(372 days)
No
The device description and performance studies focus on the material properties and biological effects of a silver-based wound gel, with no mention of computational analysis, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is indicated for the management and topical treatment of various types of wounds and burns, which are therapeutic applications.
No
Explanation: The device is a wound gel applied topically to manage various types of wounds, aiming to maintain a moist environment and inhibit microbial growth. It does not perform any disease diagnosis or detection.
No
The device is a physical wound gel supplied in a tube, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use of LUOFUCON® Silver Wound Gel clearly state it is a topical gel applied directly to wounds on the skin. It is used for wound management and healing, not for analyzing samples from the body to diagnose or monitor a condition.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze biological samples or provide diagnostic information. Its function is to create a moist wound environment and inhibit microbial growth topically.
Therefore, LUOFUCON® Silver Wound Gel falls under the category of a wound dressing or topical wound care product, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Prescription:
LUOFUCON® Silver Wound Gel is under the medical supervision of a healthcare professional for the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.
OTC:
LUOFUCON® Silver Antimicrobial Wound Gel is indicated for the topical management of minor abrasions, minor cuts, minor lacerations and minor burns.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel is a sterile, water-based amorphous gel composed of hydrophilic polymer and silver compound. The gel helps to maintain a moist wound environment. The silver compound acts as a preservative to inhibit the growth of microorganisms in the gel during shelf storage.
LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel is supplied in a tube (collapsible, polypropylene tube, sealed on one end and fitted with a screw cap on the other end).
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
Prescription: under the medical supervision of a healthcare professional
OTC: general public
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)
Performance Testing:
- Appearance
- Fluid Affinity: EN 13726-1 Test methods for primary wound dressings - Part 1: Aspects of absorbency
- Loss on Drying: USP Loss on Drying
- pH Value: USP pH
- Preservative Effectiveness: USP Antimicrobial Effectiveness Testing
Biocompatibility Testing:
- Cytotoxicity
- Sensitization
- Irritation
- Systemic toxicity
- Implantation
- Material-mediated pyrogenicity
Animal Study:
- A Porcine Wound Healing Study was conducted to evaluate the effect of the subject device on the wound healing process. Under the conditions of the study, LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel did not inhibit normal wound healing and did not trigger adverse biological reactions.
Clinical Studies:
- No clinical study was conducted.
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.
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 shows 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 is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
April 22, 2022
Huizhou Foryou Medical Devices CO., Ltd. Huiqi Huang R&D Engineer North Shangxia Rd., Dongjiang Hi-tech Industry Park Huizhou. Guangdong 516005 China
Re: K211123
Trade/Device Name: LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel Regulatory Class: Unclassified Product Code: FRO Dated: January 24, 2022 Received: February 2, 2022
Dear Huiqi Huang:
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 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
1
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 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/cdrl-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.
for 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 Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K211123
Device Name
LUOFUCON® Silver Wound Gel (Prescription use) LUOFUCON® Silver Antimicrobial Wound Gel (OTC use)
Indications for Use (Describe)
Prescription:
LUOFUCON® Silver Wound Gel is under the medical supervision of a healthcare professional for the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.
OTC:
LUOFUCON® Silver Antimicrobial Wound Gel is indicated for the topical management of minor cuts, minor lacerations and minor burns.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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K211123 Page 1 of 7
510(k) Summary
This 510(k) Summary information is being submitted in accordance with Title 21, CFR Section 807.92.
1. SUBMITTER:
Huizhou Foryou Medical Devices Co., Ltd.
Address: No.1 Shangxia North Road., Dongjiang Hi-tech Industry Park, Huizhou,
Guangdong, China. Phone: +86-0752-5302185 Fax: +86-0752-5302020 Contact Person: Huiqi Huang Date Prepared: April 12th, 2021
2. SUBJECT DEVICE
Device Name: LUOFUCON® Silver Wound Gel (Prescription use), LUOFUCON® Silver Antimicrobial Wound Gel (OTC use) Common Name or Usual Name: Silver Wound Gel Classification Name: Dressing, Wound, Drug Regulatory Class: Unclassified Product Code: FRO
3. PREDICATE DEVICE:
510(k) Number: K083103
4
K211123 Page 2 of 7
Product Name: AcryDerm Antimicrobial Silver Gel Wound Dressing Model #B, OTC: AcryDerm Wound Gel Model #B Manufacturer: AcryMed, Inc.
4. REFERENCE DEVICE:
510(k) Number: K140483 Product Name: ASAP OTC Wound Dressing Gel Manufacturer: ABL Medical, LLC
5. DEVICE DESCRIPTION:
LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel is a sterile, water-based amorphous gel composed of hydrophilic polymer and silver compound. The gel helps to maintain a moist wound environment. The silver compound acts as a preservative to inhibit the growth of microorganisms in the gel during shelf storage.
LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel is supplied in a tube (collapsible, polypropylene tube, sealed on one end and fitted with a screw cap on the other end).
6. INDICATIONS FOR USE:
Prescription:
LUOFUCON® Silver Wound Gel is under the medical supervision of a healthcare professional for the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears,
5
K211123 Page 3 of 7
surgical incision sites, device insertion site wounds, graft sites, and donor sites. OTC:
LUOFUCON® Silver Antimicrobial Wound Gel is indicated for the topical management of minor abrasions, minor cuts, minor lacerations and minor burns.
