(510 days)
Not Found
No
The device description and performance studies focus on the physical properties, material composition, and antibacterial effectiveness of a wound dressing. There is no mention of any computational or analytical functions that would suggest the use of AI or ML.
Yes
The device is a wound dressing indicated for the management of various partial to full thickness wounds, including ulcers and burns, and is intended for exudate absorption and wound management. This falls under the definition of a therapeutic device as it directly treats or manages a medical condition.
No
This device is a wound dressing designed for exudate absorption and wound management, not for diagnosing medical conditions.
No
The device description clearly outlines a physical, multi-layer dressing with various material components (PU Film, Super Absorbent Fibre Pad, Non-woven layer, Silver PU Foam layer, Perforated Silicone layer, PE Release Film). It also details physical properties and performance testing related to these materials and their function as a wound dressing. There is no mention of any software component.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "management of partial to full thickness wounds" and "first aid management of minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns." This describes a device applied directly to the body for therapeutic purposes (wound care).
- Device Description: The description details a multi-layer dressing with materials like foam, silicone, and film, designed to absorb exudate and provide antibacterial effectiveness within the dressing. This is consistent with a wound dressing.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The device's function is to interact with the wound itself.
- Performance Studies: The performance studies focus on properties relevant to wound dressings, such as adhesive property, water absorbency, MVTR, waterproofness, antibacterial effectiveness (in vitro simulated use testing, not diagnostic testing), and biocompatibility. An animal study on wound healing was also conducted. These are not typical performance studies for IVDs.
In summary, the LUOFUCON® Silicone Ag+ Foam Dressing is a wound care product, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Prescription Use:
LUOFUCON® Silicone Ag+ Foam Dressing is indicated for exudate absorption and the management of partial to full thickness wounds, including leg and foot ulcers, pressure ulcers, 1st and 2nd degree burns, donor sites, traumatic and surgical wounds, lacerations and abrasions.
OTC Use:
LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is indicated for first aid management of minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
LUOFUCON® Silicone Ag+ Foam Dressing/LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is a sterile, single-use dressing. The device has a multi-layer structure, and its foam layer contains 0.40mg/cm² maximum content of ionic silver. According to the different compositions of product structure, the device provides four models: Bordered, Bordered Lite, Non-Bordered, and Transfer.
- (a). The first model, Bordered, consists of a Polyurethane (hereinafter referred to as PU) Film layer, a Super Absorbent Fibre Pad layer, a Non-woven layer, a Silver PU Foam layer, a Perforated Silicone layer, and a Polyethylene (hereinafter referred to as PE) Release Film covered on the Perforated Silicone.
- (b). The second model, Bordered Lite, consists of a PU Film layer, a Non-woven layer, a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
- (c). The third model, Non-Bordered, consists of a PU Film layer, a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
- (d). The fourth model, Transfer, consists of a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
The Non-Bordered model can be freely cut as needed. The Transfer model also can be freely cut and allow using together with a secondary absorbent dressing.
Silver in the dressing is intended to provide antibacterial effectiveness within the dressing for up to 7 days, as demonstrated via in vitro testing. The Bordered, Bordered Lite, and Non-Bordered model dressings are equipped with a PU film that offers waterproofing. The self-adhesive Perforated Silicone wound contact layer plays a role in minimizing the trauma on removal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Leg and foot ulcers, pressure ulcers, diabetic foot ulcers, 1st and 2nd degree burns, donor sites, traumatic and surgical wounds, lacerations and abrasions. Minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.
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)
Performance testing was conducted to verify that the subject device met all design specifications was Substantially Equivalent (SE) to the predicate device. The performance of the subject device was tested according to the following standards: Adhesive property (ASTM D6195-03), Water absorbency (BS EN 13726-1), pH Value (USP ), MVTR (BS EN 13726-2), Waterproofness (BS EN 13726-3), EO and ECH residuals (ISO 10993-7), Antibacterial effectiveness (in vitro simulated use testing), Sterility (ISO 11737-2:2019).
Biocompatibility testing was performed according to ISO 10993 standards, including Cytotoxicity (ISO 10993-5:2009), Implantation (ISO 10993-6:2016), Intracutaneous Reactivity (ISO 10993-10:2010), Sensitization (ISO 10993-10:2010), Systemic toxicity (ISO 10993-11:2017), Material-mediated pyrogenicity (USP 41-N36).
An Animal Study (Porcine Wound Healing Study) was conducted, which found that the device did not affect normal wound healing.
No clinical studies were conducted for the subject device.
