Microlyte™ Ag wound dressing is indicated for the management of wounds and can be used over-thecounter for minor wounds such as abrasions and lacerations, minor cuts, and minor scalds and burns. Under the direction of a healthcare professional, Microlyte™ Ag may be used for more serious wounds such as partial and full thickness pressure ulcers, venous stasis ulcers, first and second degree burns, abrasions and lacerations, donor sites and surgical wounds. Microlyte™ Ag wound dressing may be used over debrided and grafted partial thickness wounds.

Device Description

Microlyte™ Ag wound dressing is a sterile, single use unsupported synthetic absorbent polyvinyl alcohol hydrogel sheet with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.4 mg of silver in a 2 inch x 2 inch dressing, equivalent to 0.1 mg/sq. inch.

AI/ML Overview

The provided text is a 510(k) summary for the Microlyte™ Ag wound dressing. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing extensive clinical trials for de novo approval. As such, the information provided focuses on comparative performance and safety rather than a traditional study with ground truth established by experts.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Criteria Category	Acceptance Criteria (Proxy from Predicate Equivalence & Standards)	Reported Device Performance (Microlyte™ Ag Wound Dressing)
Intended Use/Indications For Use	Substantially equivalent to predicate devices for management of wounds, including partial/full thickness wounds, pressure ulcers, diabetic ulcers, burns, abrasions, lacerations, donor sites, and surgical wounds (Prescription Use). También, para el uso de venta libre, para abrasiones, cortes menores y quemaduras leves.	Substantially equivalent (S.E.) to predicate devices: "Microlyte™ Ag wound dressing is indicated for the management of wounds and can be used over-the-counter for minor wounds such as abrasions and lacerations, minor cuts, and minor scalds and burns. Under the direction of a healthcare professional, Microlyte™ Ag may be used for more serious wounds such as partial and full thickness pressure ulcers, venous stasis ulcers, first and second degree burns, abrasions and lacerations, donor sites and surgical wounds. Microlyte™ Ag wound dressing may be used over debrided and grafted partial thickness wounds."(Page 4) Also, specific indications for Prescription (Page 2) and OTC (Page 3) use are listed, which match the general intended use statement.
Device Description	Substantially equivalent to predicate devices in being a sterile, single-use, absorbent wound dressing with silver.	"Sterile, single use unsupported synthetic absorbent polyvinyl alcohol hydrogel sheet with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.4 mg of silver in a 2 inch x 2 inch dressing, equivalent to 0.1 mg/sq. inch." (Page 4, 11) Substantially equivalent to predicates (S.E.)
Physical Composition	Substantially equivalent to predicate devices in having an absorbent matrix and containing silver.	"The base matrix is composed of a hydrophilic polyvinyl alcohol absorbent sheet, with ionic and metallic silver complexed in a polymeric coating on the surface of the dressing." (Page 6, 13) Substantially equivalent to predicates (S.E.)
Silver Form	Substantially equivalent to predicate devices in containing ionic and/or metallic silver.	"Hydrogel sheet has a polymeric surface coating that contains ionic silver (from silver nitrate) and metallic silver." (Page 6, 13) Substantially equivalent to predicates (S.E.)
Silver Content	Quantitatively similar or functionally equivalent silver content compared to predicates (e.g., Aquacel Ag 12 mg/100 cm², AcryDerm 0.13% by weight, Silverlon 546 mg/100 cm²).	"About 1.6 mg/100 cm²" (Page 7, 14) Substantially equivalent to predicates (S.E.), despite quantitative differences, implies functional equivalence for antimicrobial activity within the dressing.
Mechanism of Action	Substantially equivalent to predicate devices: absorbs wound fluid, forms soft gel, maintains moist environment, and contains silver to prevent/minimize microbial growth within the dressing.	"The dressing absorbs wound fluid and forms a soft gel that intimately conforms to the wound surface and maintains a moist environment. The dressing contains silver only to prevent or minimize microbial growth within the dressing." (Page 7, 14) Substantially equivalent to predicates (S.E.)
Biocompatibility	Pass all relevant tests in ISO-10993-1, including cytotoxicity, acute systemic toxicity, acute intracutaneous reactivity, skin sensitization, subacute/subchronic systemic toxicity, and tissue implantation. (Implicit standard, derived from predicate compliance)	"The biocompatibility of Microlyte™ Ag wound dressing has been demonstrated through appropriate in vitro and in vivo tests, including cytotoxicity, acute systemic toxicity, acute intracutaneous reactivity, skin sensitization, subacute/subchronic systemic toxicity, and tissue implantation tests. All tests were performed in compliance with GLP regulations in accordance with ISO-10993-1... The results indicated that Microlyte™ Ag wound dressing has passed toxicity and safety tests and is safe for intended use similar to predicate devices." (Page 8, 15) Substantially equivalent to predicates (S.E.)
Antimicrobial Performance	Demonstrate antimicrobial activity (e.g., "Yes" for predicates and Microlyte™ Ag). Quantitatively, a 4 log10 reduction in viable counts of test microbes within 24 hours.	"Yes. 4 log10 reduction in viable counts of test microbes" (Page 7, 14) against specific organisms including Staphylococcus aureus (ATCC 6538), MRSA (ATCC 33591), VRE (ATCC 55175), Pseudomonas aeruginosa (ATCC 9027), Escherichia coli (ATCC 8739), Klebsiella pneumoniae (ATCC 4352), Candida tropicalis (ATCC 750) and Candida albicans (ATCC 10231). (Page 8, 15)
Sterility	Conform to sterilization standards (e.g., Gamma irradiation for predicates).	"Electron-beam irradiation" (Page 7, 14) Substantially equivalent to predicates (S.E.).
Pyrogenicity	Non-pyrogenic and meet USP/FDA requirements for endotoxin limits.	"Microlyte™ Ag wound dressings were determined to be non-pyrogenic." (Page 8, 15) "The test articles met the current FDA and USP requirements for limit of endotoxin detected on medical devices." (Page 8, 15)
Physical Performance	Pass performance acceptance criteria for appearance, size, thickness, color, silver loading, water uptake capacity, tensile strength, and oxygen and water vapor transmission rates. (General, unspecified quantitative criteria)	"The technological characteristics of the device such as appearance, size, thickness, color, silver loading, water uptake capacity, tensile strength, and oxygen and water vapor transmission rates were evaluated and determined to pass the performance acceptance criteria." (Page 8, 15)

