(110 days)
The intended function of the SECUREGARD® Retractable Safety Syringe is to provide a safe and reliable method of intramuscular and subcutaneous injection of medication into a patient. The syringe should not be used for blood collection. The SECUREGARD® Retractable Safety Syringe is also intended to prevent needle stick injuries. In addition, when the syringe user breaks the plunger, reuse of the syringe is prevented.
The SECUREGARD is a sterile, single-use, disposable hypodermic syringe with sharps injury and reuse prevention features. It is manufactured in sizes of 0.5, 1, 2, 2.5, 3, 5, 10 and 20 mL volume.
The provided document is about the SECUREGARD® Retractable Safety Syringe and describes its safety and effectiveness. However, it does not contain acceptance criteria or details of a study that proves the device meets specific acceptance criteria in the format requested.
The document is a 510(k) summary (K012121) from October 24, 2201, which primarily focuses on demonstrating substantial equivalence to a predicate device (SOLOGARD® Locking Plus Syringe).
Here's what can be extracted and why other requested information is not available in the provided text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sharps injury prevention feature: Easily and safely activated by the user. | "The sharps injury prevention feature was demonstrated to be easily and safely activated by the user." |
| Sharps protection feature: Effectively shields the needle. | "the needle was effectively shielded by the sharps protection feature." |
| Reuse prevention: Plunger breaks when user breaks it. | "when the syringe user breaks the plunger, reuse of the syringe is prevented." |
Critique: These are more descriptive statements of functionality rather than quantitative "acceptance criteria" with specific thresholds (e.g., "95% of users can activate safety feature within X seconds" or "needle fully retracted in Y% of uses").
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document states that the safety and effectiveness were "demonstrated" but does not specify how (e.g., in a formal study) or the sample size, data provenance, or study design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not provided. This type of information is not relevant for a mechanical device like a syringe and is not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided. Not applicable as no formal expert adjudication process is described for this type of device.
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 device is a retractable safety syringe, not an AI-powered diagnostic tool. Therefore, an MRMC study and AI performance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the functional claims, the "ground truth" implicitly relies on direct observation or testing of the syringe's physical operation by undefined evaluators. There is no mention of pathology, expert consensus, or outcomes data in the context of proving the safety features.
8. The sample size for the training set:
- Not applicable. This is a mechanical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI model.
In summary: The provided text is a regulatory submission for a medical device (syringe) focused on demonstrating substantial equivalence to a legally marketed predicate. It reports on the device's functional characteristics related to safety (sharps injury and reuse prevention) but lacks the detailed experimental design, acceptance criteria, and performance metrics typically found in a study report for more complex diagnostic or AI-driven 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).