(29 days)
These infusion sets are indicated for the subcutaneous infusion of medication from an external Infusion Pump.
The asante comfort™ Subcutaneous Infusion Sets for use with the Asante Pearl™ pump and the currently marketed Comfort™ Subcutaneous Infusion Sets are both sterile, non-pyrogenic, single use subcutaneous infusion sets. For the connection to the infusion set, the current Comfort™ sets have a standard female luer connector compatible with many commercially available infusion devices while the new asante comfort™ sets have the unique connector/adapter only compatible with the Asante Insulin Infusion Pump cleared as part of the Asante Pearl™ Diabetes Management System 510(k), file number K100567. This connector/adapter is provided to Unomedical as a finished, tested component by Asante Solutions, the manufacturer of the Asante Pump, and is bonded,us ing the same adhesive, to the pump end of a standard Comfort™ infusion set in lieu of the female luer by Unomedical. The remainder of the set, including all fluid contact materials, sterile packaging, and the manufacturing and sterilization process are unchanged. The method of use of the devices is the same as for the unmodified devices including attaching the connector end of the set to the pump per the pump manufacturers' instructions and the use of the pump with the Comfort™ Subcutaneous Infusion Sets were included as part of the Asante 510(k) file.
The asante conset™ Subcutaneous Infusion Sets for use with the Asante Pearl™ pump and the current Inset™ Subcutaneous infusion Sets are both sterile, nonpyrogenic, single use subcutaneous infusion sets with an integrated springpowered catheter insertion device. For the connection to the infusion set, the current Inset™ infusion sets have a standard luer connector compatible with commercially available infusion devices while the new Asante Conset™ sets have a unique connector/adapter compatible with the Asante Pearl™ Infusion Pump cleared as part of the Asante Pearl™ Diabetes Management System 510(k), file number K100567. This part is provided to Unomedical as a finished, tested component by Asante Solutions, the manufacturer of the Asante Pump, and is bonded, using the same adhesive, to the pump end of a standard Inset™ infusion set in lieu of the female luer by Unomedical. The remainder of the set, including all fluid contact materials, sterile packaging, and the manufacturing and sterilization process are unchanged. The method of use of the devices is the same as for the unmodified devices including attaching the connector end of the set to the pump per the pump manufacturers' instructions and the use of the pump with the Inset™ Subcutaneous Infusion Sets were included as part of the Asante 510(k) file.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Asante Conset™ and Asante Comfort™ Subcutaneous Infusion Sets:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Asante Conset™ and Asante Comfort™) | Outcome |
|---|---|---|---|
| Flow (Occlusion) – Asante Comfort™ | Minimum 40 mL/min at 1 bar pressure | Not explicitly stated; "verification testing was performed" and conclusion is "substantially equivalent." Implies meeting or exceeding this. | Met |
| Flow (Occlusion) – Asante Conset™ | Minimum 80 mL/min at 1 bar pressure | Not explicitly stated; "verification testing was performed" and conclusion is "substantially equivalent." Implies meeting or exceeding this. | Met |
| Leak Test | No leaks at 0.56 bar pressure for 30 seconds | Not explicitly stated; "verification testing was performed" and conclusion is "substantially equivalent." Implies meeting or exceeding this. | Met |
| Pull Test (Tubing to Asante Adapter) | Minimum 15 N | Not explicitly stated; "verification testing was performed" and conclusion is "substantially equivalent." Implies meeting or exceeding this. | Met |
Note: The document states "The following verification testing was performed on the modified sets" and then lists the criteria, followed by a conclusion that the new products are "substantially equivalent." It does not explicitly provide the numerical results for the modified sets, but the substantial equivalence claim implies that the acceptance criteria were met.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the verification testing (Flow, Leak, and Pull tests). The data provenance is also not specified (country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. The study involves performance testing of a medical device (infusion sets) against engineering specifications, not a clinical diagnostic assessment that would require expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. The study involves objective engineering measurements, not subjective evaluations requiring adjudication.
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
This information is not applicable and not provided. This is a 510(k) submission for an infusion set, not an AI-powered diagnostic device. Therefore, no MRMC study or AI-related comparative effectiveness was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided. This device is not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests (Flow, Leak, Pull) is established by the specified acceptance criteria (e.g., minimum flow rate, no leaks, minimum pull force). These are objective engineering specifications derived from the predicate devices' performance and industry standards.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This submission is for a physical medical device, not a machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as there is no training set for this device.
§ 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.