Medline Burn and Wound Dressing is intended to cleanse and moisten the wound bed and for the management of ulcers (including diabetic foot and leg ulcers), 1st and 2nd degree burns, partial and full thickness wounds, and surgical incisions. It can be used to provide a moist environment that supports autolytic debridement of necrotic tissue.

Device Description

Medline Burn and Wound Dressing is a translucent, biocompatible, odorless, semisolid gel intended to cleanse and moisten the wound bed. The dressing maintains moisture in the wound and protects the wound from dessication to provide an optimal moist wound environment conducive to wound healing. Medline Burn and Wound Dressing contains a gentle surfactant and is water soluble to aid in the removal of wound debris in between dressing changes. Medline Burn and Wound Dressing is provided non-sterile for single patient use. Polyhexanide (PHMB) acts as a preservative to inhibit the growth of microorganisms within the product.

AI/ML Overview

The provided document is a 510(k) summary for the Medline Burn and Wound Dressing, which is a medical device. This type of regulatory submission establishes substantial equivalence to a predicate device and typically does not involve a clinical study to prove device performance against acceptance criteria in the manner that AI/ML devices do.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for proving device performance cannot be extracted from this document because the device is a wound dressing, not an AI/ML device.

The document primarily focuses on demonstrating substantial equivalence to existing predicate devices (Prontosan Wound Gel and Manuka Fill) through a comparison of technological characteristics and non-clinical testing.

Here's a breakdown of what can be extracted, and why the other requested points are not applicable:

Table of acceptance criteria and reported device performance: Not applicable. This document performs a comparison for substantial equivalence, not a direct performance study against criteria for an AI/ML output. Instead, it compares characteristics and non-clinical test results to predicate devices.

DEVICE CHARACTERISTIC	PROPOSED DEVICE PERFORMANCE / CHARACTERISTICS	PREDICATE DEVICE PERFORMANCE / CHARACTERISTICS	COMPARISON ANALYSIS
Product Code	FRO	FRO (Primary & Secondary Predicates)	Same as Predicates
Intended Use	Cleanses and moistens wound bed; manages ulcers, 1st & 2nd degree burns, partial & full thickness wounds, surgical incisions; supports autolytic debridement.	Cleanses & moistens wound bed; manages ulcers, 1st & 2nd degree burns, partial & full thickness wounds, surgical incisions; softens encrusted dressings (Primary); manages leg/pressure/diabetic foot ulcers, 1st & 2nd degree burns, surgical/trauma wounds; provides moist environment for autolytic debridement (Secondary).	Same as Primary Predicate; Same as Secondary Predicate
Regulation Number	Unclassified	Unclassified (Primary & Secondary Predicates)	Same as Predicates
Configurations	1.75 oz tube	30 ml tube (Primary); Individual tubes in a variety of sizes (Secondary)	Similar to Predicates
Design Features	Clear to translucent, water soluble, virtually odorless, amorphous wound gel with a surfactant and PHMB as a preservative.	Clear, colorless, virtually odorless aqueous wound gel with a surfactant and PHMB as a preservative (Primary); Wound gel with honey, helps maintain a moist wound environment (Secondary)	Similar to Predicates
Materials	Poloxamer, Purified Water, Glycerin, Sucrose, Sodium Phosphate Dibasic, Citric Acid, PHMB	Purified Water, Glycerol, Hydroxyethylcellulose, Undecylenamidopropyl Betaine, PHMB (Primary); 100% Leptospermum scoparium honey from New Zealand (Secondary)	Similar to Primary Predicate
Non-Clinical Testing Conducted	- Biocompatibility in accordance to ISO 10993-1- Shelf Life- USP <51> Antimicrobial Effectiveness- Wound Healing Study (GLP)	- Biocompatibility in accordance to ISO 10993-1- Shelf Life- USP <51> Antimicrobial Effectiveness- USP <85> Bacterial Endotoxin Testing (Primary); - Biocompatibility in accordance to ISO 10993-1- Sterilization Validation- Packaging Validation- Shelf Life- Wound Healing Study (Secondary)	Similar to Predicates
Sterile vs. Non-Sterile	Non-sterile	Sterile by aseptic filtration until first opened (Primary); Sterile by gamma irradiation (Secondary)	Different than Predicates
Reusable vs. Single Use	Single patient, multiple use	Single patient, multiple use (Primary); Single use (Secondary)	Same as Primary Predicate; Similar to Secondary Predicate

