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The Sterile Disposable Syringe with Safety Needle is 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 needle sticks.

The Sterile Disposable Syringe with Needle is intended for use in the aspiration of fluids for medical purpose.

The Sterile Disposable Syringe is a sterile luer slip syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.

The Sterile Disposable Safety Needle is intended to be used with a luer slip or luer lock syringe for aspiration and injection 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 needlestick.

The Sterile Disposable Needle is intended to be used with a luer lock syringe for aspiration and injection of fluids for medical purpose.

The Sterile Disposable Syringe with Safety Needle is intended for manual and single use only, which consists of a hypodermic needle with a safety sheath attached to the needle hub and a luer slip or luer lock syringe. The proposed device is available in a variety combination of syringe volume and needle size. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Disposable Syringe with Needle is intended for manual and single use only, which consists of a hypodermic needle and a luer slip or luer lock syringe. The proposed device is available in a variety combination of syringe volume and needle size.

The Sterile Disposable Syringe is intended for manual and single use only, which consists of barrel, plunger and piston. The proposed device is available in a variety syringe volume. The syringe is available in luer slip and luer lock two connector types which are intended to be connected with a hypodermic needle.

The Sterile Disposable Safety Needle is intended for manual and single use only, which consists of a hypodermic needle with a safety sheath attached to the connector hub. The proposed device is available in variety combination of needle gauge and needle length. The proposed device is compatible for use with a luer slip or luer lock syringe. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Disposable Needle is intended for manual and single use only, which is compatible for use with a luer slip or luer lock syringe. The proposed device is available in variety combination of needle gauge and needle length.

The provided document describes the predicate devices and performance tests for Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, and Sterile Disposable Needle (K170651) manufactured by Yangzhou Medline Industry Co., Ltd.

Here's an analysis of the acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

The document details performance against various international standards rather than explicit acceptance criteria with numerical targets. However, the implicit acceptance criterion is compliance with the specified standard. The reported device performance is that the device meets or complies with these standards.

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

The document does not explicitly state the specific sample sizes used for each individual non-clinical performance test. It only indicates that "Non clinical tests were conducted to verify that the proposed device met all design specifications."

• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of performance and biocompatibility testing for medical devices, these would typically be prospective laboratory studies conducted by the manufacturer or contracted labs.

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

This information is not applicable in this context. The "ground truth" for the performance criteria of a medical device like a syringe and needle is established by the specified international standards (ISO, ASTM, USP) and FDA guidance documents. These standards define the verifiable physical, chemical, and biological properties expected of the device. There isn't a "ground truth" established by human experts in the same way as, for example, image interpretation in a diagnostic AI study. The tests themselves are designed to objectively measure properties against defined limits.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used when expert opinion is required to establish a gold standard or "ground truth" for subjective assessments, typically in clinical studies or when interpreting complex medical data. For objective performance testing against engineering and biological standards, the results are typically quantitative measurements or pass/fail determinations based on defined thresholds in the standards, not subject to expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical study is included in this submission." This type of study is usually for evaluating diagnostic devices or complex interventional systems where human interaction and interpretation are key.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical medical instrument (syringe and needle), not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept for this submission.

7. The Type of Ground Truth Used

As mentioned in point 3, the "ground truth" for this device is based on international standards and regulations. Specifically:

• Engineering Standards: ISO 7886-1, ISO 7864, ISO 9626, ISO 594-1, ISO 594-2 for various physical and mechanical properties.
• Packaging Standards: ASTM F88, F1140, F1929 for sterile barrier integrity.
• Sterilization Residue Standards: ISO 10993-7 for Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) residues.
• Biocompatibility Standards: ISO 10993-5, 10993-10, 10993-11, 10993-4 for various biological responses, and ASTM F756-13 for hemolysis.
• Pyrogenicity Standards: USP <151> and Bacterial Endotoxin Limits (USP 38-NF 33 <85>).
• FDA Guidance: "Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005" for the simulated clinical study of the safety mechanism.

8. The Sample Size for the Training Set

Not Applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not Applicable. As explained above, no training set was used for this device.

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