(1212 days)
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.
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.
The provided text describes the regulatory filing for a medical device (Microlyte® Ag/Lidocaine Wound Dressing) and extensively discusses its comparison to predicate devices, performance, and safety data. However, it does not contain information about the acceptance criteria or a study that uses a designated test set with ground truth established by experts for evaluating a classification or detection algorithm's performance.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than proving performance against specific acceptance criteria for an AI/ML-based device.
Therefore, I cannot provide the requested information, which would typically be found in a clinical study report or a detailed performance validation report for an AI/ML device.
Here's why the information is not present:
- Device Type: Microlyte® Ag/Lidocaine Wound Dressing is a physical wound dressing containing lidocaine and silver, not a software or AI/ML-based diagnostic or therapeutic device.
- Regulatory Pathway: The 510(k) pathway for this device emphasizes comparison to predicates to establish safety and effectiveness, not direct performance against algorithmic metrics.
- Performance Data: The "Performance and Safety Data" section lists physical performance, antimicrobial performance, biocompatibility, animal studies, and pyrogenicity testing. These are typical tests for a physical wound dressing and do not involve AI/ML algorithm evaluation.
To directly answer your request based on the provided text, the answer is that this document does not contain the information needed to fill out the table regarding AI/ML acceptance criteria and study details.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG" in a larger font size and "ADMINISTRATION" in a smaller font size below.
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"
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(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.
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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
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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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510(k) SUMMARY
(As required by 21 CFR 807.92)
| SUBMITTER: | Imbed Biosciences, Inc.2241 Pinehurst DriveMiddleton, WI 53562, USA |
|---|---|
| CONTACT: | Ankit Agarwal, PhDPhone/Fax: 608-237-1525 |
| SUBMISSION DATE: | September 23, 2024 |
| DEVICETRADE NAME:COMMON NAME:CLASSIFICATION NAME:REGULATORY CLASS:PRODUCT CODE:CLASSIFICATION PANEL:PERFORMANCESTANDARDS: | Microlyte® Ag/Lidocaine Wound DressingWound DressingDressing, Wound With DrugUnclassifiedFROGeneral and Plastic SurgeryNo applicable performance standards have been established underSection 514 of the FD&C Act. Biocompatibility tests were done inconformance with relevant requirements of ISO 10993. |
| 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.
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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® MedicatedWound Dressing | AMERIGEL® WOUNDDRESSING plus(marketed as ASTERO®hydrogel + topicalanesthetic Lidocaine HCL4%) | Microlyte® Ag WoundDressing | Microlyte® Ag/LidocaineWound Dressing | 1Substantial Equivalence (S.E.)ornot |
|---|---|---|---|---|---|
| Manufacturer | AT Squared, LLC | Amerx Health CareCorporation | 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 ofuse | "The product is intendedas a primary dressing foruse in the localmanagement of painfulskin wounds.""Management of partialand full-thickness wounds,including diabetic ulcers,venous stasis ulcers,pressure ulcers, surgicalwounds, ischemic ulcers,traumatic wounds,superficial burns, donorsites, and abrasions andlacerations. Absorbswound exudates andmaintains a moistenvironment." | "Indicated for painfulwounds such as stage I-IVpressure ulcers, venousstasis ulcers, ulcerationscaused by mixed vascularetiologies, diabetic skinulcers, first and seconddegree burns, post-surgicalincisions, cuts andabrasions." | "Indicated for themanagement of woundsand can be used over-the-counter for minor woundssuch as abrasions andlacerations, minor cuts,and minor scalds andburns.Under the direction of ahealthcare professional,Microlyte® Ag may be usedfor more serious woundssuch as partial and fullthickness pressure ulcers,venous stasis ulcers,diabetic ulcers, first andsecond degree burns,abrasions and lacerations,donor sites and surgicalwounds.