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 27, 2024
Huizhou Foryou Medical Devices Co., Ltd. Guosheng Tan R&D Engineer North Shangxia Road Dongjiang Hi-Tech Industry Park Huizhou, Guangdong 516005 China
Re: K223360
Trade/Device Name: LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing Regulatory Class: Unclassified Product Code: FRO Dated: February 28, 2024 Received: February 28, 2024
Dear Guosheng Tan:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
3
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,
Mustafa A. Mazher -S
for Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K223360
Device Name
LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing
Indications for Use (Describe)
Prescription Use:
LUOFUCON® Silicone Ag+ Foam Dressing is indicated for exudate absorption and the management of partial to full thickness wounds, including leg and foot ulcers, pressure ulcers, 1st and 2nd degree burns, donor sites, traumatic and surgical wounds, lacerations and abrasions.
OTC Use:
LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is indicated for first aid management of minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
This 510(k) Summary information is being submitted in accordance with Title 21, CFR Section 807.92.
I. SUBMITTER:
Huizhou Foryou Medical Devices Co., Ltd.
| Address: | North Shangxia Rd. Dongjiang Hi-tech Industry Park, 516005, | ||
|---|---|---|---|
| Huizhou, PEOPLE'S REPUBLIC OF CHINA | |||
| Phone: | +86-0752-5302185 | ||
| Contact Person: | Guosheng Tan | ||
| Date Prepared: | November 3, 2022 |
II. SUBJECT DEVICE
| Trade/Proprietary Names: | LUOFUCON® Silicone Ag+ Foam Dressing
(Prescription use)/ LUOFUCON® Silicone Ag+
Antibacterial Foam Dressing (OTC use) |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Silicone Silver Foam Dressing |
| Classification Name: | Dressing, Wound, Drug |
| Regulatory Class: | Unclassified |
| Product Code: | FRO |
III.PREDICATE DEVICE:
Primary Predicated Device:
| 510(k) Number: | K170077 |
|---|---|
| Product Name: | LUOFUCON® Silicone Ag Foam Dressing With Border |
| Manufacturer: | Huizhou Foryou Medical Devices Co., Ltd. |
Secondary Predicated Device:
5
510(k) Number: K083133
Andover Healthcare, Inc. X AFD Dressings Product Name:
Andover Healthcare, Inc. Manufacturer:
IV. DEVICE DESCRIPTION:
LUOFUCON® Silicone Ag+ Foam Dressing/LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is a sterile, single-use dressing. The device has a multi-layer structure, and its foam layer contains 0.40mg/cm² maximum content of ionic silver. According to the different compositions of product structure, the device provides four models: Bordered, Bordered Lite, Non-Bordered, and Transfer.
- (a). The first model, Bordered, consists of a Polyurethane (hereinafter referred to as PU) Film layer, a Super Absorbent Fibre Pad layer, a Non-woven layer, a Silver PU Foam layer, a Perforated Silicone layer, and a Polyethylene (hereinafter referred to as PE) Release Film covered on the Perforated Silicone.
- (b). The second model, Bordered Lite, consists of a PU Film layer, a Non-woven layer, a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
- (c). The third model, Non-Bordered, consists of a PU Film layer, a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
- (d). The fourth model, Transfer, consists of a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
The Non-Bordered model can be freely cut as needed. The Transfer model also can be freely cut and allow using together with a secondary absorbent dressing.
Silver in the dressing is intended to provide antibacterial effectiveness within the dressing for up to 7 days, as demonstrated via in vitro testing. The Bordered, Bordered Lite, and Non-Bordered model dressings are equipped with a PU film that offers waterproofing. The self-adhesive Perforated Silicone wound contact layer plays a role in minimizing the trauma on removal.
V. INDICATIONS FOR USE:
Prescription Use:
LUOFUCON® Silicone Aq+ Foam Dressing is indicated for exudate absorption and the management of partial to full-thickness wounds, including leg and foot ulcers, pressure ulcers, diabetic foot ulcers, 1st and 2nd degree burns, donor sites, traumatic and surgical wounds, lacerations and abrasions.
6
OTC Use:
LUOFUCON® Silicone Ag+ Antibacterial Foam Wound Dressing is indicated for first aid management of minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.
VI.COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
LUOFUCON® Silicone Ag+ Foam Dressing/LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing Compared with the Predicate Devices in terms of technological characteristics. The following table shows their similarities and differences.
| Item | Subject Device | Primary Predicate Device
(K170077) | Secondary Predicate
Device (K083133) |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Class | Unclassified | Unclassified | Unclassified |
| Product Code | FRO | FRO | FRO |
| Intended Use | Prescription:
LUOFUCON® Silicone Ag+
Foam Dressing is indicated
for exudate absorption and
the management of partial to
full thickness wounds,
including leg and foot ulcers,
pressure ulcers, diabetic foot
ulcers, 1st and 2nd degree
burns, donor sites, traumatic
and surgical wounds,
lacerations and abrasions.
