(350 days)
To administer fluids with Baxter infusion pumps to a patient's vascular system from a container though a needle or catheter inserted into a vein, primarily used to admining the chemotherapeutic drug paclitaxel, but can also be used for general solution administration.
The Paclitaxel Sets product line consists of single use disposable devices intended for the administration of fluids from a container into the patient's vascular system through a vascular device, primarily for solutions containing the chemotherapeutic drug paclitaxel. These devices are the same as the current marketed devices, which were previously cleared under 510(k) premarket notification K981792 (cleared August 17, 1998).
The sets are each comprised of a non-DEHP drip chamber with a spike, 0.2 micron filter, non-DEHP polyvinyl chloride tubing pump segment, polyethylene (PE)-lined trilayer tubing, and a luer lock. On all sets there is a fixtured slide clamp and an on-off roller clamp. Configurations of these sets differ in overall length, type of injection site (Interlink or Clearlink), and type of spike (vented or non-vented).
The basis for this premarket notification is a change to the PE-lined trilayer tubing and the 0.2 micron filter currently used in this product line. The inner layer material of the trilayer tubing is changing from Low Density Polyethylene to Linear Low Density Polyethylene. The solution membrane material of the 0.2 micron filter is changing from a hydrophilic polyethersulfone (PES) to another equivalent hydrophilic PES. All changes have been previously cleared under 510(k) premarket notifications for other Baxter Intravascular (IV) Administration Sets.
The provided text describes a 510(k) premarket notification for "Paclitaxel Sets" by Baxter Healthcare Corporation. It outlines the changes made to an existing device, its intended use, and the nonclinical tests conducted to demonstrate equivalence to a predicate device.
However, the document does NOT describe the acceptance criteria and the study that proves a device (e.g., an AI algorithm, a diagnostic tool) meets the acceptance criteria in the context of improving human reader performance or a standalone algorithmic performance.
Instead, this document pertains to a resubmission for a physical medical device (intravenous administration sets) with material changes, and the "acceptance criteria" discussed are largely related to bench testing and material compatibility to ensure that the modified physical device performs equivalently to the original predicate device.
Therefore, many of the requested points, such as AI-assisted human reader improvement, standalone algorithm performance, number of experts for ground truth, adjudication methods, training set details, and MRMC studies, are not applicable to this type of device submission.
Here's an attempt to answer the
questions based on the provided text, highlighting what is present and what is absent/not applicable:
1. A table of acceptance criteria and the reported device performance
The document lists various bench tests and their acceptance criteria, which are consistently stated as "Per Baxter test method" or "Equivalence to predicate device." The actual quantitative performance data that verifies these acceptance criteria are not reported in this summary document, only that the tests were conducted and the results met their criteria.
| Test | Acceptance Criteria | Reported Device Performance (as stated in document) |
|---|---|---|
| Clear Passage Test | Per Baxter test method. | "All test results meet their acceptance criteria, and support that the proposed devices are appropriately designed for their intended use." (Specific data not provided) |
| Roller Clamp Force Test | Per Baxter test method. | "All test results meet their acceptance criteria, and support that the proposed devices are appropriately designed for their intended use." (Specific data not provided) |
| Roller Clamp Shut-Off Test | Per Baxter test method. | "All test results meet their acceptance criteria, and support that the proposed devices are appropriately designed for their intended use." (Specific data not provided) |
| Roller Clamp Tubing Leak Test | Per Baxter test method. | "All test results meet their acceptance criteria, and support that the proposed devices are appropriately designed for their intended use." (Specific data not provided) |
| Solvent Bond Tensile Strength Test | Per Baxter test method. | "All test results meet their acceptance criteria, and support that the proposed devices are appropriately designed for their intended use." (Specific data not provided) |
| Solvent Bond Air Pressure Test | Per Baxter test method. | "All test results meet their acceptance criteria, and support that the proposed devices are appropriately designed for their intended use." (Specific data not provided) |
| Air Diffusion Test | Per Baxter test method. | "All test results meet their acceptance criteria, and support that the proposed devices are appropriately designed for their intended use." (Specific data not provided) |
| Bubble Point Test | Per Baxter test method. | "All test results meet their acceptance criteria, and support that the proposed devices are appropriately designed for their intended use." (Specific data not provided) |
