Search Results

IV Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy. Extension Sets may be used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.

IV Administration Sets are gravity, single use, disposable, IV sets and extension sets. IV Administration Sets are used to deliver fluids from a container into a patient's vascular system. Extension sets are connected to primary IV administration sets to add length and provide clamping capabilities or added to an intravascular catheter hub as a conduit for flow to and from the catheter and are used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications. These sets may be comprised of various components which are broadly used throughout industry including insertion spike, drip chamber, clamp, luer access device, check valve, tubing, luer connections (connector/adaptor), y-connector, and flow regulator.

This is a 510(k) summary for IV Administration Sets by B. Braun Medical Inc. The document discusses the substantial equivalence of their proposed device (K202618) to two predicate devices (K170595 and K153293). It details the non-clinical performance testing conducted.

Here's an analysis of the provided text in response to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" alongside specific quantitative performance metrics as typically seen in device efficacy studies (e.g., Sensitivity, Specificity, Accuracy for diagnostic devices). Instead, it lists various non-clinical tests performed to demonstrate substantial equivalence to predicate devices and conformity to established standards. The "performance" is reported as a conclusion that the tests were "successfully completed" or that "verification results confirm that the differences in the set components do not raise new or different questions of safety and effectiveness."

Here's a compilation of the tests and the implicit performance:

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

The document does not specify the sample sizes used for the non-clinical tests. Non-clinical studies for devices like IV administration sets typically involve testing a statistically significant number of units to ensure reliability, but the exact numbers are not disclosed in this summary.

The data provenance is from non-clinical performance testing conducted by B. Braun Medical Inc. The studies are by nature prospective as they are specifically conducted to support the 510(k) submission. There is no information regarding the country of origin of the data beyond the manufacturer being B. Braun Medical Inc. (located in Allentown, Pennsylvania, USA).

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

This information is not applicable in the context of this 510(k) summary. The ground truth for the non-clinical performance tests is based on objective measurements against established engineering standards (e.g., ISO, USP) and internal B. Braun procedures, not on expert consensus or interpretation.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or assessments. The tests described here are physical and mechanical performance tests with objective pass/fail criteria based on 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

There was no MRMC comparative effectiveness study done. This device is an IV administration set, a physical medical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of human readers improving with or without AI assistance is irrelevant here.

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

There was no standalone (algorithm only) performance study done. As mentioned, this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance tests is derived from established industry standards (ISO, USP) and internal B. Braun procedures, which outline specific test methodologies, parameters, and pass/fail criteria. For instance, for flow rate, the ground truth would be the expected flow rate range defined by the standard under specific conditions. For tensile strength, it would be the minimum force the material must withstand.

8. The Sample Size for the Training Set

This is not applicable. This is a physical medical device, and the evaluation involves non-clinical performance testing, not machine learning or AI that requires a "training set" of data.

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

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

Ask a specific question about this device

The IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.

IV Administration Sets are single use, disposable, intravenous administration sets used to deliver fluids from a container into a patient's vascular system. These sets may be comprised of various components which are broadly used throughout industry including insertion spike, drip chamber, clamp, luer access device, check valve, stopcock, manifold, tubing, luer connections (connector, adaptor), and filter. IV Administration sets are configured to ensure the intended use of the device is met. The proposed device, IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system.

The provided text describes a 510(k) premarket notification for "IV Administration Sets" by B. Braun Medical Inc. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving that the device meets specific acceptance criteria in the manner of an AI/algorithm-based device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable to this type of regulatory submission, as it's for a physical medical device (IV administration sets), not an AI/ML algorithm.

However, I can extract information related to acceptance criteria (performance standards) and the "study" (non-clinical performance testing) used to demonstrate adherence to these criteria.

Here's the information formatted as requested, with "N/A" for inapplicable fields:

Acceptance Criteria and Device Performance for IV Administration Sets (K170595)

1. Table of Acceptance Criteria and Reported Device Performance

Details of the "Study" (Non-Clinical Performance Testing)

2. Sample size used for the test set and the data provenance: Not explicitly stated how many individual IV sets were tested for each performance test. The data provenance is from "nonclinical performance testing" performed by B. Braun Medical Inc. (manufacturer), as part of a 510(k) submission to the FDA. This is considered prospective testing for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth for physical device testing is typically based on objective measurements against established technical standards, not expert consensus in the diagnostic sense.

4. Adjudication method for the test set: N/A. Testing is based on objective measurement against defined pass/fail criteria from international 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: N/A. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This is not an AI/ML device.

7. The type of ground truth used: The "ground truth" for this device's performance is adherence to the specified international performance standards (e.g., ISO 594-1, ISO 8536-4) and biocompatibility standards (ISO 10993-1). This involves objective measurement of physical and material properties.

