(79 days)
The BD AutoShield™ Pen Needle is intended for use with pen injector devices for the injection of drugs, including insulin and exinatide.
Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the shield also serves to hide the needle before and after injection.
The BD AutoShield™ 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. The BD AutoShield™ Pen Needles are offered in various gauges sizes (29G, 30G, and 31G) and lengths (5mm, 8mm, and 12.7mm). The BD AutoShield™ Pen Needle is sterile (gamma irradiation sterilization), non-toxic, and non-pyrogenic. It is a disposable, single use device.
Additionally, the BD AutoShield™ Pen Needle is designed to reduce occurrence of accidental needle sticks from the patient end of the needle by providing a shield that locks over the needle after use. Prior to injection, the user will attach the AutoShield™ Pen Needle to the pen. The shield of AutoShield™ Pen Needle will hide the needle from the user prior to use. As the user proceeds with inserting the needle into the skin at a 90° angle, the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. The AutoShield™ Pen Needle should be removed from the pen and discarded.
The provided text describes the BD AutoShield™ Pen Needle and its clearance. However, it does not include the detailed information required to fill out a table of acceptance criteria, reported device performance, or specifics about a study design (like sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies).
The document is a 510(k) Summary of Safety and Effectiveness for the BD AutoShield™ Pen Needle, which details its features and intended use, and states that "Bench testing and simulated clinical testing was performed to confirm the device's safety and efficacy." It also mentions "Clinical testing was performed to evaluate the function of the of the safety feature in a simulated clinical environment utilizing both professional health care workers and non-clinician pen users."
However, it does not provide any specific quantitative acceptance criteria or detailed performance results from these studies. It concludes broadly that "Based on these performance testing results, the BD AutoShield™ Pen Needle is safe and effective when used as intended."
Therefore, based on the input provided, I cannot complete the requested information.
Here's what I can extract and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | "safe and effective when used as intended" |
| Not specified in the document | "confirms the device's safety and efficacy" |
| Not specified in the document | "function of the safety feature... evaluated" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The study is described as "simulated clinical testing" and "clinical testing in a simulated clinical environment."
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):
- Number of experts: Not specified.
- Qualifications of experts: The study involved "professional health care workers and non-clinician pen users," but their specific qualifications or experience levels are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
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 MRMC comparative effectiveness study is mentioned. This device is a physical pen needle, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the device is a physical pen needle and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The document implies that "bench testing and simulated clinical testing" were used to assess safety and efficacy, and the "function of the safety feature" was evaluated. The specific "ground truth" methodology (e.g., direct observation, quantitative measurements against a standard) for these assessments is not detailed.
8. The sample size for the training set:
- Not applicable/Not specified. This is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not specified.
§ 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).