(240 days)
The Nipro Disposable Syringes are intended for use to inject fluids into or withdraw fluids from the body.
The subject devices can be classified as piston syringes as described in 21 CFR 880.5860. Among the syringe types described here are: flat-head; circular irrigation syringes; and, screw nozzle syringes. Various sizes are described including: 1, 2, 2.5, 3, 5, 10, 20, 30, 50, and 100 milliliters.
The provided text describes a 510(k) premarket notification for Nipro Disposable Syringes (K030683). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics of the new device itself.
Therefore, the information required to populate the table and answer the study-related questions is not present in the provided text. The document states that "Performance tests demonstrated that the devices are substantially equivalent," but it does not elaborate on these tests, their acceptance criteria, or the specific results.
Here's why the information is missing based on the nature of the document:
- 510(k) Summary: A 510(k) summary (or statement, as this appears to be part of) primarily aims to show that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technical characteristics and showing that any differences do not raise new questions of safety or effectiveness.
- Performance Tests Mentioned but Not Detailed: While "Performance tests demonstrated that the devices are substantially equivalent" is stated, the summary does not include the specifics of these tests, such as the actual criteria, methodologies, or outcomes. These details would typically be in a more comprehensive testing report submitted to the FDA, but not necessarily in the publicly available summary.
- Device Type: The device is a "Piston Syringe, Hypodermic, Single Lumen Syringe" and is classified as Class II. For such straightforward, well-understood devices, the "performance tests" likely refer to standard engineering and biocompatibility tests (e.g., sterilization validation, material strength, leakage, plunger force) that confirm it performs as expected for its intended use, rather than complex clinical studies involving human readers or AI algorithms.
Based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or AI-related metrics because this information is not included in the 510(k) summary.
If this were a submission for a sophisticated AI/ML-based device, the content would be vastly different and would include detailed clinical validation studies addressing these points.
§ 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).