(19 days)
The VACLOK Syringe is intended to be used by a cardiologist or radiologist during angiographic or radiologic procedures.
The Merit Vaclok Syringe is a polycarbonate piston syringe modified for the use in applications requiring vacuum.
The provided text is related to a 510(k) premarket notification for the "VACLOK Syringe." This document focuses on the substantial equivalence of the VACLOK Syringe to a previously cleared device (Merit Coronary Control Syringe) for its intended use, rather than presenting a study with acceptance criteria and measured device performance in the way clinical studies for diagnostic accuracy or performance efficacy would.
Therefore, the provided document does not contain the information required to answer your request about acceptance criteria and a study proving a device meets those criteria.
Here's why and what's missing:
- No Acceptance Criteria: The document explicitly states: "Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act." This means there were no predefined quantitative criteria (e.g., sensitivity, specificity, accuracy, mechanical failure rates, etc.) that the device needed to meet.
- No Performance Study Results: The document summarizes a substantial equivalence argument, which typically involves comparing the new device's design, materials, and intended use to a predicate device. It does not present results from a clinical or laboratory performance study that would measure specific metrics against acceptance criteria.
- No Information on Sample Size, Ground Truth, Experts, etc.: Because no performance study is described, there's no mention of sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
In summary, the provided text describes a regulatory submission for a Class II medical device based on substantial equivalence, not a performance study designed to demonstrate meeting specific acceptance criteria.
§ 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).