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For the administration of fluids from a container into the patient's vascular system through a vascular access device.

The proposed devices consist of Solution Administration Sets. These devices include Basic, Secondary, CONTINU-FLO solution sets, Stand-Alone devices and Chemotherapy devices (see Table 2 for a list of subject device set names per product family). They are single use disposable, non-pyrogenic, sterile devices intended for the administration of fluids from a container into the patient's vascular system.

This is a 510(k) premarket notification for "Solution Administration Sets" by Baxter Healthcare Corporation. The document states that the devices are substantially equivalent to a predicate device (K203609 cleared on September 30, 2021).

Here's the breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a specific table of acceptance criteria with corresponding performance values in the format usually seen for AI/ML devices. Instead, it describes general conformance to recognized standards and the positive outcomes of various tests.

Note: This submission is for a traditional medical device (solution administration sets), not an AI/ML device. Therefore, the questions related to AI/ML specific studies (sample size for test set, data provenance, number of experts for ground truth, adjudication, MRMC study, standalone performance, training set sample size, training set ground truth) are not applicable to this document. The "tests" described are standard engineering, biocompatibility, and sterilization validations for physical medical devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable, as this is a traditional medical device, not an AI/ML device. The testing described is bench testing and biocompatibility assessments, not a study involving patient data or a specific test set in the AI/ML context.

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)

Not applicable, as this is a traditional medical device, not an AI/ML device. Ground truth as typically defined for AI/ML models is not relevant here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is a traditional medical device, not an AI/ML device.

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, as this is a traditional medical device, not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as this is a traditional medical device, not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as this is a traditional medical device, not an AI/ML device. Instead of "ground truth," the device relies on conformance to established international and national standards (ISO, ASTM, USP) and predefined acceptance criteria for various physical, chemical, and biological tests.

8. The sample size for the training set

Not applicable, as this is a traditional medical device, not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable, as this is a traditional medical device, not an AI/ML device.

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For the retention of microorganisms and removal of air and particulate matter from infusion fluids.

The Solution Administration Sets with a 0.2 micron filter product line consists of sterile, non-pyrogenic, single use disposable devices used for the administration of fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. They are indicated for the retention of microorganisms and removal of air and particulate matter from infusion fluids. The filter consists of a 0.2 micron polyethersulfone (PES) solution membrane and 0.1 micron polyvinylidene fluoride air vent membrane enclosed in a copolyester housing.

The provided text is a 510(k) summary for a medical device (Solution Administration Sets with 0.2 Micron Filter) and, as such, focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance rather than a comprehensive study evaluating device performance against established acceptance criteria in a research context.

This document does not contain the kind of detailed information about a study that would rigorously prove a device meets acceptance criteria in the typical scientific sense (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies). It is a regulatory submission, so the "studies" are verification tests to ensure the modified device is equivalent to the predicate.

However, I can extract the acceptance criteria mentioned and the reported "performance" based on the provided text, while noting the limitations in the depth of information available.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document only states that "All tests met the acceptance criteria" without providing the specific numerical or qualitative thresholds for those criteria. It implies that these criteria were pre-established internally by Baxter Healthcare Corporation for their risk analysis and design verification.

Here's why the other requested information is largely not present in this type of regulatory document:

2. Sample size used for the test set and the data provenance:

• Not explicitly stated. The document is a summary and does not include the detailed protocols, sample sizes, or statistical analysis reports from the bench tests or biocompatibility assessments.
• Data Provenance: The tests were conducted by Baxter Healthcare Corporation. The document doesn't specify the country of origin for the data beyond that. These are typically internal corporate studies (retrospective in the sense that they are conducted on manufactured samples, but prospective in terms of the test design).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not mentioned. This information is typically relevant for studies involving human interpretation (e.g., image analysis, clinical evaluations). For bench tests and biocompatibility tests of a physical device, the "ground truth" is typically defined by scientific principles, international standards (e.g., ISO-10993), and validated test methodologies. There's no "expert ground truth" in the sense of consensus from adjudicators.

4. Adjudication method for the test set:

• Not applicable/Not mentioned. As above, adjudication is not a standard part of these types of engineering and biological safety tests. The results are typically quantitative measurements against defined specifications.

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:

• No. This is a completely different type of study, relevant for AI/radiology devices. This document is a 510(k) for an administration set with a filter, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This question pertains to AI algorithms. The device discussed is a physical medical device.

7. The type of ground truth used:

• For Performance Data (e.g., flow rate, bacterial retention): The "ground truth" would be established by the validated test methods themselves, based on physical and microbiological principles, often referenced to international standards or established industry practices for filter performance.
• For Biocompatibility: The "ground truth" is defined by the requirements of international standards like ISO-10993-1 and FDA guidance, which specify the types of biological responses that are considered acceptable or unacceptable.

