(95 days)
Artsana disposable sterile hypodermic needles are intended for use to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Artsana disposable sterile pen needles are used with insulin pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.
Not Found
Here's a breakdown of the requested information based on the provided FDA 510(k) summary for Artsana Hypodermic Needles and InsuPen® Insulin Pen Needles:
Important Note: The provided document is an FDA letter of substantial equivalence, not a detailed technical report or study summary. Therefore, much of the requested information (like specific performance metrics, sample sizes for test/training sets, expert qualifications, and detailed study designs) is not available within these pages. The FDA 510(k) process for these types of devices primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with detailed performance metrics as might be seen for novel or high-risk devices.
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Hypodermic Needles: | |
| * Sterility | Met (as implied by regulatory compliance) |
| * Ability to inject fluids | Met (intended use) |
| * Ability to withdraw fluids | Met (intended use) |
| * Compatibility with intended use (general medical procedures) | Substantially equivalent to predicate devices |
| Insulin Pen Needles: | |
| * Sterility | Met (as implied by regulatory compliance) |
| * Ability to inject insulin | Met (intended use) |
| * Compatibility with insulin pen injector devices | Met (intended use) |
| * Subcutaneous injection | Met (intended use) |
| General: | |
| * Biocompatibility | Met (implied by material and process controls) |
| * Physical/Mechanical integrity | Met (implied by manufacturing controls) |
| * Safety & Effectiveness (comparable to predicate) | Established through substantial equivalence |
Note: The "acceptance criteria" for these types of devices are generally established by recognized standards (e.g., ISO for sterility, needle dimensions, penetration force) and the performance of the predicate device. The document states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it meets similar performance and safety profiles. Specific numerical criteria and corresponding data are not detailed in this summary.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided document. The 510(k) process for hypodermic needles often relies on bench testing and comparison to predicate devices, rather than large-scale clinical test sets.
- Data Provenance: Not specified, but generally, for substantial equivalence, the data would come from internal testing conducted by the manufacturer (Artsana S.P.A.) or from established performance data of the predicate device. It is generally retrospective in the sense that it relies on existing knowledge and testing methodologies. Country of origin for testing is not stated, but the manufacturer is Artsana S.P.A. (an Italian company).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified in the context of this 510(k) submission. "Ground truth" in this context usually refers to objective measurements against established standards for physical and material properties (e.g., needle sharpness, sterility validation). Human expert consensus is typically not the primary method for establishing "ground truth" for basic medical devices like needles, unless it involves usability or patient feedback studies, which are not outlined here.
4. Adjudication method for the test set
- Not applicable/Not specified. The assessment is primarily against technical specifications and predicate device equivalence, not through expert adjudication in the classic sense.
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. This is not an AI-enabled device. This question is not relevant to a hypodermic needle or insulin pen needle.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI-enabled device and does not involve an algorithm in the sense of a diagnostic or therapeutic AI.
7. The type of ground truth used
- The ground truth would be based on objective technical standards (e.g., ISO standards for medical devices, specifically needles), bench testing results (e.g., injection force, integrity, flow rates, sterility tests), and data demonstrating equivalence to the performance characteristics of predicate devices. It would likely incorporate pathology indirectly through biocompatibility testing (e.g., materials not causing adverse tissue reactions). Outcomes data would typically not be a primary ground truth for basic device clearance unless significant clinical safety or efficacy questions were raised.
8. The sample size for the training set
- Not applicable/Not specified. For medical devices like needles, there isn't a "training set" in the machine learning sense. Performance is typically established through manufacturing process controls, quality assurance testing, and adherence to design specifications and standards.
9. How the ground truth for the training set was established
- Not applicable. As there's no "training set" in the machine learning context, this question is not relevant. The performance and safety of these devices are assured through design validation, verification testing (against established standards), and manufacturing quality systems rather than through data training.
§ 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).