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This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries.

The p&p Safety Syringe consists of a calibrated hollow barrel (which can contain the medication) and the distal end of the barrel has Luer Lock Tip. The needle can be changed depending on the required gauge, since the syringe is compatible with general needles. The Safety Cap can be moved back and forth as safety feature. The safety cap has a printing mark "LOCK LINE". The adaptor is colored with medical grade blue pigment . The plunger and gasket are the same shape as the conventional syringes. When user gives the intramuscular/subcutaneous injection, he/she pushes the knob of the plunger to the end. After completing the intramuscular/ subcutaneous injection, the user turns the safety cap to the left side, and then pushes it forward until the marking ("LOCK LINE") on the safety cap touches the bottom line of the blue adaptor in order to lock the safety cap and the adaptor. The blue color of the adaptor allows the user to distinguish the locking position clearly and easily. Then the safety cap can no longer be moved back and forth, thus preventing needlestick injury. Then the syringe can be disposed in the appropriate sharps container. This is a simple and elegant design which is highly reliable.

The provided text describes a 510(k) submission for the "p&p Safety Syringe," seeking clearance based on substantial equivalence to a predicate device, the "SEZ safety syringe [K031163]". The document focuses on comparing the new device to the predicate device and does not contain detailed information about specific acceptance criteria or a dedicated study proving device performance against those criteria in a quantitative manner (e.g., sensitivity, specificity, accuracy, etc.) as might be found for a diagnostic algorithm.

Instead, the "clinical investigation" mentioned is likely a human factors study or a performance study designed to demonstrate that the safety mechanism of the p&p Safety Syringe functions as intended and is comparable to or better than the predicate device in terms of preventing needlestick injuries, as per guidance documents like "Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA."

Given the information provided, here's a breakdown, with acknowledgements of missing details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative targets (e.g., "must achieve X% reduction in needlestick injuries"). Instead, the primary "acceptance criterion" appears to be substantial equivalence to the predicate device, the SEZ safety syringe [K031163], in terms of:

• Intended Use: Identical clinical application (intramuscular and subcutaneous injections, prevention of needlestick injuries).
• Principle of Operation: While the mechanism of activation differs, the outcome (locking the needle to prevent injury) is equivalent. The provided text details the steps for each device's safety feature activation.
• Performance Characteristics:
  • Volume: 3ml/cc (Identical)
  • Nozzle type: Male conical lock fitting (Luer Lock Tip) with rotatable internally threaded neck, functionally equivalent to the predicate's female conical lock fitting with rotatable internally threaded neck for needle attachment.
  • Barrel Marking: Conforms to ISO7886-1:1993(E) (Identical)
  • Reuse: Non-reusable (Identical)
  • Biocompatibility: Conforms to ISO 10993-1 (Identical)
  • Materials: Identical (Polypropylene, thermoplastic rubber, Medipeel film, Ethypel paper)
  • Sterility: Sterilized by ethylene oxide gas, SAL = 10-6 (Identical)

The "reported device performance" is that "The results of the investigation showed that the p&p Safety Syringe is clinically acceptable" and "In all material respects, the p&p Safety Syringe is substantially equivalent to the predicate device." While not precise metrics, this is the reported performance against the overarching regulatory requirement of substantial equivalence.

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

The document mentions "A clinical investigation was performed," but does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information would typically be detailed in the full study report, which is not provided here.

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

This information is not provided in the document. For a medical device focused on safety features, "experts" might refer to healthcare professionals evaluating the ease of use and effectiveness of the safety mechanism.

4. Adjudication Method for the Test Set

This information is not provided.

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

No, an MRMC comparative effectiveness study in the context of diagnostic AI (e.g., radiologists interpreting images with and without AI assistance) was not done. This submission is for a physical medical device (safety syringe), not a diagnostic algorithm. The "clinical investigation" mentioned would likely involve observational studies or human factors assessments of the syringe's physical safety mechanism.

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

This question is not applicable as the device is a physical safety syringe, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for a safety syringe would primarily be established through:

• Experimental testing: Verifying the mechanical function of the safety lock (e.g., does it consistently lock, can it be easily unlocked unintentionally).
• Human factors evaluation/clinical observation: Assessing whether healthcare professionals can effectively activate the safety mechanism in a clinical setting and if it demonstrably reduces the risk of needlestick injuries.
• Comparison to predicate device performance: Demonstrating that the new device performs at least as well as a legally marketed device in preventing injuries.

The document states, "A clinical investigation was performed, and test for the comparison between p&p Safety Syringe and the legally marketed predicate device was performed in accordance with 'Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA'." This guidance would outline the expected methods to establish "ground truth" or evidence of effectiveness for such devices, which primarily relies on performance testing and potentially user studies to confirm the safety feature's efficacy.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical safety syringe and does not involve AI model training.

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

This question is not applicable as the device is a physical safety syringe and does not involve AI model training.

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