(46 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of the dressing, with no mention of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is a wound dressing indicated for the management of various types of wounds, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device description and indications for use clearly state its purpose is for managing and healing wounds by providing a moist environment, not for diagnosing any condition.
No
The device description explicitly states it is a "dressing consisting of sesame oil, beeswax and fabric dressing," which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The MEBO Wound Dressing is a topical dressing applied directly to wounds on the skin. Its purpose is to provide a moist environment for wound healing. It does not involve testing samples taken from the body.
The information clearly describes a wound care product, not a diagnostic test.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- 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 Pyrogen test
- f. USP42 Medical device-Bacterial Endotoxin Test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
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
1
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
2
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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3
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
4
-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 and
Differences |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Manufacturer | MEBO Life Science
Inc. | MEBO Life Science
Inc. | |
| Trade Name | MEBO Wound Dressing | MEBO Wound Dressing | |
| 510(k) number | NA | K193439 | -- |
| Device Class | Unclassified | Unclassified | Same |
| Product Code | FRO | FRO | Same |
| Device
classification
Name | Dressing, Wound, Drug | Dressing, Wound, Drug | Same |
| Regulation
number | NA | NA | Same |
| Indications for Use
(Rx) | Indicated for
management of the
following types of
wound:
- Skin graft recipient
sites
-Newly sutured
wounds
-Lacerations and
abrasions | Indicated for
management of the
following types of
wound: - Skin graft recipient
sites
-Newly sutured
wounds
-Lacerations and
abrasions | Same |
| | -Minor or superficial-
partial thickness
burns | -Minor or superficial-
partial thickness burns | |
| Indications
for Use (OTC) | Indicated for
-Minor cuts
-Minor abrasions
-Minor lacerations
-Minor burns | N/A | Different
Subject device has
additional OTC Use
with narrowed
indication range of
predicate device. |
| Mechanism | Provides a moist
environment for
optimal wound
healing | Provides a moist
environment for
optimal wound healing | Same |
| Delivery System | Dressing | Dressing | Same |
| Applied Duration | The maximum
contact duration time
of each piece of
dressing does not
exceed 24h, and the
cumulative duration
time of contacting
with wounds
shouldn't exceed 30
days. | The maximum contact
duration time of each
piece of dressing does
not exceed 24h, and
the cumulative
duration time of
contacting with
wounds shouldn't
exceed 30 days. | Same |
| Structure/Material | Non-woven fabric
(50% polyester and
50% viscose)
immersed with a
mixture of sesame oil
and beeswax. | Non-woven fabric (50%
polyester and 50%
viscose) immersed
with a mixture of
sesame oil and
beeswax. | Same |
| Biocompatibility | Biocompatibility
established | Biocompatibility
established | Same |
| Single use | Yes | Yes | Same |
| Sterilization | Electron beam
irradiation | Gamma irradiation | Different |
| | | Both are sterilized to
SAL 10-6 level. The
sterilization of subject
device is validated per
ANSI AAMI ISO 11137-
1: 2006/ (R)2015. | |
| | | | |
| SAL: 10-6 | SAL: 10-6 | Same | |
5
6
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
7
- 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 Pyrogen test
- f. USP42 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.