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intended for single use by trained physician to assist in vessel cannulation.

Vascular Access Kit - containing dilators, guide wire, scalpel, introducer needle, and syringe.

The provided text describes the 510(k) submission for the Avalon Elite Vascular Access Kit. This is a medical device, and the information presented primarily focuses on its substantial equivalence to a predicate device based on validation testing. It does not describe an AI/ML-based device, a comparative effectiveness study with human readers, or an algorithm-only standalone performance study. Therefore, several sections of your request are not applicable.

Here's an analysis of the provided text based on your request, focusing on what is available:

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

The document does not explicitly list "acceptance criteria" in a quantitative manner (e.g., "device must achieve X% accuracy"). Instead, it lists validation tests conducted to demonstrate safety and effectiveness compared to a predicate device. The "reported device performance" is a general conclusion that the device "is as safe and effective as the legally marketed predicate device" based on these tests.

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 sample sizes for any of the validation tests. It also does not provide information on data provenance (country of origin, retrospective/prospective). This type of detail is typically found in the full study reports, not the 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualitications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the device is not an AI/ML-based diagnostic device that relies on expert interpretation for ground truth establishment. The validation tests are largely laboratory-based and engineering assessments.

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

Not applicable. There's no mention of an adjudication process, as the validation tests are not based on subjective interpretation requiring expert consensus.

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. The device is a physical vascular access kit, not an AI-assisted diagnostic tool, so an MRMC study is not relevant.

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

Not applicable. The device is a physical medical kit and does not involve an algorithm with standalone performance.

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

For the validation tests conducted (Biocompatibility, Packaging Integrity, Transportation Integrity, Sterilization Validation, Functional Testing), the "ground truth" would be established through defined scientific and engineering standards and methods relevant to each test. For example:

• Biocompatibility: In vitro and/or in vivo tests according to ISO standards (e.g., ISO 10993 series). Ground truth is meeting predefined toxicity/irritation thresholds.
• Packaging/Transportation Integrity: Physical tests to ensure sterility barrier and product integrity are maintained under simulated conditions. Ground truth is successful completion of tests without integrity compromise.
• Sterilization Validation: Microbiological testing and adherence to validated sterilization cycles (e.g., ISO 11135 or 11137). Ground truth is achieving a specified sterility assurance level (SAL).
• Functional Testing: Bench testing to evaluate component strength, fit, ease of use, etc. Ground truth is meeting specified performance parameters.

8. The sample size for the training set

Not applicable. The device is not an AI/ML-based device that requires a training set.

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

Not applicable. As there is no training set for an AI/ML model, the establishment of ground truth for such a set is irrelevant.

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The Avalon Elite™ Bi-Caval Dual Lumen Catheter is intended for use as a single catheter for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures.

The Avalon Elite™ Bi-Caval Dual Lumen Catheter is a single catheter with two lumens within the cannula body to collect, separate, and return the blood. The product is offered in a range of sizes to address varying patient size requirements. Inlet ports/openings at the distal tip, and proximally, collect blood from the inferior and superior vena cavae and deliver it to the extracorporeal components consisting of at least, a pump and gas exchange device. Blood returns to the patient through the infusion lumen of the cannula where it exits at a port located in the right atrium. The lumens within the cannula body are completely separate throughout their length. This separation is achieved via a thin septum that divides the otherwise circular internal cross section of the main cannula body. The lumens become separate, or split out, at the proximal end of the cannula as is typical of many types of dual lumen cannulae/catheters so that they may be attached by conventional tube fittings. The ratio of the drainage lumen to reinfusion lumen cross sectional area is approximately 2 to 1 deriving from typical pre and post pump pressure/flow characteristics. The catheter is supplied with a dilator/introducer to facilitate placement into the vasculature by normal access techniques. The introducer/dilator is intended to follow a pre positioned standard guidewire (not supplied.) The device is supplied sterile, non-pryogenic and is intended for single use via prescription.

This submission pertains to the Avalon Elite™ Bi-Caval Dual Lumen Catheter. The provided information is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive clinical study to establish novel performance criteria. Therefore, the acceptance criteria and study details discussed below will reflect this regulatory pathway.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are generally demonstrated through substantial equivalence to a legally marketed predicate device across various characteristics and performance tests. The specific numerical acceptance criteria are not explicitly stated as they would be for a direct performance claim; instead, the "performance" here refers to the device meeting the same functional and safety requirements as its predicate.

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

The document does not specify a "test set" in the context of a clinical trial or a dataset for an AI algorithm. Instead, it refers to performance testing conducted on the device itself (e.g., Pressure/Burst, Simulated Use, Kink Resistance, etc.).

• Sample Size: The exact number of catheters or test specimens used for each performance test (Pressure/Burst, Simulated Use, Kink Resistance, Tensile Strength, Flow Characteristics, Hemolysis, and Biocompatibility) is not provided in this summary.
• Data Provenance: The provenance of the data (e.g., country of origin, retrospective/prospective) is not specified. These tests would typically be conducted in a laboratory setting by the manufacturer (Avalon Laboratories, LLC).

