(31 days)
The BD FlowSmart™MiniMed™ Pro-Set™ infusion set is intended for the subcutaneous infusion of medication, including insulin, from an external infusion pump.
The BD FlowSmart™MiniMed™ Pro-Set™ infusion set is a subcutaneous administration set 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. The 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. It is a single-use sterile device.
This document, a 510(k) summary for the BD FlowSmart™ Set/MiniMed™ Pro-Set™ infusion set, describes non-clinical testing performed to demonstrate substantial equivalence to a predicate device. It does not contain information about acceptance criteria and device performance in the format of AI/ML device studies. Therefore, many of the requested fields cannot be directly answered.
Here's an analysis based on the provided text, highlighting what is available and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative table for specific performance metrics like accuracy, sensitivity, or specificity, as would be common for AI/ML device evaluations. Instead, it states that "Results of these tests were found to be acceptable and demonstrated that the subject infusion set met requirements for its intended use and is substantially equivalent to its predicate device."
The testing included:
- Device material biocompatibility: ISO 10993 (Biological evaluation of medical devices)
- Device functional performance:
- ISO 10555-1 (Sterile single use intravascular catheters)
- ISO ID26 (Medical Electrical Equipment. Part 2: Particular requirements for the safety of infusion pumps)
- ISO 11135-1 (Sterilization of healthcare products)
Since this is a physical medical device (infusion set) and not an AI/ML diagnostic or predictive tool, the "performance" here refers to meeting standards for safety, biocompatibility, and intended mechanical/fluidic function. The document does not provide specific numerical performance results against these standards.
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 provided in the document. The testing described is non-clinical (biocompatibility and functional performance), likely involving laboratory testing of materials and device prototypes, rather than testing on patient data.
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)
This information is not applicable as the device is a physical infusion set, and the "ground truth" concept as typically applied to AI/ML for diagnostic tasks does not apply here. The testing involves adherence to established international standards for medical devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the type of non-clinical testing described.
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
This information is not applicable. The device is an infusion set, not an AI-assisted diagnostic tool for 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)
This information is not applicable in the context of AI/ML device evaluation. For this infusion set, "ground truth" would be defined by the specifications and performance requirements outlined in the referenced ISO standards (e.g., material compatibility as per ISO 10993, fluidic integrity as per ISO 10555-1). Compliance with these standards serves as the benchmark.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable. There is no "training set" as this is not an AI/ML device.
Summary of what the document does provide:
The document describes a 510(k) premarket notification for the BD FlowSmart™ Set/MiniMed™ Pro-Set™ infusion set. It declares substantial equivalence to a predicate device (K150059 - BD FlowSmart™ Set) based on non-clinical testing. This testing focused on:
- Device material biocompatibility: According to ISO 10993
- Device functional performance: According to ISO 10555-1, ISO ID26 (related to infusion pumps), and ISO 11135-1 (sterilization).
The conclusion states that the analysis and testing demonstrate the subject device is substantially equivalent to its predicate device. This type of submission relies on demonstrating that the new device performs as safely and effectively as a legally marketed predicate device, especially when technological changes (like different adhesive material or tubing configuration) are not significant enough to alter fundamental principles or intended use.
§ 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.