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The HemCon GuardIVa® Antimicrobial Hemostatic IV Dressing is intended for use as a hydrophilic wound dressing to absorb exudate, cover and protect catheter sites. Common applications include IV catheters, other intravenous catheters and percutaneous devices. It is also indicated for control of surface bleeding from percutaneous catheters and vascular access sites.

The HemCon® GuardIVa® Antimicrobial Hemostatic IV Dressing is a sterile hydrophilic, absorptive polyurethane sponge dressing impregnated with the broad spectrum antimicrobial agent chlorhexidine gluconate (CHG) and HemCon's proprietary hemostatic agent, microdispersed oxidized cellulose (m.doc™). The dressing is backed with a non-stick polyurethane film and is individually packaged in a peelable low density polyethylene (LDPE) and Tyvek® pouch. The dressing is provided both sterile. The sterile version of the dressing is terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10-°. The hemostatic properties of m.doc™ enhances the ability of the foam to control surface bleeding from percutaneous catheters and vascular access sites. CHG is a well known antiseptic agent with broad spectrum antimicrobial and antifungal activity against a wide range of gram positive and gram negative organisms yeast and fungi. The CHG antimicrobial agent protects the dressing from microbial colonization. GuardIVa® is an adjunct to infection control measures by providing sustained IV site protection, GuardIVa® has not been clinically tested for its ability to reduce catheter related blood stream infections (CR-BSI).

The provided document is a 510(k) summary for the HemCon GuardIVa® Antimicrobial Hemostatic IV Dressing, seeking to demonstrate substantial equivalence to a predicate device (GuardIVa™ Antimicrobial Hemostatic IV Dressing, K093729). This type of submission focuses on comparing the new device to an already cleared one, rather than establishing acceptance criteria and validating performance against those criteria in a standalone manner.

Therefore, the document does not report acceptance criteria or a study designed to prove the device meets specific acceptance criteria in the format requested. Instead, it summarizes performance data to demonstrate that the device is "as safe and effective as the predicate device" and that new information does not affect its fundamental technological characteristics.

However, I can extract the relevant performance data and study details to present what was reported for this substantial equivalence submission:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit "acceptance criteria" for a new device are not provided in this 510(k) summary. The summary focuses on showing performance comparable to, or better than, the predicate device and standard methods for certain functionalities. The reported "performance" is based on various in-vitro and in-vivo studies.

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

• Biocompatibility: The document mentions "standard protocols" for cytotoxicity, irritation, and sensitization testing but does not specify the sample sizes or the "test set" in terms of number of samples evaluated. Data provenance is implied to be from "contract testing laboratories under GLP conditions." No country of origin is mentioned.
• In Vivo Efficacy - Dermal Wound Healing: Two independent studies in rats were performed. Specific sample sizes for each group (GuardIVa, untreated, control CHG dressing) are not provided. Data provenance: "contract testing laboratories under GLP conditions." No country of origin is mentioned.
• In Vivo Efficacy - Hemostatic Properties: Tested in a rabbit ear model. No specific sample size (number of rabbits or ears) is provided. Data provenance: Not explicitly stated, implied to be internal or contract research. No country of origin is mentioned.
• In Vivo Efficacy - Suppression of Skin Flora Re-growth: Conducted on "healthy human volunteers." The number of volunteers is not specified. Data provenance: Centre for Laboratory Activities in Public Health Protection and Promotion, National Reference Laboratory for Disinfection and Sterilization, National Institute of Health, Prague, Czech Republic. This suggests prospective human data from the Czech Republic.
• Sustained Antimicrobial Efficacy (7-Day Log Reduction): GuardIVa® dressings were tested "in triplicate" against seven bacterial strains, one diploid yeast, and one fungus. This means 3 samples per organism were tested. Data provenance: In vitro study. No specific country mentioned.
• Antimicrobial Efficacy (Bactericidal/Bacteriostatic - Kirby-Bauer): Individual test articles were placed onto agar plates. No specific number of replicates or distinct test articles is mentioned. Data provenance: In vitro study. No specific country mentioned.
• Sterility: A sterility validation was completed following ISO 11137:2006 requirements. This standard specifies how to perform sterility validation, which includes sample size determination based on lot size and sterility assurance level targets. Specific sample sizes for the validation are not provided in this summary. Data provenance: Not specified, implied to be internal or contract testing.