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

Test Set Sample Size: The document does not specify a "test set" in the context of a clinical study with patients. The performance data is based on in vitro and in vivo (animal, not human clinical) biocompatibility and antimicrobial tests. Specific sample sizes for these internal tests are not provided in the summary, but they would typically involve multiple replicates or samples per test condition.
Data Provenance: The data comes from in vitro microbiological assays, in vitro and in vivo biocompatibility tests, and physical performance evaluations conducted by the manufacturer, Imbed Biosciences Inc., and a test lab (NAMSA for biocompatibility). The document does not specify the country of origin for the data beyond stating "performed at NAMSA (Northwood, OH)" for some biocompatibility tests (Page 6, 13). The studies are retrospective in the sense that they are laboratory tests conducted to support substantial equivalence to existing devices.

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

This documentation does not involve "ground truth" established by experts in the typical sense of a human-AI diagnostic study. The determination of "substantial equivalence" is made by the FDA based on the presented data and comparison to predicate devices, and internal testing is performed by qualified personnel or labs. There is no mention of external clinical experts reviewing a test set for ground truth.

4. Adjudication method

Not applicable. There is no mention of an adjudication method as no clinical test set requiring expert consensus or adjudication was performed.

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 is a medical device for wound dressing, not an AI-powered diagnostic or decision support system that would involve human readers or AI assistance.

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

Not applicable. This device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

In the context of this 510(k) submission, "ground truth" for demonstrating substantial equivalence is based on:

Regulatory Standards: Compliance with FDA-recognized standards (e.g., ISO 10993 for biocompatibility, USP/ASTM for physical/antimicrobial tests).
Predicate Device Characteristics: The characteristics and established safety/effectiveness of the legally marketed predicate devices.
Laboratory Test Results: Quantified results from physical, chemical, and biological tests (e.g., 4 log10 reduction in microbial counts, non-pyrogenic status, passing biocompatibility assays).

There is no "expert consensus" or "pathology" ground truth described for a patient-level dataset.

8. The sample size for the training set

Not applicable. There is no AI/ML component, so there is no "training set."

