(218 days)
Not Found
No
The summary describes a wound dressing with antimicrobial properties and does not mention any computational or analytical functions that would involve AI/ML.
Yes
The device is a wound dressing indicated for the management of various wounds, from minor cuts to more serious ulcers and burns, which falls under the definition of a therapeutic device.
No
Explanation: The device is a wound dressing used for management of wounds, not for diagnosis. Its purpose is therapeutic and protective, not to identify or characterize a medical condition.
No
The device description clearly states it is a physical wound dressing made of hydrogel with silver, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of wounds, which is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a wound dressing, a physical barrier and treatment for wounds. It does not involve analyzing biological samples.
- Performance Studies: The performance studies focus on physical properties, antimicrobial activity, and biocompatibility, all relevant to a wound dressing. There are no studies related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing patient samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic results.
Therefore, the Microlyte™ Ag wound dressing is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
For over-the-counter use, Microlyte™ Ag wound dressing may be used for: abrasions, minor cuts, and minor scalds and burns.
Product codes (comma separated list FDA assigned to the subject device)
FRO
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wounds (including partial and full thickness wounds, pressure ulcers, diabetic ulcers, first and second degree burns, abrasions, lacerations, donor sites, surgical wounds, debrided, and grafted partial thickness wounds), minor cuts, minor scalds.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Under the supervision of a healthcare professional (for more serious wounds); Over-the-counter (for minor wounds).
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 log10 reduction in the viable counts of a broad spectrum of test organisms (cells/cm2) 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Antimicrobial performance: 4 log10 reduction in viable counts of test microbes.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
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.
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."
4
510(k) SUMMARY
(As required by 21 CFR 807.92) Rx Only
| I. SUBMITTER: | Imbed Biosciences, Inc.
5520 Nobel Drive, Suite 100
Madison, WI 53711, USA |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Ankit Agarwal, PhD
CEO
Phone: 515.708.1330
Fax: 608.237.1271
Email: ankit@imbedbio.com |
| SUBMISSION DATE: | December 2015 |
| II. DEVICE
TRADE NAME:
COMMON NAME:
CLASSIFICATION NAME:
REGULATORY CLASS:
PRODUCT CODE:
CLASSIFICATION PANEL:
PERFORMANCE
STANDARDS: | Microlyte™ Ag
microfilm wound dressing
Dressing, Wound, Drug
Unclassified
FRO
General and Plastic Surgery
No applicable performance standards have been established under
Section 514 of the FD&C Act. Biocompatibility tests were done in
conformance with relevant requirements of ISO 10993. |
| III. PREDICATE DEVICES: | AQUACEL® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing; K080383
AcryDerm® (or SilvaSorb®) Silver Antimicrobial Dressing; K002599
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.
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 WITH | ||||
| HYDROFIBER® SILVER | |||||
| IMPREGNATED | |||||
| ANTIMICROBIAL | |||||
| DRESSING | ACRYDERM® (or | ||||
| SILVASORB®) SILVER | |||||
| ANTIMICROBIAL WOUND | |||||
| DRESSING | SILVERLON™ CONTACT | ||||
| WOUND DRESSING | MICROLYTE™ AG WOUND | ||||
| DRESSING | S.E.1 | ||||
| or | |||||
| 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, | |||||
| and partial thickness burns | |||||
| (second degree), wounds | |||||
| that are prone to bleeding, | |||||
| oncology wounds and | |||||
| management of painful | |||||
| wounds." | exudating first and second | ||||
| degree burns, and | |||||
| abrasions." "May be used | |||||
| over debrided and grafted | |||||
| partial thickness wounds." | dressings intended for | ||||
| local management of | |||||
| partial thickness burns, | |||||
| incisions, skin grafts, donor | |||||
| sites, lacerations, | |||||
