← Product Code FRO · K090345

# MENDASIL TWG GEL ANTIMICROBIAL SKIN AND WOUND GEL (K090345)

_Conseal International, Inc. · FRO · Jan 7, 2010 · SU · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K090345

## Device Facts

- **Applicant:** Conseal International, Inc.
- **Product Code:** FRO
- **Decision Date:** Jan 7, 2010
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** SU
- **Attributes:** Therapeutic

## Intended Use

MendaSil™-TWG Gel Skin and Wound Gel is indicated for use under the supervision of a healthcare professional for management of partial to full thickness wounds from mild to moderate exudate such as Stage I-IV Pressure Ulcers, Partial and Full Thickness Wounds, 1st and 2nd Degree Burns, Diabetic Foot Ulcers, Venous Stasis Ulcers and Surgical Incision Wounds. The Gel can also be used for management of minor cuts, scrapes/abrasions, and irritated skin.

## Device Story

MendaSil™ TWG Skin and Wound Gel is an amorphous hydrogel wound dressing. It functions by maintaining a moist wound environment through exudate absorption or moisture donation. The gel incorporates a silver compound acting as a barrier to bacterial penetration by inhibiting growth of microorganisms contacting the gel. Supplied in HDPE bottles with flip-top dispensers. Used in clinical settings under healthcare professional supervision for wound management. The silver barrier action is localized within the hydrogel. Benefits include moisture balance and antimicrobial protection, facilitating healing of dermal wounds and inflamed skin.

## Clinical Evidence

Bench testing only. Performance testing included USP Preservative Efficacy and Kirby Bauer Zone Inhibition testing to confirm antimicrobial barrier effectiveness. Biocompatibility testing conducted per ISO 10993 standards, including cytotoxicity, sensitization, and irritation, showed no irritation or sensitization and negligible cytotoxicity.

## Technological Characteristics

Amorphous hydrogel wound dressing containing a silver compound. Inert viscosity-enhancing agents provide hydrogel structure. Supplied in HDPE bottles. Antimicrobial barrier via silver ions. Biocompatibility assessed per ISO 10993. Manufacturing follows GMP guidelines.

## Predicate Devices

- SilvaSorb Silver Antimicrobial Wound Gel ([K011994](/device/K011994.md))
- AcryDerm Silver Antimicrobial Wound Gel ([K011994](/device/K011994.md))
- Silver Shield Antimicrobial Skin and Wound Gel ([K062212](/device/K062212.md))

## Submission Summary (Full Text)

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## 510(K) SUMMARY

| Company:                   | ConSeal International, Inc.                               |
|----------------------------|-----------------------------------------------------------|
|                            | 90 Kerry Place, Suite 2                                   |
|                            | Norwood, MA 02062                                         |
|                            | JAN - 7 2010                                              |
| Contact:                   | Stephen C. Perry, President                               |
|                            | Telephone: 781-278-0010 / Facsimile: 781-278-0028         |
|                            | Email: sperry@consealint.com                              |
| Date of Preparation:       | January 5, 2010                                           |
| Device Name (proprietary): | MendaSil™ TWG Skin and Wound Gel                          |
| Common Name:               | Moist Wound Filler OR                                     |
|                            | Amorphous Hydrogel Wound Dressing                         |
|                            | 10:9130184781:3                                           |
| Classification Name:       | Dressing, wound and burn, hydrogel w/drug and/or biologic |
| Classification:            | Unclassified                                              |
|                            | STJ(K) SUMMARY                                            |
| Product Code:              | FRO, MEQ                                                  |

Legally Marketed Devices for substantial equivalence comparison:

MendaSil™-TWG Skin and Wound Gel is substantially equivalent to:

| SilvaSorb Silver Antimicrobial Wound Gel                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   | 781-278-0010 / Facsimile: 781-278-0028 K011994 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| AcryDerm Silver Antimicrobial Wound Gel (AcryMed, Inc., OR)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | K011994                                        |
| Silver Shield Antimicrobial Skin and Wound Gel (Anacapa Tech., Inc., CA)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   | K062212                                        |
|                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | uary 5 2010                                    |
| Description of Device:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     |                                                |
| MendaSil™ TWG Skin and Wound Gel is an amorphous wound moisture management gel that helps             maintain a moist wound environment that is conducive to healing by either absorbing the wound exudates             or donating the moisture. The Gel contains a silver compound that is an effective barrier to bacterial             penetration by inhibiting the growth of a broad spectrum of microorganisms which come into contact with             the gel. MendaSil™-TWG Skin and Wound Gel will be supplied in conventional HDPE bottles fitted             with a "flip top" dispenser closure. This bottle will be placed in a chipboard dispenser box with a             package insert. |                                                |

Intended Use of the Device:

MendaSil™-TWG Gel Skin and Wound Gel is indicated for use under the 'supervision of a healthcare
 professional for management of partial to full thickness wounds from mild to moderate exudate such as
 Stage I-IV Pressure Ulcers, Partial and Full Thickness Wounds, 1st and 2nd Degree Burns, Diabetic Foot
 Ulcers, Venous Stasis Ulcers and Surgical Incision Wounds. The Gel can also be used for management
 of minor cuts, scrapes/abrasions, and irritated skin.

