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.

Device Description

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).

AI/ML Overview

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."

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

HemCon Medical Technologies Europe Limited Barbara McGrath Manager of Regulatory Affairs 10575 SW Cascade Avenue, Suite 130 Portland, Oregon 97223-4363

April 21, 2023

Re: K121485

Trade/Device Name: GuardIVa® Antimicrobial Hemostatic IV Dressing Regulatory Class: Unclassified Product Code: QSY

Dear Barbara McGrath:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 21, 2012. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSY.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.

Sincerely,

Julie A. Morabito -S

Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

HemCon Medical Technologies Europe Limited % HemCon Medical Technologies, Incorporated Ms. Barbara McGrath Manager of Regulatory Affairs 10575 SW Cascade Avenue, Suite 130 Portland. Oregon 97223

AUG 2 1 2012

Re: K121485

Trade/Device Name: GuardIVa® Antimicrobial Hemostatic IV Dressing Regulatory Class: Unclassified Product Code: FRO Dated: July 18, 2012 Received: July 19, 2012

Dear Ms. McGrath:

We have reviewed your Section 510(k) premarket notification of intent to market the device . referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Barbara McGrath

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health .

Enclosure

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K121485-
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Indications for Use Statement

Applicant: HemCon Medical Technologies Europe Ltd.

510(k) Number: K121485

Device Name: GuardIVa® Antimicrobial Hemostatic IV Dressing

Indications for Use (Rx):

Prescription Use X (Part 21 CFR 801 Subpart D) . AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(Please Do Not Write Below This Line - Continue On Another Page If Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Knoerker MM
(Division Sign Off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K121455

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Hem Con Medical Technologies Europe Ltd.. 6 Courtyard Business Centre, Orchard Lane, Blackrock, Co. Dublin, (teland

TEL: +353 (0) 1 2064727 FAX: +1 (503) 245-1326 EMAIL: info@hemcan.com

510(k) Summary

AUG 2 1 2012

In accordance with 21 CFR 807.92 the following summary of information is provided:

Trade Name: GuardIVa® Antimicrobial Hemostatic IV Dressing Common Name: Wound Dressing Classification: Unclassified Classification Name: Dressing Product Code: FRO Predicate Device(s): GuardIVa™ Antimicrobial Hemostatic IV Dressing (K093729) Company Name: HemCon Medical Technologies Europe Ltd. Company Address: 6 Courtyard Business Centre, Orchard Lane. Blackrock, Co. Dublin Ireland Contact Person: Barbara MªGrath Regulatory Affairs Manager Contact Phone: (503) 245.0459 x120 (503) 245.1326 Contact Fax:

Date of Preparation:

. 17 Aug 2012

Description of the Device:

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 (See Table 1). 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).

Image /page/4/Picture/13 description: The image shows the logo for HemCon Europe. The logo consists of a symbol that looks like two overlapping circles on the left, followed by the text "HemCon" in a simple, sans-serif font. To the right of "HemCon", there is a vertical line, and then the word "EUROPE" in smaller, uppercase letters.

Page 1 of 5

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Hem Con Medical Technologies Europe Ltd., 6 Courtyard Business Centre, Orchard Lane, Blackrock, Co. Dublin, Ireland

TEL: +353 (0) 1 2064727

FAX: +1 (503) 245-1326 EMAIL: info@hemcon.com

Organism	Gram Stain	24 Hr LogReduction	7 Day LogReduction
Staphylococcus aureus (MRSA)	+	>4.0	>4.0
Staphylococcus epidermidis (MRSE)	+	>4.0	>4.0
Enterococcus faecium (VRE)	+	>4.0	>4.0
Pseudomonas aeruginosa		>4.0	>4.0
Acinetobacter baumanii		>4.0	>4.0
Klebsiella pneumoniae		>4 0	>4.0
Escherichia coli	-	>4.0	>4.0
Candida albicans	N/A	>4.0	>4.0
Aspergillus niger	NIA	>4.0	>4.0

Table 1: Antimicrobial Efficacy of GuardlVa® assessed using Log Reduction of Organisms

Intended Use:

Indications for Use (Rx):

Technological Characteristics:

The version of GuardIVa® Antimicrobial Hemostatic IV Dressing that is the subject of this notification is technologically identical to the currently marketed GuardIVa® dressing originally cleared in K093729. The proposed changes to the product information are based on additional performance testing completed by HemCon and do not affect the fundamental scientific technological characteristics of the product.