8. The sample size for the training set:

• Not applicable. This question refers to machine learning models. This device does not involve a "training set" in that context.

9. How the ground truth for the training set was established:

• Not applicable. As above, no training set for an AI model is involved.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document describes a series of nonclinical bench tests and biocompatibility assessments conducted by Baxter Healthcare Corporation.

• Objective: To evaluate the effect of a material modification (change in solution membrane material from one hydrophilic polyethersulfone to another hydrophilic polyethersulfone) in the 0.2 micron filter within their Solution Administration Sets. The goal was to establish substantial equivalence to the previously cleared predicate device (K964850).
• Tests Performed:
  • Performance Data: Air diffusion, bubble point, gravity flow rate, flow rate post sterile water conditioning, flow rate post parenteral nutrition conditioning, and bacterial retention.
  • Biocompatibility: Cytotoxicity, Systemic Toxicity, Intracutaneous, Hemolysis, Pyrogen, Sensitization, and USP Physicochemical. These were conducted in accordance with ISO-10993 and FDA guidance.
• Results: The document states that "All tests met the acceptance criteria."
• Conclusion: Based on these tests, Baxter concluded that "The non-clinical data demonstrate that the subject device is substantially equivalent and performs comparably to the predicate devices that are currently marketed for the same intended use."

This is a regulatory study designed to show equivalence, not an independent research study to establish novel performance claims.

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To Administer IV Fluids/medications to the patient's vascular system.
To administer IV Fluids into a patient's vascular system

The PENTADEFLU IV Administration Sets are Single Use, Sterile, Non-Pyrogenic devices used to administer IV fluids/medications to a patient's vascular system via gravity control.

The provided text describes the 510(k) summary for the PENTADEFLU IV Administration Sets, a medical device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials with acceptance criteria and comparative effectiveness studies as might be seen for novel therapeutic devices or AI-powered diagnostics.

Therefore, the information requested, such as acceptance criteria based on performance metrics, sample sizes for test and training sets, expert adjudication methods, MRMC studies, and ground truth establishment, is generally not present or applicable in the context of this 510(k) summary. The summary focuses on engineering and biocompatibility testing, along with demonstrating similarity to a predicate device.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable / Not Provided. This 510(k) summary does not describe a "test set" in the context of an AI/ML algorithm or diagnostic accuracy study. The testing mentioned refers to engineering, performance, biocompatibility, and sterility testing of the physical device. The provenance of samples for these tests (e.g., manufacturing batches) is not detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable / Not Provided. Ground truth establishment by experts during a diagnostic accuracy study is not relevant to this device's 510(k) submission.

4. Adjudication method for the test set

• Not Applicable / Not Provided. Adjudication methods are relevant for diagnostic studies, not for the type of device described here.

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 / Not Provided. This device is an IV administration set, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable / Not Provided. This device is a physical medical administration set, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable / Not Provided directly in this format. For a physical device like an IV set, "ground truth" would refer to its adherence to engineering specifications, biocompatibility standards, and sterility requirements as verified by standardized testing methods and regulatory guidelines (e.g., ISO standards, FDA regulations for IV sets). This isn't "ground truth" in the diagnostic sense.

8. The sample size for the training set

• Not Applicable / Not Provided. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

• Not Applicable / Not Provided. There is no "training set."

Summary of the Study:

The "study" described in the 510(k) summary for the PENTADEFLU IV Administration Sets is a series of performance and safety tests conducted to demonstrate the device's conformance to established standards and its substantial equivalence to a legally marketed predicate device (Victus IV Administration Sets, K023469).

The key aspects of the study are:

• Type of Study: Bench testing for mechanical properties, functioning, biocompatibility, and sterility. There are no clinical trials or human subject studies described for this 510(k).
• Purpose: To verify that the device meets safety and performance requirements for its intended use and is substantially equivalent to the predicate device.
• Methodology: Testing was conducted "using FDA recognized Standards, where applicable." The specific standards are not listed in this summary, but they would typically include ISO standards for medical devices, specifically those pertaining to IV administration sets (e.g., ISO 8536 series), as well as biocompatibility standards (e.g., ISO 10993 series) and sterility validation.
• No specific acceptance criteria values (e.g., tensile strength, flow rate tolerances) or numerical performance results are included in this high-level summary. The statement merely indicates that such testing was performed and verified.
• Comparison to Predicate: The submission asserts that the device has "the same technological characteristics" as the predicate and that "no modifications to the device design that affect safety and effectiveness" have been made. This forms the primary basis for the substantial equivalence determination.

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