(103 days)
The Nipro Disposable Syringe is intended to inject fluids into or withdraw fluids out of the body.
The NIPRO Disposable syringe is a piston syringe consisting of graduated barrel, plunger rod, gasket and nozzle tip cap. Its function is mechanical and it is intended to inject fluids into or withdraw fluids out of the body. The syringe is sterile, single to only, non-toxic, non-pyrogenic and sterilized by Gamma radiation.
The provided text describes a 510(k) summary for the NIPRO® Disposable Syringe. It outlines the device's purpose, materials, and intended use, and states that non-clinical tests were submitted to demonstrate substantial equivalence to a predicate device (K944355). However, the document does not contain specific acceptance criteria, reported device performance metrics, or details of a study that explicitly proves the device meets such criteria.
The submission focuses on establishing substantial equivalence based on what the device is and that it performs similarly to a predicate, rather than providing quantitative performance data against defined thresholds.
Therefore, many of the requested details about acceptance criteria, study methodologies, and performance metrics cannot be extracted from this document, as they are not present.
Here's a breakdown of what can be inferred or directly stated from the provided text, and what is missing:
Acceptance Criteria and Study to Prove Device Meets Criteria
1. A table of acceptance criteria and the reported device performance
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Acceptance Criteria: Not explicitly stated in the provided text. The submission focuses on demonstrating "substantial equivalence" to a predicate device (NIPRO® Disposable Syringe K944355). This implies that the 'acceptance criteria' are implicitly tied to performing similarly to the predicate in terms of "intended use, materials of construction, labeling, and overall performance characteristics," but no specific quantitative thresholds are given.
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Reported Device Performance: Not explicitly detailed with quantitative metrics. The document states:
"Biocompatibility data, performance testing and comparison testing with the predicate are included in this submission and demonstrate substantial equivalence."
"The results of the performance testing and the comparison of technological characteristics demonstrate that the NIPRO® Disposable Syringe Gamblegical characteristics device and is a from and ff device and is safe and effective when used as intended."This indicates that performance testing was done, but the results (e.g., specific measurements, values) are not reported in this summary.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable as the device is a simple mechanical piston syringe, and the "ground truth" concept (e.g., for diagnostic accuracy) does not apply in the same way it would for an AI/diagnostic device. Performance testing likely involved engineering and quality control assessments against recognized standards or internal specifications, rather than expert-derived ground truth. No experts for ground truth establishment are mentioned.
4. Adjudication method for the test set
- Not applicable for this type of device and submission.
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/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an AI/diagnostic device.
7. The type of ground truth used
- Given the device is a piston syringe, "ground truth" would likely be established through engineering specifications, material standards, and functional performance benchmarks (e.g., fluid delivery accuracy, plunger force, seal integrity, sterility, non-pyrogenicity, non-toxicity). The document mentions "Biocompatibility data" and "performance testing," which would relate to these types of ground truths, but specific methods are not detailed.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that uses training sets.
9. How the ground truth for the training set was established
- Not applicable.
Summary of available information:
The provided 510(k) summary for the NIPRO® Disposable Syringe (Gamma) confirms that:
- The device is a piston syringe for injecting or withdrawing fluids.
- It is sterile, single-use, non-toxic, non-pyrogenic, and sterilized by Gamma radiation.
- The applicant performed "Biocompatibility data, performance testing and comparison testing with the predicate" (NIPRO® Disposable Syringe K944355) to demonstrate substantial equivalence.
- The conclusion is that the device is "safe and effective when used as intended."
However, the detailed quantitative results of these tests, specific acceptance criteria (beyond "substantial equivalence"), sample sizes, and methodologies for establishing ground truth (in the context of advanced diagnostic or AI systems) are not present in this document. This level of detail is typically found in the full submission, not in the publicly available 510(k) summary.
§ 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).