(161 days)
For administration of intravenous fluids to a patient's vascular system utilizing needleless components and an I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. Use of a needle-free system may aid in the prevention of needle-stick injuries.
Sterile, single use non-pyrogenic intravenous fluid administration sets with a multiport IV manifold and integrated back-check valves, pre-attached needleless injection sites, drip chamber and roller clamps. The reason for the submission was a material change to the male luer component.
The acceptance criteria and study proving device performance are described below for the Q2® Multiport IV Administration Sets and Extension Sets.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ethylene Oxide Residuals Testing complies with ISO 10993-7:2008 | Complies with ISO 10993-7:2008 |
| Shelf Life | Verified to remain at 3 years |
| Bench Testing (high pressure, bond strength, solvent exposure) demonstrates performance similar to predicate device | Successfully demonstrated similar performance to predicate device |
| Biocompatibility of materials (new male luer: Tritan MX-711) for clinical application | Test results successfully verified biocompatibility |
2. Sample Size for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes used for each individual test (sterilization residuals, shelf life, bench testing, biocompatibility). It generally refers to "the proposed IV Administration Sets" and "the materials of construction of a fully assembled IV Administration Set."
The data provenance is from bench testing and laboratory testing performed by Quest Medical, Inc., the device manufacturer. No specific country of origin for the data is mentioned beyond the company's US address. The nature of these tests suggests they are prospective in relation to the submission, as they were conducted to support the substantial equivalence claim for the modified device.
3. Number of Experts and Qualifications for Ground Truth:
This device is an IV administration set, not an AI or diagnostic imaging device that typically requires human expert consensus for ground truth. Therefore, the concept of "experts used to establish the ground truth" in the traditional sense of medical image interpretation or clinical diagnosis does not apply directly here.
Instead, the "ground truth" for the performance criteria is established by:
- Industry standards and regulations: ISO 10993-7:2008 for sterilization residuals, and general biocompatibility testing principles per ISO 10993-1:2009.
- Engineering and materials science principles: For bench testing (high pressure, bond strength, solvent exposure) to ensure functional integrity.
The "experts" involved would be the engineers, toxicologists, and quality assurance personnel who designed, executed, and interpreted these technical tests according to established protocols and standards. Their qualifications would stem from their expertise in relevant engineering, materials science, and regulatory compliance fields.
4. Adjudication Method for the Test Set:
Not applicable in the human-in-the-loop sense. The "adjudication" is based on objective measurements against predetermined specifications and accepted industry standards (e.g., meeting ISO limits, specified bond strengths, no adverse reactions in biocompatibility tests). There is no mention of a human adjudicator reviewing conflicting interpretations of results, as the tests produce objective data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This is a medical device (IV administration set), not a diagnostic algorithm or AI-assisted diagnostic tool. Therefore, a MRMC study to compare human reader performance with and without AI assistance is not relevant to this submission.
6. Standalone (Algorithm Only) Performance:
No. This device does not involve an algorithm or AI. It is a physical medical device.
7. Type of Ground Truth Used:
The ground truth is established through:
- Objective laboratory measurements and tests: For physical performance (e.g., pressure resistance, bond strength).
- Compliance with recognized international standards: Such as ISO 10993-7:2008 for Ethylene Oxide Residuals and ISO 10993-1:2009 for Biocompatibility.
- Comparison to the legally marketed predicate device: Demonstrating that the modified device performs "similarly to the predicate device" in functional tests.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for such a device effectively comes from the established engineering principles, design specifications, and manufacturing processes, rather than a data-driven model.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as no training set (in the AI/ML sense) is involved. The "ground truth" for the design and manufacturing of such a device is established through:
- Historical performance of predicate devices.
- Industry best practices and engineering standards.
- Regulatory requirements.
- Material properties and scientific understanding of their behavior.
§ 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.