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This device is intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

The submitted device is a sterile hypodermic needle for single use. The device is a single lumen hypodermic needle offered in a 22 gauge x 1 ½ " length. The device is constructed of the material noted in the table below:

The device is classified for patient contact as externally communicating circulating blood in a limited contact duration (

This document is a 510(k) premarket notification for a medical device called "Sterile Hypodermic Needle for Single Use" by Jiangsu Shenli Medical Production Co., Ltd. The purpose of this notification is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (IMC Hypodermic Needle, K102584).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device, a "Sterile Hypodermic Needle for Single Use," the acceptance criteria are based on compliance with various international standards for medical devices, particularly those related to hypodermic needles, biocompatibility, and sterility. The reported device performance is that it meets all these standards.

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

The document does not specify a distinct "test set" in the context of AI/ML, but rather refers to various "performance testing" conducted to meet specific standards. For each of these tests (e.g., biocompatibility tests, physical performance tests), the sample sizes used are not explicitly stated in this summary document. The document states that the data is from "Jiangsu Shenli Medical Production Co., Ltd." in Changzhou City, Jiangsu Province, China, indicating the country of origin of the data. The studies are prospective in nature, as they involve testing the newly developed device against established standards.

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

This submission is for a traditional medical device (hypodermic needle) and does not involve AI/ML. Therefore, the concept of "ground truth established by experts" in the context of interpretation of results (like in image analysis) is not directly applicable here. The "ground truth" for this device's performance is objective compliance with pre-defined international standards and physical/chemical test parameters. These standards are developed and overseen by international bodies and qualified experts in the field of medical device manufacturing and safety. The expertise lies in the development of these standards and the execution and interpretation of the tests by qualified testing laboratories.

4. Adjudication Method for the Test Set

Not applicable, as this is a traditional medical device submission, not an AI/ML algorithm requiring expert adjudication of results. The "adjudication" is essentially the determination of whether the device's performance metrics meet the specified quantitative and qualitative requirements of the applicable international standards. This is typically done by qualified laboratory personnel and regulatory reviewers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This submission is for a physical medical device (hypodermic needle), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI assistance improvement are not relevant.

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

Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective adherence to internationally recognized consensus standards and validated test methods. This includes:

• Quantitative measurements: e.g., bond strength, dimensions, chemical residue levels (Ethylene Oxide).
• Qualitative biological responses: e.g., absence of cytotoxicity, sensitization, hemolysis.
• Sterility levels: Demonstrated by achieving a specific Sterility Assurance Level (SAL).

The ground truth is not subjective expert consensus on interpretations but rather the objective compliance with predefined, measurable criteria.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML algorithm that requires a "training set."

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

Not applicable. This is not an AI/ML algorithm.

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