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 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.

AI/ML Overview

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.

Summary

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HemCon Medical Technologies Europe Ltd. c/o HemCon Medical Technologies, Inc. Kevin Hawkins Director, Quality & Regulatory 10575 SW Cascade Avenue, Suite 130 Portland, Oregon 97223-4363

July 28, 2023

Re: K093729 Trade/Device Name: GuardlVa™ Regulatory Class: Unclassified Product Code: QSY

Dear Kevin Hawkins:

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 June 8, 2010. 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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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

HemCon Medical Technologies Europe Ltd. % HemCon Medical Technologies Inc. Mr. Kevin Hawkins 10575 SW Cascade Avenue, Suite 130 Portland, Oregon 97223-4363

JUN - 8 2010

Re: K093729

Trade/Device Name: GuardIVa" Regulatory Class: Unclassified Product Code: FRO Dated: May 25, 2010 Received: May 26, 2010

Dear Mr. Hawkins:

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

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Page 2 - Mr. Kevin Hawkins

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/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" (2) CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson Director Division of Surgical, Orthoped and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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TEL: +353 (0)1 2352162 FAX: +353 (0)1 2352165 EMAIL: Info@hemcon.com

093729

Applicant: HemCon Medical Technologies Europe Limited 510(k) Number: K093729 Device Name: GuardIVa™M

Indications for Use:

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.

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 Krone for MXM

(Division Sign-C Division of Surgical. Orthopedic. and Restorative Devices

510(k) Number K093729

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Hem Con Medical Technologies Europe Ltd. Alltracel House, Sallynoggin, Co. Dublin, Ireland

TEL: + 353 (0)1 2352162 FAX: + 353 (0)1 2352165 EMAIL: intolahem con c

K093729
Page 1 of 2

JUN - 8 2010

510(k) Summary

Trade Name:Common Name:Classification Name:Product Code:Predicate Device(s):	GuardIVa™Dressing, Wounds, DrugUnclassifiedFROBioPatch® (K003229)BloodSTOP™ (K072681)Seal-On™ Hemostatic Powder Spray(K010933)
Company Name:Company Address:	HemCon Medical Technologies Europe Ltd.Alltracel House, Church Place, SallynogginDublin, Ireland
Contact Person (Europe):	Keith RealExecutive Vice President, Research andDevelopment
Contact Phone:	+353-1-235 2162
Contact Fax:	+353-1-235 2165
Contact Person (US):	Kevin Hawkins
Contact Phone:Contact Fax:	Director - Quality & Regulatory+1-503-245.0459 x114+1-503-245.1326
Date of Preparation:	09 April 2010

Description of the Device:

Intended Use:

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Basis for Substantial Equivalence:

GuardIVa™ is substantially equivalent to at least three predicate devices, all of which are in the same FDA classification as GuardIVa™.

1. BioPatch® a polyurethane foam dressing containing the antimicrobial agent CHG.
1. BloodSTOP™ a standard dressing impregnated with a hemostatic agent from plant derived cellulose.
1. Seal-On™ Hemostatic Powder Spray which is made of the hemostatic agent microdispersed oxidized cellulose (m.doc TM)

BioPatch® has demonstrated the safety and efficacy of a polyurethane foam dressing containing the antimicrobial agent CHG. GuardIVa™ is also a polyurethane foam dressing impregnated with the same antibacterial agent CHG as the predicate device BioPatch® (K003229). GuardIVa™ is made from the same material, is available in the same size configurations, and is packaged in a Tyvek® and LDPE pouch like this predicate. An intended use for BioPatch® (K003229) is as a hydrophilic wound dressing that absorbs exudate and covers the wound caused by the use of vascular and non-vascular percutaneous medical devices.

The GuardIVa™ antimicrobial haemostatic IV dressing has m•doc™ impregnated in the polyurethane foam to help control surface bleeding. This design and intended use is substantially equivalent to the other two predicate devices: Seal-ON™ (K010933) and BloodSTOP® (K072681). BloodSTOP™(K072681) has demonstrated the safety and efficacy of a standard dressing impregnated with a haemostatic agent and Seal-On™ Hemostatic Powder Spray (K010933) has demonstrated the safety and efficacy of microdispersed oxidized cellulose (modoc™) as a haemostatic agent. The haemostatic agent in GuardIVa™ is the same as that in the predicate device Seal-ON™ and is substantially equivalent to BloodSTOP® as both are derived from plant source cellulose.

Summary of performance testing:

The efficacy of the GuardIVa™ antimicrobial haemostatic IV dressing was demonstrated with in vitro, in vivo and ex vivo performance testing using the predicate device BioPatch® as a comparator. GuardIVa™ displayed superior haemostatic efficacy and a higher absorption capacity than BioPatch®. The antibacterial efficacy of GuardIVa™ was tested in vitro using AATCC Test Method 100-2004, a quantitative, direct contact method for the evaluation of the degree of antimicrobial activity of a test article. GuardIVa™ demonstrated greater than log 4 reductions of all the organisms tested.

Conclusion:

The conclusion drawn from the technological characteristics and non-clinical performance data is that the device is as safe and effective as the predicate devices.

Regulation Number and Section

N/A