(57 days)
The Cleo 90 Infusion Set is designed for subcutaneous infusion of medication (including insulin) only. The set is not intended for intravenous (IV) infusion or to infuse blood or blood products.
The Cleo™ 90 Infusion Set consists of an applicator that contains an adhesive site with cannula and needle and separate extension tubing set with buckle. The infusion set has a standard luer connection. After insertion of the needle and cannula into the subcutaneous tissue, the applicator automatically retracts the needle into the applicator housing providing needle protection. The infusion set buckle attaches to the site allowing infusion of medication through the extension tubing.
The Cleo™ 90 Infusion Set is a medical device designed for subcutaneous infusion of medication, including insulin. The manufacturer conducted functional testing and a simulated clinical use evaluation to support its safety and effectiveness.
Here’s a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device functions according to specifications | In-vitro functional testing indicated the Cleo™ 90 Infusion Set functioned according to specifications. |
| Materials used are biocompatible | Biocompatibility testing confirmed the materials used in the device are biocompatible. |
| Needle protection feature operates as intended | A simulated clinical use evaluation concluded the needle protection feature operated as intended. |
| No needle sticks or injuries reported during use | No needle sticks or injuries were reported by participants in the simulated clinical use evaluation. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the exact sample size for the simulated clinical use evaluation. It mentions "Individuals who participated in the evaluation included patients who routinely use an insulin pump and infusion set, parents or guardians of patients who insert an infusion set on behalf of a patient, and health care providers who instruct patients and caregivers on the use of infusion pumps and infusion sets."
- Data Provenance: The study was a simulated clinical use evaluation, implying it was conducted specifically for this device's validation. The country of origin is not explicitly stated, but the submission is to the US FDA, suggesting the study was likely conducted in the US or under US regulatory standards. It was a prospective evaluation tailored to assess the needle protection feature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document does not mention the use of "experts" in the traditional sense for establishing ground truth regarding device performance during the simulated clinical use evaluation. Instead, the evaluation involved users of infusion sets (patients, parents/guardians, healthcare providers) who assessed the functionality and safety of the needle protection feature. Their reported experiences (or lack thereof, regarding needle sticks) served as the "ground truth" for the performance of the needle protection feature.
- Their qualifications are described by their roles: "patients who routinely use an insulin pump and infusion set," "parents or guardians of patients who insert an infusion set on behalf of a patient," and "health care providers who instruct patients and caregivers on the use of infusion pumps and infusion sets."
4. Adjudication Method for the Test Set:
- The document does not describe an adjudication method in the context of multiple independent assessments being reconciled. The simulated clinical use evaluation appears to have collected direct feedback and observations from individual participants regarding the operation of the needle protection feature and the occurrence of any needle sticks or injuries. The report simply states that "no needle sticks or injuries were reported in the evaluation by the participants," suggesting a summation of individual reports rather than a formal adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The studies described are functional testing and a simulated clinical use evaluation focused on the device's performance, particularly its needle protection feature. This type of study is more common for diagnostic imaging devices where human interpretation is a key component.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
- The concept of "standalone" performance typically applies to AI algorithms. This device is a physical medical device (an infusion set), not an algorithm. Therefore, the concept of a standalone study in this context is not applicable. The functional testing assessed the device's inherent mechanical and material properties.
7. Type of Ground Truth Used:
- For the functional testing, the ground truth was based on device specifications and biocompatibility standards.
- For the simulated clinical use evaluation, the ground truth for the needle protection feature's performance and safety was established by user feedback and reported outcomes (no reported needle sticks or injuries). This could be considered a form of "user reported safety/effectiveness data."
8. Sample Size for the Training Set:
- The document does not mention a "training set" as this device is a physical hardware product, not a machine learning model. Therefore, this question is not applicable.
9. How the Ground Truth for the Training Set Was Established:
- As there was no "training set" for a machine learning model, this question is not applicable.
§ 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.