(142 days)
The Medtronic Extended infusion set is indicated for subcutaneous infusion of medication administered by an external pump. The infusion set is indicated for single use.
The Medtronic Extended infusion set manufactured by Unomedical a/s is a sterile, non-pyrogenic, single use subcutaneous infusion set which includes a 90-degree soft cannula. It is delivered ready to use in a preloaded insertion device with automatic needle retraction. The product is indicated for subcutaneous infusion of medication administered by an external pump.
The insertion needle and soft cannula of the Medtronic Extended infusion set are hidden from the user before, during and after insertion of the soft cannula. This feature helps prevent needle stick injuries as the device does not require loading with the needle by the user, the needle is then automatically retracted after use.
The Medtronic Extended infusion set is designed to be used with a Medtronic Insulin infusion pump for up to 7 days.
This is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as sample size for test/training set, number of experts for ground truth, adjudication method, MRMC comparative effectiveness, standalone performance, and how ground truth was established) are not applicable.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and a clinical evaluation.
Here's the information that can be extracted relevant to acceptance criteria and performance, as much as possible for a non-AI/ML device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly listed in a table format within the provided document. Instead, the document states that "The Medtronic Extended infusion set meets all the requirements for overall design, sterilization, biocompatibility, and usability confirming that the design output meets the design inputs and specifications for the device." The "Reported Device Performance" is derived from the "Clinical Evaluation" section.
| Acceptance Criteria Category | Device Performance (Medtronic Extended Infusion Set) |
|---|---|
| Overall Design | Meets internal, national, and international standards. |
| Sterilization | Meets internal, national, and international standards (e.g., ISO 11135, ISO 11737). |
| Biocompatibility | Meets internal, national, and international standards (e.g., ISO 10993-1). |
| Usability | Meets internal, national, and international standards (e.g., IEC 62366-1). |
| Functional Performance (e.g., Leak/Tightness, Flow, Tensile Strength, Serter Functionality) | Meets internal requirements and is substantially equivalent to predicate based on bench testing. |
| Packaging and Transportation | Meets internal requirements. |
| Drug and Device Compatibility | Meets internal requirements. |
| Dimensional Accuracy | Meets internal requirements. |
| Pyrogen/Endotoxin | Meets internal requirements. |
| Shelf Life | Demonstrated for 2 years (reduced from 3 years for predicate). |
| Clinical Safety and Effectiveness | Safe and effective for full 7 days of use; no device-related serious adverse events. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test set sample size: For the clinical evaluation, 291 subjects were enrolled for the clinical study.
- Data provenance: The clinical study was conducted in the US and was a prospective study (implied by "clinical study has been conducted").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. For a non-AI/ML device, "ground truth" and expert involvement in establishing it as typically understood in AI/ML validation is not directly applicable. The clinical study results establish the device's safety and effectiveness.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided in the document. Adjudication methods are typically relevant for human review of AI/ML outputs, which is not the primary focus here.
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. This type of study is specific to evaluating AI assistance to human readers, which is not relevant for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a physical medical device (infusion set), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the clinical evaluation, the "ground truth" is implied by clinical outcomes data related to safety (e.g., adverse events) and effectiveness of the infusion set over the 7-day wear time.
8. The sample size for the training set
- This information is not applicable as this is not an AI/ML device requiring a training set. The clinical evaluation used 291 subjects for its primary testing.
9. How the ground truth for the training set was established
- This information is not applicable as this is not an AI/ML device requiring a training set.
§ 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.