(1212 days)
No
The summary describes a wound dressing with silver and lidocaine, focusing on its physical, antimicrobial, and biocompatibility properties. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
Yes
This device is a wound dressing containing active pharmacological ingredients (lidocaine and silver) intended for the management of wounds. By definition, a therapeutic device promotes healing or provides pain relief, which aligns with the intended use of this wound dressing.
No
Explanation: The device description and intended use indicate that Microlyte® Ag/Lidocaine Wound Dressing is for the management and treatment of wounds. It does not perform any diagnostic function such as identifying, detecting, or monitoring a disease or condition. Its performance studies focus on physical properties, antimicrobial activity, biocompatibility, and wound healing, all of which are therapeutic or management aspects, not diagnostic.
No
The device description clearly states it is a "sterile, single use absorbent polymeric matrix" with physical components (polyvinyl alcohol, lidocaine hydrochloride, silver). This is a physical wound dressing, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "management of partial and full thickness wounds" on the skin. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a wound dressing with lidocaine and silver, designed to be applied to wounds. This aligns with a therapeutic device.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (like blood, urine, or tissue) in vitro to diagnose a condition or provide information about a patient's health status.
- Performance Studies: The performance studies focus on physical characteristics, antimicrobial activity, biocompatibility, and wound healing in animal models. These are relevant to a therapeutic wound dressing, not an IVD.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is applied directly to a wound for treatment and management.
N/A
Intended Use / Indications for Use
Under the supervision of a healthcare professional, Microlyte® Ag/Lidocaine Wound Dressing may be used for the management of partial and full thickness wounds including diabetic foot ulcers, venous stasis ulcers, ischemic ulcers, surgical wounds, post-surgical incisions, donor sites, debrided partial thickness wounds, first degree burns, partial thickness burns, abrasions and lacerations.
Product codes
FRO
Device Description
Microlyte® Ag/Lidocaine Wound Dressing is a sterile, single use absorbent polymeric matrix composed primarily of synthetic polyvinyl alcohol with 2.5 mg/in² of lidocaine hydrochloride USP, with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.1 mg/in² of silver.
MECHANISM OF ACTION: Microlyte® Ag/Lidocaine Wound Dressing absorbs wound fluid and forms a soft matrix that conforms to the wound surface and maintains a moist environment. The matrix contains silver only to prevent or minimize microbial growth within the dressing releases Lidocaine Hydrochloride USP for effecting local anesthetic action in painful skin wounds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Under the supervision of a healthcare professional.
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, lidocaine loading, water uptake capacity, tensile strength, and oxygen and water vapor transmission rates were evaluated and determined to pass the performance acceptance criteria. The device released about 2.5 mg/in² (= 40 mg/100 cm²) Lidocaine Hydrochloride USP in a simulated wound fluid within an hour. The device released a total of about 0.1 mg/in² of silver over 3 days in a simulated wound fluid.
ANTIMICROBIAL PERFORMANCE: Sustained antimicrobial activity for up to 3 days was demonstrated by relevant standard in vitro microbiological assays in a simulated wound fluid using an ISO standardized test method. 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 15692), 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/Lidocaine Wound Dressing has been demonstrated through appropriate in vivo tests, including cytotoxicity, acute systemic toxicity, acute intracutaneous reactivity, skin sensitization, sub-acute/sub-chronic systemic toxicity, tissue implantation, and material mediated pyrogenicity 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 test results indicated that Microlyte® Ag/Lidocaine wound dressing has passed toxicity and safety tests and is safe for intended use similar to predicate devices.
ANIMAL STUDY: A porcine wound healing study in full-thickness wounds was performed based in part on ISO 10993-6: tests for local effects after implantation. The results of the study concluded that the subject device demonstrated minimal to no local reaction compared to cited predicate devices following repeated dermal applications over 10 and 24 days and supported the normal wound healing progression. There were no macroscopic or microscopic differences detected in the wound healing progression with the test article and controls.
PYROGENICITY TESTING: A USP Kinetic-Turbidity 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/Lidocaine Wound Dressing was determined to be non-pyrogenic.
