(111 days)
The BD FlowSmart™ Set/MiniMed™ Pro-Set™ set is intended for the subcutaneous infusion of medication, including insulin, from an external infusion pump.
The subject infusion set is a single use infusion administration set intended to be used for 48-72 hours. The product is intended to interface with commercially available infusion pumps with suitable connections. The infusion set features a flexible perforated catheter perpendicular to an adhesive patch and detachable tubing is connected on one end to the medication reservoir of an infusion pump and on the other end to the patient, attached to the skin by an adhesive base. The plastic catheter of the device contains a proprietary side-port. It is a single-use sterile device.
The provided document is a 510(k) summary for the BD FlowSmart™ Set/MiniMed™ Pro-Set™ infusion set. It describes bench performance and biocompatibility studies conducted to demonstrate substantial equivalence to a predicate device (K160651).
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Introducer Needle Integrity during Manual Insertion | Equivalent to predicate device | Pass |
| Skin Penetration and Drag Force | Equivalent to predicate device | Pass |
| Introducer Needle to Needle Hub Strength | Equivalent to predicate device | Pass |
| Catheter to Base Attachment Strength | Testing in accordance with ISO 10555-1:1995 | Pass |
| Tip Radial Strength | Equivalent to predicate device | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each bench study. It only states that "BD has verified the modifications of the subject device through bench performance and biocompatibility studies." The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective), but these are bench tests conducted by BD, likely in their own facilities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The studies described are bench performance tests (e.g., strength, integrity), not studies involving human interpretation or clinical outcomes that would require expert ground truth establishment.
4. Adjudication method for the test set
This information is not applicable as the studies were bench tests, not clinical studies requiring adjudication of human performance or expert consensus.
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 comparative effectiveness study was not done. The submission is for an intravascular administration set, and the studies described are bench performance tests to demonstrate substantial equivalence to a predicate device, not an AI-based diagnostic or assistive device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical infusion set, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the bench tests is defined by the technical specifications and standards (e.g., "Equivalent to predicate device," "Testing in accordance with ISO 10555-1:1995") for each physical characteristic being tested. It's a quantitative measurement against predefined criteria.
8. The sample size for the training set
This information is not applicable. This is not an AI/ML device that requires a training set. The studies are for a physical medical device.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this device.
§ 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.