(13 days)
The Rapid-Fill Tubeset, manufactured by Baxa Corporation, is a fluid transfer device used in the pharmacy to provide the fluid path for transferring large source container ingredients into a smaller containers.
The Rapid-Fill Tubeset, is a tubeset used in conjunction with the Rapid-Fill pharmacy pump to fill multiple syringes.
This document describes a 510(k) premarket notification for the Rapid-Fill™ Tubeset, a medical device used for fluid transfer. The submission focuses on demonstrating substantial equivalence to a predicate device, the Exacta-Mix™ 2400 Compounding System Administration Set. The information provided outlines the device's intended use and design, and the testing conducted is primarily focused on safety and manufacturing compliance rather than performance metrics related to diagnostic accuracy or clinical outcomes.
Here's an analysis of the provided text in relation to your request:
1. Table of acceptance criteria and the reported device performance:
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the way one would typically expect for a diagnostic or AI-powered device. Instead, the "acceptance criteria" are implied by the nature of a 510(k) submission, which aims to demonstrate substantial equivalence to a legally marketed predicate device. This equivalence is primarily shown through shared features and safety/manufacturing testing.
| Acceptance Criteria Category | Specific Criteria (Implied from 510(k)) | Reported Device Performance | Comments |
|---|---|---|---|
| Intended Use Equivalence | To transfer fluid from large source containers to smaller containers (pharmac y setting). | The Rapid-Fill™ Tubeset is a fluid transfer device used in the pharmacy to provide the fluid path for transferring large source container ingredients into smaller containers. | Matches the predicate device's function, though the direction of transfer (multiple large to one final product vs. one large to multiple small) is noted as a difference but deemed acceptable for equivalence. |
| Material Equivalence | Non-DEHP Polyvinyl Chloride (PVC) tubing. | Non-DEHP Polyvinyl Chloride (PVC) tubing. | Met. Identical to predicate. |
| Sterilization Equivalence | Radiation Sterilized fluid path. | Radiation Sterilized fluid path. | Met. Identical to predicate. |
| Inlet Spike Design Equivalence | Vented and non-Vented source container spike. | Vented and non-Vented source container spike. | Met. Identical to predicate. |
| Biocompatibility | Meets ISO 10993-1 standards for medical device biocompatibility. | "Biocompatibility testing - ISO 10993-1" is listed as planned/completed testing. | Implied Met. Specific results are not provided, but completion of this testing is crucial for 510(k) clearance. |
| Packaging Validation | Ensures sterility and integrity of the device until use. | "Packaging validation" is listed as planned/completed testing. | Implied Met. Specific results are not provided. |
| Sterilization Validation | Ensures the device is sterile according to established standards. | "Sterilization validation" is listed as planned/completed testing. | Implied Met. Specific results are not provided. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not applicable and not provided in the document. The testing described (biocompatibility, packaging, sterilization) relates to manufacturing and material safety, not to clinical performance or algorithm evaluation with test sets of patient data.
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):
This information is not applicable and not provided. The device is an intravascular administration set, not an AI or diagnostic tool that requires ground truth established by experts for performance evaluation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable and not provided.
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:
This information is not applicable and not provided. The device is an administration set, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. The device is a physical medical device (tubing set), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not applicable and not provided. For this type of device, "ground truth" would refer to established standards for material safety, sterility, and manufacturing quality, verified through laboratory testing rather than clinical expert consensus or pathology on patient data.
8. The sample size for the training set:
This information is not applicable and not provided. The device is not an AI algorithm, so there is no "training set."
9. How the ground truth for the training set was established:
This information is not applicable and not provided. As there's no training set for an AI algorithm, no ground truth needs to be established in this context.
§ 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.