LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM

Q: Who is the manufacturer of LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM?

Huizhou Foryou Medical Devices Co., Ltd. filed the 510(k) submission for LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM (K120181).

Q: What is the FDA product code for LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM?

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

Q: What is the regulatory pathway for LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM?

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

Q: What are the predicate devices for LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM?

Silver Alginate II Dressing (K041316); Antibacterial Barrier Wound Contact Dressing (K023612).

Q: Who can help prepare an FDA 510(k) submission like LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM?

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.

K120181 · Huizhou Foryou Medical Devices Co., Ltd. · FRO · Feb 14, 2013 · SU

Device Facts

Record ID	K120181
Device Name	LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM
Applicant	Huizhou Foryou Medical Devices Co., Ltd.
Product Code	FRO · SU
Decision Date	Feb 14, 2013
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

Luofucon Silver Alginate Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including, postoperative wounds, trauma wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites. Luofucon Antibacterial Alginate Dressing (OTC): First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns.

Device Story

Sterile, non-woven pad composed of high G calcium alginate and metallic silver particles. Absorbs wound exudate to form a gel, maintaining a moist wound environment and allowing intact removal. Metallic silver provides broad-spectrum antibacterial protection against Gram-positive and Gram-negative bacteria; reduces odor. Available in various pad sizes. Used in clinical or home settings; applied by clinicians or patients. Dressing requires daily changes. Benefits include exudate management, moist healing environment, and protection against microbial contamination.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993-5, -10, and -11. Antibacterial effectiveness evaluated per AATCC 100-2004 against six bacterial strains (three Gram-positive, three Gram-negative), demonstrating >99.99% reduction in bacteria.

Technological Characteristics

Non-woven pad; high G calcium alginate and metallic silver particles (50ug/100cm2). Sterilized via radiation per ISO 11137-2:2006. Single-use. No software or electronic components.

Indications for Use

Indicated for patients with moderate to heavily exuding partial to full thickness wounds (postoperative, trauma, leg/pressure/diabetic ulcers, graft/donor sites) or minor first aid wounds (abrasions, cuts, lacerations, scrapes, scalds, burns).

Predicate Devices

Silver Alginate II Dressing (K041316)
Antibacterial Barrier Wound Contact Dressing (K023612)

Related Devices

K143335 — Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC) · Roosin Medical Devices Co., Ltd. · Jun 1, 2015
K230190 — Polyver Silver Alginate Dressing (Prescription and OTC) · Roosin Medical Co., Ltd. · Nov 17, 2023
K172554 — LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing · Huizhou Foryou Medical Devices Co., Ltd. · May 1, 2018
K202982 — Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) · Winner Medical Co., Ltd. · Oct 19, 2021
K080503 — SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING · Advanced Medical Solutions Limited · Nov 12, 2008

Submission Summary (Full Text)

