(85 days)
The intended use of the Patient Safe Syringe™ is to aspirate fluid and inject fluids into the body. Additionally, the unique design of the syringe protects the luer tip from contact contamination prior to injection, thus reducing the risk of medication contamination and bloodstream infections resulting from luer tip contamination.
The Patient Safe Syringe™ is a 3 piece piston syringe consisting of a calibrated hollow barrel and a movable plunger with a plunger seal. One end of the barrel has a male connector (nozzle) which permits attachment to a female (hub). The collar on the luer end is slightly extended to protect and prevent contact contamination of the luer tip and is compatible with most luer fittings.
Here's an analysis of the provided text regarding the Patient Safe Syringe™, focusing on acceptance criteria and study details.
Important Note: The provided document is a 510(k) summary, which is a premarket notification for a medical device. These summaries typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed standalone performance studies with specific acceptance criteria as might be found for novel technologies or software. This particular document makes no mention of AI or machine learning.
The document emphasizes a comparison to a predicate device and states that "The manual operation, similar design and identical materials between the predicate device and the subject device do not raise new issues of safety and effectiveness." This strongly suggests that a formal study with quantitative acceptance criteria, in the way one might expect for a diagnostic or AI device, was not conducted or is not necessary for this type of submission. The focus is on the design change (the collar) and its protective function.
Acceptance Criteria and Device Performance (Based on provided text)
Given the nature of the 510(k) summary for a piston syringe and the lack of specific performance quantitative metrics, the "acceptance criteria" are implied by the claim of substantial equivalence and the intended benefit of the design change.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied from comparison) |
|---|---|
| Safe and Effective for fluid aspiration and injection. | Functions equivalently to the predicate Nipro Disposable Syringes (K030683) for fluid aspiration and injection, due to similar design, manual operation, and identical materials. |
| Protects the luer tip from contact contamination prior to injection. | The unique design of the collar at the luer end is described as "slightly extended to protect and prevent contact contamination of the luer tip." |
| Reduces the risk of medication contamination and bloodstream infections from luer tip contamination. | The design change is stated to "thus reducing the risk of medication contamination and bloodstream infections resulting from luer tip contamination." This is presented as an intended benefit of the luer tip protection, rather than a quantitatively proven outcome from a clinical study within this submission. |
| Does not raise new issues of safety and effectiveness compared to the predicate device. | The submission explicitly states: "The manual operation, similar design and identical materials between the predicate device and the subject device do not raise new issues of safety and effectiveness." |
Study Details (Based on provided text)
The document does not describe a formal study with a test set, ground truth, experts, or statistical analysis in the way modern AI/ML device submissions would. The evaluation appears to be based on design comparison and engineering principles rather than clinical trials or reader studies.
- Sample size used for the test set and the data provenance: Not applicable. No test set or associated data is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No expert review or ground truth establishment for a test set is described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication method is described.
- 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 mechanical piston syringe; there is no AI component or human-in-the-loop performance measurement.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm or software component.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No formal ground truth for a performance study is described. The "ground truth" for this submission is essentially the predicate device's established safety and effectiveness, and the engineering rationale for the modification.
- The sample size for the training set: Not applicable. No training set is mentioned as there is no AI/ML component.
- How the ground truth for the training set was established: Not applicable. No training set or ground truth establishment is mentioned.
§ 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).