(82 days)
This device is intended to be used as a conduit for the delivery of I.V. fluids from a container to a patient's vascular system through a needle or cather inserted into a vein. Additionally, this device is intended to serve as an injection site for other influsion fluids. This device is intended to be used only by trained professionals in a clinical or hospital environment.
The KippMed I.V. Manifold is substantially equivalent to the Braun Safesite Manifold, Minor differences in design specifications have been listed in Table One. Both devices are intended to provide connections to an I.V. Administration Set. Both devices provide a multi-port connector with a female leur-lock adapter, three normally closed backcheck valves and a connection adapter. The inlet connection adapter for both devices includes a free-spinsing hub/leur lock to connect to I.V. lines. Both devices are sterile and nonpyrogenic.
This document (K970255) describes an I.V. Manifold, a low-risk medical device. The information requested in your prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is typically associated with studies for higher-risk devices, particularly those involving AI/ML components or complex diagnostic functions with human interpretation.
For this I.V. Manifold, the "acceptance criteria" and "study" are focused on demonstrating substantial equivalence to a predicate device and confirming basic safety and performance requirements, not on diagnostic accuracy, reader performance, or AI efficacy.
Here's a breakdown based on the provided text, addressing your points where applicable, and explaining why others are not relevant for this type of submission:
1. A table of acceptance criteria and the reported device performance
For this device, the "acceptance criteria" are essentially demonstrating substantial equivalence to the predicate device in terms of design, materials, intended use, and meeting basic safety standards (sterilization, biocompatibility). The "reported device performance" refers to the device meeting these equivalence points and safety validations.
| Acceptance Criteria Category | KippMed I.V. Manifold Performance |
|---|---|
| Intended Use | Conduit for I.V. fluids, injection site for infusion fluids. Substantially equivalent to predicate. |
| Technological Characteristics | Multi-port connector, female leur-lock, three normally closed backcheck valves, connection adapter with free-spinning hub/leur lock. Substantially equivalent to predicate (minor differences in design specifications detailed in Table 1, not provided in excerpt). |
| Sterility Assurance Level (SAL) | 10⁻⁶ |
| Material Biocompatibility | All tested components were biocompatible according to ISO 10993 and FDA G95-1. |
| Non-pyrogenic | Device is non-pyrogenic. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided in the document. The "tests" for this device are primarily related to:
- Sterilization validation: This typically involves laboratory testing on a statistically significant sample of devices to demonstrate the Sterility Assurance Level (SAL). The specific sample size or provenance is not detailed in this summary but would be part of the full validation report.
- Biocompatibility testing: This involves in vitro and potentially in vivo tests on the raw materials and finished components. Specific sample sizes for these material tests are not in the summary.
- Bench testing for functional equivalence: This would confirm aspects like leak integrity, flow rates, and connection strength. The document mentions "minor differences in design specifications" and a comparison in "Table 1," implying such testing was done, but details are not provided. These are typically laboratory tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no concept of "ground truth" or "expert readers" in the context of an I.V. manifold submission. This device performs a mechanical function, not a diagnostic one requiring human interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for the same reasons as point 3.
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 device is an I.V. manifold; it does not involve AI, human readers, or diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "truth" for this device is its physical integrity, sterility, biocompatibility, and functional equivalence to its predicate. These are established through validated testing methodologies, not expert consensus on diagnostic findings or clinical outcomes data in the way you might see for an AI diagnostic device.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI, and therefore has no "training set."
9. How the ground truth for the training set was established
Not applicable for the same reasons as point 8.
§ 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.