The MEBO Wound Dressing is indicated for management of the following types of wound:-Skin graft recipient sites Newly sutured wounds Lacerations and abrasions Minor or superficial-partial thickness burns

Device Description

The MEBO Wound Dressing is a CO60 gamma-radiation sterilized dressing consisting of sesame oil, beeswax and fabric dressing, which provides a moist environment for wound healing.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "MEBO Wound Dressing." It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria for a new clinical claim. Therefore, much of the requested information about performance testing, ground truth, expert opinions, and comparative effectiveness studies is not present in the provided document.

The document discusses various tests for the wound dressing (e.g., appearance, size deviation, liquid absorbency, biocompatibility), but these are primarily for substantiating equivalence to the predicate device, not for establishing a new clinical performance claim with defined acceptance criteria for efficacy or diagnostic accuracy.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is missing:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The document doesn't define "acceptance criteria" in the sense of predefined thresholds for clinical performance (e.g., sensitivity, specificity, or wound healing rates) that a novel device needs to meet. Instead, it aims to show substantial equivalence to a predicate device. The performance testing conducted is to demonstrate that the new device performs similarly in critical characteristics to the predicate, implying it is equally safe and effective.

Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Acceptance Criteria (Implied by Equivalence)	Reported Device Performance (Summary)
Physical/Chemical	Comparable to predicate device	Appearance: Verified
		Size Deviation: Verified
		Liquid Absorbency: Verified
		Acid Value: Verified
		Paste Content: Verified
		B-Sitosterol Content: Verified
Biocompatibility	Compliant with ISO 10993 standards	Endotoxin Level: Verified
		Cytotoxicity (ISO 10993-5): Verified
		Local Effects after Implantation (ISO 10993-6): Verified
		Irritation/Skin Sensitization (ISO 10993-10): Verified
		Systemic Toxicity (ISO 10993-11): Verified
		Pyrogen Test (USP41-NF36 <151>): Verified
		Bacterial Endotoxin Test (USP42 <161>): Verified

Note: The document states "The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device." It does not provide specific numerical results or detailed comparison tables for each test, only that they were completed and found to meet the equivalence claim.

Study Details

The provided text describes bench testing to support a 510(k) submission for substantial equivalence, not a study proving clinical efficacy or diagnostic accuracy of an AI/algorithm-based device. Therefore, many of the requested points are not applicable or not detailed in this type of submission.

Sample sizes used for the test set and data provenance:
- Not specified for any performance tests. The document refers to "bench testing" but does not detail sample sizes for physical or biological tests.
- Data Provenance: Not applicable in the context of clinical data for AI testing; tests are laboratory-based.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: This document is for a wound dressing, not an AI/algorithm-based device requiring expert interpretation for ground truth. The "ground truth" for the characteristics tested (e.g., size, pH, cytotoxicity) would be established by standard laboratory measurement techniques and expert interpretation of those lab results (e.g., pathologist for biocompatibility slides), but specific numbers/qualifications of these experts are not provided as they would be for image-based AI studies.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable: This pertains to establishing ground truth in expert-read data (e.g., radiology images), which is not the subject of this 510(k).
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable: This is an MRMC study and applies to AI/CADe/CADx devices, not a wound dressing. No human readers or AI assistance are involved in the performance testing described.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable: This is for AI/algorithm performance. The device is a physical wound dressing composed of sesame oil, beeswax, and fabric.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the physical and chemical properties (e.g., size, absorbency, acid value, paste content, B-sitosterol content), the "ground truth" is established by standard analytical and quantitative laboratory methods (e.g., gravimetry, titration, chemical analysis).
- For biocompatibility, the "ground truth" is established by standardized biological assays as per ISO 10993 series and USP monographs (e.g., cell culture for cytotoxicity, animal models for irritation/sensitization/systemic toxicity, bacterial tests for endotoxins/pyrogens), with expert interpretation of results (e.g., by toxicologists or pathologists for tissue reactions).
The sample size for the training set:
- Not Applicable: This refers to machine learning/AI models. The device is not an AI algorithm; it's a physical wound dressing.
How the ground truth for the training set was established:
- Not Applicable: As above, this document describes a physical medical device, not an AI system.

