Under the supervision of a healthcare professional, AcryDerm Silver Antimicrobial Wound Gel Model #B is indicated for the management of 1ª and 2ª degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.
OTC: AcryDerm Wound Gel Model #B is indicated for the management of minor abrasions, cuts, lacerations and scalds.

Device Description

AcryDerm Antimicrobial Silver Gel Model #B is a repeat use, amorphous hydrogel containing antimicrobial silver for use in the management of wounds.

AI/ML Overview

The provided text is a 510(k) summary for the AcryDerm Antimicrobial Silver Gel Wound Dressing Model #B. This type of regulatory submission primarily focuses on establishing substantial equivalence to a predicate device rather than demonstrating performance against specific, quantitative acceptance criteria through clinical or complex technical studies as would be seen for AI/ML devices or novel diagnostic tools.

Therefore, many of the requested categories for a study proving acceptance criteria are not applicable to this document. The device is a wound dressing, and the assessment centers on safety, biocompatibility, and manufacturing practices, not on diagnostic performance or AI model evaluation.

Here's an analysis based on the provided text, highlighting what is (and isn't) present:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Reported Device Performance
Safety and Biocompatibility	Meets or exceeds safety and biocompatibility assurance guidelines as provided in Part-1 of the ISO standard (Biological Evaluation of Medical Devices) and NIH Publication 99-4494.
Preservative Assurance	Meets or exceeds USP <25> Preservative Assurance Testing requirements for a repeat use product.
Manufacturing	Will be manufactured according to product specifications and in accordance with good manufacturing practices to ensure the device is safe and effective for its intended uses.
Performance Standards (FDA)	No performance standards are prescribed for the new product.
Substantial Equivalence	Determined to be substantially equivalent to legally marketed predicate devices (AcryDerm Silver Antimicrobial Wound Gel and AcryDerm Silver Antimicrobial OTC Wound Gel).

Study Information (as applicable to this type of device)

Sample size used for the test set and the data provenance: Not applicable. The testing described (safety, biocompatibility, preservative assurance) would not typically involve a "test set" or "data provenance" in the way it's understood for AI/ML or diagnostic device studies. These are laboratory-based tests on the device materials themselves or microbiological performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as expert consensus is not a concept relevant to the testing methods for this wound dressing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No 'adjudication' in this sense would be used for the device's stated testing.
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 wound dressing, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the tests mentioned are:
- Safety and Biocompatibility: Conformance to established ISO and NIH standards (pre-defined thresholds for toxicological and biological responses).
- Preservative Assurance: Conformance to USP <25> standards (pre-defined microbial reduction and stability criteria).
The sample size for the training set: Not applicable. There is no concept of a "training set" for this type of medical device assessment.
How the ground truth for the training set was established: Not applicable, as there is no training set.

Summary

{0}------------------------------------------------

K083103
page 1 of 1

FEB 2 6 2009

510(k) Summary

Sponsor:

AcryMed, Inc. 9560 SW Nimbus Avenue Beaverton, OR 97008

Dressing Model #B

Contact Person:

Device Name

Dr. Bruce L. Gibbins; (503)-624-9830 ext 301 AcryDerm Antimicrobial Silver Gel Wound

Common Name:

Amorphous Hydrogel Gel Wound Dressing

Classification Product Code:

Classification Advisory Panel:

General and Plastic Surgery

Legally marketed device(s) for substantial equivalence comparison:

AcryDerm Silver Antimicrobial Wound Gel (AcryMed, Inc. Portland OR) AcryDerm Silver Antimicrobial OTC Wound Gel (AcryMed, Inc. Portland OR)

FRO

Description of Device: AcryDerm Antimicrobial Silver Gel Model #B is a repeat use, amorphous hydrogel containing antimicrobial silver for use in the management of wounds.

Intended use of the Device: Under the supervision of a healthcare professional, AcryDerm Silver Antimicrobial Wound Gel Model #B is indicated for the management of 1ª and 2ª degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.

Technological Characteristics: The AcryDerm Antimicrobial Silver Gel Wound Dressings incorporate proprietary stabilized silver salt to facilitate the action of antimicrobial ionic silver in the dressing and wound environment. The gel possesses both moisture donating and moisture sequestering action depending on the moisture level in the wound.

Testing: the new products meets or exceeds safety and biocompatibility assurance guidelines as provided in the guidance of Part-1 of the ISO standard (Biological Evaluation of Medical Devices) and the NIH Publication 99-4494. The products meet or exceed the USP <25> Preservative Assurance Testing requirements for a repeat use product.

Manufacturing: The new antimicrobial gel product will be manufactured according to the product specifications and in accordance with good manufacturing practices to ensure the device is safe and effective for their intended uses.

Performance Standards: No performance standards are prescribed for the new product.

{1}------------------------------------------------

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle with its wings spread, clutching a staff entwined with a serpent, which is a symbol associated with medicine and healing.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AcryMed, Inc. % Bruce Gibbins, Ph.D Chief Technical Officer 9560 SW Nimbus Avenue Beaverton, Oregon 97008

FEB 2 6 2009

Re: K083103

Trade/Device Name: AcryDerm Antimicrobial Silver Gel Model #B, OTC: AcryDerm Wound Gel Model #B

Regulatory Class: Unclassified Product Code: FRO Dated: January 20, 2009 Received: February 17, 2009

Dear Dr. Gibbins:

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. Iisting 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 (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.

{2}------------------------------------------------

Page 2 - Bruce Gibbins, 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 of device adverse events (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,

H. A. Aims. for

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

Enclosure

{3}------------------------------------------------

Indications for Use

K083103 510(k) Number (if known): _

. . . .

AcryDerm Antimicrobial Silver Gel Model #B Device Name:

Indications for Use: Under the supervision of a healthcare professional, AcryDerm Silver Antimicrobial Wound Gel Model #B is indicated for the management of 1* and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR ·

Over-The-Counter Use __ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, (Division Sign-Off)
------------------------------------------	--

Division of General, Restorative,
and Neurological Devices

AcryDerm Silver Pre-market Notification 510(k)
510(k) Number	K083603 Page No. 4

2/26/2009

{4}------------------------------------------------

Page 10 of 10

Indications for Use

510(k) Number (if known):

K083103

OTC: AcryDerm Wound Gel Model #B Device Name:

Over the Counter Use: OTC: AcryDerm Wound Gel Model #B is indicated for the management of minor abrasions, cuts, lacerations and scalds.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE) 2/25/2009

(Division Sign-Off) Division of General, Restorative, and Neurological Devices Page No. 5

510(k) Number K

AcryDerm Silver Pre-market Notification 510(k)

Regulation Number and Section

N/A