Search Results

Qitexio® 4-Way Stopcock is intended to serve as a flow control and delivery device for I.V. fluids injection to the patient's vascular system. The device is indicated for medium pressure injection of fluids. It is also used for delivery of Lipiodol® (Ethiodized Oil) injection. It is intended for single use only. The device is not indicated for use in infusion.

Qitexio® 4-Way Stopcock is intended to serve as a flow control and delivery device for I.V. fluids injection to the patient's vascular system. Qitexio® 4-Way Stopcock is not intended to facilitate bi-directional flows, thus is not designed to be used in infusion. Qitexio® 4-Way Stopcock is designated for single use only (disposable) and is MR safe. Qitexio® 4-Way Stopcock is robust under medium pressure and is verified to be used for Lipiodol (Ethiodized oil) delivery.

Qitexio® 4-Way Stopcock is made of a body with four ports (3 female and one male) and one handle with a L-Shape diverter. The L-shaped diverter opens two neighboring ports at the same time, creating a L-shaped communication channel. The male connector includes a mobile ring assembled on the end of male port, and it enables connection locking over female Luer. A small amount of lubricant is applied on the handle stem before placing it in the Stopcock body. The neighboring female port(s) is connected to the I.V. set to accept the delivered drug or fluid. One female port, that is on the opposite side of the male port, does not directly communicate with the patient (male port). This extra port is designed to enable users to inject multiple I.V. fluids, if needed.

The operating mechanism is manual and with a simple twisting handle position to determine direction of the fluids. Qitexio® 4-Way Stopcock has only two ports communicating at a time.

This document is a 510(k) clearance letter for the Qitexio® 4-Way Stopcock, a physical medical device (an intravascular administration set), not an AI/Software as a Medical Device (SaMD).

Therefore, many of the requested criteria related to AI/SaMD performance studies (e.g., sample size for test/training sets, ground truth establishment for AI, expert adjudication, MRMC studies, standalone performance) are not applicable to this type of device submission.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through:

• Bench testing: Verifying physical properties, mechanical integrity, and resistance to fluids.
• Biocompatibility testing: Ensuring the materials are safe for patient contact.
• Sterilization and packaging integrity testing: Confirming the device remains sterile and its packaging intact.
• User-related risk analysis: Assessing potential human factors issues.

Below is an attempt to address your request based only on the information provided, highlighting why certain sections are not applicable to this physical device.

Acceptance Criteria and Device Performance for Qitexio® 4-Way Stopcock

As the Qitexio® 4-Way Stopcock is a physical medical device, not a software or AI-based device, the concept of "acceptance criteria" and "device performance" in this context refers to meeting established engineering, material, and safety standards rather than diagnostic accuracy or algorithmic performance metrics. The information provided in the 510(k) summary focuses on demonstrating that the device meets these standards and is substantially equivalent to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not present a single, consolidated table of quantitative acceptance criteria with specific performance values. Instead, it refers to compliance with recognized consensus standards (e.g., ISO, ASTM, USP) and internal criteria. The "Conclusions" column in Table 2 (Performance Testing) serves as the "reported device performance" by stating that the test results were "satisfactory for the requirements" or "compliant with Medex internal criteria."

Here's an attempt to synthesize the closest equivalent based on the provided text, focusing on the key performance attributes mentioned:

Information Not Applicable to This Device Type (Physical Medical Device)

The following points are not applicable to this 510(k) submission as it pertains to a physical, non-AI/software medical device. If this were an AI/SaMD, this information would be critical.

• 2. Sample size used for the test set and the data provenance: Not applicable. Performance testing for a physical device refers to bench testing on physical samples, not a data test set for an algorithm. There is no "data provenance" in the sense of clinical data from patients.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device is established through engineering and laboratory standards and measurements, not expert consensus on clinical data.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication is for resolving discrepancies in expert labeling of data, which is irrelevant for physical device testing.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. MRMC studies are used for evaluating the impact of AI on human reader performance, which doesn't apply to a mechanical stopcock.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to AI algorithm performance, not a physical device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Ground truth for this device is based on established engineering and material science standards (e.g., "Luer Lock standard," "ISO," "ASTM," "USP" requirements).
• 8. The sample size for the training set: Not applicable. There is no "training set" for a physical medical device.
• 9. How the ground truth for the training set was established: Not applicable. No training set for a physical medical device.

Ask a specific question about this device

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.

Ask a specific question about this device