(88 days)
The solution adminstration set will be used to administer fluids to a patient's vascular system from a container through a needle or catheter inserted into a vein. The proposed solution set will be primarily used to administer solutions containing the chemotherapeutic drug paclitaxel, but can also be used for general solution administration with Baxter Flo-Gard® (6200 and 6300 series) and Colleague" volumetric infusion pumps.
The proposed solution set will be used for the administration of intravenous solutions containing the chemotherapeutic drug paclitaxel. The package insert for paclitaxel recommends that the drug be administered parenterally through a polyethylene-lined set because of the concern with diethyl-2-hexylphthalate (DEHP) leaching from DEHP plasticized polyvinyl chloride (PVC). The proposed set is designed to meet the package insert recommendations in that it contains polyethylene-lined tubing, an in-line 0.22 um filter, and no DEHP plasticized PVC in contact with the solution.
The provided 510(k) Premarket Notification document (K981792) is for a "Solution Administration Set". This type of medical device is a physical product, not an AI/ML algorithm. Therefore, many of the requested criteria related to AI/ML device studies (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment for training set) are not applicable to this submission.
However, based on the non-clinical tests described, here's an attempt to extract relevant information and note the inapplicable sections:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Functional performance meets requirements for administering IV solutions. | "proposed paclitaxel device meets or exceeds all functional requirements" |
| Compatibility with paclitaxel (does not leach DEHP into solution). | Compatibility with paclitaxel "has been generated." |
| No DEHP plasticized PVC in contact with the solution (specific design feature). | "contains polyethylene-lined tubing... and no DEHP plasticized PVC in contact with the solution." |
| In-line 0.22 um filter is present and functional. | "contains... an in-line 0.22 um filter." |
| New device is substantially equivalent to predicate device (Baxter nitroglycerin set K83284A). | Stated as "similar" with "principal differences" accounted for (spike design, 0.22µm filter, TEHTM plasticizer). |
| All solution contact materials are identical to materials used in legally marketed devices. | "All solution contact materials to be used in the proposed set are identical to materials used in legally marketed devices under comparable conditions of use." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the document. The document refers to "Data regarding the functional performance" being "generated," but does not provide details on the number of units tested.
- Data Provenance: Not explicitly stated, but assumed to be generated from non-clinical laboratory testing performed by Baxter Healthcare Corporation. It is prospective testing of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This criterion is not applicable. The device is a physical administration set; its "ground truth" is its physical and chemical properties and functional performance, which are evaluated through direct testing, not expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This criterion is not applicable. Adjudication methods are typically used for expert consensus on image interpretation or complex clinical outcomes. The functional testing of a physical device does not involve such methods.
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 criterion is not applicable. The device is a physical medical device, not an AI/ML algorithm. No human reader studies with AI assistance were performed or are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This criterion is not applicable. The device is a physical medical device, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance would be established through direct physical and chemical testing standards and laboratory analyses. For example:
- Measurement of flow rates.
- Chemical analysis for DEHP leaching.
- Filtration efficacy.
- Material compatibility tests.
- Sterility validation (implied for an IV set, though not explicitly detailed here).
8. The sample size for the training set
- This criterion is not applicable. The device is a physical medical device, not an AI/ML algorithm. "Training sets" are for AI/ML models.
9. How the ground truth for the training set was established
- This criterion is not applicable. The device is a physical medical device, not an AI/ML algorithm.
§ 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.