Sample size used for the test set and the data provenance: Not applicable. The document refers to "non-clinical testing" including a "Wound Healing Study" (animal study, conducted under GLP - 21 CFR 58), but does not specify a "test set" in the context of an AI/ML algorithm or provide sample sizes for such. Data provenance (country, retrospective/prospective) is also not relevant here for an AI/ML "test set."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This concept applies to AI/ML devices where human experts label data. For a wound dressing, "ground truth" would relate to the outcome of biological or chemical tests, or healing observed in the animal study, not expert consensus on image interpretation or similar.
Adjudication method: Not applicable. No "adjudication" of expert opinions for a test set is required for this type of device.
If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done: Not applicable. MRMC studies are specific to imaging and AI/ML devices where the performance of human readers, with and without AI assistance, is evaluated. This is not relevant for a wound dressing.
If a standalone performance (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is not an algorithm.
The type of ground truth used: For the non-clinical "Wound Healing Study," the ground truth would be the observed biological outcome of wound healing in the animal model. For biocompatibility and antimicrobial effectiveness, the ground truth would be the results of standard laboratory tests against established criteria (e.g., ISO 10993-1, USP <51>).
The sample size for the training set: Not applicable. There is no AI/ML algorithm, and therefore no "training set."
How the ground truth for the training set was established: Not applicable. No training set exists.

Summary

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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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

July 19, 2018

Medline Industries, Inc. Bethany Benoit-DiMaria Senior Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093

Re: K173911

Trade/Device Name: Medline Burn and Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: June 13, 2018 Received: June 14, 2018

Dear Bethany Benoit-DiMaria:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

David Krause -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K173911

Device Name Medline Burn and Wound Dressing

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image features the Medline logo, which is set against a blue square. The word "MEDLINE" is prominently displayed in white, sans-serif font. A white, stylized starburst symbol is positioned to the right of the text, adding a visual element to the logo. A gray bar is visible on the right side of the image.

Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093

K173911 510(k) Summary [AS REQUIRED BY 21CFR807.92(c)]

Submitter / 510(k) Sponsor

Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093

Registration Number: 1417592

Contact Person

Bethany Benoit-DiMaria Senior Regulatory Affairs Specialist Phone: 847-643-3256 Email: BBenoit-Dimaria@medline.com

Summary Preparation Date December 21, 2017

Type of 510(k) Submission Traditional

Device Name / Classification

Name of Device: Medline Burn and Wound Dressing Proprietary Name: Medline Burn and Wound Dressing Common Name: Wound Cleanser, Wound Dressing Classification Name: Dressing, Wound, Drug Product Code: FRO Classification Panel: General & Plastic Surgery Regulatory Class: Unclassified

Primary Predicate Device Prontosan Wound Gel K101882

Secondary Predicate Device Manuka Fill K131796

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Image /page/4/Picture/0 description: The image shows the Medline logo. The logo is set against a blue square background. The word "MEDLINE" is written in bold, sans-serif font, stacked on top of a white star-like shape. The star shape has four points, resembling a compass rose.

ledline Industries. Inc hree Lakes Drive

Device Description

Medline Burn and Wound Dressing is provided non-sterile for single patient use. Polyhexanide (PHMB) acts as a preservative to inhibit the growth of microorganisms within the product.

Indications for Use

For Prescription Use: Medline Burn and Wound Dressing is intended to cleanse and moisten the wound bed and for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 1st and 2nd degree burns, partial and full thickness wounds, and surgical incisions. It can be used to provide a moist environment that supports autolytic debridement of necrotic tissue.

Summary of Technological Characteristics

Medline Burn and Wound Dressing was developed for the management of wounds that benefit from a moist wound environment and cleansing without unnecessary mechanical trauma. Polyhexanide (PHMB) acts as a preservative to inhibit the growth of microorganisms within the product.