KI21+88
Page 2 of 5

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Hem Con Medical Technologies Europe Ltd., 6 Courtyard Business Centre, Orchard Lane, Blackrock, Co. Dublin, freland

FAX: +1 (503) 245-1326 EMAIL: info@hemcon.com TEL: +353 (0) 1 2064727

Summary of Performance Data:

Biocompatibility

Biocompatibility has been demonstrated per ISO 10993. Categorization of the device by nature of body contact deduces the GuardIVa® Antimicrobial Hemostatic IV Dressing is a surfacecontacting device that contacts breached or compromised surfaces. The duration of contact may be prolonged at more than 24 hours, but no more than 30 days. Cytotoxicity, irritation and sensitization testing was performed by contract testing laboratories under GLP conditions per standard protocols.

In Vivo Efficacy - Dermal Wound Healing Studies

Two independent in vivo dermal wound healing studies in rats were performed by contract testing laboratories under GLP conditions to demonstrate that the CHG in GuardlVa® does not adversely affect the rate of wound healing compared to un-treated wounds. Wounds treated with GuardIVa® healed at a rate comparable to untreated wounds with no visible signs of erythema and with an edema response comparable to that of un-treated wounds. Another commercially available CHG containing sponge dressing was used as a control and it did have a pronounced adverse effect on healing and edema.

In Vivo Efficacy - Hemostatic Properties of GuardIVa®

The haemostatic efficacy of GuardIVa® Antimicrobial Hemostatic IV Dressing was tested in comparison to standard gauze dressing in a rabbit ear model. The time to hemostasis was significantly reduced in wounds treated with GuardIVa® (48 s) compared to standard gauze (113 s). Furthermore, up to seven times less blood loss was observed for wounds treated with GuardIVa® (0.17 g) compared with standard gauze (1.30 g).

In Vivo Efficacy - Suppression of Skin Flora Re-growth in Healthy Volunteers

A study, conducted independently by the Centre for Laboratory Activities in Public Health Protection and Promotion, National Reference Laboratory for Disinfection and Sterilization, National Institute of Health, Prague, Czech Republic, on healthy human volunteers, demonstrated the ability of Guard|Va® to suppress skin flora re-growth for up to 10 days, maintaining skin flora at a level equivalent to that observed immediately following preoperative skin preparation (70% isopropy) alcohol solution).

HemCon EUROPE

K12 1485
Page 3 of 5

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HemCon Medical Technologies Europe Ltd., 6 Courtyard Business Centre, Orchard Lane, Blackrock, Co. Dublin, Ireland

TEL: +353 (0) 1 2064727 FAX: +1 (503) 245-1326 EMAIL: info@hemcon.com

Sustained Antimicrobial Efficacy - 7 Day Log Reduction Values.

The sustained antimicrobial efficacy of GuardIVa® Antimicrobial Hemostatic IV Dressing, for up to 7 days, was demonstrated in vitro using a modified version of the AATCC Test Method 100-2004 "Assessment of Antibacterial Finishes on Textiles". GuardIVa® dressings were tested in triplicate against seven [7] bacterial strains, S. aureus (MRSA), S. epidermidis (MRSE), E. faecium (VRE), P. aeruginosa, A. baumanii, K. pneumoniae and E. coli, the diploid yeast C. albicans and the fungus A. niger. A greater than 4 log reduction in microbial count was observed for all test organisms.