8. The sample size for the training set: N/A. This is not an AI/ML device.

9. How the ground truth for the training set was established: N/A. This is not an AI/ML device.

Ask a specific question about this device

The IV Administration Sets with 200um Blood Filter are used to deliver blood, blood components, and IV fluids from a container to a patient's vascular system. When the hand pump component is activated, the device is intended to deliver blood, blood products and crystalloid and colloid resuscitative fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and the duration of therapy.

The IV Administration Sets with 200um Blood Filter are single use, disposable, intravenous administration sets used to deliver blood, blood components, and IV fluids from a container to a patient's vascular system, rapidly through the use of a hand pump, or through gravity flow. The sets include tubing, a 60 cm filter with a 200 micron pore size, bag spike, luer connector, roller clamp and slide clamp. The sets may be equipped with a manually activated hand pump, stopcocks, manifolds, and/or luer access devices.

I am sorry, but the provided text does not contain the specific information required to answer your request about acceptance criteria and the study that proves the device meets them. The document is a 510(k) premarket notification for an IV Administration Set with a blood filter, primarily focused on establishing substantial equivalence to a predicate device.

Here's what is missing that would be needed to fulfill your request:

• Specific acceptance criteria values: While the document mentions utilizing acceptance criteria from ISO 1135-4 for "Blood Filter Surface Area" and "Blood Filter Composition," it does not explicitly state what those acceptance criteria values are.
• Reported device performance values: Similarly, it lists types of performance tests conducted (e.g., "Flow rate under gravity," "Blood Filter Mesh Efficiency Test"), but it does not provide the actual numerical results or performance metrics achieved by the device for these tests.
• Details about the study and its results: The document broadly states that "functional performance testing was completed" and "performance data were provided in support of the substantial equivalence determination," but it does not detail the methodology, sample sizes, data provenance, ground truth establishment, or multi-reader studies for these performance tests.

Without these specific details about the acceptance criteria and the quantitative results of the performance testing, I cannot create the requested table or describe the study in the manner you specified. This document focuses more on what tests were done and why they were done (to prove substantial equivalence) rather than the precise results of those tests.

Ask a specific question about this device

The IV Administration Sets with Ultrablock UV-Resistant Tubing are intended for the pump or gravity administration of IV fluids involving light sensitive solutions.

The IV Administration Sets with Ultrablock UV-Resistant Tubing are a single-use, sterile, non-pyrogenic tubing set intended for the administration of light sensitive solutions from a container to a patient's vascular system. The device is composed of UV-Resistant IV tubing and may include one or more of the following: universal chamber assembly, injection site, male luer lock, slide clamp, 0.2 micron air eliminating filter, flow clip assembly, and pump cassette.

This 510(k) pertains to "IV Administration Sets with Ultrablock UV-Resistant Tubing." The provided document is a 510(k) summary and the FDA's clearance letter, which means it describes the device and its intended use, and states that the device is substantially equivalent to predicate devices.

However, the provided text does NOT contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

This type of information is typically found in detailed testing reports, design validation documentation, or perhaps summarized within a more extensive 510(k) submission, but it is not present in the excerpt provided.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study that proves the device meets the acceptance criteria from the given text. The document primarily focuses on regulatory clearance based on substantial equivalence to existing devices.

Ask a specific question about this device

An intravascular administration set with needle access to be used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vessel.

IV Extension/Administration Sets with Needle

The provided text pertains to a 510(k) premarket notification for an "IV Extension/Administration Sets with Needle" device (K980994) received by the FDA in 1998. The document is an FDA clearance letter confirming substantial equivalence to a predicate device.

This document does not contain any information regarding acceptance criteria, device performance, study details (sample sizes, data provenance, expert-established ground truth, adjudication methods, MRMC studies, standalone performance), or training set information for an AI/algorithm-based device.

The document is a regulatory clearance letter for a physical medical device (IV administration sets), not a software or AI medical device. Therefore, the questions posed in the prompt about AI/algorithm performance and study methodologies are not applicable to the content provided.

Ask a specific question about this device

An extension set to be used as an extension to the Intravascular administration set to be assul in the IV extension set will connect the administration set to a catheter or needle inserted into a vessel. The IV IV administration bet to a calleless access devices to protect the users from needle stick injuries.

Not Found

This document is a marketing clearance letter from the FDA for a medical device, specifically "Starluck® IV Extension Sets with Needleless Access Devices." It states that the device is substantially equivalent to legally marketed predicate devices and outlines general controls and regulations.

Unfortunately, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is an administrative document related to market approval, focusing on regulatory classification and substantial equivalence, not performance testing details.

Therefore, I cannot provide the requested information based on the provided text.

Ask a specific question about this device