(231 days)
The Sparta Infusion Set for Insulin is indicated for the subcutaneous infusion of insulin, administered by an external pump. The infusion set is indicated for use with adult and pediatric users weighing greater than 10 kg. The infusion set is indicated for single-use.
The Sparta Infusion Set is a sterile, single-use, subcutaneous infusion set that establishes a sealed fluid path from an external portable infusion pump to the patient. Fluid is delivered to the patient through a 6 mm, 90°, soft cannula inserted in the subcutaneous tissue. The cannula is inserted using the preloaded, single-use mechanical Inserter. The infusion set has a 23-inch tubing length that terminates in a Luer connecter.
The provided FDA 510(k) summary for the Sparta Infusion Set for Insulin (K243841) does not contain information about acceptance criteria and a study proving a software-driven device meets those criteria. The device described is an infusion set, which is a physical medical device, not an AI/software device. The document explicitly states:
"No clinical testing is required to support the Subject Device's indications for use or a substantial equivalence determination."
And regarding human factors, it says:
"Human Factors validation testing was performed... Testing demonstrated that use of the Sparta Infusion Set is safe and effective for its intended users, uses, and use environments." This is typical for physical devices, not an AI output study.
Therefore, I cannot provide the specific details about acceptance criteria, study design, sample sizes, expert involvement, or MRMC studies that you requested, as these are typically applicable to AI/software-driven diagnostic or imaging devices.
The document primarily focuses on:
- Biocompatibility Testing: To ensure the materials used are safe for contact with the body.
- Bench Performance Testing: To verify physical performance characteristics like leak resistance, insertion performance, needle safety, occlusion performance, etc.
- Sterilization and Shelf Life: To ensure the device remains sterile and functional over time.
- Human Factors: To ensure the device can be used safely and effectively by its intended users.
These are standard types of studies for a physical medical device like an infusion set, not for a software or AI product.
If you have a document describing an AI/software medical device, I would be happy to analyze it against your criteria.
§ 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.