Table 2: Organisms causing CRBSI and their prevalence

Organism	Prevalence	GuardIVa Test Organism
Coagulase-negativestaphylococci	31%† - 37%‡	Staphylococcus epidermidis
Staphylococcus aureus	20%† - 22%‡	Staphylococcus aureus (MRSA)
Enteric Gram negative bacilli	11%† - 12.4%‡	Escherichia coli, Klebsiella pneumoniae
Yeast (Candida species)	9%† - 9.3%‡	Candida albicans
Pseudomonas	5.5%‡	Pseudomonas aeruginosa
Enterococci and Streptococci	4.9%‡ - 9%†	Enterococcus faecium,
Other	8.9%‡ - 20%†	Acinetobacter baumanii

† Data from Abad & Safdar (2011) #Data from Fletcher (2005)

Antimicrobial Efficacy - Zone of Inhibition Measurements

Kirby-Bauer Zone of (nhibition (Zol) measurements were used to demonstrate the bactericidal or bacteriostatic properties of GuardIVa® Antimicrobial Hemostatic IV Dressing aqainst a range of micro-organisms over a 7 day period (See Table 3). Individual test articles were placed onto agar plates and incubated for 24 hr at 35 - 37°C. The area under the test articles was swabbed and the swab was transferred onto sterile agar plates. The test articles were then placed on a freshly inoculated agar plates and the procedure repeated for 7 days. Growth from the swabs taken from the test articles indicated bacteriostatic action (slowed growth over 7 days) of the CHG in GuardlVa®, while no growth over 7 days indicated bactericidal action. GuardIVa® Antimicrobial Hemostatic IV Dressing was shown to be bactericidal against five of the test organisms (MRSA, MRSE, VRE, E.coli and K. pneumoniae) and bacteriostatic against the other three organisms (P. aeruginosa, A. baumanii and C. albicans).

Table 3: Bactericidal and Bacteriostatic properties of GuardIVa® assessed using Kirby-Bauer Zone of Inhibition Measurements ,

Organism

Staphylococcus aureus (MRSA) Staphylococcus epidermidis (MRSE) Enterococcus faecium (VRE) Escherichia coli

Bactericidal Bactericidal Bactericidal Bactericidal

Image /page/7/Picture/13 description: The image shows the logo for HemCon Europe. The logo consists of a stylized symbol on the left, followed by the text "HemCon" in a simple, sans-serif font. A vertical dashed line separates "HemCon" from the word "EUROPE" on the right. The overall design is clean and professional.

K12/485
Page 4 of 5

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Hem Con Medical Technologies Europe Ltd., 6 Courtyard Business Centre, Orchard Lane, Blackrock, Co. Dublin, Ireland

FAX: +1 (503) 245-1326 EMAIL: info@hemcan.com TEL: +353 (0) 1 2064727

Organism

Pseudomonas aeruginosa Bacteriostatic Acinetobacter baumanii Bacteriostatic Klebsiella pneumoniae Bactericidal Candida albicans Bacteriostatic

Sterility

A sterility validation for GuardIVa® Antimicrobial Hemostatic IV Dressing was completed following ISO 11137:2006 requirements to demonstrate a 10° SAL using the VDma25 method.

Conclusion:

GuardIVa® Antimicrobial Hemostatic IV Dressing is technologically identical to the predicate device. The conclusion drawn from the technological characteristics and performance data is that the GuardIVa® Antimicrobial Hemostatic IV Dressing is as safe and effective as the predicate device.

Image /page/8/Picture/8 description: The image shows the logo for HemCon Europe. The logo consists of a stylized infinity symbol to the left of the word "HemCon", which is written in a thin, sans-serif font. To the right of "HemCon" is a vertical line, followed by the word "EUROPE" in a smaller, sans-serif font.

K121485
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Regulation Number and Section

N/A