MEBO Wound Dressing

K193439 · Mebo Life Science, Inc. · FRO · Sep 4, 2020 · SU

Device Facts

• Record ID: K193439
• Device Name: MEBO Wound Dressing
• Applicant: Mebo Life Science, Inc.
• Product Code: FRO · SU
• Decision Date: Sep 4, 2020
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

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 Story

MEBO Wound Dressing is a sterile, single-use wound dressing consisting of a non-woven fabric (50% polyester, 50% viscose) impregnated with a mixture of sesame oil and beeswax. It is applied topically to wounds to provide a moist environment, which facilitates the healing process. The dressing is intended for use in clinical or home settings for the management of various wound types, including skin grafts, lacerations, and minor burns. The device is sterilized via gamma radiation. It is applied by a healthcare provider or patient, with a maximum contact duration of 24 hours per dressing and a cumulative duration not exceeding 30 days. The moist environment provided by the sesame oil and beeswax mixture supports wound healing and protects the wound site.

Clinical Evidence

Bench testing only. Testing included appearance, size deviation, liquid absorbency, acid value, paste content, B-Sitosterol content, and endotoxin levels. Biocompatibility testing was conducted per ISO 10993-1, -5, -6, -10, and -11, alongside USP <151> (pyrogen) and USP <161> (bacterial endotoxin) standards.

Technological Characteristics

Non-woven fabric (50% polyester, 50% viscose) impregnated with sesame oil and beeswax. Sterilization: Gamma radiation (10^-6 SAL). Form factor: Dressing. Mechanism: Moist wound environment maintenance. No electronic components or software.

Indications for Use

Indicated for management of skin graft recipient sites, newly sutured wounds, lacerations, abrasions, and minor or superficial-partial thickness burns.

Predicate Devices

• Roosin Xeroform Petrolatum Dressing (K181478)

Reference Devices

• EPICERAM® Skin Barrier Emulsion (K052643)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [e-mail] Telephone No.: [phone]

## 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 and<br>Differences |
| Manufacturer | MEBO<br>Life<br>Science Inc. | Roosin Medical<br>Co., Ltd. | CERAGENIX<br>CORPORATION | |
| Trade Name | MEBO<br>Wound<br>Dressing | Roosin Xeroform<br>Petrolatum<br>Dressing | EPICERAM® Skin<br>Barrier Emulsion | |
| 510(k) number | K193439 | K181478 | K052643 | -- |
| Device Class | Unclassified | Unclassified | Unclassified | Same |
| Product Code | FRO | FRO | FRO | Same |
| Device<br>classification<br>Name | Dressing,<br>Wound, Drug | Dressing, Wound,<br>Drug | Dressing,<br>Wound, Drug | Same |
| Regulation<br>number | NA | NA | NA | Same |
| Indications for Use | The MEBO<br>Wound Dressing<br>is indicated for<br>management of<br>the following<br>types of wound:<br>- Skin graft<br>recipient sites<br>-Newly sutured<br>wounds<br>-Lacerations and<br>abrasions<br>-Minor or<br>superficial-<br>partial | Roosin Xeroform<br>Petrolatum<br>Dressing is<br>intended for use<br>as a primary<br>contact layer in<br>dressing wounds<br>such as<br>lacerations, skin<br>graft recipient<br>sites, newly<br>sutured wounds,<br>abrasions, and<br>minor or partial<br>thickness burns.<br>It may also be | EpiCeram is a<br>Skin Barrier<br>Emulsion to be<br>used to treat<br>dry skin<br>conditions and<br>to manage and<br>relieve the<br>burning and<br>itching<br>associated with<br>various types of<br>dermatoses,<br>including atopic<br>dermatitis,<br>irritant contact | Same as primary<br>predicate.<br>Different from<br>reference<br>device.<br>Reference devic<br>provides a moist<br>wound<br>environment<br>which is the<br>same mechanism<br>as the subject<br>device. |
| | thickness<br>burns | used as an initial<br>layer in dressing<br>surgical wounds<br>with light<br>exudate. | dermatitis,<br>radiation<br>dermatitis.<br>EpiCeram helps<br>to relieve dry,<br>waxy skin by<br>maintaining a<br>moist wound<br>and skin<br>environment,<br>which is<br>beneficial to the<br>healing process.<br>Apply Epiceram<br>a thin layer to<br>affected skin<br>area 2 times per<br>day and<br>massage gently<br>into the skin. If<br>the skin is<br>broken, cover<br>Epiceram with a<br>dressing of<br>choice. | |
| Mechanism | Provides a moist<br>environment for<br>optimal<br>wound<br>healing | Maintains a moist<br>wound<br>environment | Maintain a moist<br>wound and skin<br>environment. | Same |
| Delivery System | Dressing | Dressing | Topical<br>Emulsion | Same as primary<br>predicate.<br>Different from<br>reference<br>device. |
| Applied Duration | The maximum<br>contact duration<br>time of each<br>piece of dressing<br>does not exceed<br>24h, and the<br>cumulative<br>duration time of<br>contacting with<br>wounds<br>shouldn't<br>exceed 30 days. | This product<br>should not be<br>used for more<br>than 7 days at<br>most, and should<br>not be used for<br>more than 30<br>days. | Apply twice<br>daily or as<br>indicated by the<br>radiation<br>therapist. If<br>condition does<br>not improve<br>within 10 to 14<br>days, consult a<br>physician. | Similar to<br>primary<br>predicate and<br>reference<br>device. |
| Structure/Material | Non-woven<br>fabric (50%<br>polyester and<br>50% viscose)<br>immersed with a<br>mixture of<br>sesame oil and<br>beeswax. | Cotton Gauze, 3%<br>Bismuth<br>Tribromophenate,<br>and Petrolatum | Capric Acid,<br>Cholesterol,<br>Citric Acid,<br>Conjugated<br>Linoleic Acid,<br>Dimethicone,<br>Disodium EDTA,<br>E. Cerifera<br>(Candelilla) | Different from<br>primary<br>predicate in<br>material, but<br>similar design<br>feature.<br>Reference<br>device contains<br>one similar |
| | | | | |
| | | | Wax, Food<br>Starch, Modified<br>Corn Syrup<br>Solids, Glycerin,<br>Glyceryl<br>Stearate,<br>Hydroxypropyl<br>Bispalmitamide<br>MEA<br>(Ceramide),<br>Palmitic Acid,<br>PEG-100<br>Stearate,<br>Petrolatum,<br>Phenoxyethanol,<br>Potassium<br>Hydroxide,<br>Purified Water,<br>Sorbic Acid,<br>Squalane,<br>Xanthan Gum. | component,<br>Candelilla Wax,<br>to beeswax in<br>the subject<br>device. The<br>main component<br>of both beeswax<br>and Candelilla<br>Wax is<br>triacontanyl<br>palmitate. |
| Biocompatibility | Biocompatibility<br>established | Biocompatibility<br>established | Biocompatibility<br>established | Same |
| Single use | Yes | Yes | N/A | Same as primary<br>predicate.<br>Different from<br>reference<br>device. |
| Sterilization | Gamma, Sterile<br>to 10-6 SAL | Gamma, Sterile to<br>10-6 SAL | Non-sterile | Same as primary<br>predicate.<br>Different from<br>reference<br>device. |

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# K193439
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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.