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

Not applicable. There is no AI/ML component or training set.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 4, 2016

Imbed Biosciences. Inc. c/o Albert Rego, Ph.D. 27001 La Paz Road, Suite 314 Mission Viejo, CA 92691

Re: K153756

Trade/Device Name: Microlyte Ag Regulatory Class: Unclassified Product Code: FRO Dated: June 30, 2016 Received: July 6, 2016

Dear Dr. Rego:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K153756

Device Name Microlyte™ Ag

Indications for Use (Describe)

Under the supervision of a healthcare professional,

MicrolyteTM Ag wound dressing may be used for the management of:

-Wounds,

-Partial and full thickness wounds including pressure ulcers, diabetic ulcers, first and second degree burns, abrasions and lacerations, donor sites and surgical wounds,

-May be used over debrided and grafted partial thickness wounds.

Type of Use (Select one or both, as applicable)

|X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

Indications for Use

510(k) Number (if known) K153756

Device Name Microlyte™ Ag

Indications for Use (Describe) For over-the-counter use,

Microlyte™ Ag wound dressing may be used for: abrasions, minor cuts, and minor scalds and burns.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

510(k) SUMMARY

(As required by 21 CFR 807.92) Rx Only

I. SUBMITTER:	Imbed Biosciences, Inc.5520 Nobel Drive, Suite 100Madison, WI 53711, USA
CONTACT:	Ankit Agarwal, PhDCEOPhone: 515.708.1330Fax: 608.237.1271Email: ankit@imbedbio.com
SUBMISSION DATE:	December 2015
II. DEVICETRADE NAME:COMMON NAME:CLASSIFICATION NAME:REGULATORY CLASS:PRODUCT CODE:CLASSIFICATION PANEL:PERFORMANCESTANDARDS:	Microlyte™ Agmicrofilm wound dressingDressing, Wound, DrugUnclassifiedFROGeneral and Plastic SurgeryNo applicable performance standards have been established underSection 514 of the FD&C Act. Biocompatibility tests were done inconformance with relevant requirements of ISO 10993.
III. PREDICATE DEVICES:	AQUACEL® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing; K080383AcryDerm® (or SilvaSorb®) Silver Antimicrobial Dressing; K002599Silverlon™ Contact Wound Dressing; K981299

IV. INTENDED USE:

V. DEVICE DESCRIPTION:

{5}------------------------------------------------

MECHANISM OF ACTION: The dressing absorbs wound fluid and forms a soft gel that conforms to the wound surface and maintains a moist environment. The dressing contains silver only to prevent or minimize microbial growth within the dressing.

VI. INDICATIONS FOR USE:

Under the supervision of a healthcare professional, Microlyte™ Ag wound dressing may be used for the management of:

-Wounds ,

-Partial and full thickness wounds including pressure ulcers, diabetic ulcers, first and second degree burns, abrasions and lacerations, donor sites and surgical wounds, -May be used over debrided and grafted partial thickness wounds.

VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:

The predicate devices used for direct comparison and the determination of substantial equivalence in function and intended use are:

. AQUACEL® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing (K080383)
. AcryDerm (or Silvasorb - Current Trade Name) Silver Antimicrobial Wound Dressing (K002599)
. Silverlon™ Contact Wound Dressing (K981299)

The technological characteristics of Microlyte™ Ag wound dressing such as sterile, single use, flexible primary contact wound dressing, permeability to oxygen and moisture, absorption of wound exudate, and protection against microbial contamination of the dressing, are substantially equivalent to the predicate devices cited. Microlyte™ Ag and the predicate devices have same intended use and are recommended for same indications for use.

Microlyte™ Ag and the predicate devices are of similar composition of an absorbent matrix to absorb wound exudate and create a moist wound environment supportive of the healing process. Microlyte™ Ag contains silver in the absorbent matrix, similar to predicate devices, which may control microbial contamination of the dressing. A comparison of the technological characteristics of Microlyte™ Ag wound dressing and cited predicate devices are summarized in the table below.

Microlyte™ Ag is substantially equivalent to Aquacel Ag Antimicrobial Dressing in that an aqueous base hydrogel matrix absorbs wound fluid and forms a soft gel that conforms to the wound surface and maintains a moist environment. They both contain ionic silver nitrate. Primary difference is in the polymeric composition of the base matrix and metallic silver. Aquacel Ag is composed of a natural polymer- sodium carboxymethylcellulose, whereas Microlyte™ Ag is composed of a non-toxic synthetic polymer- polyvinyl alcohol. However, this minor difference doesn't affect their function, safety and effectiveness.

