(91 days)
BD 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, hub, and shield assembly. The BD Pen Needle is offered in a variety of needle gauge sizes (29G, 30G, 31G, and 32G) and lengths (4mm, 5mm, and 12.7mm). It is a single-use disposable device that is provided sterile. The BD Pen Needle is non-toxic and nonpyrogenic.
The provided text is a 510(k) summary for the BD Pen Needle, which is a medical device. This document is a regulatory submission to the FDA, asserting that the device is substantially equivalent to previously cleared devices. It does not describe a study proving the device meets acceptance criteria in the manner of a clinical trial or a performance study with reported metrics and statistical analyses.
Instead, the document states that the device has the "same technological characteristics as the predicate devices" and that BD has "validated the design of the subject device as part of its design control process in accordance with the Quality System Regulation." It also mentions "functional performance per ISO 11608-2: Needle-based injection systems for medical use - Requirements and test methods- Part 2: Needles." However, no specific acceptance criteria or performance results are provided in the document.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present in the document. The document refers to ISO 11608-2 but does not detail what specific tests were performed, what the acceptance criteria for those tests were, or what the device's performance results were.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not a study involving expert ground truth.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable, as this is a physical medical device.
- How the ground truth for the training set was established: Not applicable.
Summary of what is stated in the document regarding testing:
- Testing performed: "functional performance per ISO 11608-2: Needle-based injection systems for medical use - Requirements and test methods- Part 2: Needles."
- Purpose of the testing: To validate the design as part of BD's design control process and to support the compatibility of its pen needle devices with "all leading diabetes pen injectors available on the market to ensure connectivity and dose accuracy."
- Conclusion of testing: "This testing demonstrates the BD Pen Needle device meet requirements for its intended use and supports the proposed clarification."
The document focuses on demonstrating substantial equivalence based on similar technological characteristics and adherence to quality systems and relevant standards, rather than providing detailed study results against specific acceptance criteria.
§ 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).