(447 days)
Qitexio Luer Lock Syringes are manual devices used to inject fluids into the body. They are also used for delivery of Lipiodol (Ethiodized Oil) Injection.
Medex, a subsidiary of Guerbet Group, designed and manufactures the Qitexio® Luer Lock Syringe, a disposable, handheld syringe available in 3 different volumes (1, 3 and 20 mL). Oitexio® Syringes are standard syringes which are verified to endure the potentially damaging chemical effects of Lipiodol® (Ethiodized Oil), an oil-based contrast media manufactured by Guerbet.
Qitexio® Luer Lock Syringes are manual devices used to inject fluids into the body. Qitexio® Syringes are also used for delivery of Lipiodol® (Ethiodized Oil) Injection.
They are single-use devices, sterilized by gamma radiation.
Standard five-piece piston syringe constructed with a clear hollow barrel into which is inserted a closely fitting movable plunger, O-Ring, rotative finger flange, and backstop. Fitting offered with male luer lock.
This document describes the premarket notification (510(k)) for the Qitexio Luer Lock Syringes, a medical device. The information provided heavily focuses on proving the substantial equivalence of the new device to a predicate device, the Merit Syringe (K173601).
The acceptance criteria for this type of device (a piston syringe) are primarily defined by conformity to established FDA recognized consensus standards and a battery of performance, biocompatibility, and sterilization tests. The document does not describe an AI/ML-driven device or study. Therefore, some of the requested information regarding AI/ML study design, such as MRMC studies, ground truth establishment for training sets, and expert adjudication, are not applicable to this submission.
Here's a breakdown of the acceptance criteria and proof, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For the Qitexio Luer Lock Syringes, acceptance criteria are generally met by demonstrating conformity to recognized consensus standards and by passing specific performance tests. The document repeatedly states that the device "complies with" or "met the established acceptance criteria" for these standards and tests. Specific numerical performance results are not provided in this summary, as is common for 510(k) summaries which focus on demonstrating equivalence rather than presenting raw data.
| Acceptance Criteria Category | Specific Criteria (Standard/Test) | Reported Device Performance |
|---|---|---|
| Performance Testing | ISO 7886-1 Sterile Hypodermic Syringes For Single Use - Part 1: Syringes For Manual Use | Complies; specific for Lipiodol® (Ethiodized Oil) Injection delivery. |
| ISO 80369-7 Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications | Complies. | |
| Functional performance testing (with preconditioning: double sterilization, accelerated/real-time aging) | Met established criteria; performs as intended. | |
| Biocompatibility | ISO 10993 Biological Evaluation of Medical Devices (Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Hemolysis, Material-Mediated Pyrogenicity, Chemical Characterization) | Non-toxic, biocompatible for intended use; all tests passed. |
| USP Particulate Matter in Injections (Method 1 Light Obscuration Particle Count) | Met USP 1B acceptance criteria (for ≤ 100 mL volume). | |
| Sterilization | ISO 11137-1:2006 (Sterilization, Validation, and Routine Control of a Sterilization Process for Medical Devices) | Validated sterilization cycle; SAL 10-6 achieved; dose 25-50 kGy. |
| ISO 11137-2:2013 (Establishing the Sterilization Dose) | Determined 25 kGy requirement. | |
| USP 39 -NF 34 and European Pharmacopoeia (9th Edition) requirements for Material-mediated Pyrogenicity | Confirmed non-pyrogenicity (Rabbit Pyrogen study). | |
| Limulus Amebocyte Lysate (LAL) test for Bacterial endotoxins | Met 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).