SilverMed™ Antimicrobial Hydrogel is indicated for the management of minor burns, superficial cuts, lacerations, abrasions and minor irritation of the skin. Under the supervision of a healthcare professional, it is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.

Device Description

The Argentis SilverMedIM Antimicrobial Hydrogel is a moist hydrogel dressing designed to deliver antimicrobial silver that inhibits the growth of microbial contaminants. The high moisture content gel absorbs destructive components of wound exudate while promoting healthy tissue healing. Stabilizers prevent discoloration and staining from the dressing. The product is available in 1.5 oz and 3 oz containers.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the SilverMed™ Antimicrobial Hydrogel:

This document is a 510(k) summary for a medical device seeking clearance, not a study report detailing clinical trial results or a comparative effectiveness study. Therefore, the information typically found in such a study for AI/software devices (like sample sizes for test/training sets, ground truth establishment, MRMC studies, or standalone performance) is largely not applicable or not present in this type of submission.

Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics, intended use, and performance data from in vitro and in vivo biocompatibility/antimicrobial tests.

Here's a breakdown of the requested information based on the provided text, with explanations where information is missing or not relevant to this type of regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Evaluation	Acceptance Criteria (Implicit)	Reported Device Performance
Biocompatibility	ISO Modified Intracutaneous Study	Safe for contact with skin	Supports safe use in contact with breached or compromised skin.
	ISO Intracutaneous Reactivity Test	Safe for contact with skin	Supports safe use in contact with breached or compromised skin.
	ISO Delayed Hypersensitivity Study	Safe for contact with skin	Supports safe use in contact with breached or compromised skin.
Cytotoxicity	ISO Agar Diffusion (Direct)	Non-cytotoxic	Supports safe use in contact with breached or compromised skin.
Antimicrobial Efficacy	USP Antimicrobial Effectiveness Test <51>	Inhibit microbial growth	Exceeds the requirements as set forth by the USP.
Substantial Equivalence	Comparisons to predicate devices (K011994, K062212, K061227, K071703, K932291)	Similar indications, technological properties, and performance	"Substantially equivalent" to predicate devices for indications of use, technological properties, and performance.

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

This document does not describe a "test set" in the context of an AI/software device evaluation. The studies referenced are in vitro and in vivo biocompatibility and antimicrobial efficacy tests.

Sample Size: Not specified for individual biocompatibility or antimicrobial tests.
Data Provenance: The studies are described as in vitro (Antimicrobial Effectiveness) and in vivo (Biocompatibility). The document does not specify country of origin for these tests. They are standard laboratory tests.

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

This information is not applicable to this type of device submission. Ground truth, in the context of expert consensus, is typically relevant for evaluating the performance of diagnostic algorithms or imaging devices. For a hydrogel dressing, "ground truth" relates to objective measurements from laboratory and animal studies (biocompatibility, antimicrobial efficacy).

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies among multiple human readers for diagnostic evaluations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is a hydrogel wound dressing, not an AI or diagnostic imaging system that would typically be evaluated with an MRMC study comparing human reader performance with and without AI assistance.

6. If a Standalone Performance Study Was Done

The device performance was evaluated through standalone in vitro and in vivo tests (biocompatibility and antimicrobial efficacy) as described, not "standalone performance" in the context of an AI algorithm without human-in-the-loop. The term "standalone performance" often refers to the algorithm's performance independent of human input, which isn't relevant here. The device's performance stands alone on its merit in safety and efficacy tests.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on objective measurements derived from standardized laboratory tests:

Biocompatibility: Results from ISO Modified Intracutaneous study, ISO Intracutaneous Reactivity test, and ISO Delayed Hypersensitivity study. These tests define what is considered a safe biological response.
Cytotoxicity: Results from ISO Agar Diffusion (Direct) test.
Antimicrobial Efficacy: Results from the standard USP Antimicrobial Effectiveness Test <51>. This test provides objective measurements of reduction in microbial contaminants.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" for this device as it is not an AI/machine learning model.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. There is no "training set" or corresponding ground truth establishment methodology in the context of AI/machine learning for this device.