CLINICAL STUDY: Clinical data is not needed to support substantial equivalence to previously cleared predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
More than 4 log10 reduction in the viable counts of a broad spectrum of test organisms.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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October 17, 2024
Imbed Biosciences % Albert Rego Regulatory Consultant Albert Rego, Ph D, Inc 27001 La Paz Road. Suite 314 Mission Viejo, California 92691
Re: K211943
Trade/Device Name: Microlyte Ag/Lidocaine Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: February 20, 2024 Received: February 21, 2024
Dear Albert 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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K211943
Device Name Microlyte® Ag/Lidocaine Wound Dressing
Indications for Use (Describe)
Under the supervision of a healthcare professional,
Microlyte® Ag/Lidocaine Wound Dressing may be used for the management of partial and full thickness wounds including diabetic foot ulcers, venous stasis ulcers, ischemic ulcers, surgical wounds, post-surgical incisions, donor sites, debrided partial thickness wounds, first degree burns, partial thickness burns, abrasions and lacerations.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(k) SUMMARY
(As required by 21 CFR 807.92)
| SUBMITTER: | Imbed Biosciences, Inc.
2241 Pinehurst Drive
Middleton, WI 53562, USA |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Ankit Agarwal, PhD
Phone/Fax: 608-237-1525 |
| SUBMISSION DATE: | September 23, 2024 |
| DEVICE
TRADE NAME:
COMMON NAME:
CLASSIFICATION NAME:
REGULATORY CLASS:
PRODUCT CODE:
CLASSIFICATION PANEL:
PERFORMANCE
STANDARDS: | Microlyte® Ag/Lidocaine Wound Dressing
Wound Dressing
Dressing, Wound With 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. |
| PREDICATE DEVICES: | Primary Predicate - WoundPal® Medicated Wound Dressing (K053476)
Secondary predicate devices –
• Microlyte® Ag Wound Dressing (K153756)
• Amerigel® Wound Dressing (K092086) [Now marketed as ASTERO® Hydrogel + Topical Anesthetic (Lidocaine HCl 4%)] |
INTENDED USE:
Microlyte® Ag/Lidocaine Wound Dressing is intended for use as a primary dressing in the local management of wounds. Under the direction of a healthcare professional, Microlyte® Ag/Lidocaine Wound Dressing may be used for the management of wounds such as partial and full thickness diabetic foot ulcers, venous stasis ulcers, pressure ulcers, ischemic ulcers, surgical incisions, donor sites, debrided partial thickness wounds, first-degree burns, partial thickness burns, abrasions and lacerations.
DEVICE DESCRIPTION:
Microlyte® Ag/Lidocaine Wound Dressing is a sterile, single use absorbent polymeric matrix composed primarily of synthetic polyvinyl alcohol with 2.5 mg/in² of lidocaine hydrochloride USP, with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.1 mg/in² of silver.
MECHANISM OF ACTION: Microlyte® Ag/Lidocaine Wound Dressing absorbs wound fluid and forms a soft matrix that conforms to the wound surface and maintains a moist environment. The matrix contains silver only to prevent or minimize microbial growth within the dressing releases Lidocaine Hydrochloride USP for effecting local anesthetic action in painful skin wounds.
5
INDICATIONS FOR USE:
Under the supervision of a healthcare professional, Microlyte® Ag/Lidocaine Wound Dressing may be used for the management of partial and full thickness wounds including diabetic foot ulcers, venous stasis ulcers, pressure ulcers, ischemic ulcers, surgical wounds, post-surgical incisions, donor sites, debrided partial thickness wounds, traumatic wounds, first degree burns, partial thickness burns, abrasions and lacerations.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
The form, fit, function and the intended use for the subject device - Microlyte® Ag/Lidocaine Wound Dressing - are substantially equivalent to the cited primary and secondary predicate devices, as summarized in the table below.
| Category | WoundPal® Medicated
Wound Dressing | AMERIGEL® WOUND
DRESSING plus
(marketed as ASTERO®
hydrogel + topical
anesthetic Lidocaine HCL
4%) | Microlyte® Ag Wound
Dressing | Microlyte® Ag/Lidocaine
Wound Dressing | 1Substantial Equivalence (S.E.)
or
not |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Manufacturer | AT Squared, LLC | Amerx Health Care
Corporation | Imbed Biosciences Inc. | Imbed Biosciences Inc. | N/A |
| 510K Number | K053476 | K092086 | K153756 | K211943 | N/A |
| Class | Unclassified | Unclassified | Unclassified | Unclassified | S.E. |
| Product code | MGQ | MGQ | FRO | FRO | S.E. |
| Intended use/
Indications of
use | "The product is intended
as a primary dressing for
use in the local
management of painful
skin wounds."
