(256 days)
The IVX Fluid Transfer Set is a single use device indicated for use with the IVX Station Pharmacy Compounding System. The IVX Fluid Transfer device contains three separate tubing configurations and is indicated for the following applications:
- Aseptic withdraw of fluid from I.V. bag(s) in preparation for compounding,
- aseptic reconstitution of lyophilized drug in vial(s) from an I.V. bag source and
- aseptic transfer of fluid from an I.V. bag of compounded drug into a final container(s) for use in the preparation of final compounded drugs for patient infusion administration.
The IVX Fluid Transfer Set is a sterile, single-use fluid transfer tubing set that contain three separate tubing configurations, Withdraw Transfer Set, Reconstitution Transfer Set and Stock Solution Transfer Set.
- The Withdraw Transfer Set is used to remove excess fluid from an I.V. bag and place the fluid in a waste container for disposal.
- The Reconstitution Transfer Set is used to withdraw fluid from an I.V. bag and transfer the fluid to a vial that contains powdered drug so that the drug can be reconstituted.
- The Stock Solution Transfer Set is used to transfer fluid from an I.V. bag of a compounded drug into a final container, which is a syringe.
Each process is performed using aseptic technique within the ISO 5 environment using the IVX Pharmacy Compounding Station.
The IVX Fluid Transfer Set is intended to be used by trained healthcare personnel and is not intended to be used for direct patient contact.
The provided text is a 510(k) Premarket Notification from Omnicell, Inc. for the IVX Fluid Transfer Set. It focuses on demonstrating substantial equivalence to a predicate device (KIRO Set) primarily through performance bench testing and biocompatibility testing, rather than clinical studies involving human readers or AI algorithms.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML medical device (referring to MRMC studies, ground truth, expert adjudication, training/test sets, etc.) is largely not applicable to this specific device (IVX Fluid Transfer Set). This is a physical fluid transfer device, not a software or AI/ML product.
However, I can extract the relevant "acceptance criteria" and "device performance" in the context of this physical medical device as presented in the document.
Here's a breakdown based on the provided text, addressing what is applicable and noting what is not:
Acceptance Criteria and Device Performance (for a physical medical device)
The document states that "The IVX Fluid Transfer Set has met all established acceptance criteria for performance testing and design verification testing." While specific numerical acceptance criteria values are not explicitly laid out in a table with corresponding measured performance alongside, the types of tests performed serve as the basis for demonstrating that the device meets its intended use and is safe and effective.
Here's how the general concept of "acceptance criteria" and "device performance" can be interpreted from the text for this physical medical device:
1. A table of acceptance criteria and the reported device performance:
The document lists various tests performed. The "acceptance criterion" for each would generally be "compliance with the standard" or "no adverse findings." The "reported device performance" is implicitly "met the standard" or "passed the test."
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility: | |
| Hemolysis (ISO 10993-4:2017) acceptable limits | Passed (supports substantial equivalence, does not raise new questions of safety and effectiveness) |
| Cytotoxicity (ISO 10993-5:2009) acceptable limits | Passed (supports substantial equivalence, does not raise new questions of safety and effectiveness) |
| Irritation and Sensitization (ISO 10993-10:2010) acceptable limits | Passed (supports substantial equivalence, does not raise new questions of safety and effectiveness) |
| Acute Systemic Toxicity (ISO 10993-11:2017) acceptable limits | Passed (supports substantial equivalence, does not raise new questions of safety and effectiveness) |
| Material Mediated Pyrogen Testing (USP ) acceptable limits | Passed (supports substantial equivalence, does not raise new questions of safety and effectiveness) |
| Bench Performance Testing: | |
| Performance (ISO 22413:2021) compliance | Passed (No new questions of safety and effectiveness) |
| Performance (ISO 8536-4:2019) compliance | Passed (No new questions of safety and effectiveness) |
| Performance (ISO 80369-7:2021) compliance | Passed (No new questions of safety and effectiveness) |
| Performance (ISO 80369-20:2015) compliance | Passed (No new questions of safety and effectiveness) |
| Particulate Matter in Injections (USP) acceptable limits | Passed (No new questions of safety and effectiveness) |
| Microbial Ingress Testing acceptable limits | Passed (No new questions of safety and effectiveness) |
| Dose accuracy with representative fluids (when used with IVX Pharmacy Compounding Station) acceptable limits | Evaluated and met (No new questions of safety and effectiveness) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in terms of number of devices tested for each performance or biocompatibility test. The document refers to "Performance bench testing was conducted," implying a sufficient number of samples were tested to meet the requirements of the standards.
- Data Provenance: The tests were conducted internally by Omnicell, Inc. or by a contracted lab following established medical device testing standards (ISO, USP). The document indicates these are "bench tests," not clinical studies. Therefore, specific country of origin or retrospective/prospective designation for data from human subjects is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. This is a physical device, not an AI/ML diagnostic tool. Ground truth in this context would be established by validated laboratory equipment and protocols, not expert human readers.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. This concept applies to human expert review for establishing ground truth in diagnostic studies, not to bench testing of a physical device.
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. "No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device."
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 concensus, pathology, outcomes data, etc.):
- Bench Testing Standards/Validated Methods: For biocompatibility, ground truth is established by the results of standardized biological tests (e.g., cell viability assays for cytotoxicity, hemolytic index for hemolysis). For performance, ground truth is established by direct measurement against specified engineering requirements and compliance with international standards (e.g., flow rates, pressure resistance, particulate matter counts).
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device. Training sets are relevant for machine learning algorithms.
9. How the ground truth for the training set was established:
- Not Applicable. As above, training sets and their ground truth are concepts for AI/ML development.
Summary regarding the nature of this submission:
This 510(k) submission is for a Class II physical medical device (IVX Fluid Transfer Set). The primary pathway for clearance is demonstrating substantial equivalence to an existing predicate device (KIRO Set) through benchtop performance testing and biocompatibility testing. The concepts of AI/ML performance, human reader studies, and training/test set ground truth as typically discussed for software as a medical device (SaMD) are not relevant to this specific submission. The "acceptance criteria" and "performance" here refer to meeting engineering specifications and safety standards.
§ 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.