(91 days)
The device is intended for use to inject fluids or withdraw fluids from the body. The needle protection device covers the needle after use to help prevent needle sticks.
Subject Device: The Hypodermic Needle-Pro® EDGE™ Safety Device with Syringe is intended for injection or aspiration of fluids using a Luer slip syringe. The Needle-Protection device covers the needle after use to help prevent needle sticks. The device features a "one-piece" design of polypropylene needle hub and protective sheath with a living hinge. The stainless-steel needle cannula is permanently affixed into the hub. The sheath has an "arrow" indicating the bevel orientation, i.e. when the sheath is oriented to the right, the bevel is in the "up position." After the procedure is completed, the needle is pressed into the sheath using a one-handed technique. As the needle enters the protective sheath, the lugs on the needle hub snap into the clips of the protective sheath resulting in a "bottom snap" and the needle is contained within the sheath. In addition to the "bottom snap," the Needle-Protection sheath has 2 retaining hooks. The EDGE™ safety device may be removed from the syringe when required by a specific medical procedure.i.e., the EDGE™ safety device may be removed from a blood sampling syringe to process the blood sample. The EDGE™ safety device is then discarded into a sharps container. The Subject device is comprised of a 1mL Luer lock syringe with a 23G x 1.5in needle/cannula. This configuration is not currently offered within the Smiths Medical portfolio of Hypodermic Needle-Pro® EDGE™ with syringe devices.
The provided document is a 510(k) summary for the Hypodermic Needle-Pro® EDGE™ Safety Device. It details the device's characteristics, its comparison to a predicate device, and the performance data supporting its substantial equivalence.
Here's an analysis based on your requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for each test in a numerical or pass/fail format. Instead, it indicates that testing was performed in accordance with relevant ISO standards and that "There were no failures identified" for shelf-life, and "Results of the testing conducted, demonstrate the Subject device will perform as intended." This implies that meeting the requirements of these standards constitutes the acceptance criteria.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Not explicitly stated; leveraged from predicate device | Leveraged from the predicate submission. |
| Sterilization | Sterility confirmation according to AAMI TIR28:2016 | Microbiology Product Adoption confirmed the Subject device is similar in componentry, packaging, and complexity and will not adversely affect the currently validated Ethylene Oxide sterilization. |
| Shelf-Life | No failures under accelerated aging to support 2-year claim | No failures identified, supporting the claimed expiration date of 2 years. |
| Non-Clinical Bench Testing | Compliance with specified ISO standards (e.g., ISO 7886-1, ISO 7864, ISO 594-2, ISO 23908, ISO 9626, ISO 6009) | Testing performed in accordance with pertinent FDA consensus standards. "Results... demonstrate the Subject device will perform as intended." Specifically: |
- Compatibility (Luers): Compliance to ISO 594-2 for Luers on Needle Hub/Safety Sheath and Hypodermic Syringe. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any of the performance tests (biocompatibility, sterilization, shelf-life, or non-clinical bench testing). It also does not mention the country of origin of the data or whether it was retrospective or prospective, beyond stating that it was generated for the 510(k) submission.
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)
This information is not applicable. The device is a hypodermic needle product, not an AI or diagnostic imaging device that would require expert-established ground truth for performance evaluation in the described tests. The "ground truth" for these tests would be defined by the physical and chemical properties measured against the standards, not expert interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the type of device and tests described. Adjudication methods are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in ground truth establishment, which is not relevant here.
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 such study was performed or mentioned. This device is a physical medical device (hypodermic needle), not an AI or diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically used for AI or diagnostic devices (e.g., expert consensus, pathology, outcomes data) does not apply here. For the performance tests conducted:
- Biocompatibility: Likely based on standard chemical and biological assays and expert interpretation of material safety.
- Sterilization: Determined by microbial inactivation assays and compliance with sterilization standards.
- Shelf-Life: Determined by stability testing (physical and functional properties) over time.
- Non-Clinical Bench Testing: Determined by objective measurements against quantitative physical and dimensional requirements specified in the relevant ISO standards (e.g., fluid leakage, force required for activation, dimensions).
8. The sample size for the training set
This information is not applicable. No "training set" is mentioned as this is not an AI/machine learning device. The document mentions "predicate device" which is used for comparison, but not as a "training set" in the computational sense.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" for this physical device.
§ 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).