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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 gravity, 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, needleless luer access device, injection site, check valve, tubing, clamp, and luer connection (connector, adaptor). IV Administration sets are configured to ensure the intended use of the device is met.

The provided document is a 510(k) summary for an IV Administration Set, not an AI-powered medical device. Therefore, the information required to answer your query (acceptance criteria and study details for an AI/algorithm-based device) is not present in the given text.

The document focuses on demonstrating substantial equivalence of a conventional medical device (IV administration set) to a predicate device, based on:

• Similar indications for use and intended use.
• Similar principle of operation and fundamental scientific technology.
• Similar component types and materials (with specific testing for material differences).
• Compliance with recognized performance standards (e.g., ISO 8536-4, ISO 10993-1).
• Successful completion of non-clinical performance and biocompatibility testing.

The concept of "acceptance criteria" in this context refers to meeting the performance specifications outlined in the relevant ISO standards and the functional and performance tests listed. There is no mention of an algorithm, AI, or comparative effectiveness studies involving human readers and AI assistance.

To summarize why I cannot provide the requested information:

1. Nature of the Device: The device is a physical medical administration set, not a software or AI-based diagnostic/assistive tool.
2. Type of Submission: This is a 510(k) premarket notification for substantial equivalence, not a de novo or PMA submission that would typically involve extensive clinical performance data for novel AI devices.
3. No AI/Algorithm Mentioned: The document does not describe any AI component, algorithm, or software functionality.
4. No Human-in-the-Loop Study: Since there's no AI, there's no MRMC study, no human reader improvement data, and no standalone algorithm performance.
5. No Ground Truth Establishment: The concept of "ground truth" for diagnostic accuracy is not applicable to a physical IV administration set.

Therefore, I cannot populate the table or answer the specific questions related to AI device evaluation based on the provided text.

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The I.V. Administration Set is a single use, sterile I.V. set for administration of drugs and/ or fluids from a container to a patient vascular system.

The I.V. Administration Set is single use, sterile, non-pyrogenic device used to administer intravenous solutions and/or drugs solutions from a container to a patient's vascular system. This device is not made with natural rubber latex. The I.V Administration set is comprised of various generic components which are broadly used through the industry such as: Spike, drip chamber, Y-site, tubing, flow regulator, clamp, needless injection site and luer connection. The set may include two unique components: 1. Spike: The Spike is intended for connection to the spike port of an infusion bag. In cases when a drug needs to be introduced, a septum enables connection to the Tevadaptor™ Syringe Adaptor for withdrawal of diluents or introduction of drug. 2. ULTRASITE In Injection site (cleared under 510(k) No. K031923). The Ultrasite Valve is a needle-free, cap less positive displacement valve to be use in place of needles for the administration of fluids. The ULTRASITE™ Valve may be accessed with standard male luer connectors and requires no special accessories devices. The Ultrasite device eliminates the use of needles to access the set during IV administration and aids in the prevention of needle stick injuries. Teva Medical Migada Plant offers both standard and custom sets with tubing of various lengths to meet customer requirements and specifications.

The provided text is a 510(k) summary for an I.V. Administration Set, which is a medical device, not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., performance metrics, ground truth, expert adjudication, MRMC studies, standalone performance) does not apply.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway than proving performance of an AI/ML algorithm.

Therefore, I cannot extract the requested information as it is not present in the provided document. The document describes a traditional medical device and its regulatory submission, not an AI/ML product.

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The A6 Luer Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. The A6 Luer Access Device may be used with power injectors at a maximum pressure of 300 psi and a maximum flow rate of 10 mL/sec.

B. Braun's A6 Luer Access Device is a positive displacement valve intended to provide needle-free access to IV gravity sets, pump sets and extension sets for the administration of IV fluids and blood. The piston/valve assembly of the A6 is a 3-piece assembly containing an elastomeric piston with a pre-slit septum, which is housed within a clear, rigid body. The A6 requires swabbing to disinfect prior to insertion of a male Luer connector. The A6 Luer Access Device may be used with power injectors at a maximum pressure of 300 psi and a maximum flow rate of 10 mL/sec. The A6 is individually packaged and is supplied as a sterile, non-pyrogenie, single use, disposable device.

