(65 days)
To provide the pharmacist or health practitioner a means of connecting a standard 20 mm single dose drug vial to an I.V. solution container without mixing the vial contents with the diluent until immediately before administration of the patient.
The VIAL-MATE Reconstitution Device is intended for use by the pharmacist or health practitioner in the reconstitution and transfer of drugs into Baxter solution containers. The VIAL MATE Reconstitution Device provides a means of connecting a standard 20 mm single dose powdered drug vial to an I.V. solution container without mixing the vial contents with the diluents until immediately before reconstitution and administration of the drug to the patient. This device has been previously cleared under 510(k) premarket notification K973654 (cleared on October 24, 1997).
The basis for this premarket notification is a modification to the labeling of the product. This modification will update the label to clarify the description of the product and user instructions. Additionally, Baxter will update the product labeling to comply with Baxter's labeling standards and add the indications for use statement that was previously cleared for this device under 510(k) premarket notification K973654. The modification to the labeling does not impact the intended use or the fundamental scientific technology of the device. No new materials of construction are being introduced into this device as part of this update.
This document is a 510(k) premarket notification for the VIAL-MATE Reconstitution Device, where the basis for the submission is a modification to the labeling of an already cleared device (K973654). Therefore, the provided text does not contain information about a study proving the device meets acceptance criteria in the context of clinical performance or algorithm accuracy as would be typical for AI/ML devices.
Instead, the "acceptance criteria" and "study" refer to bench tests conducted to evaluate the functional performance and safety of the device, particularly in ensuring its physical integrity and proper operation.
Here's the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Functional Performance & Safety) | Reported Device Performance |
|---|---|
| Seal flange to bag port adapter integrity | All tests met the acceptance criteria. |
| Cannula to medication port integrity | All tests met the acceptance criteria. |
| Septum to cannula hub integrity | All tests met the acceptance criteria. |
| Septum to drug vial stopper integrity | All tests met the acceptance criteria. |
| Port adapter removal force from the VIAFLEX container medication port | All tests met the acceptance criteria. |
| Tamper evident seal integrity | All tests met the acceptance criteria. |
| Vial gripper removal force from drug vial | All tests met the acceptance criteria. |
| Flow through device to and from drug vial and VIAFLEX container | All tests met the acceptance criteria. |
| Residual volume: Device vial and VIAFLEX container | All tests met the acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for each individual bench test. The phrase "All tests met the acceptance criteria" implies that a sufficient number of devices were tested to draw this conclusion, but the exact numbers are not provided. These are bench tests, not clinical studies, so "data provenance" in terms of country of origin or retrospective/prospective is not applicable in the same way it would be for patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a physical reconstitution device, and the "ground truth" for its functional performance is established through defined engineering and quality control specifications and measurements, not expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. The tests involve objective measurements of physical properties and functional aspects, not subjective interpretations requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. This is a physical medical device, not an AI/ML algorithm requiring an MRMC study.
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 AI/ML algorithm.
7. The Type of Ground Truth Used
The "ground truth" for these tests would be objective, measurable engineering specifications and performance standards (e.g., specific force ranges for removal, defined integrity thresholds for seals, quantifiable flow rates, measurable residual volumes).
8. The Sample Size for the Training Set
Not applicable. This is a physical device submission based on labeling changes to an existing device. There is no AI/ML model or "training set" in this context.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no AI/ML model or training set, this question is not relevant to the provided information.
§ 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.