(272 days)
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:
| Type of Performance Test / Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from standards/statements) | Reported Device Performance (as stated in document) |
|---|---|---|
| Mechanical Performance | Bore connectors (Luer Lock standard): Compliance with ISO 80369-7, ISO 80369-20. | "The test results are satisfactory for the requirements." |
| Stopcock Body Pressure Withstand: Compliance with ISO 80369-7, ISO 80369-20. Max pressure resistance of 550 psi. | "The test results are satisfactory for the requirements." Device withstands "medium pressure up to 500 psi" (in direct comparison to predicate) and "Up to 550 psi" (under its own specifications). | |
| Mechanical resistance to Lipiodol: Maintenance of physical performance (breakaway torque, mean torque, withstands pressure, stop resistance torque) after 24h exposure to Lipiodol. | "Lipiodol® analysis report is compliant with the Medex internal criteria." "maintains its physical performance characteristics after 24 hrs of exposure to Lipiodol®." | |
| Stopcock Lever Rotation & Tightness: Verification of breakaway torque and mean torque during rotation. | "Verification results met the Medex internal criteria." | |
| Sterilization & Package Integrity | Sterile Barrier Integrity: Compliance with ISO 11607-1, ASTM F1980-21, ASTM F1886/F1886M-16. | "The test results are satisfactory for the requirements." |
| Microbiological Validation of Sterilization: Compliance with ISO 11137-1, ISO 11137-2, ISO 11737-1, ISO 11737-2. | "The test results are satisfactory for the requirements." | |
| Biocompatibility | Cytotoxicity: Compliance with ISO 10993-5. | "The test results are satisfactory for the requirements." |
| Irritation & Sensitization: Compliance with ISO 10993-10. | (No specific conclusion stated, but implies compliance as part of overall biocompatibility) | |
| Acute Systemic Toxicity: Compliance with ISO 10993-11. | (No specific conclusion stated, but implies compliance as part of overall biocompatibility) | |
| Hemocompatibility: Compliance with ISO 10993-4, ISO 10993-12, ASTM F756-17. | (No specific conclusion stated, but implies compliance as part of overall biocompatibility) | |
| Chemical Characterization (Extractables): Compliance with ISO 10993-17, ISO 10993-18, ISO/TS 10993-19. | (No specific conclusion stated, but implies compliance as part of overall biocompatibility) | |
| Material-mediated pyrogen: Compliance with USP. | (No specific conclusion stated, but implies compliance as part of overall biocompatibility) | |
| Particulate Contamination | Compliance with USP. | "The test results are satisfactory for the requirements." |
| Pyrogenicity | Bacterial Endotoxins: Compliance with USP , ANSI/AAMI ST72. | "The test results are satisfactory for the requirements." |
| Transportation | Simulated Transportation Study: Compliance with ISTA 3A-2018. | "The test results are satisfactory for the requirements." |
| User Related Risk Analysis | No use-related critical task identified per IEC 62366-1 and FDA Guidance "Human Factors and Usability Engineering to Medical Devices." | "No Use-related critical task was identified due to differences between the predicate and the Qitexio® 4-Way Stopcock." |
| Shelf Life | Verified by accelerated and real-time aging for 3 years. | "The shelf life of the subject device has been verified... 3 years." |
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.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.