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 Description

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.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called MendaSil™ TWG Skin and Wound Gel. It focuses on demonstrating substantial equivalence to predicate devices rather than fully detailing a standalone study with acceptance criteria and performance metrics in the way a clinical trial for a novel AI diagnostic device would.

However, I can extract the relevant information and present it in the requested format, interpreting "acceptance criteria" from the context of what the device needs to prove to be considered substantially equivalent and effective.

Here's an analysis of the provided information:

Acceptance Criteria and Device Performance for MendaSil™ TWG Skin and Wound Gel

This document describes a 510(k) submission for MendaSil™ TWG Skin and Wound Gel, which aims to demonstrate substantial equivalence to legally marketed predicate devices. The acceptance criteria are implicitly derived from the common performance characteristics and safety profiles of such devices, as well as specific tests conducted to show the properties of the new device.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) submission for a wound gel, the "acceptance criteria" are not quantitative thresholds like sensitivity/specificity for a diagnostic AI. Instead, they relate to:

Maintaining a moist wound environment: A primary function of hydrogel dressings.
Antimicrobial efficacy: The silver compound's ability to inhibit bacterial growth.
Biocompatibility: Showing the material is safe for human contact.
Manufacturing quality: Adherence to GMP.
Substantial equivalence: Demonstrating similar technological characteristics and intended use to predicate devices.

Acceptance Criterion Category	Specific Criterion/Test	Reported Device Performance
Moisture Management	Maintain a moist wound environment (hydrogel function)	MendaSil™-TWG Skin and Wound Gel helps maintain a moist wound environment by either absorbing wound exudates or donating moisture. Exhibits the capacity to absorb moisture and control light wound exudates.
Antimicrobial Efficacy	Inhibit growth of a broad spectrum of microorganisms	Contains a silver compound that acts as an effective barrier to bacterial penetration by inhibiting the growth of a broad spectrum of microorganisms which come into contact with the gel. USP Preservative Efficacy and Kirby Bauer Zone Inhibition Testing were performed, demonstrating effectiveness against test organisms and additional bacterial strains.
Safety/Biocompatibility	Non-cytotoxic, non-irritating, non-sensitizing	Biocompatibility assessed according to ISO 10993 Standard. Cytotoxicity was between none and slight. No irritation or sensitization.
Manufacturing Quality	Produced under Good Manufacturing Practices (GMP)	Will be manufactured according to product specifications and under GMP guidelines. Risk analysis performed, controls developed to address identified risks. GMPs will assure the device meets specifications, and is safe and effective.
Substantial Equivalence	Comparable to predicate devices in:
	- Intended Use	Primary Predicate: SilvaSorb Silver Antimicrobial Wound Gel (K011994), AcryDerm Silver Antimicrobial Wound Gel (Acrymed, Inc., OR) / Silvershield™ Antimicrobial Skin and Wound Gel (Anacapa Tech., Inc., CA) (K062212). Intended Use: "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." This matches the predicate devices.
	- Technological Characteristics	Contains a silver compound for antimicrobial action and an inert viscosity enhancing agent for hydrogel characteristics, similar to predicate devices. "Represents substantial equivalence to the predicate devices."
	- Performance	"The performance testing exceeds the requirements as set forth by USP as well, exceeds those demonstrated by the predicate devices." (Referring to antimicrobial efficacy). "The biocompatibility testing and the performance testing performed for the device also demonstrated that the device is safe and effective for the indications of use."

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated as a "test set" in the context of human clinical data. The performance testing involves laboratory-based tests.
- For USP Preservative Efficacy and Kirby Bauer Zone Inhibition Testing: These tests typically use standardized microbial cultures (test organisms and additional bacterial strains). The exact number of strains or replicates is not specified but follows USP guidelines.
- For Biocompatibility (Cytotoxicity, Sensitization, Irritation): These are typically in vitro or in vivo (animal) studies, not human clinical trials for a 510(k). The exact sample size (e.g., number of cell cultures, number of animals) is not provided in this summary.
Data Provenance: The data comes from laboratory testing. The country of origin for the studies is not specified, but the submission is to the US FDA. The information is prospective in the sense that these tests were performed specifically for this 510(k) submission, not gathered retrospectively from existing patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this type of submission. "Ground truth" established by experts (like radiologists for imaging devices) is typically relevant for diagnostic devices, especially those involving human interpretation. For a wound gel, the "ground truth" is established by laboratory methods based on scientific principles (e.g., microbial inhibition zones, cell viability assays). The experts involved would be laboratory scientists and toxicologists interpreting these test results.

4. Adjudication method for the test set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve disagreements among multiple human readers in clinical studies, particularly for diagnostic accuracy. Since the performance testing here is laboratory-based, this concept does not apply.

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 submission is for a material-based medical device (wound gel), not an AI algorithm or a diagnostic device involving human readers. Therefore, an MRMC study related to AI assistance is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm. The performance testing mentioned (antimicrobial efficacy, biocompatibility) are "standalone" in the sense that they assess the device's intrinsic properties in a controlled laboratory environment. They are not assessing an algorithm's performance.

7. The type of ground truth used

The "ground truth" for the performance claims typically relies on:
- Validated laboratory assay results: For antimicrobial activity (Kirby Bauer, USP Preservative Efficacy) and biocompatibility (cytotoxicity, sensitization). These assays have established endpoints and interpretative criteria.
- Established scientific principles: For evaluating the physical property of maintaining a moist wound environment, which is a known characteristic of hydrogels.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI models that require a "training set."

9. How the ground truth for the training set was established

Not applicable. No training set is involved.

Summary

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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,

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:

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

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Regulation Number and Section

N/A