3 | Page

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#### Device Technological Characteristics:

MendaSil™-TWG Skin and Wound Gel exhibits the capacity to absorb moistire and control light wound exudates. The Gel contains a silver compound that acts as an effective barrier to a wide spectrum of bacteria which come into contact with the gel. Hydrogel characteristics are imparted by an inert viscosity enhancing agent as contained in the predicate device (AcryDerm Silver Antimicrobial Wound Gel, Acrymed, Inc., OR aka Silvasorb™ Antimicrobial Wound. Gel, #K011994, and Silvershield™ Antimicrobial Skin and Wound Gel #K062212.) MendaSil™-TWG Skin and Wound Gel represents substantial equivalence to the predicate devices.

#### Manufacturing:

MendaSil™ TWG Skin and Wound Gel will be manufactured according to product specifications and under the guidelines of Good Manufacturing Practices (GMP). Risk analysis has been performed to identify possible failure mode during manufacturing controls have been developed and implemented to address the identified risk factors based on the criticality of the failure mode. All established GMPs will assure that the device manufactured meets all the established specifications prior to release and is safe and effective for its intended use.

#### Performance Testing:

USP Preservative Efficacy and Kirby Bauer Zone Inhibition Testing were performed to establish that MendaSil™ TWG Skin and Wound Gel is an effective antimicrobial barrier. The tests were performed using the test organisms in accordance with USP and some additional; bacterial strains. Biocompatibility has been assessed according to fatt 1 . 0 . the . Sondard ( Biological Evaluation of Medical . Devices) [Cytotoxicity, Sensitization]; The cytonicity was between none and sijeht. .. There, was no irritation or sensitization. In we | edicate device (AcryD. m Silver Antimierobial Wow 1 Grel 1. tha Silvenorbild Antinicrobial Wound Gel, 14 KO 1924, and Shownan.

Substantial Equivalence Discussionsik (622). \ MendaSilTM-TWG Skin and Wor ... MendaSil™-TWG Skin and Wound Gel 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, MendaSil™-TWG Skin and Wound Gel has two modes offaction of the product is the device omponents' action to provide moisture to demal. wounds and inflamed sking Another model of action of the product is that of the silver contained in the hydroge which acts as a bacterial penetration by inhibiting the growth ; of .a . encad spectrum of mist come . into ; contact .with the hydrogel. This latter barrier action of silver is limited to within the hydrogel. 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.

,让心!! The indications, of institutionical. Properties the sidesting to series in a like MendaSil™ TWG <Skin; and : Wound . Och are rsubstantially; equivalent . jobose . espredicate + device AcyrDerm™ Silver Antimicrobial, Mound; Gel, Acrymed, Ind., OB, aka: Silvasord The Antimicrobial Wound Gel, #K011994 and Silvershield ... Antimicrobial Sking and Sel. #K062212- The performance testing exceeds the requirements as set forth by USP as well, exceeds those, demonstrated by the predicate The biocompatibility testing and the performance testing performed for the device also devices. demonstrated that the device is safe and effective for the indications of use.

| Skin and Wound Gel is a                                         |                                 |
|-----------------------------------------------------------------|---------------------------------|
| drug and Cosmetic Act (Act) and Title 21 of th                  | section 410B(a,g,e              |
|                                                                 | Regulations (CFR)               |
| In accordance with section 503(g)(1) of the Act and 21 CFR sect |                                 |
| Wound Gel has two mode of action. One action of the pro         |                                 |
|                                                                 | in wound and film skin. Further |
|                                                                 | the acts as a barrier to        |
| a broad spectrum of micr                                        | contact with                    |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Conseal International, Inc. % Mr. Stephen C. Perry President & CEO 90 Kerry Place, Suite 2 Norwood, Massachusetts 02062

JAN - 7 2010

Re: K090345

Trade/Device Name: MendaSil™ TWG Skin and Wound Gel Regulatory Class: Unclassified Product Code: FRO Dated: December 9, 2009 Received: December 28, 2009

Dear Mr. Perry:

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 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. Stephen C. Perry

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/cdrh/mdr/ 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/cdrh/industry/support/index.html

Sincerely yours,

Sincerely yours,

for
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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# Indications

Indications for Use

510(k) Number (if known): K090345

Device Name: MendaSil™ TWG Skin and Wound Gel

Indications for Use:

MendaSil™-TWG Gel Skin and Wound Gel is indicated for use under the supervision of a healthcare professional for management of partial to full thickness wounds from mild to moderate exudate such as Stage I-IV Pressure Ulcers, Partial and Full Thickness Wounds, 1st and 2nd Degree Burns, Diabetic Foot Ulcers, Venous Stasis Ulcers and Surgical Incision Wounds. The Gel can also be used for management of minor cuts, scrapes/abrasions, and irritated skin.

inor cuts, scrapes/abrasions, and irritated skin.

9130184781.8

Prescription Use
(Part 21 CFR 801 Subpart D)
Skin and Wound Gel
AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart C)

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

ario full thicsness wounds from md to moderate exudates...
cers Partial anu Full Thickness Wounds, 1st and 2nd Degree Burns, Diabetic Foot
Ulcers and Surgical tutition Wounds., The Gel can also be used for managenant of
Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
Page of
510(k) Number K090345

6|Pag

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**Source:** [https://fda.innolitics.com/device/K090345](https://fda.innolitics.com/device/K090345)

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