Microlyte™ Ag is substantially equivalent to Acryderm Silver Antimicrobial Wound Dressing in that a synthetic absorbent hydrogel sheet containing silver manages wound moisture. Microlyte™ Ag is substantially equivalent to Silverlon Contact Wound Dressing in that an absorbent matrix contacts the wound and where metallic silver is present in both products to prevent or minimize microbial growth within the dressing.

The stated differences in technological characteristics of Microlyte™ Ag and its predicates are minor and do not present any new questions regarding its safety and effectiveness, as documented by biocompatibility and performance testing.

{6}------------------------------------------------

Comparison of Technological Characteristics with Predicate Devices

				1Substantial Equivalence (S.E.)
CATEGORY	AQUACEL® AG WITHHYDROFIBER® SILVERIMPREGNATEDANTIMICROBIALDRESSING	ACRYDERM® (orSILVASORB®) SILVERANTIMICROBIAL WOUNDDRESSING	SILVERLON™ CONTACTWOUND DRESSING	MICROLYTE™ AG WOUNDDRESSING	S.E.1ornot
Manufacturer	ConvaTec Limited	AcryMed Inc.	Argentum Medical LLC	Imbed Biosciences Inc.	N/A
510K Number	K080383	K002599	K981299	Subject of this 510(K)	N/A
Class	Unclassified	Unclassified	Unclassified	Unclassified	S.E.
Product code	FRO	FRO	FRO	FRO	S.E.
Intended	Under the direction of a	"Intended for use on	"Silverlon contact wound	Under the direction of a	S.E.
use/	healthcare professional,	partial and full thickness	dressings are external	healthcare professional,
Indications	Aquacel Ag may be used	external wounds such as	wound dressings that are	Microlyte™ Ag may be
for use	for more serious wounds	pressure sores, arterial	designed as an interface	used for more serious
	such as diabetic foot and	ulcers, diabetic ulcers, and	between the wound and a	wounds such as partial and
	leg ulcers, pressure ulcers	venous stasis ulcers and on	conventional occlusive	full thickness pressure
	(partial and full-thickness),	acute wounds such as	dressing. Silver contact	ulcers, venous stasis
	surgical wounds or	draining surgical wounds,	wound dressings are	ulcers, diabetic ulcers, first
	traumatic wounds left to	lacerations, donor site, and	sterile, non-adherent	and second degree burns,
	heal by secondary intent,and partial thickness burns(second degree), woundsthat are prone to bleeding,oncology wounds andmanagement of painfulwounds."	exudating first and seconddegree burns, andabrasions." "May be usedover debrided and graftedpartial thickness wounds."	dressings intended forlocal management ofpartial thickness burns,incisions, skin grafts, donorsites, lacerations,abrasions, and Stage I-IVdermal ulcers (vascular,venous, pressure, anddiabetic)."	abrasions and lacerations,donor sites and surgicalwounds.-May be used overdebrided and graftedpartial thickness wounds.
Description of	"Soft, sterile, non-woven	"Sterile, single use	"Silverlon contact wound	Sterile, single use	S.E.
Device (brief)	pad or ribbon dressingcomposed of absorbenthydrocolloid fibers(sodiumcarboxymethylcellulose)and 1.2% ionic silver whichallows for a maximum of12 mg of silver for a 4 inchx 4 inch dressing."	unsupported syntheticabsorbent polyacrylatehydrogel containing silverhalide and stabilizers. Theproduct carries the generalclassification name-Hydrophilic wounddressing."	dressings are made offlexible, sterile, non-adherent fabric consistingof 1 or 4 layers of a knittedcontinuous nylon fibersubstrate with a metallicsilver surface containingapproximately 1% silveroxide."	unsupported syntheticabsorbent polyvinylalcohol hydrogel sheetwith a polymeric surfacecoating containing ionicand metallic silver. It hasvery low amounts of silver,with a maximum of 0.4 mgof silver in a 2 inch x 2 inchdressing, equivalent to 0.1mg/sq. inch.
Physicalcomposition	Sodiumcarboxymethylcellulosefibers and 1.2% ionic silver.	"The base matrix iscomposed of a hydrophilicpolyacrylate absorbent	"The surface of nylonfibers in Silverlon contactwound dressing consists of	The base matrix iscomposed of a hydrophilicpolyvinyl alcohol	S.E.
