(87 days)
The Sterile Safety Hypodermic Needles for Single Use are intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.
The Sterile Safety Hypodermic Needles for Single Use are composed of a hypodermic needle with a needle safety shield attached to the needle hub, which can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks. The device is compatible for use with standard luer slip and luer lock syringes. The Sterile Safety Hypodermic Needles for Single Use is for single use only. It is provided sterile. The sterilization method is EO sterilization and the sterilization assurance level is 10-6.
This is an FDA 510(k) clearance letter for a medical device, specifically Sterile Safety Hypodermic Needles for Single Use. The primary purpose of this document is to establish substantial equivalence to a predicate device, not to present a detailed study on the device's original performance against a specific set of acceptance criteria with explicit human reader performance metrics, as would be typical for an AI/ML medical device.
Therefore, many of the requested items (e.g., sample size for test set with ground truth, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of device clearance and the information provided in this document.
However, I can extract the acceptance criteria and performance data that are relevant to this type of conventional medical device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard & Clause) | Reported Device Performance (Compliance) |
|---|---|
| Biocompatibility: | |
| Cytotoxicity (ISO 10993-5:2009) | Compliant |
| Skin sensitization (ISO 10993-10:2010) | Compliant |
| Hemolysis (ISO 10993-4:2017) | Compliant |
| Intracutaneous reactivity (ISO 10993-10:2010) | Compliant |
| Acute systemic toxicity (ISO 10993-11:2017) | Compliant |
| Pyrogenicity (ISO 10993-11:2017) | Compliant |
| Particulate Matter (USP Method 1) | Met USP acceptance criteria |
| Sterilization & Shelf Life: | |
| EO Sterilization Validation (ISO 11135:2014) | Validated |
| EO Sterilization Residuals (ISO 10993-7:2008) | Compliant |
| Packaging Requirements (ISO 11607-1:2019) | Compliant |
| Packaging Validation (ISO 11607-2:2019) | Compliant |
| Accelerated Aging for Packaging (ASTM F1980-16) | Used for shelf life determination |
| Performance Testing: | |
| Sterile Single-Use Hypodermic Needles (ISO 7864:2016) | Compliant |
| Stainless Steel Needle Tubing (ISO 9626:2016) | Compliant |
| Small-bore Connectors (ISO 80369-7:2016) | Compliant |
| Sharps Injury Protection (ISO 23908) | Compliant |
| Medical Devices with Sharps Injury Prevention Features Guidance for Industry and FDA Staff | Compliant (implicitly, as part of sharps injury protection) |
| Labeling (21 CFR Part 801) | Met requirements |
2. Sample size used for the test set and the data provenance:
This document describes a premarket notification for a conventional medical device (hypodermic needles), not an AI/ML device. Therefore, there isn't a "test set" in the context of diagnostic performance evaluation with specific data provenance (country of origin, retrospective/prospective clinical data) as requested. The performance is assessed through engineering and biological testing against established international and national standards. The sample sizes for these tests would be determined by the specific standards and protocols followed (e.g., number of units tested for particulate matter, tensile strength, sterility, etc.), but are not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth, in the context of AI/ML, refers to a definitive diagnosis or finding. For this device, ground truth is established by objective measurements and standardized testing against predefined physical, chemical, and biological properties as specified in the referenced ISO, ASTM, and USP standards. The "experts" involved would be the qualified personnel performing the laboratory and engineering tests, whose qualifications are implicit in their ability to conduct these standardized tests accurately.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This device does not involve human interpretation of outputs that would require adjudication for establishing ground truth in a diagnostic context.
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:
Not applicable. This is not an AI/ML device, and no human reader studies are mentioned or relevant for its clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is established by objective measurements and results from standardized laboratory and engineering tests (e.g., sterility testing, material strength, biocompatibility assays, particulate counts, sharps injury prevention mechanism functionality) against predefined acceptance criteria established in international and national standards.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device. There is no concept of a "training set" for this type of medical device clearance.
9. How the ground truth for the training set was established:
Not applicable.
§ 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).