| abrasions, and Stage I-IV | |||||
| dermal ulcers (vascular, | |||||
| venous, pressure, and | |||||
| diabetic)." | abrasions and lacerations, | ||||
| donor sites and surgical | |||||
| wounds. | |||||
| -May be used over | |||||
| debrided and grafted | |||||
| 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 | ||||
| composed of absorbent | |||||
| hydrocolloid fibers | |||||
| (sodium | |||||
| carboxymethylcellulose) | |||||
| and 1.2% ionic silver which | |||||
| allows for a maximum of | |||||
| 12 mg of silver for a 4 inch | |||||
| x 4 inch dressing." | unsupported synthetic | ||||
| absorbent polyacrylate | |||||
| hydrogel containing silver | |||||
| halide and stabilizers. The | |||||
| product carries the general | |||||
| classification name- | |||||
| Hydrophilic wound | |||||
| dressing." | dressings are made of | ||||
| flexible, sterile, non- | |||||
| adherent fabric consisting | |||||
| of 1 or 4 layers of a knitted | |||||
| continuous nylon fiber | |||||
| substrate with a metallic | |||||
| silver surface containing | |||||
| approximately 1% silver | |||||
| oxide." | 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. | |||||
| Physical | |||||
| composition | Sodium | ||||
| carboxymethylcellulose | |||||
| fibers and 1.2% ionic silver. | "The base matrix is | ||||
| composed of a hydrophilic | |||||
| polyacrylate absorbent | "The surface of nylon | ||||
| fibers in Silverlon contact | |||||
| wound dressing consists of | The base matrix is | ||||
| composed of a hydrophilic | |||||
| polyvinyl alcohol | S.E. | ||||
| sheet containing silver | |||||
| halide and stabilizers." | a thin layer of metallic | ||||
| silver containing | |||||
| approximately 1% silver | |||||
| oxide." | absorbent sheet, with ionic | ||||
| and metallic silver | |||||
| complexed in a polymeric | |||||
| coating on the surface of | |||||
| the dressing. | |||||
| Silver form | Ionic silver (from silver | ||||
| nitrate) complexed inside a | |||||
| sodium | |||||
| carboxymethylcellulose | |||||
| matrix | Silver chloride complex | ||||
| inside an aqueous base | |||||
| polyacrylate hydrogel | |||||
| matrix. | Surface coating of a thin | ||||
| layer of metallic silver | |||||
| containing ~1% silver oxide | |||||
| is deposited on the nylon | |||||
| fibers by a proprietary | |||||
| autocatalytic electroless | Hydrogel sheet has a | ||||
| polymeric surface coating | |||||
| that contains ionic silver | |||||
| (from silver nitrate) and | |||||
| metallic silver. | S.E. | ||||
| CATEGORY | AQUACEL® AG WITH | ||||
| HYDROFIBER® SILVER | |||||
| IMPREGNATED | |||||
| ANTIMICROBIAL | |||||
| DRESSING | ACRYDERM® (or | ||||
| SILVASORB®) SILVER | |||||
| ANTIMICROBIAL WOUND | |||||
| DRESSING | SILVERLONT™ CONTACT | ||||
| WOUND DRESSING | MICROLYTE™ AG WOUND | ||||
| DRESSING | S.E. | ||||
| or | |||||
| not | |||||
| chemical plating | |||||
| technique. | |||||
| Silver content | About 12 mg/100 cm2 | Nominally 0.13% by weight | |||
| of silver chloride | About 546 mg/100 cm2 | About 1.6 mg/100 cm2 | S.E. | ||
| Mechanism | |||||
| of action | "The dressing absorbs high | ||||
| amounts of wound fluid | |||||
| and bacteria and creates a | |||||
| soft, cohesive gel that | |||||
| intimately conforms to the | |||||
| wound surface, maintains | |||||
| a moist environment and | |||||
| aids in the removal of non- | |||||
| viable tissue from the | |||||
| wound (autolytic | |||||
| debridement). The moist | |||||
| wound healing | |||||
| environment and control | |||||
| of wound bacteria | |||||
| supports the body's | |||||
| healing process and helps | |||||
| reduce the risk of wound | |||||
| infection. The silver in the | |||||
| dressing kills wound | |||||
| bacteria held in the | |||||
| dressing and provides an | |||||
| antimicrobial barrier to | |||||
| protect the wound." | "Moist sheet wound | ||||
| dressing that contains | |||||
| silver halide that may help | |||||
| to reduce growth of | |||||
| microbial contaminants of | |||||
| the dressing." | "Silverlon contact wound | ||||
| dressings are designed to | |||||
| intimately contact the | |||||
| wound as a primary | |||||
| dressing and permit the | |||||
| passage of fluids. The silver | |||||
| provides effective | |||||
| protection of the dressing | |||||
| against microbial | |||||
| contamination." | |||||
