(174 days)
The Sterile Hypodermic Needles for Single Use are intended to be used with a luer slip syringe and injection devices for general purpose fluid injection/aspiration.
The Sterile Hypodermic Needles for Single Use is composed of a needle hub, protective cover, needle tube and jointing. The Sterile 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.
The provided document, K211214, is an FDA 510(k) summary for a medical device: Sterile Hypodermic Needles for Single Use. This document outlines the manufacturer's claims that their device is substantially equivalent to an existing legally marketed predicate device (K180417 from Berpu Medical Technology Co., Ltd).
However, it's crucial to understand that this document describes a conventional medical device (a hypodermic needle), NOT an AI/ML-based device. Therefore, the questions related to AI/ML device testing (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone algorithm performance, effect size of human improvement with AI, ground truth establishment for training set) are not applicable to this submission.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" for a physical medical device like a hypodermic needle are based on performance testing against recognized industry standards (ISO standards, USP standards), and biocompatibility, sterilization, and shelf-life testing. These are fundamentally different from the validation methods for AI/ML algorithms.
Here's a breakdown of the requested information based on the provided document, addressing what is relevant and explicitly stating what is not applicable:
Acceptance Criteria and Device Performance (for a Hypodermic Needle)
1. Table of Acceptance Criteria and Reported Device Performance
For this conventional medical device, the "acceptance criteria" are compliance with various ISO and USP standards for physical and biological properties. The "reported device performance" is a statement that the device "meets the requirements" or "acceptance criteria" of these standards.
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance Statement |
|---|---|---|
| Biocompatibility | ISO 10993-1:2018 (for "External communication device – Blood path indirect" with contact duration "Limited ( Particulate Matter in Injections | "met the USP acceptance criteria." |
| Sterilization | ISO 11135:2014 (Validation of sterilization method) | "The sterilization method has been validated to ISO11135" |
| EO/ECH Residue | ISO 10993-7:2008 | Not explicitly stated as "met," but implied by "The following tests were performed... and met..." |
| Bacterial Endotoxin | USP42-NF37 | Not explicitly stated as "met," but implied by "The following tests were performed... and met..." |
| Shelf-Life/Packaging | Seal Strength (ASTM F88/F88M-15), Dye Penetration (ASTM F1929-15), Creep/Burst Testing (ASTM F1140/F1140M-13), Gross Leakage (ASTM F2096-11), Antibacterial Testing (DIN 58953-6:2010) | Determined the shelf-life to be five (5) years based on stability study. |
| Performance (ISO 7864) | Clause 4.3 (Cleanliness), 4.4 (Acidity/Alkalinity), 4.5 (Extractable Metals), 4.6 (Designation), 4.7 (Color Coding), 4.8 (Needle Hub), 4.9 (Needle Cap), 4.10 (Needle Tube), 4.11 (Needle Point), 4.12 (Bond), 4.13 (Patency) | "All evaluation acceptance criteria were met." / Implied by "Performance testing is performed according to the following standards:" |
| Performance (ISO 9626) | Clause 5.2 (Surface Finish), 5.3 (Cleanliness), 5.4 (Acidity/Alkalinity), 5.5 (Size Designation), 5.6 (Dimensions), 5.8 (Stiffness), 5.9 (Resistance to Breakage), 5.10 (Resistance to Corrosion) | "All evaluation acceptance criteria were met." / Implied by "Performance testing is performed according to the following standards:" |
| Performance (ISO 80369-7) | Clause 5 (Dimensional requirements), 6.1.3 (Fluid leakage), 6.2 (Sub-atmospheric air leakage), 6.3 (Stress cracking), 6.4 (Axial load separation), 6.5 (Unscrewing separation), 6.6 (Overriding) | "All evaluation acceptance criteria were met." / Implied by "Performance testing is performed according to the following standards:" |
| Labeling | 21 CFR Part 801 | "Meets the requirements of 21 CFR Part 801." |
Information Relevant to AI/ML Device Testing (Not Applicable to this Device)
The following points are typically relevant for AI/ML-based medical devices but are not applicable to this 510(k) submission concerning a sterile hypodermic needle.
- Sample size used for the test set and the data provenance: Not applicable. Testing involves physical samples of needles, not data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a needle is based on objective physical and chemical measurements against standards, not expert interpretation of AI outputs.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No human adjudication is involved in assessing a needle's compliance with ISO standards.
- 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 for AI-assisted diagnostic or interpretative devices.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a hypodermic needle, "ground truth" is established by the specifications and performance requirements defined in the international standards (e.g., ISO 7864, ISO 9626, ISO 80369-7, ISO 10993 for biocompatibility) and direct physical/chemical measurements. It's not expert consensus on an image or pathology.
- The sample size for the training set: Not applicable. There is no AI model to train.
- How the ground truth for the training set was established: Not applicable. There is no AI model to train.
In summary: K211214 describes the regulatory clearance for a traditional medical device (hypodermic needle). The "acceptance criteria" and supporting "study" are engineering and biological validations demonstrating the device meets established international safety and performance standards for its physical form and intended use. The questions posed in your prompt are tailored for Artificial Intelligence/Machine Learning (AI/ML) medical devices, which operate under a entirely different set of validation and regulatory expectations than conventional devices.
§ 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).