(24 days)
The Interpore Cross International Manifold with Extension Set is intended to provide multiple access sites into a common fluid path for blood, plasma or solutions. The luer connectors on either end of the stopcock gang allow connection to the Extension Set for fluid transfer (i.e., blood, plasma, or solution).
The Interpore Cross Manifold with Extension Set consists of individual stopcocks assembled in series through common luer fittings to form a manifold or stopcock gang. These pre-assembled stopcock gangs provide multiple access sites into a common fluid path for blood, plasma or solutions. The luer connectors on either end of the stopcock gang (Manifold) allow connection to the Extension Set for fluid transfer. The backing plate can be used to attach the stopcock manifold gang to an IV pole.
The provided text describes a 510(k) submission for the "Interpore Cross Manifold With Extension Set." This is a medical device, and the information primarily focuses on its substantial equivalence to a predicate device and its functional performance testing.
Here's an analysis of the provided information, specifically addressing your numbered points:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that the device "meets or exceeds all functional requirements," but it does not provide a specific table of acceptance criteria with quantitative metrics nor a detailed report of the device's performance against those metrics. It only lists the types of tests performed.
| Acceptance Criterion Category | Reported Device Performance |
|---|---|
| Ease of Assembly | Meets or exceeds all functional requirements |
| Unscrewing Torque | Meets or exceeds all functional requirements |
| Air Leakage | Meets or exceeds all functional requirements |
| Liquid Leakage | Meets or exceeds all functional requirements |
| Separation Force | Meets or exceeds all functional requirements |
| Resistance to Overriding | Meets or exceeds all functional requirements |
| Pressure Seal Testing | Meets or exceeds all functional requirements |
| Manifold Flow Rate | Meets or exceeds all functional requirements |
| Mechanical Security of Stopcock Gangs to Backing Plate | Meets or exceeds all functional requirements |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the sample size for any of the tests conducted.
- Data Provenance: The data was "generated" by Interpore Cross International. The country of origin is not explicitly stated, but the company's address is Irvine, California, USA, suggesting the testing was likely conducted in the USA or under US regulations. The study would be considered prospective as it involves new testing specifically for the 510(k) submission of this device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
This question is not applicable to the type of device and study described. The "Interpore Cross Manifold With Extension Set" is a mechanical fluid transfer device. Its performance is assessed through objective, physical tests (e.g., leakage, flow rate, torque), not through expert interpretation like medical imaging or diagnostic algorithms. Therefore, there's no "ground truth" to be established by experts in the sense of clinical diagnosis or interpretation.
4. Adjudication Method for the Test Set:
Not applicable. As explained above, this study involves objective mechanical testing, not subjective interpretation requiring adjudication among experts.
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. This is a study of a mechanical fluid transfer device, not an AI-assisted diagnostic tool. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are irrelevant to this document.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm or software. It is a physical medical device.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is based on objective, quantitative physical measurements against predefined engineering and functional specifications. For example, "air leakage" would have a maximum allowable leakage rate, and the test would verify if the device stays within that limit. This is unlike clinical studies where ground truth might be derived from pathology, expert consensus, or patient outcomes.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its functionality is based on its mechanical design and materials.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As there is no training set for this type of device, this question is irrelevant.
§ 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.