Summary of Document's Purpose:

The provided document is a 510(k) clearance letter and summary for a wound dressing, demonstrating its substantial equivalence to a legally marketed predicate device. The "study" referenced is a series of bench tests (physical, chemical, and biological/biocompatibility) designed to show that the MEBO Wound Dressing performs equivalently to the predicate and raises no new questions of safety or effectiveness. It is not a clinical trial or performance study for a novel diagnostic or AI device with specific clinical performance acceptance criteria (like sensitivity/specificity).

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 4, 2020

MEBO Life Science Inc. % Wei-Shan Hsu Regulatory manager Vee Care (Asia) Limited 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong, CHN Hong Kong

Re: K193439

Trade/Device Name: MEBO Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: November 29, 2019 Received: August 4, 2020

Dear Wei-Shan Hsu:

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. 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 located 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.

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

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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) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (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,

Anjana Jain, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic 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) K193439

Device Name MEBO Wound Dressing

Indications for Use (Describe) The MEBO Wound Dressing is indicated for management of the following types of wound:-Skin graft recipient sites Newly sutured wounds Lacerations and abrasions Minor or superficial-partial thickness burns

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date Prepared 1

Sep 4th, 2020

Submitter's Information 2

Name of Sponsor: MEBO Life Science Inc. Address: 325 North Puente Street # A Brea, CA92821, USA. Contact Name: Guoxin Tao Contact e-mail: taoguoxin@hotmail.com Telephone No.: (626)617-5110

Trade Name, Common Name, Classification ന

Trade/Device Name: MEBO Wound Dressing Classification name: Dressing, Wound, Drug Product code: FRO Device Class: Unclassified

Identification of Predicate Device/Reference Device য Primary Predicate Device: K181478 Roosin Xeroform Petrolatum Dressing Reference Device: K052643 EPICERAM® Skin Barrier Emulsion

5 Description of the Device

The MEBO Wound Dressing is a CO60 gamma-radiation sterilized dressing consisting of sesame oil, beeswax and fabric dressing, which provides a moist environment for wound healing.

6 Indication

The MEBO Wound Dressing is indicated for management of the following types of wound:

Skin graft recipient sites .
Newly sutured wounds .
= Lacerations and abrasions
Minor or superficial-partial thickness burns

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7 Similarities and Differences of the Proposed Devices to the Predicate Device/Reference Device

MEBO Wound Dressing described in this premarket notification is compared with the following Predicate Device and Reference Device in terms of indication, mechanism, delivery system, structure/material, applied duration, and sterilization method.

(1) Primary Predicate Device: K181478 Roosin Xeroform Petrolatum Dressing
(2) Reference Device: K052643 EPICERAM® Skin Barrier Emulsion

The following table shows similarities and differences between our device and the predicate device/reference device.

