(95 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, 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.
| Performance Characteristic | Reported Device Performance (GuardIVa® Antimicrobial Hemostatic IV Dressing) |
|---|---|
| Biocompatibility | Demonstrated per ISO 10993: Cytotoxicity, irritation, and sensitization testing performed under GLP conditions per standard protocols. |
| In Vivo Efficacy - Dermal Wound Healing | Healed at a rate comparable to untreated wounds, with no visible signs of erythema and edema response comparable to untreated wounds. (Better than another commercially available CHG dressing which had pronounced adverse effects). |
| In Vivo Efficacy - Hemostatic Properties | Time to hemostasis: 48 seconds (GuardIVa) vs. 113 seconds (standard gauze). |
| Blood loss: 0.17 g (GuardIVa) vs. 1.30 g (standard gauze). | |
| In Vivo Efficacy - Suppression of Skin Flora Re-growth | Suppressed skin flora re-growth for up to 10 days, maintaining levels equivalent to immediately following preoperative skin preparation (70% isopropyl alcohol solution). |
| Sustained Antimicrobial Efficacy (7-Day Log Reduction) | >4.0 Log Reduction in microbial count for all 7 bacterial strains, 1 diploid yeast, and 1 fungus tested (Staphylococcus aureus (MRSA), S. epidermidis (MRSE), E. faecium (VRE), P. aeruginosa, A. baumanii, K. pneumoniae, E. coli, Candida albicans, Aspergillus niger). |
| Antimicrobial Efficacy (Bactericidal/Bacteriostatic) | Bactericidal against: MRSA, MRSE, VRE, E.coli, K. pneumoniae. |
| Bacteriostatic against: P. aeruginosa, A. baumanii, C. albicans. | |
| Sterility | Demonstrated 10⁻⁶ SAL (Sterility Assurance Level) using VDmax25 method per ISO 11137:2006. |
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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