(268 days)
No
The device description and performance studies focus on the physical and chemical properties of a wound dressing, with no mention of AI or ML.
Yes
The device is a wound dressing designed to provide a moist environment for wound healing, which is a therapeutic function.
No
The device is a wound dressing designed to provide a moist environment for wound healing, not to diagnose a medical condition.
No
The device description clearly states it is a physical dressing consisting of sesame oil, beeswax, and fabric, which are hardware components.
Based on the provided information, the MEBO Wound Dressing is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the management of various types of wounds on the skin. This is a direct application to the body for therapeutic purposes.
- Device Description: The description details a dressing made of sesame oil, beeswax, and fabric, designed to provide a moist environment for wound healing. This is a physical barrier and treatment applied externally.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside of the body to diagnose a condition, monitor a disease, or screen for a disease.
- Performance Studies: The performance studies focus on physical and chemical characteristics of the dressing and its biocompatibility, not on diagnostic accuracy or performance metrics typically associated with IVDs (like sensitivity, specificity, AUC).
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. The MEBO Wound Dressing is clearly intended for in vivo (within the body) application for wound management.
N/A
Intended Use / Indications for 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
Product codes
FRO
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.
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
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
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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
1
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
2
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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3
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
4
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 | ||||
| Differences | ||||
| Manufacturer | MEBO | |||
| Life | ||||
| Science Inc. | Roosin Medical | |||
| Co., Ltd. | CERAGENIX | |||
| CORPORATION | ||||
| Trade Name | MEBO | |||
| Wound | ||||
| Dressing | Roosin Xeroform | |||
| Petrolatum | ||||
| Dressing | EPICERAM® Skin | |||
| Barrier Emulsion | ||||
| 510(k) number | K193439 | K181478 | K052643 | -- |
| Device Class | Unclassified | Unclassified | Unclassified | Same |
| Product Code | FRO | FRO | FRO | Same |
| Device | ||||
| classification | ||||
| Name | Dressing, | |||
| Wound, Drug | Dressing, Wound, | |||
| Drug | Dressing, | |||
| Wound, Drug | Same | |||
| Regulation | ||||
| number | NA | NA | NA | Same |
| Indications for 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 | Roosin Xeroform
Petrolatum
Dressing is
intended for use
as a primary
contact layer in
dressing wounds
such as
lacerations, skin
graft recipient
sites, newly
sutured wounds,
abrasions, and
minor or partial
thickness burns.
It may also be | EpiCeram is a
Skin Barrier
Emulsion to be
used to treat
dry skin
conditions and
to manage and
relieve the
burning and
itching
associated with
various types of
dermatoses,
including atopic
dermatitis,
irritant contact | Same as primary
predicate.
Different from
reference
device.
Reference devic
provides a moist
wound
environment
which is the
same mechanism
as the subject
device. |
| | thickness
burns | used as an initial
layer in dressing
surgical wounds
with light
exudate. | dermatitis,
radiation
dermatitis.
EpiCeram helps
to relieve dry,
waxy skin by
maintaining a
moist wound
and skin
environment,
which is
beneficial to the
healing process.
Apply Epiceram
a thin layer to
affected skin
area 2 times per
day and
massage gently
into the skin. If
the skin is
broken, cover
Epiceram with a
dressing of
choice. | |
| Mechanism | Provides a moist
environment for
optimal
wound
healing | Maintains a moist
wound
environment | Maintain a moist
wound and skin
environment. | Same |
| Delivery System | Dressing | Dressing | Topical
Emulsion | Same as primary
predicate.
Different from
reference
device. |
| 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. | This product
should not be
used for more
than 7 days at
most, and should
not be used for
more than 30
days. | Apply twice
daily or as
indicated by the
radiation
therapist. If
condition does
not improve
within 10 to 14
days, consult a
physician. | Similar to
primary
predicate and
reference
device. |
| Structure/Material | Non-woven
fabric (50%
polyester and
50% viscose)
immersed with a
mixture of
sesame oil and
beeswax. | Cotton Gauze, 3%
Bismuth
Tribromophenate,
and Petrolatum | Capric Acid,
Cholesterol,
Citric Acid,
Conjugated
Linoleic Acid,
Dimethicone,
Disodium EDTA,
E. Cerifera
(Candelilla) | Different from
primary
predicate in
material, but
similar design
feature.
Reference
device contains
one similar |
| | | | | |
| | | | Wax, Food
Starch, Modified
Corn Syrup
Solids, Glycerin,
Glyceryl
Stearate,
Hydroxypropyl
Bispalmitamide
MEA
(Ceramide),
Palmitic Acid,
PEG-100
Stearate,
Petrolatum,
Phenoxyethanol,
Potassium
Hydroxide,
Purified Water,
Sorbic Acid,
Squalane,
Xanthan Gum. | component,
Candelilla Wax,
to beeswax in
the subject
device. The
main component
of both beeswax
and Candelilla
Wax is
triacontanyl
palmitate. |
| Biocompatibility | Biocompatibility
established | Biocompatibility
established | Biocompatibility
established | Same |
| Single use | Yes | Yes | N/A | Same as primary
predicate.
Different from
reference
device. |
| Sterilization | Gamma, Sterile
to 10-6 SAL | Gamma, Sterile to
10-6 SAL | Non-sterile | Same as primary
predicate.
Different from
reference
device. |
5
K193439
Page 3 of 5
6
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
7
- 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
- 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.