(355 days)
For administering fluids from container to a patient's vascular system through a vascular access device. Used for the removal of particulate matter and elimination of air from infusion fluids while administering. May be used with TPN solutions containing lipid emulsions.
The Solution Set with 1.2 Micron Air Eliminating Filter product line consists of single use disposable device for administering fluids from container to a patient's vascular system through a vascular access device. Used for the removal of particulate matter and elimination of air from infusion fluids while administering. The filter consists of a 1.2 micron filter consisting of polysulfone solution membrane and a Teflon air vent media enclosed in an acrylic housing and may be used with TPN solutions containing lipid emulsions. The 1.2 micron filter has a maximum pressure of 45 psi (2241 kPa). The Solution Set with 1.2 Micron Air Eliminating Filter was previously cleared under 510(k) premarket notification K952074 (cleared July 27, 1995).
The basis for this premarket notification is modifications to the Solution Set with 1.2 Micron Air Eliminating Filter product line. The modifications consists of the use of a Non-DEHP PVC tubing material that uses Di (2-Ethylhexyl) terephthalate as a plasticizer to provide an alternate to the current Non-DEHP PVC tubing material, conversion to sterile packaging, addition of an expiration date, and updates to the labeling.
The provided document is a 510(k) premarket notification from Baxter Healthcare Corporation to the FDA for a "Solution Set with 1.2 Micron Air Eliminating Filter." This document is not about an AI/ML medical device. It concerns a physical medical device (an intravenous administration set) and its modifications.
Therefore, many of the requested categories related to AI/ML device studies (such as the number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details) are not applicable to this document. The document describes traditional medical device performance testing and biocompatibility assessments.
However, I can extract the acceptance criteria and performance results for the physical device as described in the document.
Here's an analysis of the provided document focusing on the acceptance criteria and study that proves the device meets them, adapted to the context of a physical medical device.
Device Name: Solution Set with 1.2 Micron Air Eliminating Filter
Purpose of the Submission:
The basis for this premarket notification is modifications to an existing device (previously cleared under K952074). The modifications include:
- Use of a Non-DEHP PVC tubing material that uses Di (2-Ethylhexyl) terephthalate as a plasticizer.
- Conversion to sterile packaging.
- Addition of an expiration date.
- Updates to the labeling.
The submission aims to demonstrate that these modifications do not impact the intended use or the fundamental technology of the devices and that the modified devices are substantially equivalent to the predicate device.
1. Table of Acceptance Criteria and the Reported Device Performance:
The document lists performance tests conducted to evaluate the effect of using the proposed Non-DEHP PVC tubing material. The acceptance criterion for all these tests is "Per Baxter Test Method." The document explicitly states the overall performance: "All tests met the acceptance criteria."
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Solvent Bond Tensile Strength Test | Per Baxter Test Method. | Met acceptance criteria. |
| Solvent Bond Air Pressure Test | Per Baxter Test Method. | Met acceptance criteria. |
| Continuous Bubble Test (Pump Compatibility Test) | Per Baxter Test Test Method. | Met acceptance criteria. |
| Accumulated Bubble Test (Pump Compatibility Test) | Per Baxter Test Method. | Met acceptance criteria. |
| Slide Clamp Shut-Off Test | Per Baxter Test Method. | Met acceptance criteria. |
| Slide Clamp Shut-Off Test-Post 24 Hour | Per Baxter Test Method. | Met acceptance criteria. |
| Slide Clamp 7 Day Subsystem and Tubing Damage Test | Per Baxter Test Method. | Met acceptance criteria. |
| Slide Clamp Flow Stability Test | Per Baxter Test Method. | Met acceptance criteria. |
| Slide Clamp Tug Stability Test | Per Baxter Test Method. | Met acceptance criteria. |
| Upstream Occlusion Test (Pump Compatibility Test) | Per Baxter Test Method. | Met acceptance criteria. |
| Downstream Occlusion Test (Pump Compatibility Test) | Per Baxter Test Method. | Met acceptance criteria. |
| Roller Clamp Force Test | Per Baxter Test Method. | Met acceptance criteria. |
| Roller Clamp Shut-Off Test | Per Baxter Test Method. | Met acceptance criteria. |
| Roller Clamp 7 Day Subsystem and Tubing Damage Test | Per Baxter Test Method. | Met acceptance criteria. |
| Roller Clamp Flow Stability Test | Per Baxter Test Method. | Met acceptance criteria. |