The provided document, K083723, is a 510(k) Pre-Market Notification for the B. Braun Medical Inc. A6 Luer Access Device. It describes the device, its intended use, and claims substantial equivalence to a predicate device. This document is a regulatory submission for a medical device and does not contain a study that proves the device meets specific acceptance criteria in the way that an AI algorithm's performance would be evaluated.

Instead, the submission demonstrates substantial equivalence through a variety of tests. For a device like the A6 Luer Access Device (a physical medical device, not an AI algorithm), "acceptance criteria" are typically defined by recognized standards and internal company specifications for product performance, safety, and effectiveness. The "study" refers to the battery of tests conducted to ensure these criteria are met and to prove substantial equivalence to a predicate device.

Given this context, I will interpret your request to describe the tests conducted and their outcomes as they relate to the "acceptance criteria" for this physical device. Many of your specific points (e.g., sample sizes for test sets in AI, ground truth establishment, expert qualifications, MRMC studies) are not applicable to the type of device and regulatory submission presented in the text.

Here's an interpretation based on the provided text for the A6 Luer Access Device:

Description of Acceptance Criteria and Substantiating "Study" for the A6 Luer Access Device

Since the A6 Luer Access Device is a physical medical device and not an AI algorithm, the concept of "acceptance criteria" and "study" differs from an AI performance evaluation. The submission demonstrates substantial equivalence to a predicate device by meeting various performance, safety, and effectiveness standards through a series of tests.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table with specific numerical acceptance criteria. Instead, it states that the device was subjected to various tests to demonstrate substantial equivalence and verify safe and effective use. The "reported device performance" generally means that the device successfully passed these tests, indicating it met the implicit or explicit performance criteria for each test according to relevant standards or internal specifications.

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

The document does not specify the exact sample sizes (e.g., number of units tested) for each individual test. For a physical device, testing typically involves a statistically relevant number of units to ensure reliability. The data provenance is internal to B. Braun Medical Inc. and is generated through prospective testing conducted by the company or its contractors. No information on country of origin for data is provided, but it's implied to be U.S. based on the applicant's location.

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

This concept is not applicable here. "Ground truth" for physical device testing is established through standardized test methods, calibrated equipment, and objective measurements (e.g., pressure gauges, flow meters, bacterial culture results). Expert opinion might be involved in designing the test protocols or interpreting complex results, but it's not "ground truth" in the AI sense.

4. Adjudication Method for the Test Set

This concept is not applicable here. Performance is determined by objective measurements against predefined pass/fail criteria for each test, not by human adjudication of qualitative results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. This type of study is relevant to imaging diagnostics or AI algorithms where human readers interpret cases. For a luer access device, comparative effectiveness is shown by demonstrating equivalent functional performance and safety as a predicate device through engineering and biological testing.

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

This concept is not applicable as the A6 Luer Access Device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests conducted on the A6 Luer Access Device is established through:

• Standardized Test Methods: Adherence to recognized industry standards (e.g., ISO, ASTM) for medical device performance and safety testing.
• Objective Measurements: Using calibrated instruments to measure parameters like pressure, flow rate, and sterility.
• Biological Endpoints: For biocompatibility and microbial ingress, "ground truth" is determined by established biological safety criteria and microbiological methods.

8. The Sample Size for the Training Set

This concept is not applicable. There is no "training set" for a physical medical device in the context of an AI algorithm. The device is designed, manufactured, and then tested to ensure it meets specifications.

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

This concept is not applicable as there is no training set. The design specifications and performance requirements for the device are driven by medical necessity, regulatory standards, and the performance characteristics of predicate devices.

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