(126 days)
The Uniever Disposable Epidural Anesthesia Needle is intended to injection into the epidural space / or placing the epidural catheter into the epidural space.
Uniever Disposable Nerve Blockade Needle is intended to be used for injection of local anesthetic agent near the nerve for temporary pain control.
The UNIEVER Disposable Epidural Anesthesia Needles and UNIEVER Disposable Nerve Blockade Needles are available in an array of sizes, lengths, and bevel and tip designs. Both have a tightly fitting removable stylet.
The UNIEVER Disposable Epidural Anesthesia Needles are available with Huber, Hustead, or Crawford tips. Available sizes are 14G to 25G (Huber), 16G to 19G (Hustead), and 16G to 22G (Crawford) for lengths of 30-160mm.
The UNIEVER Disposable Nerve Blockade Needles are available with Back-Cut, K-3, or Huber tips. Available sizes are 18G, 20G to 26G for lengths of 25-260mm (Back Cut and K-3), and 20G, 22G and 25G for lengths of 30-160mm (Huber).
The provided document is a 510(k) premarket notification for two medical devices: the Uniever Disposable Epidural Anesthesia Needle and the Uniever Disposable Nerve Blockade Needle. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove a device meets those criteria from scratch, which is typical for novel devices or PMAs (Premarket Approval Applications).
Therefore, the information for acceptance criteria and a detailed study proving performance against those criteria in the way one might expect for a new diagnostic or AI-based device is not explicitly present in this document. The document describes performance testing to ensure compliance with voluntary safety standards and internal functional specifications.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a formal table of acceptance criteria and reported device performance in the way requested for a new device. Instead, it describes performance testing conducted to demonstrate compliance with recognized international standards and internal specifications, implying that meeting these standards constitutes "acceptance."
Implicit Acceptance Criteria (based on compliance with standards):
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Material Biocompatibility | Complies with ISO 10993-1, including cytotoxicity, sensitization, irritation, and pyrogenicity testing. |
| Sterilization (EtO) | Achieves a Sterility Assurance Level (SAL) of $10^{-6}$. In addition, endotoxin and particulate testing for CSF contact was performed. |
| Luer Connections | Complies with ISO 594-1 (Conical fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment - Part 1: General requirements). |
| Sterile Hypodermic Needles | Complies with ISO 7864 (Sterile hypodermic needles for single use). |
| Stainless Steel Needle Tubing | Complies with ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods). |
| Functional Specifications | Passed verification/validation testing to internal functional specifications, demonstrating the devices are safe and effective. (Specific functional details not provided). |
2. Sample size used for the test set and the data provenance:
The document does not specify the sample size used for any of the performance tests (e.g., how many needles were tested for biocompatibility, sterility, or functional aspects). It also does not mention the data provenance (e.g., country of origin, retrospective/prospective). This information is typically detailed in the underlying test reports, which are not included in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This type of information (experts, ground truth for a test set) is typically relevant for diagnostic devices or AI algorithms where a "truth" needs to be established (e.g., presence/absence of a disease). For a physical medical device like an anesthesia needle, "ground truth" is established by adherence to engineering performance standards and biological safety standards. Therefore, this information is not applicable in the context of this 510(k) summary. Quality engineers, material scientists, and microbiologists would have conducted and reviewed the tests, but they wouldn't be referred to as "experts establishing ground truth" in this manner.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
As mentioned above, adjudication methods like 2+1 or 3+1 are used for interpreting ambiguous cases or establishing consensus in diagnostic studies. This is not applicable to the performance testing of a physical medical device like an anesthesia needle, where test results are typically objective measurements against a standard.
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:
This is explicitly for AI-assisted diagnostic devices. This 510(k) is for a physical epidural and nerve block needle, so an MRMC study is not applicable and was not done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is also explicitly for AI-driven algorithms. This 510(k) is for a physical medical device, so a standalone algorithm performance evaluation is not applicable and was not done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For this device, "ground truth" is defined by compliance with established international consensus standards (ISO standards) and verified internal functional specifications for physical and biological properties. It is not expert consensus on diagnostic images, pathology results, or patient outcomes data.
8. The sample size for the training set:
There is no "training set" in the context of this 510(k) for a physical medical device. Training sets are applicable to machine learning algorithms.
9. How the ground truth for the training set was established:
Again, no training set exists for this type of device.
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).