| "The nylon fabric permits | |||||
| the passage of oxygen and | |||||
| fluids to and from the | |||||
| dressing." Silver coating | |||||
| delivers antimicrobial | |||||
| silver ions in the dressing | |||||
| when activated by | |||||
| moisture. | 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. | S.E. | ||||
| Bio- | |||||
| compatibility | Assessed according to Part | ||||
| 1 of ISO-10993 standards | Assessed according to Part | ||||
| 1 of ISO-10993 standards | Cytotoxicity, | ||||
| Sensitization, | |||||
| Acute intracutaneous | |||||
| reactivity, | |||||
| Acute systemic toxicity, | |||||
| Tissue compatibility. | |||||
| All tests performed at | |||||
| NAMSA (Northwood, OH) | |||||
| in accordance with Part 1 | |||||
| of ISO-10993 standards. | Cytotoxicity, | ||||
| Sensitization, | |||||
| Acute intracutaneous | |||||
| reactivity, | |||||
| Acute systemic toxicity, | |||||
| Tissue implantation, and | |||||
| Sub-acute/Sub-chronic | |||||
| toxicity. | |||||
| All tests performed at | |||||
| NAMSA (Northwood, OH) | |||||
| in accordance with Part 1 | |||||
| of ISO-10993 standards. | S.E. | ||||
| Antimicrobial | Yes | Yes | Yes | Yes. 4 log10 reduction in | |
| viable counts of test | |||||
| microbes | 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 sealed | |||||
| pouches | Supplied as sterile sheets | ||||
| of 2"x2", 2"x4", 4"x4", | |||||
| 4"x8", 8"x8" sizes in single | |||||
| use heat sealed foil | |||||
| pouches | 4"x4", 4"x8", 4"x12" sizes | ||||
| in individually sealed | |||||
| envelopes | Supplied as sterile sheets | ||||
| of 1"x1", 2"x2", 4"x4", | |||||
| 6"x6", 8"x8" and 8"x10" | |||||
| sizes in single use heat | |||||
| sealed 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 100
Madison, WI 53711, USA |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Ankit Agarwal, PhD
CEO
Phone: 515.708.1330
Fax: 608.237.1271
Email: ankit@imbedbio.com |
| SUBMISSION DATE: | December 2015 |
| II. DEVICE
TRADE NAME:
COMMON NAME:
CLASSIFICATION NAME:
REGULATORY CLASS:
PRODUCT CODE:
CLASSIFICATION PANEL:
PERFORMANCE
STANDARDS: | Microlyte™ Ag
microfilm wound dressing
Dressing, Wound, Drug
Unclassified
FRO
General and Plastic Surgery
No applicable performance standards have been established under
Section 514 of the FD&C Act. Biocompatibility tests were done in
conformance with relevant requirements of ISO 10993. |
| III. PREDICATE DEVICES: | AQUACEL® Ag with Hydrofiber® Silver Impregnated Antimicrobial
Dressing; K080383
AcryDerm® (or SilvaSorb®) Silver Antimicrobial Dressing; K002599
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.
11
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.
12
| Comparison of Technological Characteristics with Predicate Devices | ||
|---|---|---|
| -------------------------------------------------------------------- | -- | -- |
| | AQUACEL® AG WITH
HYDROFIBER® SILVER
IMPREGNATED
ANTIMICROBIAL
DRESSING | ACRYDERM® (or
SILVASORB®) SILVER
ANTIMICROBIAL WOUND
DRESSING | SILVERLON™ CONTACT
WOUND DRESSING | MICROLYTE™ AG WOUND
DRESSING | S.E.1
or
not |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| 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. |
| Intended
use/
Indications
for use | 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. | "Intended for use on
partial and full thickness
external wounds such as
pressure sores, arterial
ulcers, diabetic ulcers, and
venous stasis ulcers and on
acute wounds such as
draining surgical wounds,
lacerations, donor site, and
exudating first and second
degree burns, and
abrasions." "May be used
over debrided and grafted
partial thickness wounds." | "Silverlon contact wound
dressings are external
wound dressings that are
designed as an interface
between the wound and a
conventional occlusive
dressing. Silver contact
wound dressings are
sterile, non-adherent
dressings intended for
local management of
partial thickness burns,
incisions, skin grafts, donor
sites, lacerations,
abrasions, and Stage I-IV
dermal ulcers (vascular,
venous, pressure, and
diabetic)." | 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. | S.E. |
| Description of
Device (brief) | "Soft, sterile, non-woven
pad or ribbon dressing
composed of absorbent
hydrocolloid fibers
(sodium
carboxymethylcellulose)
and 1.2% ionic silver which
allows for a maximum of
12 mg of silver for a 4 inch
