a pen injector for subcutaneous injection of a desired dose of insulin. The pen needle consists of a needle, hub, needle shield and outer needle shield assembly. The Ultra-Fine Pen Needles are offered in various needles sizes and lengths. The syringe fluid path is sterile (gamma irradiation sterilization), non-toxic, and non-pyrogenic. BD Pen Needles are disposable, single use devices.
Here is a breakdown of the acceptance criteria and study information based on the provided 510K summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalent Technological Characteristics | The BD Ultra-Fine™ Original Pen Needle, BD Ultra-Fine™ III Short Pen Needle and BD Ultra-Fine™ III Pen Needle have identical technological characteristics and perform equivalently as the predicate device. |
| Enhanced Puncture Resistance (Outer Needle Shield) | Bench tests demonstrated that the polypropylene material had a greater penetration resistance capability than the previous polyethylene material. This change was the only difference from the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided document. The summary only mentions "Bench tests relating to the performance of the outer needle shield were conducted."
- Data Provenance: The document does not specify the country of origin or whether the tests were retrospective or prospective. Given the nature of a 510K submission for a medical device, these would typically be internal laboratory tests conducted by Becton Dickinson.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a physical medical device (pen needle), not an AI or diagnostic imaging device that requires expert ground truth for interpretation of complex data. The performance evaluation was based on bench tests for material properties.
4. Adjudication Method for the Test Set
Not applicable. Performance was measured directly through bench tests of material properties, not through human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a physical medical device, not a diagnostic or AI-assisted system that would involve human readers or image interpretation.
6. Standalone Performance Study
Yes, a standalone study (bench testing) was performed on the device. However, "standalone" in this context refers to the device's physical properties being tested in a controlled laboratory setting, not an algorithm's performance without human intervention. The tests focused on the penetration resistance of the outer needle shield material.
7. Type of Ground Truth Used
The "ground truth" for this device's performance was the measured properties of the material (polypropylene vs. polyethylene) under specific bench test conditions, particularly penetration resistance. This is a direct physical measurement rather than an expert consensus, pathology, or outcomes data typically associated with diagnostic or AI systems.
8. Sample Size for the Training Set
Not applicable. This device's development and testing do not involve a "training set" in the context of machine learning or AI. Its design and material selection would be based on engineering principles and material science.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set." The understanding of material properties (polypropylene vs. polyethylene) and their respective penetration resistance would be established through standard material science testing and engineering knowledge.
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