(46 days)
Rx Indications for Use:
For professional use, 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
OTC Indications for Use:
For over-the-counter use, MEBO Wound Dressing is indicated for:
-Minor cuts
-Minor abrasions
-Minor lacerations
-Minor burns
The MEBO Wound Dressing is a electron beam irradiation sterilized dressing consisting of sesame oil, beeswax and fabric dressing, which provides a moist environment for wound healing.
The provided text is related to an FDA 510(k) premarket notification for a medical device called "MEBO Wound Dressing". However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.
The document primarily focuses on establishing substantial equivalence to a predicate device (K193439 MEBO Wound Dressing) based on similarities in:
- Indications for Use: Both professional and over-the-counter uses are detailed, with the new device having additional OTC indications.
- Mechanism of Action: Providing a moist environment for wound healing.
- Material and Structure: Non-woven fabric immersed with sesame oil and beeswax.
- Applied Duration and Single Use.
- Biocompatibility: Established for both.
The "Performance Testing Summary" section describes bench testing to verify the subject device's performance characteristics are substantially equivalent to the predicate device. These tests relate to the physical and chemical properties of the wound dressing itself (not AI/ML model performance), such as:
- Appearance
- Size deviation
- Liquid absorbency
- Acid Value
- Paste content
- B-Sitosterol content
- Endotoxin level
- Biocompatibility (in vitro cytotoxicity, irritation, skin sensitization, systemic toxicity, pyrogen test, bacterial endotoxin test).
Therefore, I cannot fulfill the request as the provided text pertains to a traditional medical device (wound dressing) equivalency submission, not an AI/ML medical device performance study. The questions posed in your prompt (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance) are relevant to AI/ML device evaluations, which are not detailed in this document.
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October 18, 2022
MEBO Life Science Inc. % Wei Hsu Regulatory Manager Vee Care (Asia) Limited 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong, Hong Kong China
Re: K222657 Trade/Device Name: MEBO Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: September 21, 2022 Received: September 22, 2022
Dear Wei 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
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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) 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 (QS) 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 medical devices and radiation-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,
Julie Morabito, Ph.D. 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) K222657
Device Name MEBO Wound Dressing
Indications for Use (Describe)
Rx Indications for Use:
For professional use, 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
OTC Indications for Use:
For over-the-counter use, MEBO Wound Dressing is indicated for:
-Minor cuts
-Minor abrasions
-Minor lacerations
-Minor burns
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------- |
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 22nd, 2022
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 K193439 MEBO Wound Dressing
- 5 Description of the Device
The MEBO Wound Dressing is a electron beam irradiation sterilized dressing consisting of sesame oil, beeswax and fabric dressing, which provides a moist environment for wound healing.
- 6 Indication
For professional use, 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
For over-the-counter use, MEBO Wound Dressing is indicated for: -Minor cuts
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-Minor abrasions -Minor lacerations -Minor burns
- 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 Predicate Device in terms of indication, mechanism, delivery system, structure/material, applied duration, and sterilization method.
The following table shows similarities and differences between our device and the predicate device/reference device.
| Subject Device | Predicate Device | Similarities andDifferences | |
|---|---|---|---|
| Manufacturer | MEBO Life ScienceInc. | MEBO Life ScienceInc. | |
| Trade Name | MEBO Wound Dressing | MEBO Wound Dressing | |
| 510(k) number | NA | K193439 | -- |
| Device Class | Unclassified | Unclassified | Same |
| Product Code | FRO | FRO | Same |
| DeviceclassificationName | Dressing, Wound, Drug | Dressing, Wound, Drug | Same |
| Regulationnumber | NA | NA | Same |
| Indications for Use(Rx) | Indicated formanagement of thefollowing types ofwound:- Skin graft recipientsites-Newly suturedwounds-Lacerations andabrasions | Indicated formanagement of thefollowing types ofwound:- Skin graft recipientsites-Newly suturedwounds-Lacerations andabrasions | Same |
| -Minor or superficial-partial thicknessburns | -Minor or superficial-partial thickness burns | ||
| Indicationsfor Use (OTC) | Indicated for-Minor cuts-Minor abrasions-Minor lacerations-Minor burns | N/A | DifferentSubject device hasadditional OTC Usewith narrowedindication range ofpredicate device. |
| Mechanism | Provides a moistenvironment foroptimal woundhealing | Provides a moistenvironment foroptimal wound healing | Same |
| Delivery System | Dressing | Dressing | Same |
| Applied Duration | The maximumcontact duration timeof each piece ofdressing does notexceed 24h, and thecumulative durationtime of contactingwith woundsshouldn't exceed 30days. | The maximum contactduration time of eachpiece of dressing doesnot exceed 24h, andthe cumulativeduration time ofcontacting withwounds shouldn'texceed 30 days. | Same |
| Structure/Material | Non-woven fabric(50% polyester and50% viscose)immersed with amixture of sesame oiland beeswax. | Non-woven fabric (50%polyester and 50%viscose) immersedwith a mixture ofsesame oil andbeeswax. | Same |
| Biocompatibility | Biocompatibilityestablished | Biocompatibilityestablished | Same |
| Single use | Yes | Yes | Same |
| Sterilization | Electron beamirradiation | Gamma irradiation | Different |
| Both are sterilized toSAL 10-6 level. Thesterilization of subjectdevice is validated perANSI AAMI ISO 11137-1: 2006/ (R)2015. | |||
| SAL: 10-6 | SAL: 10-6 | Same |
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The MEBO Wound Dressing has same mechanism, material, product design, applied duration as the predicate device.
The differences above between the subject device and predicate devices do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety.
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
- 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
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- 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
- の Conclusion
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 is as safe, as effective and performs as well as the legally marketed predicate device.
N/A