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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 are single use disposable devices intended for the administration of fluids from a container to the patient's vascular system. The extension sets consist of a combination of the following components: PVC or PE lined PVC tubing, a clamp, female Luer with non-vented cap, male Luer with filter vented cap. The accessories consist of an anti-siphon valve, back check valve, and 1.2 µm Filter. The accessories are used in combination with IV sets to administer solutions directly from a container to a patient's vascular system.

This FDA 510(k) summary describes an intravascular extension set and accessories. The filing primarily focuses on demonstrating substantial equivalence to a predicate device (K192366) and the removal of a caution statement related to body weight. Therefore, the information provided does not detail a study involving AI or complex performance metrics as typically seen for AI/ML-enabled devices.

Based on the provided text, the acceptance criteria and study information are as follows:

1. A table of acceptance criteria and the reported device performance

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

The document does not specify a "test set" in the context of performance evaluation with a defined sample size for the device itself. The primary testing mentioned is biocompatibility. For biocompatibility, there is no information about sample size or data provenance provided in this summary.

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. This device is a physical medical device (intravascular extension set and accessories), not an AI/ML-enabled device requiring expert ground truth for performance evaluation of diagnostic accuracy.

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

Not applicable. This device is a physical medical device, not an AI/ML-enabled device requiring adjudication of expert interpretations.

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. No MRMC study was performed as this is a physical medical device, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a physical medical device, not an algorithm.

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

Not applicable. For biocompatibility testing, the "ground truth" would be established by standardized testing methods and international standards (e.g., ISO 10993 series), not expert consensus, pathology, or outcomes data in the context of diagnostic performance.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable. As there is no training set mentioned, there is no ground truth established for a training set.

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

The proposed device consists of an IV Extension Set (Light Resistant Extension Set). It is a single use disposable, non-pyrogenic, sterile device intended for the administration of fluids from a container into the patient's vascular system. This IV extension set can be directly attached to a syringe but also used as an extension set to a primary set that is connected to a syringe (primarily to add length). The Light Resistant Extension Set consists of non-DEHP (<0.1% DEHP) PVC tubing, a notch clamp, female Luer, non-vented cap for female Luer, and filter vented cap for male Luer. It is used to administer fluids from a syringe into the patient's vascular system through a vascular access device, specifically fluids/drugs sensitive to light to the patients of all ages ranges - neonatal, pediatric, and adult.

The provided text describes the regulatory clearance of the Baxter Healthcare Corporation's Intravascular Extension Set (Light Resistant Extension Set) (K210430). The focus is on demonstrating substantial equivalence to a predicate device (K192366) through non-clinical testing.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

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

The document explicitly states that the studies were non-clinical bench tests. Therefore, the concept of "sample size for the test set" as applied to human subjects or medical imagery doesn't directly apply here. Instead, samples refer to manufactured units of the device tested in a laboratory setting. Specific numbers of units tested are not provided in this summary.

• Data Provenance: The tests are internal to Baxter Healthcare Corporation ("Per Baxter Test Method") or adhere to international standards (ISO, BS EN ISO, USP, ANSI/AAMI/ISO). There is no mention of country of origin for the data (beyond the standard bodies) or whether it's retrospective or prospective, as these terms are generally applicable to clinical or observational studies involving patients.

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

Not applicable. This report details non-clinical bench testing for device performance and safety, guided by engineering standards and internal protocols. There is no concept of "ground truth" established by medical experts for these types of tests.

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

Not applicable. Adjudication methods are typically used in clinical studies or studies involving expert interpretation of medical data to resolve discrepancies. This document describes objective bench testing with predefined acceptance criteria.

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 not a study involving AI assistance for human readers or interpretation of medical cases. It is a submission for a physical medical device (intravascular extension set).

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

Not applicable. This is not an algorithm or software device.

7. The type of ground truth used:

The "ground truth" in this context is defined by the objective pass/fail criteria outlined in the referenced international standards (e.g., ISO 80369-7, BS EN ISO 8536-9, USP 788) and Baxter's internal validated test methods. Meeting these established criteria confirms the device's functional performance, material properties, and safety.

8. The sample size for the training set:

Not applicable. There is no training set in the context of this physical device's non-clinical testing. Training sets are relevant to machine learning or AI models.

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

Not applicable, as there is no training set.

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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 IV Extension sets and IV set accessories. They are single use disposable devices intended for the administration of fluids from a container into the patient's vascular system. They are non-pyrogenic, sterile devices that can be used with or without a syringe. The extension sets consist of PVC tubing or polyethylene lined PVC tubing, a notch clamp, female luer, non-vented cap, male luer, and filter vented cap. They are used to administer solutions, drugs, antibiotics, lipids to the patient. The accessories consists of an anti-siphon valve, back check valve, and 1.2 µm Filter. They attach to the proposed sets to add a specific feature to facilitate the administration of fluid when used with a syringe. The anti-siphon valve reduces the risk of free flow from the syringe and backflow into the primary infusion line. The back check valve prevents backflow into the primary infusion line. The 1.2 um Filter prevents particulate matter and eliminates air bubbles.

The provided document is a 510(k) Summary for Baxter Healthcare Corporation's Intravascular Extension Sets and Accessories (K192366). It describes a Class II medical device intended for the administration of fluids into a patient's vascular system.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various tests conducted and generally states that "All tests met the acceptance criteria" without providing specific numeric results for each test. The acceptance criteria themselves are primarily referenced by external standards, not internal performance metrics.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for the individual performance tests (e.g., Luer tests, tensile strength, leak test, etc.). It only states that tests were conducted.

The data provenance is retrospective testing performed by Baxter Healthcare Corporation to verify the functional performance of the proposed devices. No information about the country of origin of the data is provided beyond the submitting company being U.S.-based (Illinois).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable to this type of device submission. The tests are bench tests verifying physical and chemical properties of the device, not clinical performance requiring expert medical review or ground truth establishment in a diagnostic context.

4. Adjudication Method for the Test Set

This section is not applicable. As mentioned above, the tests are primarily bench tests against engineering standards, not subjective assessments requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data. The device in question is an intravenous extension set and accessories, which are physical medical components.

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

This section is not applicable. The device is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the performance tests, the "ground truth" or reference is established by the acceptance criteria outlined in various international standards (e.g., ISO, BS EN ISO) and Baxter's internal test methods. For biocompatibility, it's the biological response against established toxicology and biocompatibility standards. For sterility, it's the validation against a specified Sterility Assurance Level (SAL).

8. The Sample Size for the Training Set

This section is not applicable. The device is a physical medical device. There is no "training set" in the context of an algorithm or AI system. The manufacturing process and quality control would involve ongoing sampling and testing, but not in the sense of a machine learning training set.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the same reasons as point 8.

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