(159 days)
The OnSite-IV™ is a single use sterile device for the preparation and / or transfer of drugs from a standard pharmaceutical vial into an elastomeric pump or IV bag.
The OnSite-IV™ device is a sterile, single use device that, through the use of an integrated vial spike, facilitates creation of a sterile fluid path to transfer liquid from the syringe body to a standard pharmaceutical vial with a 20 mm cap containing a drug, in order to mix or reconstitute the drug and aspirate and transfer the prepared drug back into the syringe body for delivery into an IV bag or elastomeric pump. The device is intended to be used by health care professionals (HCPs) such as physicians, nurses and pharmacists in a clinical setting.
This is a 510(k) premarket notification for a medical device (OnSite-IV™), not an AI/ML device. As such, the information typically requested regarding acceptance criteria and studies for AI/ML performance (like sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, and training set information) is not applicable here.
This document describes the equivalence of a physical medical device (Intravascular Administration Set) to existing predicate devices based on its design features, intended use, and non-clinical performance testing.
Here's a summary of the non-clinical testing performed and the general acceptance criteria inferred, as best as can be derived from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria values for each test, but rather confirms that the device "operates as specified" and "functions as intended." The "reported device performance" is a confirmation of passing these tests.
| Acceptance Criteria Category | Specific Test (Standard) | Reported Device Performance |
|---|---|---|
| Sterility | Sterilization Validation (ANSI/AAMI/ISO 11137-2:2013) | Achieves 10^-6 sterility assurance level (SAL) |
| Biocompatibility | Cytotoxicity (ISO 10993-5) | Passed |
| Maximization Sensitization (ISO 10993-10) | Passed | |
| Intracutaneous Reactivity Irritation (ISO 10993-10) | Passed | |
| Acute Systemic Toxicity (ISO 10993-11) | Passed | |
| Hemolysis, Extract Method (ASTM F 756) | Passed | |
| Hemolysis, Direct Method (ASTM F 756) | Passed | |
| Materials Mediated Pyrogen Test (ISO 10993-11, USP ) | Passed | |
| Physical Performance (ISO 7886-1:1993 for syringes) | Limits for Acidity or Alkalinity | Passed |
| Limits for Extractable Metals | Passed | |
| Tolerance on Graduated Capacity | Passed | |
| Dead Space | Passed | |
| Liquid Leakage at Syringe Piston under Compression | Passed | |
| Air Leakage at Syringe Piston under Compression | Passed | |
| Air Leakage past Syringe Piston during Aspiration | Passed | |
| Fiducial Line | Passed | |
| Fit of Piston in Barrel | Passed | |
| Additional Performance Testing | Luer Connection Performance (ISO 594-1, ISO 594-2) | Passed |
| Particulate Matter (USP ) | Passed | |
| Performance of the Bacterial Retentive Filter (ASTM F2101) | Passed | |
| Internal Requirements (after sterilization, transport, aging) | Visual Inspection | All features verified to operate as specified (passed) |
| Device Retained Volume After Use | All features verified to operate as specified (passed) | |
| Drug Mixing | All features verified to operate as specified (passed) | |
| Force to Operate Valve | All features verified to operate as specified (passed) | |
| Graduated Marking Durability | All features verified to operate as specified (passed) |
2. Sample size used for the test set and the data provenance
Not applicable as this is a physical device, not an AI/ML system evaluated on a dataset. The testing refers to physical samples of the device. The document does not specify the number of devices or components tested for each non-clinical performance test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth and expert review are concepts for diagnostic performance evaluation of AI/ML systems. This document describes physical and biological performance tests.
4. Adjudication method for the test set
Not applicable. Adjudication methods are relevant for human interpretation disagreement in diagnostic performance studies.
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 not an AI/ML device, and no human reader studies are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's performance is adherence to established international standards (ISO, ASTM, USP) and internal specifications for physical and biological properties.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.