Who is the manufacturer of LUOFUCON Silicone Ag Foam Dressing with Border?

Huizhou Foryou Medical Devices Co., Ltd. filed the 510(k) submission for LUOFUCON Silicone Ag Foam Dressing with Border (K170077).

What is the FDA product code for LUOFUCON Silicone Ag Foam Dressing with Border?

FRO. as a Class U device in the SU panel.

What is the regulatory pathway for LUOFUCON Silicone Ag Foam Dressing with Border?

510(k) clearance (submission type: Traditional).

What are the predicate devices for LUOFUCON Silicone Ag Foam Dressing with Border?

Mepilex Border Ag Dressing (K100029); LUOFUCON® Silicone Ag Foam Dressing (K160022).

Who can help prepare an FDA 510(k) submission like LUOFUCON Silicone Ag Foam Dressing with Border?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

LUOFUCON Silicone Ag Foam Dressing with Border

K170077 · Huizhou Foryou Medical Devices Co., Ltd. · FRO · Mar 30, 2017 · SU

Device Facts

Record ID	K170077
Device Name	LUOFUCON Silicone Ag Foam Dressing with Border
Applicant	Huizhou Foryou Medical Devices Co., Ltd.
Product Code	FRO · SU
Decision Date	Mar 30, 2017
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

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. Silver compounds present in the dressing helps reduce bacterial colonization in the dressing.

Device Story

Multilayer wound dressing; consists of soft silicone wound contact layer, absorbent polyurethane foam pad containing silver ions (0.25-0.35mg/cm²), super absorbent fibre pad, vapor-permeable waterproof film, and release PE films. Used for management of exuding wounds; absorbs exudates; maintains moist wound healing environment; provides antibacterial properties for up to 7 days. Applied by clinicians or patients to wound site; silicone layer provides self-adhesion. Silver ions reduce bacterial colonization within dressing. Benefits include exudate management and infection control support.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), and ISO 10993-11 (systemic toxicity). Antibacterial efficacy evaluated via modified ASTM E2149-13a, demonstrating >4 log reduction for six bacteria over 7 days.

Technological Characteristics

Multilayer dressing: silicone contact layer, polyurethane foam with silver ions, super absorbent fibre, non-woven fabrics, polyurethane film. Sterilization: Ethylene Oxide (ISO 11135:2014). Antibacterial mechanism: silver ion release. Form factor: border dressing.

Indications for Use

Indicated for patients with exuding wounds, including leg/foot ulcers, pressure ulcers, traumatic/surgical wounds, and superficial/partial thickness burns.

Predicate Devices

Mepilex Border Ag Dressing (K100029)
LUOFUCON® Silicone Ag Foam Dressing (K160022)

