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The BeneHold™ Surgical Incise Drape with CHG is indicated for use as an incise drape with continuous antibacterial activity (in vitro) from 2.5 to 4 hours against the following organisms; S. epidermidis, E. faecalis, E. coli, P. aeruginosa and E. aerogenes.

It is intended for external use only. Correlation between in vitro results and any clinical event has not been tested.

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The provided document is a 510(k) clearance letter from the FDA for a medical device called "BeneHold™ Surgical Drape with CHG". This type of document does not contain the information requested regarding acceptance criteria and a study proving a device meets them in the context of a performance study (e.g., for an AI/ML powered device).

Instead, this document confirms that the device is substantially equivalent to a legally marketed predicate device and outline general regulatory requirements. It does not include performance data, expert qualifications, sample sizes for test/training sets, or details about comparative effectiveness studies.

The "Indications for Use" section mentions "continuous antibacterial activity (in vitro) from 2.5 to 4 hours against the following organisms; S. epidermidis, E. faecalis, E. coli, P. aeruginosa and E. aerogenes." This refers to laboratory testing of the antimicrobial properties of the drape, not a clinical study involving human patients or a performance study for an AI-powered device.

Therefore, I cannot extract the requested information from this document.

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The BD ChloraShield IV Dressing with CHG antimicrobial is intended to cover and protect catheter sites and to secure devices to the skin. Common applications include securing IV catheters, other intravascular catheters and percutaneous devices.

The BD ChloraShield™ IV Dressing with CHG antimicrobial consists of a transparent adhesive dressing integrated with Chlorhexidine Gluconate (CHG), a well known antiseptic agent with broad-spectrum antimicrobial activity, which serves as a preservative within the dressing.

This document is a 510(k) Summary for a medical device called the "BD ChloraShield IV Dressing with CHG antimicrobial." It describes the device, its intended use, and the rationale for its substantial equivalence to a predicate device.

It does NOT contain information about acceptance criteria or a study proving that a device meets acceptance criteria for an AI/algorithm-based system.

The document focuses on a change in the sterilization method (from gamma radiation to Ethylene Oxide gas) for an existing medical dressing. The performance testing section (Section 7) states that "Performance testing for the BD ChloraShield™ IV Dressing with CHG antimicrobial utilized the same test methodology as the predicate device within K113836." It emphasizes that the CHG concentration, materials, and manufacturing methods remain unchanged and that the sterility requirements (Sterility Assurance Level - SAL) of 10^-6 are met without compromising the device's performance.

Therefore, I cannot extract the requested information regarding AI/algorithm acceptance criteria or study details from this document. The questions about sample sizes, expert qualifications, ground truth establishment, MRMC studies, or standalone performance are not relevant to the content of this 510(k) summary.

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The BD ChloraShield IV Dressing with CHG antimicrobial, per K152923, is intended to cover and protect catheter sites and to secure devices to the skin. Common applications include securing IV catheters, other intravascular catheters and percutaneous devices.

The BD ChloraShield IV Dressing with CHG antimicrobial consists of a transparent adhesive dressing with integrated Chlorhexidine Gluconate (CHG), a well known antiseptic agent with broad-spectrum antimicrobial activity, which serves as a preservative within the dressing.

This document is a 510(k) premarket notification for a medical device called the "BD ChloraShield IV Dressing with CHG antimicrobial". It describes a special 510(k) application, which is used for modifications to a previously cleared device where the modification does not affect the indications for use or the fundamental scientific technology of the device.

The core purpose of this document is to demonstrate "substantial equivalence" to a predicate device (K113836, Benehold CHG Transparent Film Dressing) after a specific change: expanding the specification for Chlorhexidine Gluconate (CHG) content in the dressing.

There is no information in this document about the use of AI, machine learning, or any form of algorithmic performance that would necessitate the detailed acceptance criteria and study design requested in the prompt.

The "performance testing" section (Section 7) refers to:

• Antimicrobial efficacy testing to the requirements set forth within USP 51.
• Verification/validation activities confirming that the specification change was "well within the requirements".
• Antimicrobial efficacy test results demonstrating conformance.

This is a chemical/material performance study, not a performance study of an AI/ML diagnostic or assistive device. Therefore, I cannot extract the requested information regarding AI/ML performance, ground truth establishment, expert review, or MRMC studies, as those concepts are irrelevant to this specific device and its regulatory submission.

The prompt asks for acceptance criteria and study details related to an AI/ML device, which this document is clearly not about.

As such, I cannot fulfill the request in the way it is structured. I can only confirm that the document describes a regulatory submission for an IV dressing and indicates that performance testing involved antimicrobial efficacy testing, demonstrating the modified CHG specification still met the requirements of the original submission.

No information regarding AI/ML performance, ground truth, experts, or MRMC studies is present in the provided text.

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The ChloraShield IV Dressing with CHG Antimicrobial is intended to cover and protect catheter sites and to secure devices to the skin. Common applications include securing and covering IV catheters, other intravascular catheters and percutaneous devices.

The ChloraShield IV Dressing with CHG antimicrobial consists of a transparent adhesive dressing with integrated Chlorhexidine Gluconate (CHG), a well known antiseptic agent with broad-spectrum antimicrobial activity, which serves as a preservative within the dressing.

The provided text describes a Special 510(k) submission for the "ChloraShield IV Dressing with CHG antimicrobial" due to a change in packaging material. The study reported focuses on verifying that this packaging change does not negatively impact the device's sterility and functionality.