		sheet containing silverhalide and stabilizers."	a thin layer of metallicsilver containingapproximately 1% silveroxide."	absorbent sheet, with ionicand metallic silvercomplexed in a polymericcoating on the surface ofthe dressing.
Silver form	Ionic silver (from silvernitrate) complexed inside asodiumcarboxymethylcellulosematrix	Silver chloride complexinside an aqueous basepolyacrylate hydrogelmatrix.	Surface coating of a thinlayer of metallic silvercontaining ~1% silver oxideis deposited on the nylonfibers by a proprietaryautocatalytic electroless	Hydrogel sheet has apolymeric surface coatingthat contains ionic silver(from silver nitrate) andmetallic silver.	S.E.
CATEGORY	AQUACEL® AG WITHHYDROFIBER® SILVERIMPREGNATEDANTIMICROBIALDRESSING	ACRYDERM® (orSILVASORB®) SILVERANTIMICROBIAL WOUNDDRESSING	SILVERLONT™ CONTACTWOUND DRESSING	MICROLYTE™ AG WOUNDDRESSING	S.E.ornot
			chemical platingtechnique.
Silver content	About 12 mg/100 cm2	Nominally 0.13% by weightof silver chloride	About 546 mg/100 cm2	About 1.6 mg/100 cm2	S.E.
Mechanismof action	"The dressing absorbs highamounts of wound fluidand bacteria and creates asoft, cohesive gel thatintimately conforms to thewound surface, maintainsa moist environment andaids in the removal of non-viable tissue from thewound (autolyticdebridement). The moistwound healingenvironment and controlof wound bacteriasupports the body'shealing process and helpsreduce the risk of woundinfection. The silver in thedressing kills woundbacteria held in thedressing and provides anantimicrobial barrier toprotect the wound."	"Moist sheet wounddressing that containssilver halide that may helpto reduce growth ofmicrobial contaminants ofthe dressing."	"Silverlon contact wounddressings are designed tointimately contact thewound as a primarydressing and permit thepassage of fluids. The silverprovides effectiveprotection of the dressingagainst microbialcontamination.""The nylon fabric permitsthe passage of oxygen andfluids to and from thedressing." Silver coatingdelivers antimicrobialsilver ions in the dressingwhen activated bymoisture.	The dressing absorbswound fluid and forms asoft gel that intimatelyconforms to the woundsurface and maintains amoist environment.The dressing containssilver only to prevent orminimize microbial growthwithin the dressing.	S.E.
Bio-compatibility	Assessed according to Part1 of ISO-10993 standards	Assessed according to Part1 of ISO-10993 standards	Cytotoxicity,Sensitization,Acute intracutaneousreactivity,Acute systemic toxicity,Tissue compatibility.All tests performed atNAMSA (Northwood, OH)in accordance with Part 1of ISO-10993 standards.	Cytotoxicity,Sensitization,Acute intracutaneousreactivity,Acute systemic toxicity,Tissue implantation, andSub-acute/Sub-chronictoxicity.All tests performed atNAMSA (Northwood, OH)in accordance with Part 1of ISO-10993 standards.	S.E.
Antimicrobial	Yes	Yes	Yes	Yes. 4 log10 reduction inviable counts of testmicrobes	S.E.
Sterility	Gamma irradiation	Gamma irradiation	Gamma irradiation	Electron-beam irradiation	S.E.
Packaging	2"x2", 4"x4", 6"x6", 8"x12"sizes in individually sealedpouches	Supplied as sterile sheetsof 2"x2", 2"x4", 4"x4",4"x8", 8"x8" sizes in singleuse heat sealed foilpouches	4"x4", 4"x8", 4"x12" sizesin individually sealedenvelopes	Supplied as sterile sheetsof 1"x1", 2"x2", 4"x4",6"x6", 8"x8" and 8"x10"sizes in single use heatsealed foil pouches	S.E.

{7}------------------------------------------------

{8}------------------------------------------------

VIII. PERFORMANCE DATA

No applicable performance standards have been established under Section 514 of the FD&C Act. The following FDA guidance document was referred for performance testing: -Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Wound Dressing with Poly(diallyl dimethyl ammonium chloride) (pDADMAC) Additive. Document issued on: October 16, 2009.

