(64 days)
The BD AutoShield Duo™ Pen Needle is intended for use with pen injector devices for the subcutaneous injection of drugs.
The product has two safety shields, which lock in place after use (patient-end) and upon removal of the needle from the pen (pen connection-end). The locked shields help reduce the occurrence of needle sticks from both ends of the needle.
The pen needle assembly consists of a double-ended cannula that is assembled onto an injection molded hub. The internal threads allow the subject device to be screwed onto a pen injector device, further enabling the non-patient end of the cannula to penetrate through the septum of the pen injector cartridge.
The patient and non-patient ends of the cannula are visible prior to attachment to the pen injector device. The BD AutoShield Duo™ Pen Needle has safety mechanisms on both the patient and non-patient ends of the needle, allowing the needle to be shielded and locked after use, which is designed to reduce the occurrence of accidental needle-stick injuries. The BD AutoShield Duo™ Pen Needle is a single use disposable device and is provided sterile. The subject device is non-toxic and non-pyrogenic.
The provided document describes the FDA 510(k) clearance for the BD AutoShield Duo™ Pen Needle. It focuses on demonstrating substantial equivalence to a predicate device (K110703) rather than a comprehensive study proving the device meets specific acceptance criteria for a novel functionality.
Therefore, much of the requested information regarding detailed acceptance criteria and a study to prove meeting them, particularly in the context of AI/ML or comparative effectiveness, is not directly applicable or available in this document. This submission is for a medical device that has minor administrative updates to its intended use statement, harmonizing it with other existing pen needles, and confirms its continued safety and effectiveness through non-clinical testing.
Here's an attempt to extract and infer the information based on the provided text, while noting the limitations:
1. A table of acceptance criteria and the reported device performance
The document doesn't present a specific table of acceptance criteria with corresponding performance metrics as would be typical for a new device claiming specific performance against a novel metric. Instead, it refers to compliance with established international standards and internal BD test requirements. The "performance" is generally stated as "passed" or "met requirements".
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance |
|---|---|---|
| Functional Performance | ISO 11608-2:2012 (Needles) | Passed |
| ISO 9626:2016 (Needle Tubing) | Passed | |
| ISO 23908:2011 (Sharps Injury Protection) | Passed | |
| BD internal test requirements | Passed | |
| Biocompatibility | ISO 10993-1:2018 (General) | Passed |
| - Cytotoxicity | Passed | |
| - Intracutaneous Reactivity | Passed | |
| - Skin Sensitization | Passed | |
| - Acute Systemic Toxicity | Passed | |
| - Subacute/Subchronic Toxicity | Passed | |
| - Genotoxicity | Passed | |
| - Material-Mediated Pyrogenicity | Passed | |
| - Implantation | Passed | |
| Particulate Matter | USP | Met USP acceptance criteria |
| Sterility | ISO 11137-2:2013 (Sterilization Dose) | Sterilization dose provides a minimum SAL of 10-6 |
| Endotoxin Content | Limulus Amebocyte Lysate (LAL) assay | Met requirement, product is non-pyrogenic |
| Package Integrity | ASTM D4169-16 (Shipping and Shelf-Life) | All packaging deemed acceptable for protection of product and sterility maintenance |
| Shelf-Life | Accelerated stability testing | Supported 3 years |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for each specific test conducted (e.g., number of needles tested for each ISO standard). It generally mentions that testing was conducted to validate the design.
- Sample Size: Not specified in the provided text for individual tests.
- Data Provenance: The testing was conducted by BD (Becton, Dickinson and Company) as part of its design control process, implying internal, prospective testing for regulatory submission. The country of origin of the data is not specified beyond being generated by Becton, Dickinson and Company in Franklin Lakes, New Jersey.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the type of tests described. The "ground truth" for these tests (functional performance, biocompatibility, sterility) is established by adhering to widely accepted international standards (ISO, ASTM, USP) and internal engineering/quality requirements, rather than expert consensus on subjective evaluations.
4. Adjudication method for the test set
Not applicable. The tests performed are objective, measurable parameters against defined standards, not requiring an adjudication method like those used for subjective clinical assessments or AI model evaluations.
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. The BD AutoShield Duo™ Pen Needle is a physical medical device (pen needle), not an AI/ML software device or a diagnostic tool that involves human readers or AI assistance in interpretation. No MRMC study was mentioned or implied.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As mentioned in point 3, the ground truth for the non-clinical tests is based on the specifications and acceptance criteria defined within established international standards (ISO, USP, ASTM) and the manufacturer's own validated internal requirements for device function, safety, and sterility. For example:
- Functional: Compliance with dimensional tolerances, force measurements, safety mechanism activation as per ISO standards.
- Biocompatibility: Absence of toxicological responses as per ISO 10993 series.
- Sterility: Sterility assurance level (SAL) of 10-6 as per ISO 11137-2.
8. The sample size for the training set
Not applicable. This is not an AI/ML product that utilizes a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device submission.
§ 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).