K Number

Device Name

SILVACIDE SKIN & WOUND MOISTURIZING SOLUTION

Manufacturer

MEDICAL MOLECULAR THERAPUETICS LLC

Date Cleared

2007-07-03

(270 days)

Product Code

FRO

Regulation Number

N/A

Intended Use

Over-The-Counter Indications: For minor burns, abraded skin, irritated areas and minor wounds. Professional Prescription Indications: Wound moistening solution for dermal lesions such as Stage I-IV pressure ulcers, stasis ulcers, foot ulcers, diabetic ulcers, post surgical wounds, first and second degree burns, abrasions and skin irritations.

Device Description

A buffered ionic silver aqueous wet dressing for external wound management. The product provides a moist environment that aids the body in the healing process. The non-irritating components of Silvion Antibacterial Silver Skin & Wound Moisturizing Solution allow the product to be used on mucous membranes, the skin as well as acute and chronic wounds. The silver provides effective protection of the solution against microbial contamination. The Silvion Antibacterial Silver Skin & Wound Moisturizing Solution is clear, odorless and colorless. The product is available in 2 oz, 4 oz, 8 oz and 16 oz spray bottles.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K042729, K040683, K022670, K042729, K040019, K011994, K023612

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the chemical and biological properties of a silver-based wound dressing, with no mention of AI or ML.

Therapeutic

Yes
The device is described as aiding the body in the healing process for various dermal lesions and wounds, which aligns with the definition of a therapeutic device.

Diagnostic

No
The device is a moist wound dressing solution intended to aid in healing, not to diagnose a medical condition. Its intended uses and description focus on treatment and protection, not diagnosis.

SaMD (Software as a Medical Device)

The device description clearly states it is a "buffered ionic silver aqueous wet dressing" and is available in "spray bottles," indicating it is a physical product (a liquid solution) and not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the external management of wounds and skin irritations. This involves applying the solution directly to the body surface for therapeutic purposes (moistening, aiding healing, protection against microbial contamination of the solution).
Device Description: The description clearly states it's a "wet dressing for external wound management." It's applied topically.
Lack of Diagnostic Function: There is no mention of the device being used to test samples taken from the body (like blood, urine, tissue) to diagnose a condition, monitor a disease, or screen for health issues. IVDs are designed to perform tests in vitro (outside the body).
Performance Studies: The performance studies focus on biocompatibility and antimicrobial effectiveness of the solution itself and its effect on wound healing, not on diagnostic accuracy or the ability to detect specific analytes.

Therefore, this device falls under the category of a wound care product or topical therapeutic, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Over-The-Counter Indications:

For minor burns, abraded skin, irritated areas and minor wounds.

Professional Prescription Indications:

Wound moistening solution for dermal lesions such as Stage I-IV pressure ulcers, stasis ulcers, foot ulcers, diabetic ulcers, post surgical wounds, first and second degree burns, abrasions and skin irritations.

Product codes (comma separated list FDA assigned to the subject device)

FRO

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Dermal wounds, inflamed skin, mucous membranes, skin

Indicated Patient Age Range

Not Found

Intended User / Care Setting

OTC: Not Found
Professional: Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Silvion Antibacterial Silver Skin & Wound Moisturizing Solution has been subject to in vitro and in vivo biocompatibility (ISO Modified Intracutaneous Study, the USP and ISO Modified Systemic Toxicity Study and the ISO Maximization Sensitization) and cytotoxicity testing (Agarose Overlay Method). These tests support the safe use of Silvion Antibacterial Silver Skin & Wound Moisturizing Solution in contact with breached or compromised skin. In vitro antimicrobial testing was assessed by the standard the MIC and MBC Dilution Methods, Zone of Inhibition, USP Antimicrobial Effectiveness Test . USP Microbial Limit Test , Bioburden Aerobic Total Count and Microbial Challenge Test.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K042729, K040683, K022670, K042729, K040019, K011994, K023612

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

N/A

Summary

Medical Molecular Therapeutics LLC 510(k) PreMarket Notification K063063 Silvion Antibacterial Silver Skin & Wound Moisturizing Solution Rev 15 May 07

7. 510(k) Summary Information

JUL - 3 2007 In accordance with 21 CFR 807.92, the 510(k) Summary is presented to provide an understanding for the basis of substantial equivalence.

