(156 days)
These sets are intended to be used with Medtronic Paradigm Insulin Subcutaneous Infusion Pumps for continuous subcutaneous insulin infusion by patients or caregivers in the home environment.
All of the Subcutaneous Insulin Infusion Sets are sterile, non-pyrogenic, single use subcutaneous infusion sets. Each set design has two main components provided for each device. The first is a subcutaneous indwelling Cannula component and the second is a tubing set component. For all sets, the connection of the indwelling cannula to the tubing set is made using a proprietary plastic "click-lock" connector system that enables the disconnection. The Cannula component has an adhesive backed fixation tape that is attached directly to the patient's skin over the injection site. The cannula is sometimes provided separately from, and sometimes provided pre-attached to the tubinq, but in all cases is able to be detached from the tubing to temporarily discontinue the infusion or to replace the cannula independent of the tubing. Some of the cannulas are stainless steel needles and others are soft catheters that are inserted with stainless steel insertion needles that are then removed and discarded. All except the Mio® are manually inserted into the subcutaneous tissue. The Mio® is provided integrated in an automated inserter. The second main component of the set is the tubing set. The infusion set tubing for all sets, except for the QuickSet, are comprised of a co-extruded tube with a stainless steel needle incorporated into the male portion of the proprietary plastic "click-lock" connector at the patient that punctures and penetrates a septum in the cannula connector, creating an aseptic fluid path to the user and that enables the connection and disconnection. The QuickSet tubing connects and disconnects with a snap on connection to the cannula component. The sets are offered in different lengths of tubing. As these sets are specifically designed only to be used with the commercially available MiniMed Paradigm Insulin Infusion pumps which use a MiniMed Paradigm medication reservoir with a proprietary pump reservoir connection, all of these sets terminate at the proximal end with the P-Cap connector. The P-Cap connector has a stainless steel needle that punctures and penetrates the insulin cartridge, creating an aseptic fluid path to the user. The P-Cap also attaches to the pump housing creating a water tight interface between the pump housing and the P-Cap, precluding water ingress into the pump through the cartridge reservoir chamber. Once sealed onto the pump, the hydrophobic membrane in the P-Cap enables pressure equalization between the inside of the pump (external to the drug reservoir) and the external environment under all ambient pressure conditions. This venting mechanism is designed to allow equalization of a pressure differential created by an altitude change between sea level and 10,000 feet air within 10 minutes, will withstand 8 feet of water for 30 minutes, and have a dry out time of 10 minutes or less. All of the subject sets are identical to the predicate sets in design, materials, manufacture, user interface, labeling, indications for use and intended use except for the material of the P-Cap Membrane.
The provided text describes a 510(k) summary for insulin infusion sets, specifically focusing on an upgrade to the P-Cap Connector's membrane material. While it details performance testing related to water ingress, dry-out time, and airflow, it does not provide the level of detail typically found in a clinical study report for an AI/device performance evaluation that addresses the specific questions asked about acceptance criteria, human reader performance, ground truth establishment, or sample sizes for training sets.
The information given is primarily about the device's functional performance (e.g., maintaining gas permeability, preventing water ingress) and its substantial equivalence to predicate devices, rather than a clinical performance study involving human readers or a complex AI algorithm that requires extensive ground truth and reader studies.
Therefore, many of the requested fields cannot be directly answered from the provided document. I will fill in what can be inferred or directly stated, and clearly mark what information is not available in the text.
Description of Acceptance Criteria and Study Proving Device Meets Acceptance Criteria
This document describes the validation of a minor design change (P-Cap membrane material upgrade) to existing MiniMed insulin infusion sets (MiniMed Quick-Set®, MiniMed Sure-T®, MiniMed Silhouette®, MiniMed Mio®). The study performed was a pre-clinical benchtop performance verification to ensure the upgraded P-Cap membrane maintains its function, especially when wet, and that the devices remain substantially equivalent to their predicate devices. This is not a study involving human reader performance or an AI algorithm, but rather a functional test of a medical device component.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|
| Water Ingress and Dry out Time Test: |
- Provide an effective barrier to moisture transmission into the pump cartridge when subjected to pressure equal to submersion in 8 feet of water for 30 minutes.
- Wet components dry out within 10 minutes. | "All samples passed the tests."
- Cartridge chamber checked for presence of any moisture (implying no ingress).
- Wet Components dried out within 10 minutes. |
| Dry and Wet Flow Test: - Enable a minimum of 5 SCCM (Standard Cubic Centimeters per Minute) airflow through the membrane at a constant pressure.
- Tested both when dry and when wet (to simulate insulin leakage). (5 SCCM determined as minimum for pressure equalization to ambient in the cartridge chamber). | "All samples passed the tests."
- Flow of at least 5 SCCM achieved both dry and wet. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Three (3) different lots of POREX membrane (P/N D6014672-009) were used to produce three (3) different PQ (Product Quality/Performance Qualification) lots of the PCAP assemblies (P/N D7004363-029). The exact number of individual P-Cap assemblies tested from these lots is not specified.
- Data Provenance: Not explicitly stated, but the company is Unomedical A/S based in Denmark. The testing appears to be conducted by the manufacturer as part of their design verification activities. This is a pre-clinical/benchtop performance study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. This study is a benchtop performance verification of a physical component (P-Cap membrane) and does not involve human interpretation or a "ground truth" derived from expert consensus in the clinical sense (e.g., radiologists reviewing images). The acceptance criteria are based on engineering specifications and functional requirements.
4. Adjudication Method for the Test Set:
- Not Applicable. No human adjudication was performed, as this was a physical performance test.
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:
- Not Applicable. This is a medical device performance study, not an AI or diagnostic imaging study involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a medical device performance study, not an AI or algorithm-only study.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth Type: The "ground truth" here is the pre-defined engineering and functional specifications for the P-Cap membrane's performance, such as minimum airflow (5 SCCM), water ingress prevention, and dry-out time (10 minutes or less). These are objective measurements rather than expert consensus on a clinical diagnosis.
8. The Sample Size for the Training Set:
- Not Applicable. This document describes a design verification study for a physical medical device component, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As no training set for an AI algorithm was involved, the establishment of ground truth for a training set is irrelevant to this document.
§ 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.