Summary

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SEP 1 6 2008

2. 510(k) Summary

2.1 Submitter's Name and Address

Contact Person:	Argentis Biomedical Inc11005 Indian Trail #102Dallas, Texas 75229
	Toni Miller PhDLEC Associates LLC26 Chestnut Ridge Rd #12Montvale NJ 076451 201 615 1212Fax: 1.201.785.0322Email: tfmiller@lecassociates.com

2.2 Datc Prepared 12 September 2008

2.3 Device Name

Trade Name:	SilverMed TM Antimicrobial Hydrogel
Common:	Moist antimicrobial wound gel
Classification Name:	Dressing, Wound and Burn, Hydrogel w/Drug and or Biologic
Regulatory Class:	Unclassified
Product Code:	FRO

2.4 Predicate Devices 807.92(a)(3)

SilverMed ™ Antimicrobial Silver Hydrogel is substantially equivalent to the following hydrogels:

• Eutra Gel For Wound Dressing	K932291
• SilvaSorb Silver Antimicrobial Wound Gel orAcryDerm Silver Antimicrobial Wound Dressing	K011994
• Silver Shield™ Antimicrobial Skin andWound Gel	K062212
• Hydrolyzed Collagen Gel with Silver	K061227
• Elta Silver Antimicrobial Wound Gel	K071703

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2.5 Device Description

The product is available in 1.5 oz and 3 oz containers.

2.6 Assessment of Performance Data and Safety

SilverMed™ Antimicrobial Hydrogel is substantially equivalent to several silver hydrogel wound dressings: SilvaSorb Silver Antimicrobial Wound Gel/AKA AcryDerm Silver Antimicrobial Wound Dressing (K011994), Silver Shield™ Antimicrobial Skin and Wound Gel (K062212), Hydrolyzed Collagen Gel with Silver (K061227) and most recently Elta Silver Gel™ Advanced Ionic-Silver Wound Gel (K071703) and to Eutra Gel For Wound Dressing (K932291) except that this dressing does not contain antimicrobial silver.

SilverMed™ Antimicrobial Hydrogel has been subjected to in vitro and in vivo biocompatibility testing (ISO Modified Intracutaneous study, the ISO Intracutaneous Reactivity test and the ISO Delayed Hypersensitivity study) and cytotoxicity testing (ISO Agar Diffusion Diffusion (Direct)). These tests support the safe use of SilverMed™ Antimicrobial Hydrogel in contact with breached or compromised skin. In vitro Antimicrobial testing was assessed by the standard USP Antimicrobial Effectivencss Test <51>.

2.7 Statement of Intended Use

SilverMed™ Antimicrobial.Hydrogel is indicated for the management of minor burns, superficial cuts, lacerations, abrasions and minor irritation of the skin. Under the supervision of a healthcare professional, it is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.

These indications are identical or substantially equivalent to its predicates.

2.8 Technological Characteristics and Substantial Equivalence

SilverMed™ Antimicrobial Hydrogel is an amorphous gel wound filler that controls wound moisture levels through dual function of donation and absorption. Antimicrobial

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action is conferred by its content of stabilized antimicrobial silver. The product carries the general classification name "Dressing, Wound and Burn, Hydrogel w/Drug and or Biologic". It is substantially identical to the predicate device Eutra Gel For Wound Dressing (K932291) in form and function except that its' preservative system has been replaced by antimicrobial silver technology. SilverMed™ Antimicrobial Hydrogel is substantially similar to the predicates SilvaSorb Silver Antimicrobial Wound Gel/AKA AcryDerm Silver Antimicrobial

Wound Gel (K011994), Silver Shield™ Antimicrobial Skin and Wound Gel (K062212), Hydrolyzed Collagen Gel with Silver (K061227) and Elta Silver Antimicrobial Wound Gel (K071703) in its active component of antimicrobial silver, in its hydrogel configuration and in its function.

The indications of use, technological properties and performance testing for SilverMedIM Antimicrobial Hydrogel are substantially equivalent to those of the predicate devices. The performance data testing exceeds the requirements as set forth by the USP. The biocompatibility testing and performance testing performed for the device also demonstrated that the device is safe and effective for the indications of use.

K073019 SilverMed Antimicrobial Hydrogel (Sept2008) tfiller@lecassociates.com 1 201 615 1212

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with outstretched wings, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.

SEP 1 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Argentis Biomedical Incorporated % LEC Associates, LLC Toni Miller, Ph.D. President 26 Chestnut Ridge Road #12 Montvale, New Jersey 07645

Re: K073019

Trade/Device Name: SilverMed Antimicrobial Hydrogel Regulation Number: Unclassified Product Code: FRO Dated: August 17, 2008 Received: October 14, 2008

Dear Dr. Miller:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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 – Toni Miller, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse ventures (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Milliman

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

Enclosure

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510(k) Number:

Indications for Use Statement

SilverMed Antimicrobial Hydrogel Device Name:

Indications for use:

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

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

(PLEAS DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

D.M. m/

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

N/A