7.1 Submitter's & Owners Name and Address

Arthur B. Flick MD Medical Molecular Therapeutics LLC 36 Lake Rabun Road Lakemont, Georgia 30552

Contact Person: Arthur B. Flick MD Telephone: 706 782 5064 Email: abflick@alltel,net

7.2 Date Prepared

20 September 2006

7.3 Device Name

| Trade Name: | Silvion Antibacterial Silver Skin & Wound
Moisturizing Solution | | | | | |
|----------------------|--------------------------------------------------------------------|--|--|--|--|--|
| Common Name: | Skin & Wound Moisturizing Solution | | | | | |
| Classification Name: | Liquid Bandage KMF | | | | | |

7.4 Predicate Devices 807.92(a)(3)

Dermacyn Wound Cleanser	K 042729
Saline Solution (Wound Dressing)	K040683
Restore Wound Cleanser	K022670
Dermacyn Wound Irrigation	K042729

Medical Molecular Therapeutics LLC 510(k) PreMarket Notification K063063 Rev 15 May 07 Silvion Antibacterial Silver Skin & Wound Moisturizing Solution

X-Static Silverseal Hydrogel Wound Dressing	K040019
Acryderm Silver Antimicrobial Wound Gel	K011994
Antimicrobial Barrier Wound Contact Dressing	K023612

7.5 Device Description

7.6 Assessment of Performance Data

7.7 Statement of Intended Use

OTC: Minor burns, abraded skin, irritated areas minor wounds.

Professional: Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post surgical wounds, first and second degree burns, abrasions and skin irritations.

510(k) PreMarket Notification K063063 Medical Molecular Therapeutics LLC Rev 15 May 07 Silvion Antibacterial Silver Skin & Wound Moisturizing Solution

7.8 Technological Characteristics and Substantial Equivalence

Silvion Antibacterial Silver Skin & Wound Moisturizing Solution is a combination product within the meaning of section 503(g) of the Federal Food, Drug, and Cosmetic Act (Act) and Title 21 of the Code of Federal Regulations (CFR) section 3.2(e)(1) and (2). In accordance with section 503(g)(1) of the Act and 21 CFR section 3.4, Silvion Antibacterial Silver Skin & Wound Moisturizing Solution had two modes of action. One action of the product is the device components' action to provide moisture to dermal wounds and inflamed skin. Another mode of action of the product is that of the drug component (ionic silver) to act as an antimicrobial agent. The primary mode of action of the combination product is attributable to the device components' action to provide moisture to dermal wounds and inflamed skin.

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, superimposed over three horizontal lines that represent waves. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medical Molecular Therapeutics LLC % Arthur B. Flick, MD 36 Lake Rabun Road Lakemont, Georgia 30552

JUL - 3 2007

Re: K063063

Trade/Device Name: Silvion™ Antibacterial Silver Skin & Wound Moisturizing Solution Regulatory Class: Unclassified Product Code: FRO Dated: May 22, 2007 Received: May 24, 2007

Dear Dr. Flick:

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.

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

Page 2 - Arthur B. Flick, MD

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

for
Mark N. Melkerson

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

Enclosure

Medical Molecular Therapeutics LLC 510(k) PreMarket Notification K063063 Silvion Antibacterial Silver Skin & Wound Moisturizing Solution Rev 15 May 07

5. INDICATIONS FOR USE

510(k) Number: K063063/S1

Device Name: Silvion™ Antibacterial Silver Skin & Wound Moisturizing Solution

Indications For Use:

Over-The-Counter Indications:

For minor burns, abraded skin, irritated areas and minor wounds.

Professional Prescription Indications:

Prescription Use	X	AND/OR	Over-The-Counter Use	X
(Part 21 CFR 801 Subpart D)			(21 CFR 801 Subpart C)

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

(Division Sign)

Concurrence of CDRH Division of General and Neurologic Office of Device Evaluation (ODE)

12063062

510