(261 days)
The Disposable Sterile Needle is intended for use with syringes and injection devices for general purpose fluid injection/ aspiration.
The Disposable Sterile Needle consists of three components: needle hub, and the needle cap. The Disposable Sterile Needle is supplied sterile for single use and has a shelf life of 5 years. The proposed device is available in various combinations of needle gauge, length, wall type and Edges. The hub color of the needle complies with ISO 6009: 2016 - Hypodermic needles for single use — Colour coding for identification.
This document is a 510(k) summary for a Disposable Sterile Needle, detailing its equivalence to a predicate device. It primarily focuses on regulatory compliance and performance testing against established standards for medical devices, rather than a clinical study comparing an AI system's performance to human readers. Therefore, much of the requested information regarding AI-specific studies (e.g., sample size for test/training sets, number of experts, MRMC studies, AI effect size, standalone performance) is not applicable or cannot be extracted from this document.
However, I can extract the acceptance criteria and performance data related to the device's adherence to relevant standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ISO 7864:2016 (Sterile Hypodermic Needles for Single Use) | Complies with ISO 7864:2016 |
| ISO 9626:2016 (Stainless Steel Needle Tubing for Medical Devices) | Complies with ISO 9626:2016 |
| ISO 6009:2016 (Hypodermic Needles Color Coding) | Complies with ISO 6009:2016 (Hub Color) |
| ISO 594-1:1986 (Luer Taper Fittings - General) | Complies with ISO 594-1:1986 |
| ISO 594-2:1998 (Luer Taper Fittings - Lock) | Complies with ISO 594-2:1998 |
| ASTM F1929-15 (Detecting Seal Leaks in Porous Medical Package) | Tests performed per ASTM F1929-15; pre-determined criteria met |
| ASTM F88/F88M-15 (Seal Strength of Flexible Barrier Materials) | Tests performed per ASTM F88/F88M-15; pre-determined criteria met |
| **USP ** (Bacterial Endotoxins Test) | Tests performed; pre-determined criteria met |
| ISO 11135-1:2007 (EO Sterilization Development, Validation, Control) | Sterility validated in accordance with ISO 11135-1:2007; Achieved SAL of 10-6 |
| ISO 10993 series (Biocompatibility) | Meets biocompatibility requirements for cytotoxicity, sensitization, irritation sensitivity, acute systemic toxicity, material mediated pyrogenicity, hemocompatibility |
| ISO 14971:2007 (Risk Management) | Risk analysis conducted in accordance with ISO 14971:2007; pre-determined criteria met |
| Needle Length Tolerances (per ISO 7864 Section 4.10.2) | Meets 4.10.2 Tolerances requirements of ISO 7864 |
| Needle Dimensions (per ISO 9626 Section 5.4) | All needle gauges meet 5.4 Dimensions requirements of ISO 9626 |
2. Sample Size Used for the Test Set and the Data Provenance
This document describes non-clinical performance testing against international standards for medical devices. It does not refer to a "test set" in the context of clinical data or AI model evaluation. The tests are conducted on samples of the manufactured device. The document does not specify the exact sample sizes used for each individual test (e.g., how many needles were tested for seal integrity or biocompatibility).
The data provenance is from the manufacturer's (Jiangsu Caina Medical Co., Ltd., China) internal testing/verification processes, conducted to demonstrate compliance with the referenced standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This document does not describe a clinical study requiring human experts to establish ground truth for a test set. The "ground truth" for this device's performance is compliance with the defined parameters and limits specified in the referenced international standards.
4. Adjudication Method for the Test Set
Not applicable. There is no "adjudication method" in the context of clinical data or AI systems with human-in-the-loop for this type of device submission. Performance is assessed against quantitative and qualitative criteria defined by the standards.
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 document describes a medical device (hypodermic needle), not an AI system or software that interacts with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This document is for a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is adherence to the specifications and performance criteria outlined in the cited international and national standards (e.g., ISO 7864, ISO 9626, ISO 6009, ISO 594, ASTM F1929, ASTM F88, USP , ISO 11135, ISO 10993, ISO 14971). These standards define the acceptable physical properties, sterility, biocompatibility, and safety parameters for hypodermic needles.
8. The Sample Size for the Training Set
Not applicable. This document does not describe an AI system requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This document does not describe an AI system requiring a training set.
§ 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).