-May be used overdebrided and graftedpartial thickness wounds." | "Intended for use as aprimary dressing for thelocal management ofwounds.Under the direction of ahealthcare professional,Microlyte® Ag/LidocaineWound Dressing may beused for the managementof wounds such as partialand full thickness diabeticfoot ulcers, venous stasisulcers, pressure ulcers,ischemic ulcers, surgicalwounds, post-surgicalincisions, donor sites,debrided partial thicknesswounds, traumaticwounds, first-degreeburns, partial thicknessburns, abrasions andlacerations." | S.E. |
| Description ofDevice (brief) | "WoundPal is a single usewound dressing consistingof a woven cotton gauze | "Astero® is a hydratedpolymer (Hydrogel) wounddressing containing 4% | "Microlyte® Ag WoundDressing is a sterile, singleuse unsupported synthetic | "Microlyte® Ag/LidocaineWound Dressing is asterile, single use | S.E. |
| Category | WoundPal® MedicatedWound Dressing | AMERIGEL® WOUNDDRESSING plus(marketed as ASTERO®hydrogel + topicalanesthetic Lidocaine HCL4%) | Microlyte® Ag WoundDressing | Microlyte® Ag/LidocaineWound Dressing | S.E.1ornot |
| treated with an OTCantibiotic mixturecomposed of Polymyxin BSulfate USP (10,000units/gram) and BacitracinZinc USP (500 units/gram)in a hydrogel with 2% w/wLidocaine HCl. Normalsaline 0.9% is also added tomaintain a moist dressing.A trace amount of oil ofwintergreen is added as afragrance." | w/w Lidocaine HCl USP.Each gram of Astero®contains LidocaineHydrochloride USP 4% (40mg). LidocaineHydrochloride USP ischemically designated asacetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl). Hydrogelcontains polyethyleneGlycol (PEG) 400 &polyethylene Glycol 3350as base, Oak Extract,Meadowsweet Extract,Zinc Acetate, and Water." | absorbent polyvinyl alcoholsheet with a polymericsurface coating containingionic and metallic silver. Ithas very low amounts ofsilver, with a maximum 0.1mg/in²." | absorbent polymericmatrix composed primarilyof synthetic polyvinylalcohol containing 2.5mg/in² lidocainehydrochloride USP, with apolymeric surface coatingcontaining ionic andmetallic silver. It has verylow amounts of silver, witha maximum of 0.1 mg/in²of silver." | ||
| Physicalcomposition | "The base woven cottongauze is treated with anOTC antibiotic mixturecomposed of Polymyxin BSulfate USP (10,000units/gram) and BacitracinZinc USP (500 units/gram)in a hydrogel with 2% w/wLidocaine HCl." | "The base hydrogel iscomposed of apolyethylene Glycol (PEG)400 & polyethylene Glycol3350 as base, Oak Extract,Meadowsweet Extract,Zinc Acetate, and Water." | "The base matrix iscomposed of a hydrophilicpolyvinyl alcohol absorbentsheet, with ionic andmetallic silver complexedin a polymeric coating onthe surface of thedressing." | The base matrix iscomposed of a hydrophilicpolyvinyl alcohol absorbentsheet with lidocainehydrochloride USP, andwith ionic and metallicsilver complexed in apolymeric coating on thesurface of the dressing. | S.E. |
| Antimicrobialform | The base woven cottongauze is treated with anOTC antibiotic mixturecomposed of Polymyxin BSulfate USP and BacitracinZinc USP. | N/A | Ionic silver and metallicsilver (from silver nitrate) | Ionic silver and metallicsilver (from silver nitrate) | S.E. |
| Antimicrobialcontent | Polymyxin B Sulfate USP(10,000 units/gram) andBacitracin Zinc USP (500units/gram) | N/A, because noantimicrobial agent ispresent | About 0.1 mg/in² of silver | About 0.1 mg/in² of silver | S.E. |
| Lidocaine formand content | Hydrogel contains 2% w/wlidocaine hydrochloride i.e.20 mg of lidocainehydrochloride per gram ofthe hydrogel. | Hydrogel contains 4% w/wlidocaine hydrochloride,i.e. 40 mg of lidocainehydrochloride per gram ofthe hydrogel, which is tobe applied over 100 cm² ofwound surface area. | N/A, because no lidocaineis present | The polymeric matrix isimpregnated with 2.5mg/in² (= 40 mg/100 cm²)lidocaine hydrochlorideUSP. i.e. 40 mg of lidocainehydrochloride to beapplied over 100 cm² ofwound surface area. | S.E. |
