(22 days)
Orbit Infusion Sets are intended for the subcutaneous delivery of fluids and medication, such as insulin, from an external infusion pump.
Orbit Infusion sets are comprised of tubing that is connected on one end to the medication reservoir of the infusion pump using a luer lock connection and on the other end to the patient, attached to the skin by an adhesive base, anchoring a catheter that is inserted into the subcutaneous tissue. These sets have a patented design feature which allows the tubing to freely rotate 360° at the adhesive attachment and to disconnect the tubing set from the infusion base.
The Orbit Infusion Set is intended for the subcutaneous delivery of fluids and medication from an external infusion pump. The device aims to demonstrate substantial equivalence to the predicate device, Talon Infusion Set (K033290), by meeting performance and safety criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance (Compliance) |
|---|---|---|
| Material strength of steel cannula | Per ISO 9626 | Met relevant sections of standards |
| Activated pressure leak | No leak when subjected to pumping pressures up to 20psi under normal delivery conditions and occluded fluid path conditions | Met relevant sections of standards |
| Penetration force | Needle and catheter shall penetrate a 0.025 inch thick membrane with a speed of 50mm/min. and a force of less than 0.8N | Met relevant sections of standards |
| Needle retention | No separation of the needle from the cap when subjected to a minimum force of 10N (ISO 10555-1, Annex B) | Met relevant sections of standards |
| Catheter retention | No separation of the catheter from the base when subjected to a minimum force of 3N (ISO 8536-8) | Met relevant sections of standards |
| Bond strength of tubing/fittings | No separation of the tubing assembly when subjected to a static tensile force of 15N for 15 sec. | Met relevant sections of standards |
| Bond strength of tape/base | No separation of the tape from the base when subjected to a minimum force of 18N | Met relevant sections of standards |
| Engagement force tubing cap/base | The cap locks on the base with a force less than 13N | Met relevant sections of standards |
| Disengagement force tubing cap/base | The force to remove the tubing cap from the base is more than 13N | Met relevant sections of standards |
| Occlusion test | No occlusion of the device when tested with a water flow at a hydrostatic pressure of 0.1 bar | Met relevant sections of standards |
| Tape adhesion | Removal of adhesive from a stainless steel plate with a 90 degree peel force of minimum 2.5N (0.56lbs) | Met relevant sections of standards |
The study concluded that "The verifications have shown evidence that the Orbit Infusion Sets meet the acceptance criteria of these standards. Based on the results it can be concluded that the device performance and safety are acceptable for the product."
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for each specific test. The data provenance is described as "relevant assessments specified in the following international and internal standards and protocols." This suggests that the tests were conducted in a controlled laboratory environment according to established engineering and medical device standards. There is no mention of country of origin of the data, or if it was retrospective or prospective human subject data, as these are technical performance tests on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for these performance tests is based on the specified engineering and medical device standards, which are objective measurements. Expert consensus or clinical interpretation of data is not required to establish ground truth for these types of device performance criteria.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or clinical outcomes where ambiguity might exist. For objective performance tests with clear pass/fail criteria based on standards, an adjudication method is not relevant.
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 submission is for a medical device (infusion set) and not an AI or imaging diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm, so standalone algorithm performance is not relevant.
7. The type of ground truth used
The ground truth for the performance tests is based on objective measurements defined by international and internal engineering/medical device standards. For example, "Material strength per ISO 9626," "No leak when subjected to pumping pressures up to 20psi," and "No separation...when subjected to a minimum force of 10N (ISO 10555-1, Annex B)."
8. The sample size for the training set
Not applicable. This is a physical medical device being evaluated against engineering and safety standards, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As this is not a machine learning model, there is no training set and therefore no ground truth establishment for 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.