| Roller Clamp Tug Stability Test | Per Baxter Test Method. | Met acceptance criteria. |
| Total Parenteral Nutrition (TPN) Resistance Test | Per Baxter Test Method. | Met acceptance criteria. |
| Roller Clamp Flow Control Test | Per Baxter Test Method. | Met acceptance criteria. |
| Administration Set Integrity Test After Maximum Fluid Delivery (Pump Compatibility Test) | Per Baxter Test Method. | Met acceptance criteria. |
| Flow Rate Accuracy Test (Pump Compatibility Test) | Per Baxter Test Method. | Met acceptance criteria. |
| ISO Luer Tests on Male Luer Lock Connectors | Per ISO Standard 594 | Met acceptance criteria. (Implied, as "All tests met...") |
Biocompatibility Tests:
| Biocompatibility Test | Applicable Standard | Reported Device Performance |
|---|---|---|
| In Vitro Cytotoxicity | ISO10993-5 | Biocompatible and appropriate for intended use. |
| Sensitization | ISO10993-10 | Biocompatible and appropriate for intended use. |
| Intracutaneous (Irritation) Reactivity Assay | ISO10993-10 | Biocompatible and appropriate for intended use. |
| Systemic Injection (Acute Toxicity) | ISO10993-11 | Biocompatible and appropriate for intended use. |
| Sub-Chronic Toxicity (Repeat Dose) | ISO10993-11 | Biocompatible and appropriate for intended use. |
| Material Mediated Pyrogen | ISO10993-11 | Biocompatible and appropriate for intended use. |
| Hemocompatibility (In Vitro Hemolysis) | ISO10993-4 | Biocompatible and appropriate for intended use. |
| USP Physiochemical tests | USP | Biocompatible and appropriate for intended use. |
Sterility & Shelf Life:
- Sterilization Method: Radiation (Method No. 1 as described in ISO 11137-2).
- Sterility Assessment: Minimum Sterilizing Dose (MSD) established and validated to provide a 10⁻⁶ Sterility Assurance Level (SAL).
- Package Verification: Visual Inspection, ASTM F88 Seal Strength, and ASTM F2096 Bubble Leak. ("These products are labeled 'Sterile, Nonpyrogenic.'")
- Shelf Life: Twenty-four (24) months, supported by aging testing.
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size for performance tests: Not explicitly stated in terms of a numerical count for each test. The document states, "All evaluations were performed on the product code set configuration (Code: 2R8486) that is using the proposed Non-DEHP PVC tubing material." This implies that samples of this specific configuration were used for all listed tests.
- Data Provenance: The studies were conducted by Baxter Healthcare Corporation. No specific country of origin for the data is mentioned, but the company is based in the US (Deerfield, Illinois). The studies are "bench tests" and "design verification tests," which implies a prospective testing approach conducted in a laboratory setting rather than retrospective analysis of clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not Applicable. This is a physical medical device. Ground truth, in the context of AI/ML, refers to clinically relevant labels from human annotators for image or signal data. For this device, "ground truth" is typically defined by engineering specifications, industrial standards (e.g., ISO, ASTM, USP), and established test methods, verified by objective measurements. These are not established by "experts" in the clinical sense (e.g., radiologists) for performance testing.
4. Adjudication Method for the Test Set:
- Not Applicable. As this is a physical medical device undergoing bench and biocompatibility testing, there is no need for human expert adjudication of results in the way it's done for AI/ML diagnostic tools. The results are quantitative measurements against predefined criteria/standards.
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 a physical medical device, not an AI-assisted diagnostic tool or an AI/ML algorithm.
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 or algorithm. The performance tests ("bench tests") can be considered analogous to "standalone" performance for a physical device, as they assess the device's function directly without human intervention in its operation (beyond setting up the test).
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- For Performance Data: The "ground truth" is based on the device meeting the "Per Baxter Test Method" criteria and "ISO Standard 594." These are engineering and performance specifications.
- For Biocompatibility Data: The "ground truth" is based on meeting the requirements of various ISO 10993 standards (e.g., ISO10993-4, ISO10993-5, ISO10993-10, ISO10993-11) and USP . These are international and national standards for biological evaluation of medical devices.
- For Sterility: The "ground truth" is based on meeting ISO 11137-2 for achieving a 10⁻⁶ Sterility Assurance Level (SAL).
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. This is not an AI/ML device; therefore, there is no "training set" or ground truth establishment relevant to AI/ML.
§ 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.