OTC:
LUOFUCON® Silicone Ag+
Antibacterial Foam Dressing
is indicated for first aid
management of minor
abrasions, minor cuts, minor
lacerations, minor scrapes,
minor scalds and minor
burns. | Prescription:
LUOFUCON® Silicone Ag
Foam Dressing with Border is
indicated for the
management of exuding
wounds, such as leg and foot
ulcers, pressure ulcers,
traumatic and surgical
wounds, superficial and
partial thickness burns. | Prescription:
CoFlex-X AFD® and the
CoFlex-X AFD® Pad contact
wound dressings are
indicated for use in light to
heavy exuding partial and full
thickness wounds, including
decubitus and diabetic ulcers,
1st and 2nd degree burns,
and donor sites. These
dressings may also be used
over debrided and partial
thickness wounds.
OTC:
PowerFlex NL-X AFD® and
CoFlex-X AFD® First Aid
contact wound dressings are
indicated for first aid
management of minor
abrasions, cuts, scrapes,
scalds and burns. |
| Prescription
/OTC | Prescription/OTC | Prescription | Prescription/OTC |
| Mechanism | Polyurethane foam and
absorbent fiber pad for
absorbing exudates; Silver
compounds | Polyurethane foam and
absorbent fiber pad for
absorbing liquid; Silver
compounds | Polyurethane foam for
exudate absorption and
wound care, metallic silver in
the foam for antibacterial |
7
K223360
| Item | Subject Device | Primary Predicate Device
(K170077) | Secondary Predicate
Device (K083133) |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| | present in the foam for
reducing bacteria
colonization in the
dressing; Silicone soft
contact layer for
self-adhesive; polyurethane
film offers waterproofing. | present in the foam for
reducing bacteria
colonization in the
dressing; Silicone soft
contact layer for
self-adhesive; Backing film
for waterproof. | effect; Polyurethane film
provided Waterproof. |
| Design
/Material | Polyurethane film,
polyurethane
foam containing silver,
absorbent fiber,
non- woven fabrics,
Silicone, Release film | Polyurethane film,
polyurethane
foam containing silver,
absorbent fiber,
non- woven fabrics,
Silicone, Release film | Polyurethane foam
containing metallic silver with
nylon fibre, Polyurethane
film, cohesive elastic
bandage |
| Antibacterial
Duration | 7 days | 7 days | N/A |
| Single Use | Yes | Yes | Yes |
| Sterilization | EtO
SAL:10-6 | EtO
SAL:10-6 | EtO |
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Performance testing
Performance testing was conducted to verify that the subject device met all design specifications was Substantially Equivalent (SE) to the predicate device. The performance of the subject device was tested according to the following standards.
- Adhesive property: conducted with ASTM D6195-03 ●
- Water absorbency: conducted with BS EN 13726-1
- pH Value: conducted with USP pH.
- MVTR: conducted with BS EN 13726-2
- Waterproofness: conducted with BS EN 13726-3
- EO and ECH residuals: conducted with ISO 10993-7
- Antibacterial effectiveness: in vitro simulated use testing. ●
- Sterility: conducted with ISO 11737-2:2019
Biocompatibility testing
Based on FDA Guidance Document "Use of International Standard ISO 10993-1, Biological evaluation of medical devices-Part 1_Evaluation and testing within a risk
8
K223360
management process", and series of ISO 10993 standards, the subject is categorized as surface devices for breached or compromised surface with prolonged duration. The relevant standards for biocompatibility testing of subject device are listed below.
- Cytotoxicity ISO 10993-5:2009 ●
- Implantation - ISO 10993-6:2016
- Intracutaneous Reactivity - ISO 10993-10:2010
- Sensitization - ISO 10993-10:2010
- Systemic toxicity - ISO 10993-11:2017
- Material-mediated pyrogenicity - USP 41-N36
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® Silicone Aq+ Foam Dressing/LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing did not affect normal wound healing.
Clinical Study
No clinical studies were conducted for the subject device.
CONCLUSIONS VIII.
Based on the comparison of intended use and technological characteristics with the predicate devices, the subject device, LUOFUCON® Silicone Ag+ Foam Dressing/LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing, is determined to be Substantially Equivalent (SE) to the predicate devices, LUOFUCON® Silicone Ag Foam Dressing With Border(K170077) and X AFD Dressings (K083133), in respect of safety and effectiveness.