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The Disposable Medical Safety Hypodermic Needle is intended for use in the aspiration and injection of fluids for medical purposes. The Disposable Medical Safety Hypodermic Needle is compatible for use with standard luer slip and luer lock syringes.

Additionally, 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 needle-stick.

The Disposable Medical Safety Hypodermic Needle is composed of a needle hub, a needle tube, a needle cap and a sharp injury protection feature. The sharp injury protection feature is simultaneously activated when manually pressed over the needle after use and prior to disposal to minimize the possibility of sharps injury. The sharp injury protection feature is activated with one-hand operation by pressing the sharp injury protection feature either with the finger or thumb, or by surface activation. The locking mechanism is positioned within the center and proximal end of the sharp injury protection feature. The hinge feature(sharp injury protection feature) allows the medical practitioner the flexibility to adjust the sharp injury protection feature to its desired position for use.

This document describes the FDA's 510(k) clearance for the Hantech Medical Device Co., Ltd.'s Disposable Medical Safety Hypodermic Needle. The clearance is based on the device being substantially equivalent to a legally marketed predicate device (TK Safety Needle, K191644).

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is demonstrated through adherence to various international ISO standards, indicating it meets the acceptance criteria defined within those standards. The document doesn't provide specific numerical targets for "acceptance criteria" but rather states conformity to the clauses of these standards, which implicitly define the acceptance thresholds.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each test. Instead, it indicates that testing was performed according to various ISO standards. These standards typically define appropriate sample sizes and methodologies for testing.

The data provenance is from China, as the submitting company, Hantech Medical Device Co., Ltd., is located in Ningbo, People's Republic of China. The studies are pre-market studies conducted to support the 510(k) submission, indicating a controlled, laboratory or simulated environment, rather than prospective clinical trials in humans.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the document. The studies primarily involve objective performance testing against established international standards rather than expert-driven ground truth establishment for a diagnostic or AI device.

4. Adjudication Method for the Test Set

This information is not applicable as the studies described are for the physical and functional performance of a hypodermic needle, not for diagnostic interpretation or a device requiring expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic or imaging devices to assess the impact of AI on human reader performance. The device in question is a medical needle, not an AI or diagnostic device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, a standalone performance evaluation in the context of an algorithm or AI was not done. The device is a physical medical instrument.

7. The Type of Ground Truth Used

For the performance testing, the "ground truth" is defined by the specifications and requirements set forth in the referenced ISO and ASTM standards. These standards prescribe acceptable ranges, physical properties, and functional outcomes. For example, the cleanliness clause of ISO 7864 dictates the "ground truth" for acceptable levels of contamination.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical medical product and not an AI/machine learning model that would require a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above; there is no training set for this type of device.

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