(281 days)
A device intended for medical purposes used to inject fluids into, or withdraw fluids from, the body that consists of a calibrated hollow barrel and a movable plunger. At one end of barrel there is a needle.
Not Found
The provided document is an FDA 510(k) clearance letter for the device "PenetrEase" (later clarified as "PenetrEase Syringes and Needles"). This document primarily focuses on the regulatory clearance of a medical device based on substantial equivalence to a predicate device, as opposed to a detailed clinical study report proving specific performance acceptance criteria.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, such as:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or training set details.
- The type of ground truth used.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."
This indicates that the clearance is based on a comparison to existing, legally marketed devices, rather than a clinical study establishing new performance metrics against predefined acceptance criteria. The "Indications for Use" section (Attachment 1, Page 3) describes the intended purpose of the device (injecting or withdrawing fluids) but does not provide performance metrics or acceptance criteria.
To answer your request, a different type of document, such as a clinical study report, a design verification and validation report, or specific performance testing documentation, would be needed.
§ 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).