Microlyte Ag

K153756 · Imbed Biosciences, Inc. · FRO · Aug 4, 2016 · SU

Device Facts

• Record ID: K153756
• Device Name: Microlyte Ag
• Applicant: Imbed Biosciences, Inc.
• Product Code: FRO · SU
• Decision Date: Aug 4, 2016
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

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.

Device Story

Microlyte Ag is a sterile, single-use, unsupported synthetic absorbent polyvinyl alcohol hydrogel sheet; surface coating contains ionic and metallic silver. Dressing absorbs wound fluid, forming a soft gel that conforms to wound surface; maintains moist environment. Silver content (max 0.4 mg per 2x2 inch dressing) prevents/minimizes microbial growth within dressing. Used in clinics or home settings; applied by healthcare professionals or patients (OTC). Output is physical wound interface; provides antimicrobial barrier to protect dressing from colonization. Benefits patient by supporting moist healing environment and reducing microbial contamination risk.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing only, including physical performance (size, thickness, water uptake, transmission rates), in vitro antimicrobial assays (4 log10 reduction against S. aureus, MRSA, VRE, P. aeruginosa, E. coli, K. pneumoniae, C. tropicalis, C. albicans), biocompatibility (ISO 10993-1), and pyrogenicity testing (USP Kinetic-Chromogenic LAL assay).

Technological Characteristics

Hydrophilic polyvinyl alcohol hydrogel sheet; ionic and metallic silver complexed in polymeric surface coating. Sterile; electron-beam irradiation. Permeable to oxygen/moisture. Biocompatibility per ISO 10993-1. Dimensions: 1x1 to 8x10 inch sheets.

Indications for Use

Indicated for management of wounds. Prescription use: partial/full thickness wounds (pressure/diabetic/venous ulcers, 1st/2nd degree burns, abrasions, lacerations, donor sites, surgical wounds, debrided/grafted wounds). OTC use: minor abrasions, cuts, scalds, burns.

Predicate Devices

• AQUACEL® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing (K080383)
• AcryDerm® (or SilvaSorb®) Silver Antimicrobial Dressing (K002599)
• Silverlon™ Contact Wound Dressing (K981299)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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.

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#### *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:

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# 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.*

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 [e-mail]

"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."

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#### 510(k) SUMMARY

(As required by 21 CFR 807.92) Rx Only

| I. SUBMITTER: | Imbed Biosciences, Inc.<br>5520 Nobel Drive, Suite 100<br>Madison, WI 53711, USA |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Ankit Agarwal, PhD<br>CEO<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| SUBMISSION DATE: | December 2015 |
| II. DEVICE<br>TRADE NAME:<br>COMMON NAME:<br>CLASSIFICATION NAME:<br>REGULATORY CLASS:<br>PRODUCT CODE:<br>CLASSIFICATION PANEL:<br>PERFORMANCE<br>STANDARDS: | Microlyte™ Ag<br>microfilm wound dressing<br>Dressing, Wound, Drug<br>Unclassified<br>FRO<br>General and Plastic Surgery<br>No applicable performance standards have been established under<br>Section 514 of the FD&C Act. Biocompatibility tests were done in<br>conformance with relevant requirements of ISO 10993. |
| III. PREDICATE DEVICES: | AQUACEL® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing; K080383<br>AcryDerm® (or SilvaSorb®) Silver Antimicrobial Dressing; K002599<br>Silverlon™ Contact Wound Dressing; K981299 |

#### IV. INTENDED USE:

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.

#### V. 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.

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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.

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# Comparison of Technological Characteristics with Predicate Devices