x 4 inch dressing." | "Sterile, single use
unsupported synthetic
absorbent polyacrylate
hydrogel containing silver
halide and stabilizers. The
product carries the general
classification name-
Hydrophilic wound
dressing." | "Silverlon contact wound
dressings are made of
flexible, sterile, non-
adherent fabric consisting
of 1 or 4 layers of a knitted
continuous nylon fiber
substrate with a metallic
silver surface containing
approximately 1% silver
oxide." | 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. | S.E. |
| Physical
composition | Sodium
carboxymethylcellulose
fibers and 1.2% ionic silver. | "The base matrix is
composed of a hydrophilic
polyacrylate absorbent
sheet containing silver
halide and stabilizers." | "The surface of nylon
fibers in Silverlon contact
wound dressing consists of
a thin layer of metallic
silver containing
approximately 1% silver
oxide." | 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. | S.E. |
| Silver form | lonic silver (from silver
nitrate) complexed inside a
sodium
carboxymethylcellulose
matrix | Silver chloride complex
inside an aqueous base
polyacrylate hydrogel
matrix. | Surface coating of a thin
layer of metallic silver
containing ~1% silver oxide
is deposited on the nylon
fibers by a proprietary
autocatalytic electroless | Hydrogel sheet has a
polymeric surface coating
that contains ionic silver
(from silver nitrate) and
metallic silver. | S.E. |
| CATEGORY | AQUACEL® AG WITH
HYDROFIBER® SILVER
IMPREGNATED
ANTIMICROBIAL
DRESSING | ACRYDERM® (or
SILVASORB®) SILVER
ANTIMICROBIAL WOUND
DRESSING | SILVERLON™ CONTACT
WOUND DRESSING | MICROLYTE™ AG WOUND
DRESSING | S.E.
or
not |
| | | | chemical plating
technique. | | |
| Silver content | About 12 mg/100 cm2 | Nominally 0.13% by weight
of silver chloride | About 546 mg/100 cm2 | About 1.6 mg/100 cm2 | S.E. |
| Mechanism
of action | "The dressing absorbs high
amounts of wound fluid
and bacteria and creates a
soft, cohesive gel that
intimately conforms to the
wound surface, maintains
a moist environment and
aids in the removal of non-
viable tissue from the
wound (autolytic
debridement). The moist
wound healing
environment and control
of wound bacteria
supports the body's
healing process and helps
reduce the risk of wound
infection. The silver in the
dressing kills wound
bacteria held in the
dressing and provides an
antimicrobial barrier to
protect the wound." | "Moist sheet wound
dressing that contains
silver halide that may help
to reduce growth of
microbial contaminants of
the dressing." | "Silverlon contact wound
dressings are designed to
intimately contact the
wound as a primary
dressing and permit the
passage of fluids. The silver
provides effective
protection of the dressing
against microbial
contamination."
"The nylon fabric permits
the passage of oxygen and
fluids to and from the
dressing." Silver coating
delivers antimicrobial
silver ions in the dressing
when activated by
moisture. | 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. | S.E. |
| Bio-
compatibility | Assessed according to Part
1 of ISO-10993 standards | Assessed according to Part
1 of ISO-10993 standards | Cytotoxicity,
Sensitization,
Acute intracutaneous
reactivity,
Acute systemic toxicity,
Tissue compatibility.
All tests performed at
NAMSA (Northwood, OH)
in accordance with Part 1
of ISO-10993 standards. | Cytotoxicity,
Sensitization,
Acute intracutaneous
reactivity,
Acute systemic toxicity,
Tissue implantation, and
Sub-acute/Sub-chronic
toxicity.
All tests performed at
NAMSA (Northwood, OH)
in accordance with Part 1
of ISO-10993 standards. | S.E. |
| Antimicrobial | Yes | Yes | Yes | Yes. 4 log10 reduction in
viable counts of test
microbes | 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 sealed
pouches | Supplied as sterile sheets
of 2"x2", 2"x4", 4"x4",
4"x8", 8"x8" sizes in single
use heat sealed foil | 4"x4", 4"x8", 4"x12" sizes
in individually sealed
envelopes | Supplied as sterile sheets
of 1"x1", 2"x2", 4"x4",
6"x6", 8"x8" and 8"x10"
sizes in single use heat
sealed foil | S.E. |
13
14
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 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.
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.
15
X. CONCLUSIONS
Microlyte™ Ag wound dressing is substantially equivalent in function and intended use to previously cleared predicate devices.