(332 days)
The Small Volume Syringe is a 200 µl syringe used to inject fluids into, or withdraw fluids from, the body, ports and I.V. lines.
The syringe consists of three main parts: one barrel, one plunger and one stopper. The barrel is made from clear polycarbonate and is designed with printed graduation marks ranging up to 200 ul and a Luer-Lok™ end. The plunger is also made from clear Polycarbonate. The stopper is manufactured using grey or other dark colored non-latex based rubber. The printed graduation marks facilitate appropriate and accurate volume control for the dispensing and containment of fluid by manually application of pressure. The syringe is individually packaged in a flexible package with a peel-away cover that allows the syringe to remain sterile until opened.
This is a 510(k) premarket notification for a medical device (syringe), not an AI/ML software. Therefore, the requested information about acceptance criteria, study details, expert involvement, and AI performance metrics is not applicable to this document.
However, I can extract the safety tests and standards the device aims to comply with, which serve a similar purpose to "acceptance criteria" for traditional medical devices.
Table of Acceptance Criteria (Compliance with Standards) and Reported Device Performance
| Acceptance Criteria (Standard to Comply With) | Reported Device Performance |
|---|---|
| ISO 7886, Sterile Hypodermic Syringes for Single Use | Safety tests will demonstrate compliance with applicable requirements. Materials used are the same as other currently marketed piston syringes. Device is provided sterile and intended for single use. |
| ISO 7864, Sterile Hypodermic Needles for Single Use | Safety tests will demonstrate compliance with applicable requirements. Materials used are the same as other currently marketed piston syringes. Device is provided sterile and intended for single use. |
| ISO 594, Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment | Safety tests will demonstrate compliance with applicable requirements. Materials used are the same as other currently marketed piston syringes. Device is provided sterile and intended for single use. |
| ISO 8537, Sterile, Single-Use Syringes, with or without Needle, for Insulin | Safety tests will demonstrate compliance with applicable requirements. Materials used are the same as other currently marketed piston syringes. Device is provided sterile and intended for single use. |
| ANSI/AAMI/ISO 11137:2006, Sterilization of Healthcare Products -Requirements for Validation and Routine Control - Radiation Sterilization | Safety tests will demonstrate compliance with applicable requirements. The device will be sterilized by gamma irradiation using validated processes to provide a Sterility Assurance Level (SAL) of 10-6. Materials used are the same as other currently marketed piston syringes. Device is provided sterile and intended for single use. |
Additional Information from the Document (where applicable in a traditional medical device context):
- Sample size and data provenance: Not applicable. The document describes compliance with standards and materials used, not a study involving patient data.
- Number of experts and qualifications: Not applicable. This refers to engineering and quality assurance testing against established standards.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone performance: Not applicable.
- Type of ground truth: The "ground truth" here is the set of established engineering and safety standards (e.g., ISO 7886) that the device must meet through testing.
- Sample size for training set: Not applicable (no AI/ML training involved).
- How ground truth for training set was established: Not applicable (no AI/ML training involved).
The document is a regulatory filing for a conventional medical device (syringe) seeking substantial equivalence to a predicate device. It focuses on demonstrating compliance with recognized safety and performance standards for such devices.
§ 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).