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510(k) Data Aggregation
(293 days)
EWNLTM Safety Syringe with Needle (1mL, 2 mL, 3 mL, and 10 mL) is a sterile, single-use, disposable and non-reusable manual retractable safety svringe, intended for medical purposes for injection of fluids into the body, while reducing the risks of sharps injuries and the potential for syringe reuse. This syringe is intended to be used by nurse, clinicians, or professional healthcare providers only.
EWNL " Safety Syringe with Needle is a sterile, single-use, disposable, non-reusable, manual retractable safety syringe provided with needle. EWNL™ Safety Syringe is intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. The device is intended for injection of fluids into, or withdrawal from, the body. The function of EWNL " Safety Syringe works the same as a conventional hypodermic syringe except for its ability to retract the contaminated needle inside the syringe barrel after the injection. Needle retraction is activated manually by the syringe user. The device also features a destructible plunger, which can be pulled back, snapped off, and the entire unit disposed of after the needle is locked inside the syringe barrel. With this sharps injury prevention design, the svringe user is protected from accidental needle sticks.
The provided 510(k) summary (K132557) describes the EWNL™ Safety Syringe with Needle, a sterile, single-use, disposable, and non-reusable manual retractable safety syringe. The submission aims to demonstrate substantial equivalence to predicate devices (K022806 and K034031) based on similarities in intended use, operating principle, device design, and technological characteristics.
The information regarding the acceptance criteria and the study proving the device meets these criteria is presented below, extracting the available details from the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standards Conformed To) | Reported Device Performance |
|---|---|
| ISO 7864 (Sterile hypodermic needles for single use) | Implied compliance, as the device is deemed substantially equivalent and meets the same acceptance criteria as predicate devices which would conform to this standard. |
| ISO 594 (Conical fittings with a 6 % (Luer) taper for syringes, needles, and certain other medical equipment) | Implied compliance, as the device is deemed substantially equivalent and meets the same acceptance criteria as predicate devices which would conform to this standard. |
| ISO 7886-1 (Sterile hypodermic syringes for single use) | Implied compliance, as the device is deemed substantially equivalent and meets the same acceptance criteria as predicate devices which would conform to this standard. |
| ISO 10993 series (Biological evaluation of medical devices) | Conforms (Biocompatibility) |
| ISO 11135-1 (Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices) | Conforms (Sterilization) |
| FDA Guidance (Specific to safety syringes) | Conforms (General compliance with FDA expectations) |
| Prevention of sharps injuries | Simulated clinical test results indicate "no sharps injuries." |
| Prevention of safety mechanism failures | Simulated clinical test results indicate "no failures of the safety mechanism occurred." |
| Functional performance | "Positive responses" from study participants regarding functional performance aspects. |
| Physical specification | Conforms to applicable standards for physical specifications. |
| Chemical specification | Conforms to applicable standards for chemical specifications. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for the "simulated clinical test."
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as a "simulated clinical test," implying it was conducted as part of the device's validation. It is prospective in nature as it's testing the device's performance directly.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the given summary. The "simulated clinical test" refers to evaluating the device's performance in preventing sharps injuries and mechanism failures, and obtaining user feedback. It does not mention a 'ground truth' in the context of expert consensus on diagnostic interpretations as one would find in AI/CAD systems.
4. Adjudication Method for the Test Set
This information is not applicable as the "simulated clinical test" described is not a diagnostic interpretation study requiring adjudication of expert readings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted. This type of study is typically done for diagnostic AI devices to compare human reader performance with and without AI assistance. The EWNL™ Safety Syringe is a physical medical device (syringe), not a diagnostic AI tool.
6. If a Standalone Study Was Done
The simulated clinical test described evaluates the device's performance on its own, without human-in-the-loop assistance for a diagnostic purpose. So, in the context of a physical device's function, a standalone performance evaluation was done to assess its safety mechanism and functional performance.
7. The Type of Ground Truth Used
For the "simulated clinical test":
- Safety Mechanism: The ground truth for sharps injury prevention and mechanism failure would be the direct observation of events (occurrence of sharps injuries, or failure of the retraction mechanism) during the simulated clinical use.
- Functional Performance: The ground truth was established through user feedback/positive responses from study participants, indicating satisfactory functionality.
8. The Sample Size for the Training Set
This information is not applicable. The EWNL™ Safety Syringe is a physical medical device, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for a physical medical device like a safety syringe.
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