7. COMPARISON WITH THE PREDICATE DEVICE
LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel and the predicate device/reference device consist of different ingredients. However, they have the same intended use, similar designs and performance, and meet the biocompatibility requirements.
The table below compares the subject device to the predicate and reference devices.
| Item | Subject Device
(K211123) | Predicate Device
(K083103) | Reference Device
(K140483) |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | LUOFUCON® Silver
Wound Gel /
LUOFUCON® Silver
Antimicrobial Wound
Gel | AcryDerm Antimicrobial
Silver Gel Model #B /
OTC: AcryDerm Wound
Gel Model #B | ASAP OTC Wound
Dressing Gel |
| Classification
Regulation | Unclassified | Unclassified | Unclassified |
| Product Code | FRO | FRO | FRO |
| Indications for
Use (Rx) | LUOFUCON® Silver
Wound Gel is under
the medical
supervision of a
healthcare professional
for the management of | Under the supervision
of a healthcare
professional, AcryDerm
Silver Antimicrobial
Wound Gel Model #B
is indicated for the | N/A |
| | 1st and 2nd degree
burns, wounds such as
stasis ulcers, pressure
ulcers, diabetic ulcers,
lacerations, abrasions,
skin tears, surgical
incision sites, device
insertion site wounds,
graft sites, and donor
sites. | management of 1st and
2nd degree burns,
wounds such as stasis
ulcers, pressure ulcers,
diabetic ulcers,
lacerations, abrasions,
skin tears, surgical
incision sites, device
insertion site wounds,
graft sites, and donor
sites. | |
| Indications for
Use (OTC) | LUOFUCON® Silver
Antimicrobial Wound
Gel is indicated for the
topical management of
minor abrasions, minor
cuts, minor lacerations
and minor burns. | AcryDerm Wound Gel
Model #B is indicated
for the management of
minor abrasions, cuts,
lacerations and scalds. | ASAP OTC Wound
Dressing Gel is
indicated for the
topical management
of minor cuts,
lacerations,
abrasions, 1st and
2nd degree burns,
and skin irritations. |
| Composition | Purified water,
Carbopol, glycerol,
polyethylene oxide,
polyvinyl alcohol, silver
compound | Hydrophilic polymers
and silver salt | Carbopol ETD 2020,
triethanolamine,
proprietary silver
hydrosol suspension |
| Mechanism | Hydrophilic polymer for
maintaining high
moisture content, ionic
silver for reducing
microorganism
colonization within the
dressing during shelf
storage. | Hydrophilic polymer for
maintaining high
moisture content, ionic
silver for reducing
microorganism
colonization within the
dressing during shelf
storage. | Hydrophilic polymer
for maintaining high
moisture content,
silver for reducing
microorganism
colonization within
the dressing during
shelf storage. |
| Antimicrobial
agent | Silver compound | Silver compound | Element silver |
| | | | |
| Appearance | Colorless to light yellow, transparent to slightly cloudy | Slightly cloudy | Clear to golden yellow translucent gel |
| pH Value | 5.0-7.5 | N/A | 6.5-8.0 |
| Silver Content | $0.007%-0.012% w/w$ | N/A | 24ppm |
| Moisture Donation | ≥10% | N/A | Greater than 5% |
| Moisture Absorption | preservative effectiveness testing | USP preservative assurance testing | USP |
| Sterilized | Sterile | N/A | Not provided sterile |
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K211123
Page 4 of 7
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K211123 Page 5 of 7
8. SUBSTANTIAL EQUIVALENCE DISCUSSION
LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel has been subjected to ISO 10993 biocompatibility studies to demonstrate the device is as safe as its predicate device. The performance tests were conducted to demonstrate that the subject device is as effective as its predicate device.
Performance Testing
The following performance tests were conducted on subject devices in comparison to the predicate device and the reference device:
Appearance Fluid Affinity: EN 13726-1 Test methods for primary wound dressings - Part 1: Aspects of absorbency Loss on Drying: USP Loss on Drying pH Value: USP pH
8
K211123 Page 6 of 7
Preservative Effectiveness: USP Antimicrobial Effectiveness Testing
Biocompatibility Testing
Based on Table A.1 of ISO 10993-1 and Table A.1 of FDA Guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices -Part 1_Evaluation and testing within a risk management process", the subject device is categorized as a surface device in contact with breached or compromised surface with prolonged duration. The subject device was evaluated for:
- Cytotoxicity Sensitization Irritation Systemic toxicity Implantation Material-mediated pyrogenicity
Animal Study
A Porcine Wound Healing Study was conducted to evaluate the effect of the subject device on the wound healing process. Under the conditions of the study, LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel did not inhibit normal wound healing and did not trigger adverse biological reactions.
Clinical Studies
No clinical study was conducted.
9
FORY↓↓ MEDICAL
K211123 Page 7 of 7
9. CONCLUSIONS
Based on the comparison analysis, performance tests, biocompatibility tests and animal study provided in this submission, the subject device, LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel is demonstrated to be as safe and effective as the legally marketed predicate device, AcryDerm Antimicrobial Silver Gel Wound Dressing Model #B /OTC: AcryDerm Wound Gel Model #B (K083103). So, the subject device is considered Substantially Equivalent (SE) to the predicate device.