(120 days)
The Terumo Syringe for administration of UV sensitive medicines is a sterile hypodermic syringe for single use, intended for the aspiration of fluids and blood, or for the injection of fluids immediately after filling. The opaque color of the barrel allows the administration of UV sensitive medicines.
The Terumo Syringe for administration of UV sensitive medicines is a hypodermic standard piston syringe, available in 20 ml volume, with an eccentric luer taper tip for single use, made of plastic material and a synthetic rubber gasket. The barrel of the syringe has an opaque color to avoid the transmission of UV light.
The provided text is a 510(k) Summary for a medical device (Terumo® Syringe for administration of UV sensitive medicines), not a study report. It describes the device, its intended use, and claims substantial equivalence to a predicate device.
Therefore, the document does not contain the detailed information necessary to complete the requested table and answer the study-specific questions.
Here's why and what information is available:
What the document does provide:
- Acceptance Criteria Mention: The document states, "The Terumo syringe was tested in accordance with EN ISO 7886-1 (1997). Other testing included barrel transmission and UV protection of the opaque barrel." This indicates that EN ISO 7886-1 (1997) standards and specific tests for barrel transmission and UV protection served as acceptance criteria. However, the specific quantitative criteria (e.g., minimum UV blockage percentage, specific values for plunger force, leakage, etc., as defined by the standard) and the results against those criteria are not provided in this summary.
- Device Performance Mention: It generally states, "None of the data raises any new issues of safety and effectiveness." and implicitly, "the opaque color of the barrel allows the administration of UV sensitive medicines," suggesting successful performance in UV protection. However, no specific metrics of performance (e.g., "99% UV blockage") are given.
- Intended Use: Clearly stated.
- Description & Materials: Clearly stated.
- Sterility Assurance: Methods used (EN 550, ISO 11135, SAL 10^-6, EN 556-1) and compliance with residual levels (ISO 10993-7) are mentioned.
- Biocompatibility: Confirmed by testing according to FDA G95-1 and ISO 10993-1.
- Expiration Dating: Established at 5 years.
Why the requested table and many questions cannot be answered from this text:
The 510(k) Summary is a high-level document to demonstrate substantial equivalence, not a detailed technical report of every study performed. The specifics of the "acceptance criteria" and "reported device performance" are summarized or referenced rather than explicitly detailed with quantitative data.
Therefore, I cannot fill out the table or answer questions about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided 510(k) summary.
In summary, the document states that performance testing was done against certain standards, but does not provide the results of that testing or the specific details of the study design.
§ 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).