(69 days)
intended for the administration of solutions and drugs into vascular implant ports. The proposed Huber Needle Extension Sets with InterLink® Y-Site or InterLink® T-Site. like other products containing the InterLink® injection site are designed to reduce the risk of accidental needle sticks when used in conjunction with the InterLink® cannula, as part of a "needleless" IV access system.
The proposed products consist of a line of Huber Needle Extension Sets which may be manufactured in four basic types: Huber Needle Extension Set without an injection site Huber Needle Extension Set with a standard injection site Huber Needle Extension Set with an InterLink® Y-injection site (Y-Site) Huber Needle Extension Set with an InterLink® T-injection site (T-Site)
This 510(k) summary describes a Huber Needle Extension Set. The information provided heavily emphasizes device description, comparative technological characteristics to predicate devices, and an overall statement about nonclinical testing. However, it lacks the specific details requested regarding acceptance criteria and a study proving those criteria are met.
Therefore, I cannot populate the requested table or answer most of your detailed questions. The document states:
"Testing included flow rate, total volume, pressure testing of set bonds and tensile strength testing. Performance testing indicates that the proposed sets meet or exceed all functional requirements and support their suitability for use."
This is a general statement, not a detailed report of acceptance criteria or study results.
Here's what I can extract based on the provided text, and what I cannot:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (e.g., specific thresholds) | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document beyond a general statement of meeting/exceeding functional requirements. |
| Flow rate | "meet or exceed all functional requirements" |
| Total volume | "meet or exceed all functional requirements" |
| Pressure testing of set bonds | "meet or exceed all functional requirements" |
| Tensile strength testing | "meet or exceed all functional requirements" |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. This is a medical device, not an AI or diagnostic imaging study where experts typically establish ground truth. The "ground truth" here would be the physical properties and performance characteristics of the device.
4. Adjudication method for the test set:
- Not applicable/Not specified.
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:
- No, an MRMC study was not done. This is a medical device, not an AI or diagnostic imaging study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for this type of device would be the defined engineering specifications and physical performance standards (e.g., specific tensile strength in Newtons, specific flow rate in mL/hr under certain pressure). The document states "functional requirements," implying these standards exist, but doesn't detail them.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI algorithm requiring a "training set."
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.