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

The studies described in this document do not involve establishing "ground truth" through expert consensus or interpretation of images/data by human experts in the typical sense for AI/ML device evaluations. Instead, the ground truth or endpoints are based on:

• Standardized laboratory tests: (Biocompatibility, Antimicrobial Efficacy, Sterility). The "ground truth" is determined by established assay methodologies and quantitative measurements.
• Physiological measurements: (Dermal Wound Healing - observations of erythema/edema, healing rate; Hemostatic Properties - time to hemostasis, blood loss; Skin Flora Re-growth - bacterial counts). These are objective measurements rather than subjective expert consensus.

Therefore, this section is not applicable in the context of the studies presented, as expert human review for ground truth establishment was not a component.

4. Adjudication method for the test set

Not applicable. As described above, the studies involve objective lab measurements and physiological observations, not subjective interpretations requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. These types of studies are typically performed for diagnostic imaging devices where multiple human readers interpret medical images. The GuardIVa® dressing is a medical device, not a diagnostic imaging AI.

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

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

7. The type of ground truth used

The "ground truth" in these studies refers to the direct, quantifiable outcomes of the various tests:

• Biocompatibility: Results of cytotoxicity, irritation, and sensitization assays.
• Dermal Wound Healing: Observable healing rates, presence/absence of erythema and edema.
• Hemostatic Properties: Measured time to hemostasis and quantified blood loss.
• Suppression of Skin Flora Re-growth: Measured microbial counts on the skin.
• Antimicrobial Efficacy: Measured log reduction of microorganisms and observed zones of inhibition (bactericidal/bacteriostatic effect).
• Sterility: Verification of sterility assurance level (SAL).

These are primarily laboratory/pathology-derived data (e.g., microbial counts, tissue response) and direct physiological measurements/observations, not expert consensus, pathology reports (in the sense of biopsy diagnoses), or long-term outcomes data for individual patients.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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Rx Only: HemCon GuardaGel™ is intended for management of wounds and for emergency external use for the temporary control of minor bleeding from skin surface wounds.
OTC: HemCon GuardaGel™ First Aid is intended for management of wounds and for emergency external use for the temporary control of minor bleeding from minor topical cuts and lacerations.

HemCon GuardaGel™ is intended for the management of wounds and for emergency external use in the temporary control of minor bleeding from the skin and other surface wounds where temporary control of bleeding is required. It is a homogenous aqueous, viscous opaque gel comprised of pectin, m.doc™ (HemCon's proprietary hemostatic oxidized cellulose formulation), potassium sorbate, glycerol and 5 %w/w ethanol. The gel comes in a sterile pre-filled syringe.

The available document is a 510(k) summary for the HemCon GuardaGel™ and does not contain a comprehensive study report with detailed acceptance criteria and performance data in the format requested. However, based on the information provided, I can extract the following:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that HemCon has "demonstrated the ability to repeatedly product that the meets existing acceptance criteria," but it does not explicitly list these acceptance criteria or specific numerical performance targets for hemostatic efficacy. It only provides the actual results observed in a rabbit study.

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

• Hemostatic Efficacy (in vivo): The document states "The average time for cessation of bleeding of wounds treated with HemCon GuardaGel™ was 23.1 s ± 5.8 s compared to 106.8 s ± 18.6 s for untreated wounds." The specific sample size (number of rabbits or wounds) is not provided.
• Data Provenance: The study was "in vivo in rabbits," which implies animal testing, not human data. The location is not specified, but the applicant is HemCon Medical Technologies Europe Ltd., suggesting it could be Europe. It is a prospective study as it's part of premarket notification for a new device.

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

• This information is not provided in the document, as the hemostatic efficacy study was an animal model, not a clinical study involving human expert assessment of a ground truth.

4. Adjudication method for the test set

• This information is not applicable and not provided as the hemostatic efficacy study was an animal model, not a clinical trial requiring adjudication of human assessments.

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 as the device is a hemostatic gel, not an AI software intended for image interpretation or diagnosis. No MRMC study was mentioned or performed.

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

• This information is not applicable as the device is a hemostatic gel and does not involve an algorithm or AI.

7. The type of ground truth used

• For hemostatic efficacy (in vivo): The "ground truth" was the observed time to cessation of bleeding in an animal model (rabbits), measured directly.
• For biocompatibility: The ground truth was defined by the adherence to ISO 10993 standards and the results of specified tests (cytotoxicity, irritation, sensitization).
• For sterility: The ground truth was defined by the demonstration of a 10^-6 SAL (Sterility Assurance Level) according to ISO 11137:2006.

8. The sample size for the training set

• This information is not applicable as the device is a physical medical device (hemostatic gel), not an AI algorithm requiring a training set.

