(187 days)
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.
| Performance Aspect | Acceptance Criteria (Implicit from Predicate Equivalence) | Reported Device Performance (GuardIVa™) |
|---|---|---|
| Hemostatic Efficacy | Comparable or superior hemostatic performance to predicate devices (BloodSTOP™ K072681, Seal-On™ K010933) which utilize plant-derived cellulose/m.doc™ as hemostatic agents. The predicate Seal-On™ specifically features microdispersed oxidized cellulose (m.doc™). Implicitly, it should effectively control surface bleeding from percutaneous catheters and vascular access sites. | Superior hemostatic efficacy compared to the predicate device BioPatch®. (Note: While compared to BioPatch®, the hemostatic component's substantial equivalence is primarily to BloodSTOP™ and Seal-On™, the statement implies overall superior hemostatic performance compared to at least one predicate.) The device incorporates m.doc™ (microdispersed oxidized cellulose) for hemostatic properties, which is the same as in the predicate Seal-On™ and substantially equivalent to BloodSTOP™ (both plant-source cellulose). |
| Antimicrobial Efficacy | Comparable or superior antimicrobial efficacy to predicate device BioPatch® (K003229), which contains CHG and has demonstrated its safety and efficacy as an antimicrobial agent. Implicitly, it should inhibit the growth of microorganisms within the dressing. | Tested in vitro using AATCC Test Method 100-2004. GuardIVa™ demonstrated greater than log 4 reductions of all organisms tested. The device contains Chlorhexidine Gluconate (CHG), a known antiseptic with broad-spectrum antimicrobial and antifungal activity against gram-positive and gram-negative organisms, including MRSA, VRE, and Acinetobacter baumanii. This indicates strong antimicrobial performance, likely meeting or exceeding that of BioPatch®, which also contains CHG. Important Note: The summary explicitly states: "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." This limits the scope of antimicrobial claims to in vitro efficacy within the dressing. |
| Absorption Capacity | Comparable or superior absorption capacity to a hydrophilic wound dressing predicate such as BioPatch® (K003229). Implicitly, it should be able to absorb exudate. | GuardIVa™ displayed a higher absorption capacity than the predicate device BioPatch®. |
| Biocompatibility/Safety | Based on substantial equivalence to predicate devices, the materials should be safe for contact with human tissue. | Not explicitly detailed in direct tests described, but implied by the use of similar materials and active ingredients (polyurethane foam, CHG, oxidized cellulose) as the predicate devices, which have established safety and efficacy. No adverse events or safety concerns are mentioned. |
| Sterility | The device, when provided sterile, should achieve a sterility assurance level (SAL) suitable for its intended use (10^-6 for terminally sterilized medical devices). | The sterile pouched dressing is terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10-6. This meets standard sterility requirements. |
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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