	Subject Device	Primary Predicate Device	Reference Device
				Similarities andDifferences
Manufacturer	MEBOLifeScience Inc.	Roosin MedicalCo., Ltd.	CERAGENIXCORPORATION
Trade Name	MEBOWoundDressing	Roosin XeroformPetrolatumDressing	EPICERAM® SkinBarrier Emulsion
510(k) number	K193439	K181478	K052643	--
Device Class	Unclassified	Unclassified	Unclassified	Same
Product Code	FRO	FRO	FRO	Same
DeviceclassificationName	Dressing,Wound, Drug	Dressing, Wound,Drug	Dressing,Wound, Drug	Same
Regulationnumber	NA	NA	NA	Same
Indications for Use	The MEBOWound Dressingis indicated formanagement ofthe followingtypes of wound:- Skin graftrecipient sites-Newly suturedwounds-Lacerations andabrasions-Minor orsuperficial-partial	Roosin XeroformPetrolatumDressing isintended for useas a primarycontact layer indressing woundssuch aslacerations, skingraft recipientsites, newlysutured wounds,abrasions, andminor or partialthickness burns.It may also be	EpiCeram is aSkin BarrierEmulsion to beused to treatdry skinconditions andto manage andrelieve theburning anditchingassociated withvarious types ofdermatoses,including atopicdermatitis,irritant contact	Same as primarypredicate.Different fromreferencedevice.Reference devicprovides a moistwoundenvironmentwhich is thesame mechanismas the subjectdevice.
	thicknessburns	used as an initiallayer in dressingsurgical woundswith lightexudate.	dermatitis,radiationdermatitis.EpiCeram helpsto relieve dry,waxy skin bymaintaining amoist woundand skinenvironment,which isbeneficial to thehealing process.Apply Epicerama thin layer toaffected skinarea 2 times perday andmassage gentlyinto the skin. Ifthe skin isbroken, coverEpiceram with adressing ofchoice.
Mechanism	Provides a moistenvironment foroptimalwoundhealing	Maintains a moistwoundenvironment	Maintain a moistwound and skinenvironment.	Same
Delivery System	Dressing	Dressing	TopicalEmulsion	Same as primarypredicate.Different fromreferencedevice.
Applied Duration	The maximumcontact durationtime of eachpiece of dressingdoes not exceed24h, and thecumulativeduration time ofcontacting withwoundsshouldn'texceed 30 days.	This productshould not beused for morethan 7 days atmost, and shouldnot be used formore than 30days.	Apply twicedaily or asindicated by theradiationtherapist. Ifcondition doesnot improvewithin 10 to 14days, consult aphysician.	Similar toprimarypredicate andreferencedevice.
Structure/Material	Non-wovenfabric (50%polyester and50% viscose)immersed with amixture ofsesame oil andbeeswax.	Cotton Gauze, 3%BismuthTribromophenate,and Petrolatum	Capric Acid,Cholesterol,Citric Acid,ConjugatedLinoleic Acid,Dimethicone,Disodium EDTA,E. Cerifera(Candelilla)	Different fromprimarypredicate inmaterial, butsimilar designfeature.Referencedevice containsone similar

			Wax, FoodStarch, ModifiedCorn SyrupSolids, Glycerin,GlycerylStearate,HydroxypropylBispalmitamideMEA(Ceramide),Palmitic Acid,PEG-100Stearate,Petrolatum,Phenoxyethanol,PotassiumHydroxide,Purified Water,Sorbic Acid,Squalane,Xanthan Gum.	component,Candelilla Wax,to beeswax inthe subjectdevice. Themain componentof both beeswaxand CandelillaWax istriacontanylpalmitate.
Biocompatibility	Biocompatibilityestablished	Biocompatibilityestablished	Biocompatibilityestablished	Same
Single use	Yes	Yes	N/A	Same as primarypredicate.Different fromreferencedevice.
Sterilization	Gamma, Sterileto 10-6 SAL	Gamma, Sterile to10-6 SAL	Non-sterile	Same as primarypredicate.Different fromreferencedevice.

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K193439

Page 3 of 5

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K193439

The MEBO Wound Dressing has same indications, same mechanism, same sterilization method, similar product design, similar applied duration as the predicate device, and has similar material as the reference device. The differences above between the subject device and predicate device/reference device do not affect the basic design principle, usage of the subject device.

8 Performance Testing Summary

The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:

Appearance

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Size deviation
Liquid absorbency
Acid Value
Paste content (The mass of sesame oil and beeswax mix in the nonwoven fabrics)
B-Sitosterol content
Endotoxin level ●
Biocompatibility
- a. ISO 10993-1:2009 Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process
- b. ISO 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5: Tests for in Vitro Cytotoxicity
- c. ISO 10993-6:2016 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
- c. ISO 10993-10:2010 Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization
- d. ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity-Acute and Subchronic systemic toxicity
- e. USP41-NF36<151> Pyrogen test
- f. USP42 <161> Medical device-Bacterial Endotoxin Test
Conclusion の

Based on the information provided within this 510(k) submission, MEBO Life Science Inc. concludes that the proposed MEBO Wound Dressing is substantially equivalent to the predicate device listed and does not raise different questions of safety or effectiveness.

Regulation Number and Section

N/A