The following performance data were provided in support of the substantial equivalence determination. All tests were performed on final finished packaged sterilized product. All testing was done in compliance to the current FDA recognized editions of USP and ASTM standards.

PHYSICAL PERFORMANCE: The technological characteristics of the device such as appearance, size, thickness, color, silver loading, water uptake capacity, tensile strength, and oxygen and water vapor transmission rates were evaluated and determined to pass the performance acceptance criteria.

ANTIMICROBIAL PERFORMANCE: Antimicrobial activity has been demonstrated by relevant standard in vitro microbiological assays using a GMP protocol. The dressing caused within 24 hours more than 4 logy reduction in the viable counts of a broad spectrum of test organisms (cells/cm^) incubated on its surface, including, Staphylococcus aureus (ATCC 6538), MRSA (ATCC 33591), VRE (ATCC 55175), Pseudomonas aeruginosa (ATCC 9027), Escherichia coli (ATCC 8739), Klebsiella pneumoniae (ATCC 4352), Candida tropicalis (ATCC 750) and Candida albicans (ATCC 10231). The results verify that the antimicrobial silver in the dressing suppresses the growth of microorganisms on the dressing, and is effective in preventing microbial colonization of the dressing.

BIOCOMPATIBILITY: The biocompatibility of Microlyte™ Ag wound dressing has been demonstrated through appropriate in vitro and in vivo tests, including cytotoxicity, acute systemic toxicity, acute intracutaneous reactivity, skin sensitization, subacute/subchronic systemic toxicity, and tissue implantation tests. All tests were performed in compliance with GLP regulations in accordance with ISO-10993-1, Biological Evaluations of Medical Devices Part 1: Evaluation and Testing. The results indicated that Microlyte™ Ag wound dressing has passed toxicity and safety tests and is safe for intended use similar to predicate devices.

PYROGENICITY TESTING: A USP Kinetic-Chromogenic LAL assay test-specification has been validated as an end-product release test for the presence of endotoxin. The test articles met the current FDA and USP requirements for limit of endotoxin detected on medical devices. Microlyte™ Ag wound dressings were determined to be non-pyrogenic.

CLINICAL STUDY: Clinical data was not provided and was not needed to support substantial equivalence to previously cleared predicate devices.

IX. DISCUSSION

The intended use, indications for use, device design, function, mechanism of action, material composition, biocompatibility, and performance of Microlyte™ Ag wound dressings, as designed and manufactured, are determined by Imbed Biosciences Inc. to be substantially equivalent to predicate devices cited within this submission. The differences in technological characteristics between the Microlyte™ Ag and the predicate devices are minor and do not present any new questions regarding its safety and effectiveness for the intended use.

{9}------------------------------------------------

X. CONCLUSIONS

Microlyte™ Ag wound dressing is substantial equivalent in function and intended use to previously cleared predicate devices.

{10}------------------------------------------------

510(k) SUMMARY

(As required by 21 CFR 807.92) Over-the-counter (OTC)

I. SUBMITTER:	Imbed Biosciences, Inc.5520 Nobel Drive, Suite 100Madison, WI 53711, USA
CONTACT:	Ankit Agarwal, PhDCEOPhone: 515.708.1330Fax: 608.237.1271Email: ankit@imbedbio.com
SUBMISSION DATE:	December 2015
II. DEVICETRADE NAME:COMMON NAME:CLASSIFICATION NAME:REGULATORY CLASS:PRODUCT CODE:CLASSIFICATION PANEL:PERFORMANCESTANDARDS:	Microlyte™ Agmicrofilm wound dressingDressing, Wound, DrugUnclassifiedFROGeneral and Plastic SurgeryNo applicable performance standards have been established underSection 514 of the FD&C Act. Biocompatibility tests were done inconformance with relevant requirements of ISO 10993.
III. PREDICATE DEVICES:	AQUACEL® Ag with Hydrofiber® Silver Impregnated AntimicrobialDressing; K080383AcryDerm® (or SilvaSorb®) Silver Antimicrobial Dressing; K002599Silverlon™ Contact Wound Dressing; K981299

IV. INTENDED USE:

V. DEVICE DESCRIPTION:

{11}------------------------------------------------

VI. INDICATIONS FOR USE:

For over-the-counter use, Microlyte™ Ag wound dressing may be used for: abrasions, minor cuts, and minor scalds and burns.

VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:

The predicate devices used for direct comparison and the determination of substantial equivalence in function and intended use are:

. AQUACEL Ag with Hydrofiber Silver Impregnated Antimicrobial Dressing (K080383)
AcryDerm" (or Silvasorb "- Current Trade Name) Silver Antimicrobial Wound Dressing (K002599)
Silverlon™ Contact Wound Dressing (K981299)

{12}------------------------------------------------

Comparison of Technological Characteristics with Predicate Devices
--------------------------------------------------------------------	--	--

	AQUACEL® AG WITHHYDROFIBER® SILVERIMPREGNATEDANTIMICROBIALDRESSING	ACRYDERM® (orSILVASORB®) SILVERANTIMICROBIAL WOUNDDRESSING	SILVERLON™ CONTACTWOUND DRESSING	MICROLYTE™ AG WOUNDDRESSING	S.E.1ornot
CATEGORY
Manufacturer	ConvaTec Limited	AcryMed Inc.	Argentum Medical LLC	Imbed Biosciences Inc.	N/A
510K Number	K080383	K002599	K981299	Subject of this 510(K)	N/A
Class	Unclassified	Unclassified	Unclassified	Unclassified	S.E.
Product code	FRO	FRO	FRO	FRO	S.E.
Intendeduse/Indicationsfor use	Indicated for themanagement of woundsand can be used over-the-counter for minor woundssuch as abrasions andlacerations, minor cuts,and minor scalds andburns.	"Intended for use onpartial and full thicknessexternal wounds such aspressure sores, arterialulcers, diabetic ulcers, andvenous stasis ulcers and onacute wounds such asdraining surgical wounds,lacerations, donor site, andexudating first and seconddegree burns, andabrasions." "May be usedover debrided and graftedpartial thickness wounds."	"Silverlon contact wounddressings are externalwound dressings that aredesigned as an interfacebetween the wound and aconventional occlusivedressing. Silver contactwound dressings aresterile, non-adherentdressings intended forlocal management ofpartial thickness burns,incisions, skin grafts, donorsites, lacerations,abrasions, and Stage I-IVdermal ulcers (vascular,venous, pressure, anddiabetic)."	Indicated for themanagement of woundsand can be used over-the-counter for minor woundssuch as abrasions andlacerations, minor cuts,and minor scalds andburns.	S.E.
Description ofDevice (brief)	"Soft, sterile, non-wovenpad or ribbon dressingcomposed of absorbenthydrocolloid fibers(sodiumcarboxymethylcellulose)and 1.2% ionic silver whichallows for a maximum of12 mg of silver for a 4 inchx 4 inch dressing."	"Sterile, single useunsupported syntheticabsorbent polyacrylatehydrogel containing silverhalide and stabilizers. Theproduct carries the generalclassification name-Hydrophilic wounddressing."	"Silverlon contact wounddressings are made offlexible, sterile, non-adherent fabric consistingof 1 or 4 layers of a knittedcontinuous nylon fibersubstrate with a metallicsilver surface containingapproximately 1% silveroxide."	Sterile, single useunsupported syntheticabsorbent polyvinylalcohol hydrogel sheetwith a polymeric surfacecoating containing ionicand metallic silver. It hasvery low amounts of silver,with a maximum of 0.4 mgof silver in a 2 inch x 2 inchdressing, equivalent to 0.1mg/sq. inch.	S.E.
Physicalcomposition	Sodiumcarboxymethylcellulosefibers and 1.2% ionic silver.	"The base matrix iscomposed of a hydrophilicpolyacrylate absorbentsheet containing silverhalide and stabilizers."	"The surface of nylonfibers in Silverlon contactwound dressing consists ofa thin layer of metallicsilver containingapproximately 1% silveroxide."	The base matrix iscomposed of a hydrophilicpolyvinyl alcoholabsorbent sheet, with ionicand metallic silvercomplexed in a polymericcoating on the surface ofthe dressing.	S.E.
Silver form	lonic silver (from silvernitrate) complexed inside asodiumcarboxymethylcellulosematrix	Silver chloride complexinside an aqueous basepolyacrylate hydrogelmatrix.	Surface coating of a thinlayer of metallic silvercontaining ~1% silver oxideis deposited on the nylonfibers by a proprietaryautocatalytic electroless	Hydrogel sheet has apolymeric surface coatingthat contains ionic silver(from silver nitrate) andmetallic silver.	S.E.