"Management of partial
and full-thickness wounds,
including diabetic ulcers,
venous stasis ulcers,
pressure ulcers, surgical
wounds, ischemic ulcers,
traumatic wounds,
superficial burns, donor
sites, and abrasions and
lacerations. Absorbs
wound exudates and
maintains a moist
environment." | "Indicated for painful
wounds such as stage I-IV
pressure ulcers, venous
stasis ulcers, ulcerations
caused by mixed vascular
etiologies, diabetic skin
ulcers, first and second
degree burns, post-surgical
incisions, cuts and
abrasions." | "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,
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." | "Intended for use as a
primary dressing for the
local management of
wounds.
Under the direction of a
healthcare professional,
Microlyte® Ag/Lidocaine
Wound Dressing may be
used for the management
of wounds such as partial
and full thickness diabetic
foot ulcers, venous stasis
ulcers, pressure ulcers,
ischemic ulcers, surgical
wounds, post-surgical
incisions, donor sites,
debrided partial thickness
wounds, traumatic
wounds, first-degree
burns, partial thickness
burns, abrasions and
lacerations." | S.E. |
| Description of
Device (brief) | "WoundPal is a single use
wound dressing consisting
of a woven cotton gauze | "Astero® is a hydrated
polymer (Hydrogel) wound
dressing containing 4% | "Microlyte® Ag Wound
Dressing is a sterile, single
use unsupported synthetic | "Microlyte® Ag/Lidocaine
Wound Dressing is a
sterile, single use | S.E. |
| Category | WoundPal® Medicated
Wound Dressing | AMERIGEL® WOUND
DRESSING plus
(marketed as ASTERO®
hydrogel + topical
anesthetic Lidocaine HCL
4%) | Microlyte® Ag Wound
Dressing | Microlyte® Ag/Lidocaine
Wound Dressing | S.E.1
or
not |
| | treated with an OTC
antibiotic mixture
composed of Polymyxin B
Sulfate USP (10,000
units/gram) and Bacitracin
Zinc USP (500 units/gram)
in a hydrogel with 2% w/w
Lidocaine HCl. Normal
saline 0.9% is also added to
maintain a moist dressing.
A trace amount of oil of
wintergreen is added as a
fragrance." | w/w Lidocaine HCl USP.
Each gram of Astero®
contains Lidocaine
Hydrochloride USP 4% (40
mg). Lidocaine
Hydrochloride USP is
chemically designated as
acetamide, 2-
(diethylamino)-N-(2,6-
dimethylphenyl). Hydrogel
contains polyethylene
Glycol (PEG) 400 &
polyethylene Glycol 3350
as base, Oak Extract,
Meadowsweet Extract,
Zinc Acetate, and Water." | absorbent polyvinyl alcohol
sheet with a polymeric
surface coating containing
ionic and metallic silver. It
has very low amounts of
silver, with a maximum 0.1
mg/in²." | absorbent polymeric
matrix composed primarily
of synthetic polyvinyl
alcohol containing 2.5
mg/in² lidocaine
hydrochloride USP, with a
polymeric surface coating
containing ionic and
metallic silver. It has very
low amounts of silver, with
a maximum of 0.1 mg/in²
of silver." | |
| Physical
composition | "The base woven cotton
gauze is treated with an
OTC antibiotic mixture
composed of Polymyxin B
Sulfate USP (10,000
units/gram) and Bacitracin
Zinc USP (500 units/gram)
in a hydrogel with 2% w/w
Lidocaine HCl." | "The base hydrogel is
composed of a
polyethylene Glycol (PEG)
400 & polyethylene Glycol
3350 as base, Oak Extract,
Meadowsweet Extract,
Zinc Acetate, and Water." | "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." | The base matrix is
composed of a hydrophilic
polyvinyl alcohol absorbent
sheet with lidocaine
hydrochloride USP, and
with ionic and metallic
silver complexed in a
polymeric coating on the
surface of the dressing. | S.E. |
| Antimicrobial
form | The base woven cotton
gauze is treated with an
OTC antibiotic mixture
composed of Polymyxin B
Sulfate USP and Bacitracin
Zinc USP. | N/A | Ionic silver and metallic
silver (from silver nitrate) | Ionic silver and metallic
silver (from silver nitrate) | S.E. |
| Antimicrobial
content | Polymyxin B Sulfate USP
(10,000 units/gram) and
Bacitracin Zinc USP (500
units/gram) | N/A, because no
antimicrobial agent is
present | About 0.1 mg/in² of silver | About 0.1 mg/in² of silver | S.E. |
| Lidocaine form
and content | Hydrogel contains 2% w/w
lidocaine hydrochloride i.e.
