(79 days)
Becton Dickinson Pen Needle is intended for use with pen injector devices for the subcutaneous injection of drugs.
The BD Pen Needle is designed for use with pen injectors for subcutaneous injection of a desired dose of drugs approved for delivery using a pen needle. It consists of a needle, base, and shield assembly. The BD Nano™ 2nd Gen Pen Needle is offered in a 34-gauge size and 4mm length XTW cannula. The device is non-toxic and non-pyrogenic. It is a single-use disposable device that is provided sterile.
Here's a breakdown of the acceptance criteria and the study information for the BD Nano™ 2nd Gen Pen Needle, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (Standard/Requirements) | Reported Device Performance |
|---|---|---|
| Bench Functional Performance | ||
| Cannula Straightness | ISO 11608-2:2012, ISO 9626:2016, BD Internal Specifications | Met requirements |
| Cannula Stiffness | ISO 11608-2:2012, ISO 9626:2016, BD Internal Specifications | Met requirements |
| Cannula Breakage Resistance | ISO 11608-2:2012, ISO 9626:2016, BD Internal Specifications | Met requirements |
| Flow Rate Measurement | ISO 11608-2:2012, BD Internal Specifications | Met requirements |
| Cannula Patency | ISO 11608-2:2012, BD Internal Specifications | Met requirements |
| Patient End Penetration Force | ISO 11608-2:2012, BD Internal Specifications | Met requirements |
| Cannula Pull Force | ISO 11608-2:2012, BD Internal Specifications | Met requirements |
| Dose Accuracy | ISO 11608-2:2012, BD Internal Specifications | Met requirements |
| Material/Design Characteristics | ||
| Biocompatibility | Non-toxic | Device is non-toxic |
| Pyrogenicity | Non-pyrogenic | Device is non-pyrogenic |
| Sterility (SAL) | 10^-6 | Achieved 10^-6 SAL |
| Sterilization Method | Not explicitly stated as "acceptance criteria," but gamma irradiation is used | Gamma irradiation (same as predicate) |
| Usability/Functionality | For use with pen injector devices for subcutaneous injection of drugs | Met requirements for intended use |
| Shelf Life | 5 years | Supported by testing (implied by "support the 5-year shelf life") |
2. Sample Size Used for the Test Set and Data Provenance
- The document does not specify the exact sample sizes (number of devices tested) for the bench functional performance tests. It states "Testing included functional performance per ISO 11608-2:2012... and testing following BD's Internal Specifications." While standards typically mandate minimum sample sizes, the specific numbers for this device are not provided in this summary.
- Data Provenance: The data is from "Non-Clinical Testing" performed by Becton, Dickinson and Company as part of its design control process. This indicates the testing was conducted internally by the manufacturer. It is prospective testing designed to validate the new device. The country of origin of the data is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable as the study described is a non-clinical, bench performance study of a medical device (a pen needle), not a study involving human diagnosis, interpretation of medical images, or clinical outcomes that would require expert-established ground truth. The "ground truth" here is defined by meeting physical and performance specifications outlined in international standards (ISO) and the manufacturer's internal specifications.
4. Adjudication Method for the Test Set
- This information is not applicable for the same reasons as #3. Adjudication methods like 2+1 or 3+1 are used to reconcile discrepancies among human readers or evaluators, which is not relevant to bench testing of device performance against pre-defined specifications.
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
- No, a multi-reader, multi-case comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids or clinical decision support systems, where the goal is to assess the impact of AI on human reader performance. The BD Nano™ 2nd Gen Pen Needle is a physical medical device (pen needle), not an AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical pen needle, not an algorithm or AI system. Its performance is evaluated through bench testing against physical and functional standards, not as a standalone algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance testing is based on pre-defined technical specifications, international standards (ISO 11608-2:2012, ISO 9626:2016), and the manufacturer's (BD's) internal specifications. For example, a flow rate measurement would be compared against a specified range or minimum value defined by the standard or the manufacturer, making that standard the "ground truth."
8. The Sample Size for the Training Set
- Not applicable. Training sets are used in machine learning for AI algorithms. This device is a physical medical device, and its performance is evaluated through non-clinical testing, not by training an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable for the same reasons as #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).