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The Retractable Safety Insulin Syringe is a sterile, single use, disposable and non-reusable, automatically retractable safety insulin syringe intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.

The Retractable Safety Insulin Syringe has the same technological characteristics as the Retractable Safety Syringe(manufacture by Jiangsu Caina Medical Co., Ltd.) as cleared in K191490 at date 2019/10/03. The difference between the Retractable Safety Insulin Syringe and the 1ml Retractable Safety Syringe is only the scale.

The Retractable Safety Insulin Syringe works like a conventional insulin syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe plunge, the syringe user is protected from accidental needle sticks. These accidental needle sticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.

The Retractable Safety Insulin Syringe is available in various specifications. The proposed device consists of eleven components: (1) plunger. (2) piston. (3) barrel. (4) needle cap. (5) sealing plug. (6) slide bushing, (7) needle tube, (8) spring, (9) plunger lid, (10) barrel barb, (11) hub.

The proposed device is provided sterile. The product is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.

The provided text is a 510(k) Summary for a Retractable Safety Insulin Syringe (proposed device) and focuses on demonstrating its substantial equivalence to a predicate device (U&U Insulin Syringe with/without Safety Retractable Device). The acceptance criteria and supporting study details provided are primarily non-clinical, comparing the proposed device against established standards and to the predicate.

Here's the information extracted and organized as requested, with "N/A" where the document does not provide the specific detail, indicating it was likely not part of this specific submission or the type of device.

Table of Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: Not explicitly stated for each test, but standard test methods (e.g., ISO, ASTM) typically specify lot sizes or sample numbers for compliance testing. The provided values for force measurements (e.g., 10.48-20.91 N) are ranges, suggesting multiple units were tested.
   • Data Provenance: The tests were non-clinical, conducted by the manufacturer (Jiangsu Caina Medical Co., Ltd., China) as part of their substantial equivalence submission. The studies are by nature prospective tests performed on the manufactured device.

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

   • Number of Experts: N/A. This was a non-clinical device performance and materials testing study, not a study involving expert human interpretation or ground truth establishment in a clinical sense (e.g., image-based diagnosis). The "ground truth" here is compliance with established international and national standards for medical devices and their components.
   • Qualifications of Experts: N/A. The compliance is assessed by technical testing, not expert consensus on interpretations.

3. Adjudication Method for the Test Set:

   • Adjudication Method: N/A. As a non-clinical, standards-based compliance study, there was no "adjudication" in the sense of reconciling differing expert opinions. Test results are objective measurements against predefined criteria.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • MRMC Study: No. The document explicitly states: "Simulated clinical study was not conducted on proposed device," and "No clinical study is included in this submission." This type of study is common for diagnostic AI, not for a mechanical medical device like a syringe.
   • Effect Size of Human Readers Improvement: N/A, as no MRMC study was performed.

5. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done:

   • Standalone Performance: N/A. This device is a mechanical syringe, not an algorithm. The "performance" discussed is the mechanical, biological, and material compliance of the device itself.

6. The Type of Ground Truth Used:

   • Ground Truth: The ground truth for this device's acceptance is adherence to established international and national standards (e.g., ISO, ASTM, USP) for the performance, safety, and biocompatibility of syringes and their components, as well as comparison to a legally marketed predicate device. For example, the "ground truth" for "Force to activation" is that it must be

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