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

This information is not applicable to this 510(k) submission. The "ground truth" concept is typically associated with studies involving subjective interpretation (e.g., medical imaging, pathology) where expert consensus is needed to define the correct outcome. For a physical medical device like a catheter, "ground truth" is established by objective engineering and safety standards, and validated through the performance tests mentioned above, not by expert human interpretation of a dataset.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated in point 3. Adjudication methods (e.g., 2+1, 3+1) are relevant for reconciling differing expert opinions on a "ground truth" in subjective data analysis, not for direct physical performance testing of a 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

This information is not applicable. An MRMC study is relevant for evaluating the impact of an AI system on human performance in diagnostic tasks, typically involving interpretation of medical images or data by multiple readers. This 510(k) summary is for a physical medical device (catheter), not an AI diagnostic tool. No AI component is mentioned.

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

This information is not applicable. No AI algorithm is described or evaluated in this submission.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

As discussed, the concept of "ground truth" in the context of expert interpretation is not applicable here. For this physical device, the "ground truth" for performance is established by objective engineering specifications and recognized safety standards validated through laboratory performance tests (e.g., burst pressure exceeding a certain threshold, flow rates matching specifications, non-hemolytic properties, biocompatibility according to ISO standards). It's based on empirical measurements against predefined criteria.

8. The Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device submission.

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

This information is not applicable. As there is no training set, there is no ground truth for a training set to be established.

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The Avalon Elite™ Multi-Port Venous Femoral Catheter with Introducer is indicated to drain central venous blood via the femoral vein during extracorporeal procedures for up to six hours.

The Avalon Elite Multi-Port Venous Femoral Catheter is a one piece, wire reinforced cannula with multiple side hole drainage openings proximal to an open tip. The catheter is supplied with a dilator/introducer to facilitate placement into the vasculature by normal access techniques. The introducer/dilator is intended to follow a pre-positioned standard guidewire (not supplied.) The cannulae are available in 20 Fr, 22 Fr, 24 Fr, 26 Fr, and 28 Fr sizes. The insertable length is 24 inches [61cm]. The device is supplied sterile, non-pyrogenic and is intended for single use via prescription.

The provided document is a 510(k) Premarket Notification for a medical device called the Avalon Elite™ Multi-Port Venous Femoral Catheter. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. As such, it does not contain acceptance criteria for specific performance metrics in the same way a clinical trial for a novel device would. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence through comparative testing with the predicate device.

Here's an analysis based on the provided text, addressing your questions as much as possible given the nature of a 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence, explicit "acceptance criteria" (e.g., "device must achieve X% accuracy") are not stated. The performance is reported in comparison to a predicate device, aiming to show similar or equivalent performance.

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

This document does not specify the exact sample sizes used for each performance test (e.g., number of catheters tested for pressure/burst). The tests are typically laboratory-based engineering and material performance assessments, not clinical studies with human participants. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" don't apply here.

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

Not applicable. The performance testing described (Pressure/Burst, Simulated Use, etc.) are engineering and material tests, not tests that require expert assessment of a "ground truth" derived from human interpretation.

4. Adjudication Method for the Test Set

Not applicable. This type of testing involves objective performance measurements rather than subjective expert interpretations requiring adjudication.

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 device is a physical medical catheter, not an AI/software device that assists human readers. Therefore, an MRMC study related to AI assistance is not relevant.

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

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

7. The Type of Ground Truth Used

The "ground truth" in this context is established by objective engineering measurements and material science standards for parameters like pressure resistance, tensile strength, flow rates, and biocompatibility. The comparison is then made against the established performance characteristics of the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

Not applicable. As there's no training set, there's no ground truth to be established for it.

Summary of the Study Proving Acceptance Criteria:

The "study" proving the device meets the (implicit) acceptance criteria is a series of "numerous tests and comparisons to the predicate device" conducted by Avalon Laboratories, LLC. These tests are listed as:

• Pressure/Burst
• Simulated Use
• Kink Resistance
• Tensile Strength
• Flow Characteristics
• Hemolysis
• Biocompatibility

The conclusion from these tests was that the Avalon Elite™ Multi-Port Venous Femoral Catheter is "substantially equivalent to the predicate device currently in commercial distribution," specifically the Bio-Medicus Multi-Stage Venous Femoral Cannula with Introducer (K052524). The equivalence was demonstrated across "similar design, size, and generic materials of construction," and the Avalon products were found "equivalent to the predicate products in all key areas of features and performance." The document also explicitly states that "Testing under simulated use conditions shows that the Avalon catheter maintains performance after 7 days."

The FDA's review and approval (K081933) indicate their agreement that the device demonstrates substantial equivalence based on the submitted data, allowing it to be marketed.

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