20 mg of lidocaine
hydrochloride per gram of
the hydrogel. | Hydrogel contains 4% w/w
lidocaine hydrochloride,
i.e. 40 mg of lidocaine
hydrochloride per gram of
the hydrogel, which is to
be applied over 100 cm² of
wound surface area. | N/A, because no lidocaine
is present | The polymeric matrix is
impregnated with 2.5
mg/in² (= 40 mg/100 cm²)
lidocaine hydrochloride
USP. i.e. 40 mg of lidocaine
hydrochloride to be
applied over 100 cm² of
wound surface area. | S.E. |
| Mechanism of
action | "The product is intended
as a primary dressing for
use in the local
management of painful
skin wounds. The antibiotic
mixture is present to help
prevent bacterial
contamination of the | "By providing moisture to
the wound, Astero® create
a moist healing
environment, which
promotes granulation,
epithelialization, and
autolytic debridement. The
high water content of | "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 | The dressing absorbs
wound fluid and forms a
soft matrix that conforms
to the wound surface and
maintains a moist
environment. The matrix
contains silver only to
prevent or minimize | S.E. |
| Category | WoundPal® Medicated
Wound Dressing | AMERIGEL® WOUND
DRESSING plus
(marketed as ASTERO®
hydrogel + topical
anesthetic Lidocaine HCL
4%) | Microlyte® Ag Wound
Dressing | Microlyte® Ag/Lidocaine
Wound Dressing | S.E.1
or
not |
| | dressing. The dressing may
be held in place with a
variety of secondary
dressings, including an
additional bandage or with
the addition of an outer
layer comprised of a
polymeric film that may be
secured by applying zinc
oxide ointment USP
between the film and
intact skin surrounding the
wound." | hydrogel dressings cools
the wound, producing pain
relief that can last up to 6
hours. Dressing-change
discomfort is also reduced
because Astero® doesn't
adhere to the wound
surface. Astero® releases
Lidocaine Hydrochloride
USP from the Neutral (pH
7-7.2) hydrogel to stabilize
the neuronal membrane by
inhibiting the ionic fluxes
required for initiation and
conduction of impulses,
thereby effecting local
anesthetic action." | microbial growth within
the dressing." | microbial growth within
the matrix. The dressing
releases Lidocaine
Hydrochloride USP for
effecting local anesthetic
action in painful skin
wounds. | |
| Bio-
compatibility | "Because of the long
history of safe use of the
components of WoundPal®
Medicated Wound
Dressing independently,
and in combination, the
device does not raise any
new safety issues and
biocompatibility
testing was not
performed." | "Lidocaine HCl is well
known to be GRASE
(generally regarded as safe
and effective)."
Biocompatibility of the
base hydrogel "was
previously established by
in-vitro cytotoxicity test,
dermal sensitization test in
rabbits and sensitization
test on guinea pigs." | Cytotoxicity,
Sensitization,
Acute intracutaneous
reactivity,
Acute systemic toxicity,
Tissue implantation, and
Sub-acute/Sub-chronic
toxicity.
All tests performed in
accordance with the
applicable ISO-10993
standards. | Cytotoxicity,
Sensitization,
Acute intracutaneous
reactivity,
Acute systemic toxicity,
Tissue implantation,
Sub-acute/Sub-chronic
toxicity, Porcine wound
healing, Material mediated
pyrogenicity.
All tests performed at in
accordance with of the
applicable ISO-10993
standards. | S.E. |
| Antimicrobial
Activity within
the dressing | Yes. | No | Yes.
4 log10 reduction in viable
counts of test microbes | Yes.