Related Devices

K160022 — LUOFUCON Silicone Ag foam dressing · Huizhou Foryou Medical Devices Co., Ltd. · Aug 17, 2016
K123481 — AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE · Convatec, Inc. · Jun 6, 2013
K223359 — LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing · Huizhou Foryou Medical Devices Co., Ltd. · Dec 21, 2023
K242856 — LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer) · Huizhou Foryou Medical Devices Co., Ltd. · Nov 13, 2024
K141573 — SILVERLON ISLAND WOUND DRESSING · Argentum Medical · Aug 28, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The profiles are facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 30, 2017 Huizhou Foryou Medical Devices Co., Ltd. Guosheng Tan Development Engineer North Shangxia Rd. Dongjiang Hi-tech Industry Park Huizhou. Guangdong 516005 China Re: K170077 Trade/Device Name: LUOFUCON Silicone Ag Foam Dressing with Border Regulatory Class: Unclassified Product Code: FRO Dated: January 6, 2017 Received: January 9, 2017 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 (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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # David Krause -S for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Premarket Notification 510(k) Submission Section 4: Indication for Use Staement DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. Project #: GY-002 510(k) Number (if known) Device Name LUOFUCON® Silicone Ag Foam Dressing with Border Indications for Use (Describe) 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. Silver compounds present in the dressing helps reduce bacterial colonization in the dressing. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) | 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." {3}------------------------------------------------ ## Section 5 510(k) Summary or 510(k) Statement This 510(k) Summary information is being submitted in accordance with the requirements of SMDA 1990 and Title 21, CFR Section 807.92. The assigned 510(k) Number: #### 1. Date of Submission: 1/6/2017 ### 2. Submitter Identification: Huizhou Foryou Medical Devices Co., Ltd. North Shangxia Rd., Dongjiang Hi-tech Industry Park, 516005, Huizhou, P. R. China. Establishment Registration Number: 3007735241 Contact Person: Guosheng Tan Position: Development Engineer Tel: +86-0752-5302012 Fax: +86-0752-5302020 Email: gstan@foryougroup.com ### 3. Subject Device Identification: Device Name:LUOFUCON® Silicone Ag Foam Dressing with Border Common Name: Silver Foam Dressing Classification Name: Silicone, Dressing, Wound, Drug; {4}------------------------------------------------ Product Code: FRO; Regulation Number: Unclassified; Review Panel: General & Plastic Surgery; #### 4. Predicate Device Identification: 510(k) Number: K100029 First: Product Name: Mepilex Border Ag Dressing Manufacturer: Mölnlycke Health Care Second: 510(k) Number: K160022 Product Name: LUOFUCON® Silicone Ag Foam Dressing Manufacturer: Huizhou Foryou Medical Devices Co., Ltd. #### 5. Device Description: LUOFUCON® Silicone Ag Foam Dressing with Border has a multilayer structure, it consists of a soft silicone wound contact layer, an absorbent polyurethane foam pad containing about 0.25~0.35mg/cm² silver ions, a supper absorbent fibre pad, a vapor permeable waterproof film, and release PE films. LUOFUCON® Silicone Ag Foam Dressing with Border can absorb exudates, maintains a moist wound healing environment and has good antibacterial properties. It has been shown that antibacterial effectiveness within the dressing for up to 7 days, as demonstrated in vitro. All dressings are sterilized and sold after sterilization by EO using conditions validated following ISO 11135: 2014. #### 6. Intended Use Statement: LUOFUCON® Silicone Ag Foam Dressing with Border is indicated for the {5}------------------------------------------------ management of exuding wounds, such as leg and foot ulcers, pressure ulcers, traumatic and surgical wounds, superficial and partial thickness burns. Silver compounds present in the dressing helps reduce bacterial colonization in the dressing. #### 7. Comparison to the Predicate Device LUOFUCON® Silicone Ag Foam Dressing with Border is compared with the following Predicate Device in terms of intended use, design, material, specifications, and performance. - . K100029, Mepilex Border Ag Foam Dressing, Manufactured by Mölnlycke Health Care. - K160022, LUOFUCON® Silicone Ag Foam Dressing, Manufactured by Huizhou . Foryou Medical Devices Co., Ltd. The following table shows similarities and differences of use, design, material, and processing methods between subject device and two predicate devices. These data came from commercially product labeling and 510(k) summary. | Item | Subject Device | Predicate Device 1 (K100029) | Predicate Device2 (K160022) | |-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | 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 | Mepilex Border Ag dressing 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. | LUOFUCON® Silicone Ag foam dressing 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. | | | thickness burns. Silver compounds present in the dressing helps reduce bacterial colonization in the dressing. | Mepilex Border Ag can also be used under compression bandaging. Silver sulfate present in the dressing helps reduce microbial colonization on the dressing. | Silver compounds present in the dressing helps reduce bacterial colonization in the dressing. | | Mechanism | Polyurethane foam and super absorbent fibre pad for absorbing liquid, Silver compounds present in the foam for reducing bacteria colonization in the dressing, Silicone soft contact layer for self- adhesive, baking film for waterproof. | Polyurethane foam and super absorbent fibre pad for absorb liquid, Silver compounds present in the foam for reducing bacteria colonization in the dressing, Silicone soft contact layer for self- adhesive, baking film for waterproof. | Polyurethane foam for absorbing liquid, Silver compounds present in the foam for reducing bacteria colonization within the dressing. Silicone soft contact layer for self-adhesive, baking film for waterproof. | | Material | Silicone, polyurethane foam containing silver, super absorbent fibre, non- woven fabrics, polyurethane film | Silicone, polyurethane foam containing silver and activated carbon, polyacrylate fibre, non- woven fabrics, polyurethane film | Polyurethane foam containing silver, Silicone and polyurethane film; with border version additional has non-woven fabrics | | Antibacterial Duration | Seven days | Seven days | Seven days | | Single Use | Yes | Yes | Yes | | Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | | Item | Subject Device | Predicate Device 1 (K100029) | Predicate Device2 (K160022) | | Cytotoxicity | No Toxic Effect (ISO10993-5) | Non-cytotoxic | No Toxic Effect (ISO10993-5) | | Skin Irritation and Sensitization | No Effect (ISO 10993-10) | Non-irritating Non-sensitizing | No Effect (ISO 10993-10) | | Systematic Toxicity | No Effect (ISO 10993-11) | / | No Effect (ISO 10993-11) | | Antibacterial Activity | >4 log reduction for seven days for all six bacteria | Inactivate representative bacteria up to 7 days | >4 log reduction for seven days for all six bacteria | | Antibacterial Duration | Seven days | Seven days | Seven days | Table 5-1 Comparison of Intended Use, Design and Material {6}------------------------------------------------ #### Premarket Notification 510(k) Submission Section 5: 510 (k) Summary Project #: GY-002 LUOFUCON® Silicone Ag Foam Dressing with Border and its predicate devices (K100029, K160022) utilize silver compound as the antibacterial agent, and utilize polyurethane foam and super absorbent fibre pad for the exudates absorption {7}------------------------------------------------ and wound management. LUOFUCON® Silicone Ag Foam Dressing with Border is modified from the border version of LUOFUCON® Silicone Ag Foam Dressing (K160022) which had no supper absorbent fibre. These differences do not impact the safety and efficacy of our subject devices, because their functions have no change. Therefore, LUOFUCON® Silicone Aq Foam Dressing with Border and its predicate devices are made from similar materials, utilize same antibacterial mechanism, and have similar intended use. Table 5-2 Comparison of Biocompatibility and Performance Testing LUOFUCON® Silicone Ag Foam Dressing with Border meets biocompatibility requirements per ISO 10993-5, ISO10993-10, and ISO 10993-11. Its physical performance meets the requirements of its pre-defined acceptance criteria and intended use. All dressings are sterilized and sold after sterilization by EO using conditions validated following ISO 11135: 2014. {8}------------------------------------------------ Modified ASTM E2149-13a was used to evaluate the antibacterial preservative activity of the subject device. Predicate Device 1 also chooses the ASTM E2149 as the test method. Both the subject device and predicate devices can get antibacterial duration of seven days. Therefore, the performance results are comparable to the predicate devices when the dressings are used for antibacterial preservative purpose for seven days. The product is safe and effective for its intended use. ### Substantial Equivalent Statement Based on the comparison of intended use, design, materials, and performance, the subject device, LUOFUCON® Silicone Ag Foam Dressing with Border, is determined to be Substantially Equivalent (SE) to the predicate devices, Mepilex Border Ag Foam Dressing (K100029) and LUOFUCON® Silicone Aq Foam Dressing(K160022), in respect of safety and effectiveness.