Search Results

The MySafety Syringe is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe re-use and is a single use, disposable and retractable safety syringe which is intended for injection of medical fluids into the body.

The submitted device MySafety Syringe is a 1cc / ml size, sterile, single-use, disposable, non-reusable, needle-retractable, piston syringe, provided with an attached needle , which is intended for the injection of medication into a patient, while minimizing the potential for accidental injury as a result of needle-stick ( sharps injury) and preventing syringe reuse. The submitted device MySafety® Syringe works like a conventional hypodermic syringe except for its ability to retract the used needle inside the syringe barrel at the end of injection. The needle retraction mechanism is activated as the following. "After injection is completed, remove the syringe from patient's body, add pressure to the plunger by pushing the plunger further ahead with one hand till you hear a clear audible "click" sound and you see the needle fully retracted into the syringe barrel."

The provided text describes a 510(k) summary for the "MySafety® Syringe" and demonstrates its substantial equivalence to a predicate device, rather than outlining a study with specific acceptance criteria and detailed device performance metrics in the way a clinical trial for a novel AI device might.

Based on the provided information, here's an analysis of the acceptance criteria and how the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by conformance to established standards and demonstrated "substantial equivalence" to a predicate device. The performance is not reported in quantitative metrics against specific acceptance thresholds but rather by stating that the device conforms to these standards and shares technological characteristics with the predicate.

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

This is not applicable in the context of this 510(k) summary. The submission is for a medical device (a syringe), not an AI algorithm. The performance evaluation relies on conformance to engineering and biological standards, and demonstration of substantial equivalence to a previously cleared device, rather than a clinical "test set" in the way an AI study would use. The testing described would typically involve laboratory tests on batches of devices, not clinical data from patients.

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

Not applicable. This information is relevant for AI image analysis or diagnostic studies where expert consensus establishes clinical ground truth. For a physical medical device like a syringe, "ground truth" is established through adherence to technical standards and physical/material property testing.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation, often clinical AI studies, to resolve discrepancies in expert opinions. This is not relevant for the type of device and submission described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI device. The submission describes a safety syringe.

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

Not applicable. This is not an AI device.

7. The Type of Ground Truth Used

The "ground truth" for this medical device is established by:

• Conformance to International and National Standards: These standards (e.g., ISO for biological evaluation, sterile hypodermic syringes, packaging, risk management, etc., and USP for pyrogen testing) define acceptable limits and performance characteristics.
• Demonstrated Equivalence to a Predicate Device: The predicate device (K051800 - "IN6 SAFETY SYRINGE MODEL 3ML") has already been determined by the FDA to be safe and effective. The new device is shown to have the same intended use, technological characteristics, and performance, thereby leveraging the predicate's established "ground truth" of safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

Summary of the Study Proving Acceptance Criteria:

The "study" proving the device meets its acceptance criteria is a Substantial Equivalence demonstration to a legally marketed predicate device (K051800) combined with conformance testing to relevant international and national standards.

• Rationale: The manufacturer, MedicalChain International Corp., is seeking 510(k) clearance for the MySafety® Syringe by demonstrating its "substantial equivalence" to its own previously cleared device, the "IN6 SAFETY SYRINGE MODEL 3ML" (K051800).
• Methodology:
  • Comparison of Characteristics: The submission highlights that the MySafety® Syringe has the same intended use, technological characteristics, materials, and fundamental scientific technology as the predicate device. The only stated difference is the capacity of volume (1cc/ml vs. 3cc/ml).
  • Conformance to Standards: The device underwent testing to ensure compliance with a comprehensive list of standards covering physical specifications (e.g., ISO 6009, 7864, 7886-1, 9626), biological evaluation (e.g., ISO 10993 series, USP Pyrogen Test), packaging, sterilization (e.g., ISO 11135-1, 11607-1), risk management (ISO 14971), and labeling (ISO 15223-1). These tests were conducted by a 3rd party test laboratory, TüV SüD PSB Pte Ltd.

In essence, the "study" is a regulatory submission process that demonstrates through comparative analysis and standard conformance testing that the new device is as safe and effective as a device already on the market, rather than a novel clinical trial for a new technology or AI algorithm.

Ask a specific question about this device