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

• This information is not applicable for the reasons stated above.

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The HemCon GuardIVa™ Antimicrobial Hemostatic IV Dressing is intended for use as a hydrophilic wound dressing to absorb exudate, cover and protect catheter sites. Common applications include IV catheters, other intravenous catheters and percutaneous devices. It is also indicated for control of surface bleeding from percutaneous catheters and vascular access sites.

The HemCon GuardIVa™ Antimicrobial Hemostatic IV Dressing is a sterile hydrophilic polyurethane absorptive foam impregnated with chlorhexidine gluconate (CHG) and microdispersed oxidized cellulose (m.doc™) and backed with a non-stick polyethylene film. This one inch diameter dressing is packaged in a peelable low density polyethylene (LDPE) and Tyvek® pouch. The dressing will be provided both sterile and non-sterile. The sterile pouched dressing is terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10-6. The haemostatic properties of m.doc™ provides the dressing with the ability to control surface bleeding from percutaneous catheters and vascular access sites. Chlorhexidine gluconate acts as a preservative to inhibit the growth of microorganisms within the dressing. CHG is a well known antiseptic agent with broad spectrum antimicrobial and antifungal activity against a wide range of gram positive and gram negative organisms, including methicillin resistant Staphylococcus aureus ATCC33591 (MRSA), vancomycin-resistant Enterococcus faecalis ATCC51299 (VRE) and Acinetobacter baumanii ATCC15308. GuardIVa™ has not been clinically tested for its ability to reduce local infections, catheter related blood stream infections (CR-BSI) and skin colonization of microorganisms commonly related to CR-BSI.

Here's an analysis of the provided FDA 510(k) summary regarding the HemCon GuardIVa™ Antimicrobial Hemostatic IV Dressing, structured according to your requested points:

Acceptance Criteria and Device Performance Study for HemCon GuardIVa™ Antimicrobial Hemostatic IV Dressing

This document is based on the provided FDA 510(k) summary for the HemCon GuardIVa™ Antimicrobial Hemostatic IV Dressing (K093729).

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state numerical acceptance criteria in the typical sense (e.g., "The device must achieve X% sensitivity"). Instead, it focuses on demonstrating substantial equivalence to predicate devices through various performance tests. The implicit "acceptance criterion" is that the GuardIVa™ device performs as safely and effectively as the predicate devices, or demonstrates comparable or superior performance in relevant aspects.

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

The summary does not provide specific sample sizes for the in vitro and ex vivo tests. For in vivo testing, it is mentioned, but no specifics on sample size or type of study subjects are given.

• Data Provenance: The tests are referred to as "in vitro, in vivo and ex vivo performance testing." Specific country of origin is not mentioned for the data itself, but the applicant (HemCon Medical Technologies Europe Ltd.) is based in Ireland. It is unclear if these were prospective or retrospective studies based on the provided text.

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

This section typically applies to studies involving expert review for diagnostic accuracy (e.g., reading medical images). Since the GuardIVa™ is a dressing and not a diagnostic device, the concept of "experts establishing ground truth for a test set" with regard to diagnostic findings is not applicable here. Performance was assessed through laboratory (in vitro), simulated physiological (ex vivo), and biological (in vivo) tests.

4. Adjudication Method for the Test Set

Not applicable, as this device's performance was assessed through laboratory and physiological tests, not through human reader interpretation 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 medical dressing, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is a medical dressing, not an algorithm. Its performance is inherent to the product itself.

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

The "ground truth" for the performance claims appears to be:

• Hemostatic Efficacy: Direct measurement of clotting/blood control in in vivo and ex vivo models. Compared to established performance of predicate devices.
• Antimicrobial Efficacy: Quantitative laboratory testing (AATCC Test Method 100-2004) measuring reduction in microbial count. The "ground truth" is the reduction in colony-forming units (CFUs).
• Absorption Capacity: Direct measurement of fluid absorption.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI 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 this device.

Summary of Study Design and Conclusion:

The study design described is a series of non-clinical performance tests (in vitro, in vivo, ex vivo) comparing the GuardIVa™ device to predicate devices. The primary goal was to demonstrate substantial equivalence by showing that GuardIVa™ performs as safely and effectively as the predicates or, in some cases, exhibits superior performance (e.g., hemostatic efficacy, absorption capacity). The choice of predicates was strategic, with BioPatch® covering antimicrobial and absorption aspects, and BloodSTOP™/Seal-On™ covering hemostatic properties. The conclusion is that the device is as safe and effective as the predicate devices based on these non-clinical performance data.

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