(251 days)
The Uroject 12 Syringe Lever Device is intended for use in the administration of sterile materials under aseptic conditions, in a clinical urology setting, by a clinician and in accordance with the best judgment of a physician.
The Uroject12 Syringe Lever body contains syringe housing for holding a standard 20 mL syringe and a dispensing mechanism that is manually operated by rotating a knob that presses the syringe piston. A clutch mechanism facilitates fast adaptation of the injection mechanism to the syringe piston position. The Uroject12 Syringe Lever is a reusable, reprocessed device to be sterilized before each use and cleaned after use.
The compatible syringes to be used with the Uroject12 are: 20 mL MEDALLION® syringe (Catalog Number MSS121, Merit Medical, Salt Lake City, UT, USA) and 20 mL MEDALLION® COP syringe (Catalog Number COP121PC, Merit Medical, Salt Lake City, UT, USA).
Here's an analysis of the provided text regarding the Uroject12 Syringe Lever, extracting information about its acceptance criteria and the study proving it meets them.
It's important to note upfront that this document is an FDA 510(k) K180345 clearance letter and summary for a medical device, not an AI/ML medical device. Therefore, the questions related to AI/ML specific aspects like "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e., algorithm only without human-in-the-loop performance)," "training set," and "ground truth for the training set" are not applicable to this submission. This document describes a physical medical device (a syringe lever) and its performance through bench testing, not an AI algorithm.
Acceptance Criteria and Study Proving Device Meets Criteria
The document focuses on demonstrating the substantial equivalence of the Uroject12 Syringe Lever to a predicate device through performance data from bench testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Criterion | Reported Device Performance |
|---|---|---|
| Functional Performance | Instillation Pressure and Force Testing | "Demonstrated through testing" (Specific values not provided in this summary) |
| Extreme Dispensing Resistance Testing | "Demonstrated through testing" (Specific values not provided in this summary) | |
| Residual Volume Testing | "Demonstrated through testing" (Specific values not provided in this summary) | |
| Clutch Mechanism Functionality Testing | "Demonstrated through testing" (Specific values not provided in this summary) | |
| Lifetime Functionality Testing | "Demonstrated through testing" (Specific values not provided in this summary) | |
| Reprocessing & Sterilization | Cleaning Validation | Validated in accordance with AAMI TIR30:2011 |
| Sterilization Validation | Demonstrated a sterility assurance level (SAL) of |
§ 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).