CATEGORY	AQUACEL® AG WITHHYDROFIBER® SILVERIMPREGNATEDANTIMICROBIALDRESSING	ACRYDERM® (orSILVASORB®) SILVERANTIMICROBIAL WOUNDDRESSING	SILVERLON™ CONTACTWOUND DRESSING	MICROLYTE™ AG WOUNDDRESSING	S.E.ornot
			chemical platingtechnique.
Silver content	About 12 mg/100 cm2	Nominally 0.13% by weightof silver chloride	About 546 mg/100 cm2	About 1.6 mg/100 cm2	S.E.
Mechanismof action	"The dressing absorbs highamounts of wound fluidand bacteria and creates asoft, cohesive gel thatintimately conforms to thewound surface, maintainsa moist environment andaids in the removal of non-viable tissue from thewound (autolyticdebridement). The moistwound healingenvironment and controlof wound bacteriasupports the body'shealing process and helpsreduce the risk of woundinfection. The silver in thedressing kills woundbacteria held in thedressing and provides anantimicrobial barrier toprotect the wound."	"Moist sheet wounddressing that containssilver halide that may helpto reduce growth ofmicrobial contaminants ofthe dressing."	"Silverlon contact wounddressings are designed tointimately contact thewound as a primarydressing and permit thepassage of fluids. The silverprovides effectiveprotection of the dressingagainst microbialcontamination.""The nylon fabric permitsthe passage of oxygen andfluids to and from thedressing." Silver coatingdelivers antimicrobialsilver ions in the dressingwhen activated bymoisture.	The dressing absorbswound fluid and forms asoft gel that conforms tothe wound surface andmaintains a moistenvironment.The dressing containssilver only to prevent orminimize microbial growthwithin the dressing.	S.E.
Bio-compatibility	Assessed according to Part1 of ISO-10993 standards	Assessed according to Part1 of ISO-10993 standards	Cytotoxicity,Sensitization,Acute intracutaneousreactivity,Acute systemic toxicity,Tissue compatibility.All tests performed atNAMSA (Northwood, OH)in accordance with Part 1of ISO-10993 standards.	Cytotoxicity,Sensitization,Acute intracutaneousreactivity,Acute systemic toxicity,Tissue implantation, andSub-acute/Sub-chronictoxicity.All tests performed atNAMSA (Northwood, OH)in accordance with Part 1of ISO-10993 standards.	S.E.
Antimicrobial	Yes	Yes	Yes	Yes. 4 log10 reduction inviable counts of testmicrobes	S.E.
Sterility	Gamma irradiation	Gamma irradiation	Gamma irradiation	Electron-beam irradiation	S.E.
Packaging	2"x2", 4"x4", 6"x6", 8"x12"sizes in individually sealedpouches	Supplied as sterile sheetsof 2"x2", 2"x4", 4"x4",4"x8", 8"x8" sizes in singleuse heat sealed foil	4"x4", 4"x8", 4"x12" sizesin individually sealedenvelopes	Supplied as sterile sheetsof 1"x1", 2"x2", 4"x4",6"x6", 8"x8" and 8"x10"sizes in single use heatsealed foil	S.E.

{13}------------------------------------------------

{14}------------------------------------------------

VIII. PERFORMANCE DATA

ANTIMICROBIAL PERFORMANCE: Antimicrobial activity has been demonstrated by relevant standard in vitro microbiological assays using a GMP protocol. The dressing caused within 24 hours more than 4 logio reduction in the viable counts of a broad spectrum of test organisms (cells/cm´) incubated on its surface, including, Staphylococcus aureus (ATCC 6538), MRSA (ATCC 33591), VRE (ATCC 55175), Pseudomonas aeruginosa (ATCC 9027), Escherichia coli (ATCC 8739), Klebsiella pneumoniae (ATCC 4352), Candida tropicalis (ATCC 750) and Candida albicans (ATCC 10231). The results verify that the antimicrobial silver in the dressing suppresses the growth of microorganisms on the dressing, and is effective in preventing microbial colonization of the dressing.

CLINICAL STUDY: Clinical data was not provided and was not needed to support substantial equivalence to previously cleared predicate devices.

IX. DISCUSSION

{15}------------------------------------------------

X. CONCLUSIONS

Microlyte™ Ag wound dressing is substantially equivalent in function and intended use to previously cleared predicate devices.

Regulation Number and Section

N/A