| Mechanism ofaction | "The product is intendedas a primary dressing foruse in the localmanagement of painfulskin wounds. The antibioticmixture is present to helpprevent bacterialcontamination of the | "By providing moisture tothe wound, Astero® createa moist healingenvironment, whichpromotes granulation,epithelialization, andautolytic debridement. Thehigh water content of | "The dressing absorbswound fluid and forms asoft gel that conforms tothe wound surface andmaintains a moistenvironment. The dressingcontains silver only toprevent or minimize | The dressing absorbswound fluid and forms asoft matrix that conformsto the wound surface andmaintains a moistenvironment. The matrixcontains silver only toprevent or minimize | S.E. |
| Category | WoundPal® MedicatedWound Dressing | AMERIGEL® WOUNDDRESSING plus(marketed as ASTERO®hydrogel + topicalanesthetic Lidocaine HCL4%) | Microlyte® Ag WoundDressing | Microlyte® Ag/LidocaineWound Dressing | S.E.1ornot |
| dressing. The dressing maybe held in place with avariety of secondarydressings, including anadditional bandage or withthe addition of an outerlayer comprised of apolymeric film that may besecured by applying zincoxide ointment USPbetween the film andintact skin surrounding thewound." | hydrogel dressings coolsthe wound, producing painrelief that can last up to 6hours. Dressing-changediscomfort is also reducedbecause Astero® doesn'tadhere to the woundsurface. Astero® releasesLidocaine HydrochlorideUSP from the Neutral (pH7-7.2) hydrogel to stabilizethe neuronal membrane byinhibiting the ionic fluxesrequired for initiation andconduction of impulses,thereby effecting localanesthetic action." | microbial growth withinthe dressing." | microbial growth withinthe matrix. The dressingreleases LidocaineHydrochloride USP foreffecting local anestheticaction in painful skinwounds. | ||
| Bio-compatibility | "Because of the longhistory of safe use of thecomponents of WoundPal®Medicated WoundDressing independently,and in combination, thedevice does not raise anynew safety issues andbiocompatibilitytesting was notperformed." | "Lidocaine HCl is wellknown to be GRASE(generally regarded as safeand effective)."Biocompatibility of thebase hydrogel "waspreviously established byin-vitro cytotoxicity test,dermal sensitization test inrabbits and sensitizationtest on guinea pigs." | Cytotoxicity,Sensitization,Acute intracutaneousreactivity,Acute systemic toxicity,Tissue implantation, andSub-acute/Sub-chronictoxicity.All tests performed inaccordance with theapplicable ISO-10993standards. | Cytotoxicity,Sensitization,Acute intracutaneousreactivity,Acute systemic toxicity,Tissue implantation,Sub-acute/Sub-chronictoxicity, Porcine woundhealing, Material mediatedpyrogenicity.All tests performed at inaccordance with of theapplicable ISO-10993standards. | S.E. |
| AntimicrobialActivity withinthe dressing | Yes. | No | Yes.>4 log10 reduction in viablecounts of test microbes | Yes.>4 log10 reduction in viablecounts of test microbes | S.E. |
| Sterility | Sterile | Not sterile | Sterile | Sterile | S.E. |
| Packaging | Supplied as sterile sheetsof 4"x4" size. | Supplied as 30 mL AirlessMetered Dose Bottle. Eachpump of the Astero® bottlewill deliver 0.25 mL ofAstero® (10 mg LidocaineHydrochloride USP),enough to cover a 2 inchby 2 inch area of skin. | Supplied as sterile sheetsof 1"x1", 2"x2", 2"x9",4"x4", 4"x9", 6"x6", 8"x8"and 8"x10" sizes. Packagedin single use heat sealedmedical grade foil pouches. | Supplied as sterile sheetsof 1"x1", 2"x2", 2"x9",4"x4", 4"x9", and 6"x6"sizes. Packaged in singleuse heat sealed medicalgrade foil pouches. | S.E. |
Comparison of Technological Characteristics with Predicate Devices
1Substantial Equivalence (S.E.)
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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,
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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.
N/A