Here's an analysis of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

Note: The primary acceptance criterion explicitly stated and tested related to a numerical value is the Sterility Assurance Level. For Seal Strength and Bubble Leak Test, the text only states they were "verified" or "performed" without providing specific target values or quantitative results. The overarching acceptance criterion is that the new packaging "did not negatively impact the sterility assurance level" and that "the performance, functionality and manufacturing methods remain unchanged."

Study Information

The document describes a verification/validation activity rather than a traditional clinical study with a test set of patients.

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

• Sample Size (Test Set): Not explicitly stated for any of the tests (Sterility, Seal Strength, Bubble Leak Test).
• Data Provenance: The tests were conducted internally by Avery Dennison Belgie, b.v.b.a. No information on country of origin of data or whether it was retrospective or prospective in a clinical sense. These are laboratory/engineering tests.

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

• Experts: Not applicable. Ground truth for sterility or mechanical integrity tests is established by standardized laboratory methods and measurements, not expert consensus in the way a clinical image analysis study might.
• Qualifications: Not applicable for this type of testing.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. These are objective laboratory tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• MRMC Study: No, this type of study was not done. The device is a wound dressing, and the study described focuses on the impact of a packaging change on its physical and microbiological properties, not on reader effectiveness.

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

• Standalone Performance: Not applicable. This device is a physical medical device, not an algorithm, so "standalone performance" in the context of AI algorithms does not apply. The tests described are for the device's intrinsic properties.

7. The type of ground truth used:

• Ground Truth:
  • Sterility: Established by microbiology testing to confirm the absence of viable microorganisms, adhering to a defined Sterility Assurance Level (SAL) of 10⁻⁶. This is an objective, laboratory-derived ground truth.
  • Seal Strength and Bubble Leak Test: Established through mechanical testing methods, likely comparing results against established engineering specifications or the performance of the original device packaging. This is an objective, laboratory-derived ground truth.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This is not an AI/ML algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable. As there is no training set.

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The BeneHold CHG Transparent Film Dressing is intended to cover and protect catheter sites and to secure devices to the skin. Common applications include securing and covering IV catheters, other intravascular catheters and percutaneous devices.

The BeneHold CHG Transparent Film Dressing is used to cover and protect catheter sites and to secure devices to the skin. The dressing consists of a transparent film with an acrylic adhesive which contains Chlorhexidine Gluconate (CHG), a well-known antiseptic agent with broad-spectrum antimicrobial and antifungal activity. The dressing is a barrier to liquid (waterproof), bacteria and yeast, and protects the IV site from outside contamination. The dressing absorbs between 8 and 21 ml of fluid depending on the dressing size. In vitro testing (barrier, kill time and log reduction) demonstrates that the BeneHold CHG Transparent Film Dressing has an antimicrobial effect against, and is a barrier to, the passage of a variety of gram-positive and gram-negative bacteria, yeast and fungus in the dressing. BeneHold CHG Transparent Film Dressing is transparent, allowing continual site observation, and is breathable, allowing good moisture vapor exchange.

The provided 510(k) summary (K113836) for the BeneHold CHG Transparent Film Dressing describes performance testing, but does not provide specific acceptance criteria or detailed study results for all tests. It lists the tests performed but largely states that they demonstrated "conformance to design specifications" or that "testing indicates that the BeneHold CHG Transparent Film Dressing is substantially equivalent."

Therefore, much of the requested information regarding specific acceptance criteria, detailed device performance, sample sizes, ground truth establishment, and expert involvement is not present in the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: Specific acceptance criteria and quantitative performance metrics are generally not explicitly stated in this 510(k) summary. The summary broadly states that the device "conforms to design specifications" and demonstrated "antimicrobial effect" and "barrier" properties.

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

• Sample Size:
  • Test Set: Not specified in the document. The document refers to "in vitro testing" for antimicrobial effects and barrier properties, but the sample sizes (e.g., number of dressings, number of bacterial cultures) are not provided.
  • Training Set: Not applicable as this is a physical medical device, not an AI/ML diagnostic device with a training set.
• Data Provenance: The studies are described as "in vitro testing." The country of origin of the data is not specified, but the submitter is "Avery Dennison Belgie, BVBA" (Belgium) and the contact person is in the US. The studies are described as performance tests, which are typically conducted in a laboratory setting for regulatory submission.

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

• Not applicable/Not specified. This is a physical device performance study, not an imaging/diagnostic study requiring expert ground truth establishment in a clinical context. Laboratory testing for physical and chemical properties typically relies on standardized methods and measurements rather than expert consensus on a "ground truth" derived from clinical cases.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical or imaging studies where multiple readers interpret data and discrepancies need resolution. This document describes laboratory-based performance testing of a physical device.

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

• No. An MRMC study is not mentioned or implied by the described performance testing. This type of study is relevant for diagnostic devices (especially AI-powered ones) where human reader performance is being evaluated with and without assistance.

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

• Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• In this context, the "ground truth" for the device's performance tests would be established through scientific measurements and standardized laboratory protocols. For example:
  • For fluid handling capacity, the ground truth is the measured volume of fluid absorbed.
  • For antimicrobial effectiveness, the ground truth is the measured log reduction of microbial population compared to controls based on established microbiological methods.
  • For biocompatibility, the ground truth is determined by standardized in vitro or in vivo tests for irritation, cytotoxicity, and sensitization.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI/ML diagnostic device.

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

• Not applicable. This is a physical medical device, not an AI/ML diagnostic device.

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