| | | | | 1Substantial Equivalence (S.E.) | |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| CATEGORY | AQUACEL® AG WITH<br>HYDROFIBER® SILVER<br>IMPREGNATED<br>ANTIMICROBIAL<br>DRESSING | ACRYDERM® (or<br>SILVASORB®) SILVER<br>ANTIMICROBIAL WOUND<br>DRESSING | SILVERLON™ CONTACT<br>WOUND DRESSING | MICROLYTE™ AG WOUND<br>DRESSING | S.E.1<br>or<br>not |
| 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,<br>and partial thickness burns<br>(second degree), wounds<br>that are prone to bleeding,<br>oncology wounds and<br>management of painful<br>wounds." | exudating first and second<br>degree burns, and<br>abrasions." "May be used<br>over debrided and grafted<br>partial thickness wounds." | dressings intended for<br>local management of<br>partial thickness burns,<br>incisions, skin grafts, donor<br>sites, lacerations,<br>abrasions, and Stage I-IV<br>dermal ulcers (vascular,<br>venous, pressure, and<br>diabetic)." | abrasions and lacerations,<br>donor sites and surgical<br>wounds.<br>-May be used over<br>debrided and grafted<br>partial thickness wounds. | |
| Description of | "Soft, sterile, non-woven | "Sterile, single use | "Silverlon contact wound | Sterile, single use | S.E. |
| Device (brief) | pad or ribbon dressing<br>composed of absorbent<br>hydrocolloid fibers<br>(sodium<br>carboxymethylcellulose)<br>and 1.2% ionic silver which<br>allows for a maximum of<br>12 mg of silver for a 4 inch<br>x 4 inch dressing." | unsupported synthetic<br>absorbent polyacrylate<br>hydrogel containing silver<br>halide and stabilizers. The<br>product carries the general<br>classification name-<br>Hydrophilic wound<br>dressing." | dressings are made of<br>flexible, sterile, non-<br>adherent fabric consisting<br>of 1 or 4 layers of a knitted<br>continuous nylon fiber<br>substrate with a metallic<br>silver surface containing<br>approximately 1% silver<br>oxide." | unsupported synthetic<br>absorbent polyvinyl<br>alcohol hydrogel sheet<br>with a polymeric surface<br>coating containing ionic<br>and metallic silver. It has<br>very low amounts of silver,<br>with a maximum of 0.4 mg<br>of silver in a 2 inch x 2 inch<br>dressing, equivalent to 0.1<br>mg/sq. inch. | |
| Physical<br>composition | Sodium<br>carboxymethylcellulose<br>fibers and 1.2% ionic silver. | "The base matrix is<br>composed of a hydrophilic<br>polyacrylate absorbent | "The surface of nylon<br>fibers in Silverlon contact<br>wound dressing consists of | The base matrix is<br>composed of a hydrophilic<br>polyvinyl alcohol | S.E. |
| | | sheet containing silver<br>halide and stabilizers." | a thin layer of metallic<br>silver containing<br>approximately 1% silver<br>oxide." | absorbent sheet, with ionic<br>and metallic silver<br>complexed in a polymeric<br>coating on the surface of<br>the dressing. | |
| Silver form | Ionic silver (from silver<br>nitrate) complexed inside a<br>sodium<br>carboxymethylcellulose<br>matrix | Silver chloride complex<br>inside an aqueous base<br>polyacrylate hydrogel<br>matrix. | Surface coating of a thin<br>layer of metallic silver<br>containing ~1% silver oxide<br>is deposited on the nylon<br>fibers by a proprietary<br>autocatalytic electroless | Hydrogel sheet has a<br>polymeric surface coating<br>that contains ionic silver<br>(from silver nitrate) and<br>metallic silver. | S.E. |
| CATEGORY | AQUACEL® AG WITH<br>HYDROFIBER® SILVER<br>IMPREGNATED<br>ANTIMICROBIAL<br>DRESSING | ACRYDERM® (or<br>SILVASORB®) SILVER<br>ANTIMICROBIAL WOUND<br>DRESSING | SILVERLONT™ CONTACT<br>WOUND DRESSING | MICROLYTE™ AG WOUND<br>DRESSING | S.E.<br>or<br>not |
| | | | chemical plating<br>technique. | | |
| Silver content | About 12 mg/100 cm2 | Nominally 0.13% by weight<br>of silver chloride | About 546 mg/100 cm2 | About 1.6 mg/100 cm2 | S.E. |
| Mechanism<br>of action | "The dressing absorbs high<br>amounts of wound fluid<br>and bacteria and creates a<br>soft, cohesive gel that<br>intimately conforms to the<br>wound surface, maintains<br>a moist environment and<br>aids in the removal of non-<br>viable tissue from the<br>wound (autolytic<br>debridement). The moist<br>wound healing<br>environment and control<br>of wound bacteria<br>supports the body's<br>healing process and helps<br>reduce the risk of wound<br>infection. The silver in the<br>dressing kills wound<br>bacteria held in the<br>dressing and provides an<br>antimicrobial barrier to<br>protect the wound." | "Moist sheet wound<br>dressing that contains<br>silver halide that may help<br>to reduce growth of<br>microbial contaminants of<br>the dressing." | "Silverlon contact wound<br>dressings are designed to<br>intimately contact the<br>wound as a primary<br>dressing and permit the<br>passage of fluids. The silver<br>provides effective<br>protection of the dressing<br>against microbial<br>contamination."<br>"The nylon fabric permits<br>the passage of oxygen and<br>fluids to and from the<br>dressing." Silver coating<br>delivers antimicrobial<br>silver ions in the dressing<br>when activated by<br>moisture. | The dressing absorbs<br>wound fluid and forms a<br>soft gel that intimately<br>conforms to the wound<br>surface and maintains a<br>moist environment.<br>The dressing contains<br>silver only to prevent or<br>minimize microbial growth<br>within the dressing. | S.E. |
| Bio-<br>compatibility | Assessed according to Part<br>1 of ISO-10993 standards | Assessed according to Part<br>1 of ISO-10993 standards | Cytotoxicity,<br>Sensitization,<br>Acute intracutaneous<br>reactivity,<br>Acute systemic toxicity,<br>Tissue compatibility.<br>All tests performed at<br>NAMSA (Northwood, OH)<br>in accordance with Part 1<br>of ISO-10993 standards. | Cytotoxicity,<br>Sensitization,<br>Acute intracutaneous<br>reactivity,<br>Acute systemic toxicity,<br>Tissue implantation, and<br>Sub-acute/Sub-chronic<br>toxicity.<br>All tests performed at<br>NAMSA (Northwood, OH)<br>in accordance with Part 1<br>of ISO-10993 standards. | S.E. |
| Antimicrobial | Yes | Yes | Yes | Yes. 4 log10 reduction in<br>viable counts of test<br>microbes | S.E. |
| Sterility | Gamma irradiation | Gamma irradiation | Gamma irradiation | Electron-beam irradiation | S.E. |
| Packaging | 2"x2", 4"x4", 6"x6", 8"x12"<br>sizes in individually sealed<br>pouches | Supplied as sterile sheets<br>of 2"x2", 2"x4", 4"x4",<br>4"x8", 8"x8" sizes in single<br>use heat sealed foil<br>pouches | 4"x4", 4"x8", 4"x12" sizes<br>in individually sealed<br>envelopes | Supplied as sterile sheets<br>of 1"x1", 2"x2", 4"x4",<br>6"x6", 8"x8" and 8"x10"<br>sizes in single use heat<br>sealed foil pouches | S.E. |

