(30 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.
Here's a breakdown of the acceptance criteria and study information for the BD FlowSmart™ Set/MiniMed™ Pro-Set™ based on the provided document.
It's important to note that this document is a 510(k) summary for a medical device seeking substantial equivalence, not a standalone clinical study report for an AI algorithm. Therefore, the information will be geared towards demonstrating this equivalence for a physical medical device, not AI performance. Many of the requested AI-specific details (like MRMC studies, training set ground truth, number of experts for ground truth establishment) are not applicable or provided in this type of submission.
Acceptance Criteria and Reported Device Performance
The document doesn't present explicit quantitative acceptance criteria for specific device performance metrics in a table. Instead, it relies on demonstrating that the "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." This implies the acceptance criteria are implicitly defined by the standards and predicate device performance.
The "reported device performance" is a general statement of meeting the requirements and demonstrating substantial equivalence.
Table of Acceptance Criteria and Reported Device Performance (Inferred):
| Parameter / Aspect | Acceptance Criteria (Inferred from standards/predicate) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Complies with ISO 10993 Parts 1, 5, and 18 for biological evaluation of medical devices. (Non-toxic, non-irritating, etc.) | Met requirements (tested according to ISO 10993 standards). |
| Functional Performance | Complies with ISO 10555-1 (Sterile single-use intravascular catheters) and ISO ID26 (Medical Electrical Equipment. Part 2: Particular requirements for the safety of infusion pumps). (e.g., flow rate, integrity, connection security) | Met requirements (tested according to ISO 10555-1 and ISO ID26). |
| Sterilization Efficacy | Complies with ISO 11135-1 (Sterilization of healthcare products). (Ensures sterility) | Met requirements (tested according to ISO 11135-1). |
| Substantial Equivalence | Performance and safety are equivalent to the legally marketed predicate device (K153257). | Demonstrated substantial equivalence through testing and comparison. |
Study Details
Given this is a 510(k) for a physical medical device, the concept of "test set" and "training set" as typically used for AI algorithms does not directly apply in the same way. The "testing" refers to non-clinical bench testing and adherence to standards.
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of "samples" in the context of a dataset. The testing was performed on representative samples of the device components and finished product to demonstrate compliance with the referenced ISO standards.
- Data Provenance: The studies are non-clinical, likely conducted in a laboratory setting by the manufacturer (BD) or contracted testing facilities. There is no mention of country of origin for data in the sense of patient data, as this is bench testing. The studies are prospective in the sense that the testing was performed on new device designs to evaluate their performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a physical device's non-clinical testing, "ground truth" is not established by human experts in the way it is for diagnostic image interpretation. The "ground truth" or reference standard for biocompatibility, functional performance, and sterilization is the established parameters and thresholds defined by the international ISO standards (e.g., specific chemical leaching limits, flow rate tolerances, sterility assurance levels). These standards are developed by expert committees, but not in the context of individual case "ground truth" adjudication.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in diagnostic studies, often involving multiple human readers interpreting medical images or clinical data. This document describes non-clinical laboratory testing of a physical device where results are measured against defined engineering specifications and international standards, not against human interpretations requiring adjudication.
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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. This is a physical medical device (an infusion set), not an AI algorithm. Therefore, MRMC studies and the concept of human readers improving with AI assistance are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical product, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Standards-Based Specifications and Prior Validated Methods. The "ground truth" for non-clinical testing is based on:
- Defined specifications: Engineering and design requirements for the device.
- Compliance with international standards: ISO 10993 (biocompatibility), ISO 10555-1 and ISO ID26 (functional performance), ISO 11135-1 (sterilization).
- Comparison to predicate device: The predicate device is considered safe and effective, and the new device must perform equivalently.
- Standards-Based Specifications and Prior Validated Methods. The "ground truth" for non-clinical testing is based on:
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The sample size for the training set:
- Not Applicable. This is a physical medical device, not an AI algorithm that requires a "training set" of data.
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How the ground truth for the training set was established:
- Not Applicable. As there is no training set in the AI sense, this question is not relevant.
Summary of Device and Approval Context:
This 510(k) submission is for an intravascular administration set (BD FlowSmart™ Set/MiniMed™ Pro-Set™). The device is substantially equivalent to a previously cleared predicate device (K153257). The "acceptance criteria" and "studies" are focused on demonstrating that the new device, despite a minor change in adhesive material, meets all relevant safety and performance standards (biocompatibility, functional performance, sterilization) and performs identically to its predicate. The detailed AI-specific questions are not relevant for this type of medical device submission.
§ 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.