(372 days)
Orbit®micro Infusion Sets are intended for the subcutaneous delivery of fluids and medication, such as insulin, from an external infusion pump.
All Orbit micro Infusion Sets are used for the subcutaneous delivery of fluids and medication from an external infusion pump. All Orbit micro 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. All Orbit micro Infusion 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 subject devices use a stainless steel indwelling cannula instead of the Teflon cannula in the predicate devices.
This document describes the 510(k) submission for the Orbit®micro Infusion Set. This is a medical device and not an AI/ML powered device, therefore the typical acceptance criteria and study data for AI/ML devices, such as those related to accuracy, sensitivity, specificity, MRMC studies, or ground truth establishment based on expert consensus/pathology, are not applicable here.
The provided text details the performance testing conducted to demonstrate the substantial equivalence of the Orbit®micro Infusion Set to a predicate device (K130468). The acceptance criteria are essentially the specifications that the device must meet, and the "results" column indicates whether these criteria were passed.
Here's the information as requested, adapted to the context of a medical device rather than an AI system:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Material strength of steel cannula | Material strength per ISO 9626 | Pass |
| Activated pressure leak | No leak when subjected to pumping pressures up to 20psi under normal delivery conditions and occluded fluid path conditions | Pass |
| 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 | Pass |
| Needle retention | No separation of the needle from the cap when subjected to a minimum force of 10N (ISO 10555-1, Annex B) | Pass |
| Catheter retention | No separation of the catheter from the base when subjected to a minimum force of 3N (ISO 8536-8) | Pass |
| Bond strength of tubing/fittings | No separation of the tubing assembly when subjected to a static tensile force of 15N for 15 sec. | Pass |
| Bond strength of tape/base | No separation of the tape from the base when subjected to a minimum force of 18N | Pass |
| Engagement force tubing cap/base | The cap locks on the base with a force less than 13N | Pass |
| Disengagement force tubing cap/base | The force to remove the tubing cap from the base is more than 13N | Pass |
| Occlusion test | No occlusion of the device when tested with a water flow at a hydrostatic pressure of 0.1 bar | Pass |
| Tape adhesion | Removal of adhesive from a stainless steel plate with a 90 degree peel force of minimum 2.5N (0.56lbs) | Pass |
| Biocompatibility Tests (ISO 10993-1) | Acceptable results for: Cytotoxicity ISO MEM Elution Assay; Hemolysis ASTM Assay Extract Method; Acute Systemic Injection; Guinea Pig Maximization Sensitization; Intracutaneous reactivity study; Bacterial Endotoxin. (Specific quantifiable acceptance criteria for each sub-test are not provided in the document but are implied by "acceptable results" per the standard.) | Completed with acceptable results for all listed tests. |
2. Sample sized used for the test set and the data provenance
The document does not specify the exact sample sizes used for each performance test. The tests are physical/mechanical property tests of the device components and entire system, not tests on biological or imaging data. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable in the typical sense for an AI/ML context. The tests were conducted by Ypsomed AG, a Swiss company.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for these types of device performance tests is established by adherence to international standards (e.g., ISO) and engineering specifications, often measured by calibrated equipment, rather than requiring expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML study involving human readers or interpretation.
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 is a medical device, not an AI system. No MRMC study was conducted.
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. The performance tests ("standalone") refer to the device's inherent mechanical and material properties.
7. The type of ground truth used
The "ground truth" for the device's performance is based on established engineering principles, international standards (like ISO 9626, ISO 10555-1, ISO 8536-8, ISO 10993-1), and the predefined specifications set by the manufacturer to ensure the device performs as intended and is safe. This isn't "expert consensus," "pathology," or "outcomes data" in the context of diagnostic accuracy, but rather compliance with physical and biological requirements through standardized testing.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI system that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set for an algorithm was used.
§ 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.