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#### 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.

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## X. CONCLUSIONS

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

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#### 510(k) SUMMARY

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

| I. SUBMITTER: | Imbed Biosciences, Inc.<br>5520 Nobel Drive, Suite 100<br>Madison, WI 53711, USA |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Ankit Agarwal, PhD<br>CEO<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| SUBMISSION DATE: | December 2015 |
| II. DEVICE<br>TRADE NAME:<br>COMMON NAME:<br>CLASSIFICATION NAME:<br>REGULATORY CLASS:<br>PRODUCT CODE:<br>CLASSIFICATION PANEL:<br>PERFORMANCE<br>STANDARDS: | Microlyte™ Ag<br>microfilm wound dressing<br>Dressing, Wound, Drug<br>Unclassified<br>FRO<br>General and Plastic Surgery<br>No applicable performance standards have been established under<br>Section 514 of the FD&C Act. Biocompatibility tests were done in<br>conformance with relevant requirements of ISO 10993. |
| III. PREDICATE DEVICES: | AQUACEL® Ag with Hydrofiber® Silver Impregnated Antimicrobial<br>Dressing; K080383<br>AcryDerm® (or SilvaSorb®) Silver Antimicrobial Dressing; K002599<br>Silverlon™ Contact Wound Dressing; K981299 |

#### IV. INTENDED USE:

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.

#### V. 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.

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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:

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)

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.

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| Comparison of Technological Characteristics with Predicate Devices | | |
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| | AQUACEL® AG WITH<br>HYDROFIBER® SILVER<br>IMPREGNATED<br>ANTIMICROBIAL<br>DRESSING | ACRYDERM® (or<br>SILVASORB®) SILVER<br>ANTIMICROBIAL WOUND<br>DRESSING | SILVERLON™ CONTACT<br>WOUND DRESSING | MICROLYTE™ AG WOUND<br>DRESSING | S.E.1<br>or<br>not |
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| CATEGORY | | | | | |
| Manufacturer | ConvaTec Limited…