(22 days)
The Subcutaneous Infusion Sets with Indwelling Catheters Indications for Use: are indicated for the infusion and/or injection of fluids into the body below the surface of the skin.
Click-On Infusion Set Cover
The provided text is a 510(k) summary for a medical device called the "Click-On Infusion Set Cover." This document is focused on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than detailing a clinical study with acceptance criteria and performance metrics in the way a diagnostic AI device would.
Based on the provided document, here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Met specifications | "Physical testing confirmed the covers met their specifications." |
- Note: The specific "specifications" for the Click-On Infusion Set Cover are not detailed in this document. The document states that the addition of the cover is "only cosmetic" and "does not change the technological characteristics of the current product." This suggests the specifications likely relate to basic physical integrity, fit, and compatibility with the existing infusion sets, rather than clinical performance metrics.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not specified. The document only mentions "Physical testing."
- Data Provenance: Not specified, but given it's "physical testing" of the device itself, it would be laboratory-based and likely conducted by Unomedical A/S. It is a prospective test of the device, not a study involving patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This question is not applicable in the context of this device and report. The testing described is physical product testing, not a clinical study requiring expert-established ground truth for diagnosis/assessment.
4. Adjudication Method for the Test Set
- This question is not applicable. There is no ground truth adjudication process described for physical product testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers evaluate cases with and without AI assistance. The Click-On Infusion Set Cover is a physical accessory to an infusion set and not a diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is a physical product, not an algorithm.
7. The Type of Ground Truth Used
- This question is not applicable in the traditional sense of clinical ground truth (e.g., pathology, outcomes data). The "ground truth" here would be the physical specifications and functional requirements of the device (e.g., fit, durability, material integrity), which were assessed through "physical testing."
8. The Sample Size for the Training Set
- This question is not applicable. The device is a physical product, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
- This question is not applicable. As there is no training set for an AI algorithm, no ground truth was established for it.
§ 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.