(109 days)
The BeTeC Retractable Safety Syringe (5ml) is designed as an anti-stick syringe to aid in the prevention of sharps injuries and the potential for syringe reuse and is a single use, disposable and manual retractable safety syringe which is intended for injection of medical fluids into or withdraw from the body.
The BeTeC Retractable Safety Syringe is sterile, single-use, disposable, Non-reusable, Manual , Retractable, 5ml Piston Syringe, provided with or without needle, which is used for injection of fluids into or withdraw from the body. (Only use needle 11/2" or shorter, 21-28 gauge) The BeTeC Retractable Safety Syringe consists of the following major components :barrel, plunger, plunger ring, nozzle, nozzle ring, needle cap, needle + needle hub.
The provided 510(k) summary for the BeTeC Retractable Safety Syringe (5ml) does not present a typical "acceptance criteria and study" format as would be seen for complex diagnostic or AI-driven medical devices. This submission pertains to a Class II medical device (a piston syringe), and the regulatory pathway often focuses on demonstrating substantial equivalence to a predicate device through adherence to recognized standards and basic bench testing, rather than complex clinical trials with statistical endpoints.
Based on the provided text, here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the device "conforms to applicable standards." However, it does not provide specific quantitative acceptance criteria (e.g., minimum tensile strength, maximum leakage rate) alongside reported performance values. Instead, it broadly states adherence to various ISO and USP standards.
| Acceptance Criteria Category | Applicable Standards Reported in 510(k) Summary |
|---|---|
| Physical Specification | ISO 7864 |
| ISO 7886-1 | |
| ISO 11607-1 | |
| Chemical Specification | ISO 10993 series (likely parts related to material safety and biocompatibility) |
| Biological Specification | ISO 10993 series (likely parts related to biocompatibility) |
| USP Pyrogenic standards | |
| Sterilization Specification | ISO 11135 |
| Other | Related standards (not specified in detail) |
Reported Device Performance:
The document does not list specific quantitative performance values achieved by the BeTeC Retractable Safety Syringe for comparison against detailed acceptance criteria. It instead makes a general statement: "the device conforms to applicable standards." The conclusion states that "bench testing contained in this submission and clinical testing supplied demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness." This implies that the device met the requirements of the listed standards and demonstrated comparable safety and effectiveness to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated. The document refers to "bench testing" and "clinical testing" but does not provide the number of devices or subjects included in these tests.
- Data Provenance: Not explicitly stated. "Bench testing" would typically be performed in a laboratory setting. "Clinical testing supplied" is mentioned, but details on location or whether it was retrospective or prospective are absent. Given the device type, "clinical testing" might refer to user performance studies (e.g., ease of use, successful retraction) rather than a large-scale clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not applicable and not provided. For a syringe, "ground truth" as you would define it for an AI/diagnostic device (e.g., confirmed disease state) is not relevant. The "ground truth" for a mechanical device is its adherence to engineering specifications and performance standards through testing.
4. Adjudication Method for the Test Set:
- Not applicable and not provided. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers/experts when establishing ground truth, which is not the case for evaluating a mechanical syringe.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
-
No, an MRMC comparative effectiveness study was not reported or conducted for this device. This type of study is relevant for diagnostic devices that involve interpretations by human readers.
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Effect Size of Human Readers Improve with AI vs. without AI assistance: Not applicable, as this is not an AI-assisted device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- Not applicable, as this is a mechanical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used:
- The "ground truth" for this device's evaluation would be defined by engineering specifications, recognized international and national standards (ISO, USP), and documented performance criteria. The device is deemed safe and effective if its performance during testing meets these established benchmarks.
8. The Sample Size for the Training Set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI. The design and manufacturing processes are based on established engineering principles and prior knowledge of syringe design.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no "training set" for this type of medical device.
Summary of the Study:
The "study" presented in this 510(k) notification is primarily a comparative evaluation against a predicate device and adherence to recognized performance standards, rather than a clinical trial.
- Comparison to Predicate: The key part of the study is demonstrating "substantial equivalence" to the TMD™ Safety Syringe (FA13 Series 5ml) (K022278). This involves showing that the BeTeC device has the same intended use and similar technological characteristics, and that any differences do not raise new safety or effectiveness concerns.
- Bench Testing: The submission includes "bench testing," which refers to laboratory tests conducted to evaluate physical, chemical, biological, and sterilization properties of the syringe against applicable standards (ISO 7864, ISO 7886-1, ISO 10993 series, ISO 11607-1, ISO 11135, USP Pyrogenic standards). These tests would confirm aspects like:
- Dimensional accuracy
- Leakage prevention
- Plunger force
- Needle hub attachment strength
- Biocompatibility of materials
- Sterility assurance
- Functionality of the retraction mechanism
- Clinical Testing: The document mentions "clinical testing supplied," which, in the context of a syringe, would typically involve human factors or usability studies to ensure the device performs as intended for its "anti-stick" and "retractable" features, and is safe and easy for users to operate. It would likely involve observing healthcare professionals using the syringe to ensure the retraction mechanism activates reliably post-use, preventing needlestick injuries and reuse.
Conclusion:
The 510(k) summary focuses on demonstrating that the BeTeC Retractable Safety Syringe is substantially equivalent to a legally marketed predicate device by conforming to established industry standards through bench and implied clinical (usability/performance) testing. It does not contain the detailed, quantitative acceptance criteria or study methodologies typically expected for AI-driven or highly complex diagnostic devices.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).