DEVICECHARACTERISTIC	PROPOSED DEVICE	PRIMARY PREDICATEDEVICE	SECONDARYPREDICATEDEVICE	COMPARISONANALYSIS
Product Name	Medline Burn and WoundDressing	Prontosan Wound Gel	Manuka Fill	N/A
510(k) Reference	K173911	K101882	K131796	N/A
Product Code	FRO	FRO	FRO	Same as PrimaryPredicate(K101882)Same asSecondaryPredicate(K131796)
Intended Use	Professional Use:Medline Burn and WoundDressing is intended tocleanse and moisten the	Professional Use:Prontosan Wound Gel isintended to cleanse andmoisten the wound bed and	Under the supervisionof a healthcareprofessional, ManukaFill wound dressing is	Same asPrimaryPredicate
	wound bed and for themanagement of ulcers(including diabetic foot andleg ulcers and pressureulcers), 1st and 2nd degreeburns, partial and fullthickness wounds, andsurgical incisions. It can beused to provide a moistenvironment that supportsautolytic debridement ofnecrotic tissue.	for the management ofulcers, 1st and 2nd degreeburns, partial and fullthickness wounds, andsurgical incisions. It can beused during wounddressing changes to softenencrusted wound dressings.	indicated for themanagement of:Leg Ulcers, PressureUlcers, 1st and 2ndDegree Burns,Diabetic Foot Ulcers,Surgical Wounds,Trauma Wounds.Manuka Fill wounddressing provides amoist woundenvironment. A moistwound environmentallows autolyticdebridement ofnecrotic tissue	(K101882)Same asSecondaryPredicate(K131796)
Regulation Number	Unclassified	Unclassified	Unclassified	Same asPrimaryPredicate(K101882)Same asSecondaryPredicate(K131796)
Configurations	1.75 oz tube	30 ml tube	Individual tubes in avariety of sizes	Similar toPrimaryPredicate(K101882)Similar toSecondaryPredicate(K131796)
Design Features	Clear to translucent, watersoluble, virtually odorless,amorphous wound gel witha surfactant and PHMB as apreservative	Clear, colorless, andvirtually odorless aqueouswound gel with asurfactant and PHMB as apreservative	Wound gel withhoney, helps maintaina moist woundenvironmentconducive to woundhealing	Similar toPrimaryPredicate(K101882)Similar toSecondaryPredicate(K131796)
Materials	Poloxamer, Purified Water,Glycerin, Sucrose, SodiumPhosphate Dibasic, CitricAcid, PHMB	Purified Water, Glycerol,Hydroxyethylcellulose,UndecylenamidopropylBetaine, PHMB	100% Leptospermumscoparium honey fromNew Zealand	Similar toPrimaryPredicate(K101882)
				SecondaryPredicate(K131796)
Non-Clinical Testing	-Biocompatibility inaccordance to 10993-1-Shelf Life-USP<51>AntimicrobialEffectiveness-Wound Healing Study	-Biocompatiblity inaccordance to 10993-1(breached or compromisedsurfaces with prolongedcontact (>24h to 30d)-Shelf Life-USP<51>AntimicrobialEffectiveness-USP<85> BacterialEndotoxin Testing	-Biocompatibility inaccordance to 10993-1(breached orcompromised surfaceswith prolonged contact(>24h to 30d)-SterilizationValidation-Packaging Validation-Shelf Life-Wound HealingStudy	Similar toPrimaryPredicate(K101882)Similar toSecondaryPredicate(K131796)
Sterile vs. Non-Sterile	Non-sterile	Sterile by aseptic filtrationuntil first opened	Sterile by gammairradiation	Different thanPrimaryPredicate(K101882)Different thanSecondaryPredicate(K131796)
Reusable vs.Single Use	Single patient, multiple use	Single patient, multiple use	Single use	Same asPrimaryPredicate(K101882)Similar toSecondaryPredicate(K131796)

Proposed and Predicate Device(s) Comparison

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Image /page/5/Picture/0 description: The image features the Medline logo, which is set against a blue square background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a white, stylized starburst or cross-like symbol. The starburst is vertically oriented, with its pointed ends extending upwards and downwards from the word "MEDLINE."

Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093

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Image /page/6/Picture/0 description: The image shows the Medline logo. The logo is white text on a blue background. The text "MEDLINE" is in a sans-serif font. There is a white starburst-like shape to the right of the text.

Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093

Summary of Non-Clinical Testing

Medline Burn and Wound Dressing and the predicate device have the same intended use, and similar technological characteristics that do not raise different questions of safety and effectiveness. In order to address the same questions of safety and effectiveness and demonstrate that the differences in technological characteristics do not introduce new issues of safety and effectiveness, biocompatibility testing in accordance to ISO 10993-1, shelf-life testing to finished product specifications, and nonclinical performance testing (animal wound healing study) were conducted in accordance with GLP (21 CFR 58).

Summary of Clinical Testing Not applicable.

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Image /page/7/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, stacked vertically, with a white starburst symbol to the right of the text. The background is a solid dark blue color. There is a gray bar on the right side of the image.

Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093

Conclusion

In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Medline Burn and Wound Dressing is as safe and as effective for its intended use as the predicate devices [Prontosan Wound Gel (K101882) and Manuka Fill (K131796)].

Regulation Number and Section

N/A