| Gravity Flow Rate Test | Per Baxter test method. | "All test results meet their acceptance criteria, and support that the proposed devices are appropriately designed for their intended use." (Specific data not provided) |
| Flow Rate Test Post Sterile Water Conditioning | Per Baxter test method. | "All test results meet their acceptance criteria, and support that the proposed devices are appropriately designed for their intended use." (Specific data not provided) |
| Flow Rate Test Post Parenteral Nutrition Conditioning | Per Baxter test method. | "All test results meet their acceptance criteria, and support that the proposed devices are appropriately designed for their intended use." (Specific data not provided) |
| Bacterial Retention Test | Per Baxter test method. | "All test results meet their acceptance criteria, and support that the proposed devices are appropriately designed for their intended use." (Specific data not provided) |
| Upstream/Downstream Occlusion Test (with Baxter pumps: FLO-GARD and SIGMA Spectrum) | Per Baxter test method. | "All test results meet their acceptance criteria, and support that the proposed devices are appropriately designed for their intended use." (Specific data not provided) |
| Drug Compatibility Test (Paclitaxel Concentration) | Equivalence to predicate device. | "All test results meet their acceptance criteria, and support that the proposed devices are appropriately designed for their intended use." (Specific data not provided) |
| Drug Compatibility Test (pH) | Equivalence to predicate device. | "All test results meet their acceptance criteria, and support that the proposed devices are appropriately designed for their intended use." (Specific data not provided) |
| Drug Compatibility Test (Color) | Equivalence to predicate device. | "All test results meet their acceptance criteria, and support that the proposed devices are appropriately designed for their intended use." (Specific data not provided) |
| Drug Compatibility Test (Visual Inspection) | Equivalence to predicate device. | "All test results meet their acceptance criteria, and support that the proposed devices are appropriately designed for their intended use." (Specific data not provided) |
| Biocompatibility tests (Cytotoxicity, Systemic Toxicity, Irritation/Intracutaneous Reactivity, Sensitization, Hemocompatibility, Material Mediated Pyrogen, USP Physiochemical) | In accordance with ISO-10993. | "Biocompatibility assessments were conducted... The battery of testing included the following tests." (Results stating compliance are implied, specific data not provided) |
| Sterility validation (MSD, SAL) | 10^(-6) SAL for gamma radiation. | Established and validated at 14.2 – 25.0 kGy. In compliance with ANSI/AAMI/ISO 11137-2. |
| Package verification (Visual, Seal Strength, Bubble Leak) | Per ASTM F88, ASTM F2096. | Not explicitly stated what was found, but implied to have met criteria for "Sterile, nonpyrogenic" labeling. |
| Shelf-Life (Aging tests) | Not specified. | Supported an 18-month shelf-life claim. |
2. Sample sizes used for the test set and the data provenance
- Sample Size: The document does not specify the sample sizes (number of units) used for each of the bench tests.
- Data Provenance: Not applicable in the context of patient data for a diagnostic/AI device. The testing is bench testing of physical units.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study involving human interpretation of data where expert consensus is needed for ground truth (e.g., medical image interpretation). The "ground truth" for this device is its physical and chemical properties and performance, validated through standard engineering and laboratory tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There's no human interpretation or subjective judgment that would require adjudication for this type of bench testing.
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 device is an intravenous administration set, not an AI or diagnostic device that would assist human readers.
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 algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on established engineering standards, validated laboratory tests, and equivalence to a legally marketed predicate device. For drug compatibility, it is based on observed equivalence in concentration, pH, color, and visual inspection to the predicate device. For sterility, it's based on a defined Sterility Assurance Level validated against ISO standards.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
Summary of Device Performance Study:
The studies described are non-clinical bench tests and biocompatibility assessments designed to demonstrate that the changes made to the "Paclitaxel Sets" (specifically, the inner layer material of the trilayer tubing and the solution membrane material of the 0.2 micron filter) do not negatively impact the intended use or fundamental scientific technology of the device. The reported performance is that "All test results meet their acceptance criteria," indicating successful demonstration of equivalence or performance according to internal Baxter test methods and relevant international standards (e.g., ISO-10993, ANSI/AAMI/ISO 11137-2, ASTM standards). The specific quantitative results are not included in this summary document.
§ 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.