4 log10 reduction in viable
counts of test microbes | S.E. |
| Sterility | Sterile | Not sterile | Sterile | Sterile | S.E. |
| Packaging | Supplied as sterile sheets
of 4"x4" size. | Supplied as 30 mL Airless
Metered Dose Bottle. Each
pump of the Astero® bottle
will deliver 0.25 mL of
Astero® (10 mg Lidocaine
Hydrochloride USP),
enough to cover a 2 inch
by 2 inch area of skin. | Supplied as sterile sheets
of 1"x1", 2"x2", 2"x9",
4"x4", 4"x9", 6"x6", 8"x8"
and 8"x10" sizes. Packaged
in single use heat sealed
medical grade foil pouches. | Supplied as sterile sheets
of 1"x1", 2"x2", 2"x9",
4"x4", 4"x9", and 6"x6"
sizes. Packaged in single
use heat sealed medical
grade foil pouches. | S.E. |
Comparison of Technological Characteristics with Predicate Devices
1Substantial Equivalence (S.E.)
6
7
Microlyte® Ag/Lidocaine Wound Dressing is substantially equivalent in the form, fit, function, and intended use to the cited primary predicate device – WoundPal® Medicated Wound Dressing (K053476). Both the dressings have the same technological characteristics including film dressing, sterile, single use,
8
and absorbent. Both the dressings contain antimicrobial agent(s) and a local anesthetic. They both have the same design properties and product specifications such as shape, size, and geometry.
Both the subject and the primary predicate device function as a primary wound dressing, where absorbent sheet of the dressings absorbs wound exudate and maintains a moist wound environment to support the normal wound healing. They both contain antimicrobial agents in the dressing to minimize microbial growth within the dressings and lidocaine HCl in the dressing for the local pain management in wounds.
The stated differences in the technological characteristics of Microlyte® Ag/Lidocaine Wound Dressing and its predicates are minor and do not present any new questions regarding its safety and performance, as documented by biocompatibility and performance testing.
PERFORMANCE AND SAFETY DATA:
No applicable performance standards have been established under Section 514 of the FD&C Act. 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, lidocaine loading, water uptake capacity, tensile strength, and oxygen and water vapor transmission rates were evaluated and determined to pass the performance acceptance criteria. The device released about 2.5 mg/in² (= 40 mg/100 cm²) Lidocaine Hydrochloride USP in a simulated wound fluid within an hour. The device released a total of about 0.1 mg/in² of silver over 3 days in a simulated wound fluid.
ANTIMICROBIAL PERFORMANCE: Sustained antimicrobial activity for up to 3 days was demonstrated by relevant standard in vitro microbiological assays in a simulated wound fluid using an ISO standardized test method. 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 15692), 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/Lidocaine Wound Dressing has been demonstrated through appropriate in vivo tests, including cytotoxicity, acute systemic toxicity, acute intracutaneous reactivity, skin sensitization, sub-acute/sub-chronic systemic toxicity, tissue implantation, and material mediated pyrogenicity 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 test results indicated that Microlyte® Ag/Lidocaine wound dressing has passed toxicity and safety tests and is safe for intended use similar to predicate devices.
ANIMAL STUDY: A porcine wound healing study in full-thickness wounds was performed based in part on ISO 10993-6: tests for local effects after implantation. The results of the study concluded that the subject device demonstrated minimal to no local reaction compared to cited predicate devices following repeated dermal applications over 10 and 24 days and supported the normal wound healing progression. There were no macroscopic or microscopic differences detected in the wound healing progression with the test article and controls.
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PYROGENICITY TESTING: A USP Kinetic-Turbidity 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/Lidocaine Wound Dressing was determined to be non-pyrogenic.
CLINICAL STUDY: Clinical data is not needed to support substantial equivalence to previously cleared predicate devices.
DICUSSSION
Based on the similarities in the device design, material composition, mechanism of action, biocompatibility, performance, and the proposed intended use and indications, it is determined that Microlyte® Ag/Lidocaine Wound Dressing is substantially equivalent to the cited primary predicate device. The differences in the technological characteristics between the subject and predicate devices are minor and do not raise any new questions regarding its safety and intended use.
CONCLUSIONS
Microlyte® Ag/Lidocaine Wound Dressing is substantially equivalent in function and intended use to the previously cleared predicate devices.