{0}------------------------------------------------ K120181 p 1/8 ## Section 5: 510(k) Summary: ## FEB 1 4 2013 #### Luofucon Silver Alginate Dressing (Prescription) This summary of 510k safety and effectiveness information is being submitted in accordance with the requirements of 21CFR 807.92 #### Submitter & Foreign Manufacture Identification Huizhou Foryou Medical Devices Co., Ltd. No.1, Shangxia North Road, Dongjiang Hi-Tech Industry Park, Huizhou, Guangdong Province, China Tel: (086) 0752-5302012 Submitter's FDA Registration Number: 3007735241 #### US Agent and Contact Person Chengyu Shen Manton Business and Technology Services 5 Carey Street Pennington, NJ 08534 Tel: 608-217-9358 · Email: cyshen@aol.com #### Date of Summary: December 14, 2012 Device Name: Luofucon Silver Alginate Dressing (Prescription) Trade Name: Common Name: Silver Alginate Dressing Dressing, wound, Drug Classification Name: Product Code: FRO Regulation Number: Unclassified Review Panel: General & Plastic Surgery #### Predicate Device Information: - (1) K041316, "Silver Alginate II Dressing", manufactured by "Advanced Medical Solutions. Inc" located in Cheshire, England CW7 3PD - (2) K023612, "Antibacterial Barrier Wound Contact Dressing", manufactured by "Argentum Medical LLC" located in Lakemont, Georgia 30552 1 Section 5: 510(K) Summary: Prescription p {1}------------------------------------------------ #### Device description: Luofucon Silver Alginate Dressing is a sterile, non-woven pad composed of a high G (guluronic acid) calcium alginate and metallic silver particles, which absorbs wound exudate. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal. The alginate material consists of metallic silver that provides effective protection against microbial contamination of the dressing material. Odour reduction results from the bacteria reduction effect in the dressing. The dressing has an off-white appearance and is available in the form of pad and in three different sizes (50 mm x 50 mm, 100 mm x 10 mm, 200 mm x 100 mm), packaged in pouches. Additional sizes may also be manufactured per customer request. All dressings have the exactly the same material, chemical, and physical properties and are different only in size. All dressings are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006. Product Information: | Antibacterial Agent: | Silver Particles | |------------------------------|-------------------------------------------------------------------------------------| | Active Against Pathogens: | Gram positive and Gram negative bacteria | | Spectrum of Activity: | Broad spectrum antibacterial effect for Gram positive and Gram negative bacteria | | Concentration on the device: | Each dressing contains 50ug/100 $cm^2$ silver particles | #### Intended Use: Prescription: Luofucon Silver Alginate Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including, postoperative wounds, trauma wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites #### Comparison to Predicate Devices Luofucon Silver Alginate Dressing is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance. (1) K041316, "Silver Alginate II Dressing", manufactured by "Advanced Medical Solutions, Inc" located in Cheshire, England CW7 3PD (2) K023612, "Antibacterial Barrier Wound Contact Dressing", manufactured by "Argentum Medical LLC" located in Lakemont, Georgia 30552 The following table shows similarities and differences of use, design, material, and processing Section 5: 510(K) Summary: Prescription p 2 {2}------------------------------------------------ methods between our device and the predicate devices. | Description | Our Device | Predicate Device 1 (K041316) | Predicate Device 2 (K023612) | |-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for Use | Prescription: Luofucon Silver Alginate Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including, postoperative wounds, trauma wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites | Prescription: Same as ours | Prescription: Provide an effective barrier to bacterial penetration and are intended for local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic). | | Prescription/ OTC | Prescription | Prescription | Prescription and OTC | | Mechanism | Silver for antibacterial effect; calcium alginate for exudate absorption and wound care | Same | Silver for antibacterial effect; nylon fabric for wound care | | Design/ Material | Calcium alginate and silver | Calcium alginate, carboxymethylcellulose (CMC) and silver | Nylon fabric and silver | | Single Use | Yes | Yes | Yes | | Sterile | Sterile | Sterile | Sterile | #### Table 5.1: Comparison of Intended Use, Design, and Material Both Luofucon Silver Alginate Dressing and its predicate device (K041316) utilize calcium alginate for the exudate absorption and wound management. K041316 also has small quantity of carboxymethylcellulose (CMC) while our device does not have. This slight difference is insignificant and does not affect the intended use and performance of the device. K023612 utilizes nylon fabric for the wound care purpose, which is different from our device and K041316. However, nylon fabric permits fluid passage from wound, and similar to calcium alginate, it also helps maintaining moist environment for optimal wound heal. The difference between our device and K023612 does not change the intended use and performance of the device. Luofucon Silver Alginate Dressing and its predicate devices are made from similar materials, utilize same antibacterial mechanism, and have similar intended use. Biocompatibility tests were conducted following procedures outlined in the respective consensus Section 5: 510(K) Summary: Prescription 3 p {3}------------------------------------------------ standards, and results for Luofucon Silver Alginate Dressing met all relevant requirements in the test standards, and are comparable to the predicate devices. Antibacterial activity was measured following AATCC 100-2004 for total of six (three Gram positive and three Gram negative) bacteria to evaluate the broad spectrum antibacterial effectiveness. Luofucon Silver Alginate Dressing is effective (>99.99% reduction) for all 6 bacteria and effect lasts for one day. The results are comparable to the predicate devices when the dressings are used for antibacterial purpose and changed daily during use. This is clarified in our product labeling. K041316 has longer antibacterial duration than our product. However, we have specified in the User Instruction that daily changed is required when using our products. In summary, Luofucon Silver Alginate Dressing meets biocompatibility requirements per ISO 10993-5, ISO 10993-10, and ISO 10993-11. It's physical and performance meets the requirements of its pre-defined acceptance criteria and intended uses. All dressings are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006. The product is safe and effective for its intended use. AATCC 100-2004 was used to evaluate the antibacterial activity of the product. This method only specifies the use of one gram positive bacteria (Staphylococcus aureus) and one gram negative bacteria (Klebsiella pneumoniae). However, we evaluated total of six (three Gram positive and three Gram negative) bacteria to evaluate broad spectrum antibacterial effectiveness of the silver alginate dressing. #### Substantial Equivalent Statement Based on the comparison of intended use, design, materials, and performance, our Luofucon Silver Alginate Dressing is substantial equivalent to its predicate devices. #### Section 5: 510(K) Summary: Prescription 4 p {4}------------------------------------------------ Section 5: 510(K) Summary: OTC ## Section 5: 510(k) Summary: ### Luofucon Antibacterial Alginate Dressing (OTC) This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92 #### Submitter & Foreign Manufacture Identification Huizhou Foryou Medical Devices Co., Ltd. No.1, Shangxia North Road, Dongjiang Hi-Tech Industry Park, Huizhou, Guangdong Province, China Tel: (086) 0752-5302012 Submitter's FDA Registration Number: 3007735241 #### US Agent and Contact Person Chengyu Shen Manton Business and Technology Services 5 Carey Street Pennington, NJ 08534 Tel: 608-217-9358 Email: cyshen@aol.com #### Date of Summary: December 14, 2012 Device Name: Trade Name: Luofucon Antibacterial Alginate Dressing (OTC) Common Name: Silver Alginate Dressing Classification Name: Dressing, wound, Drug Product Code: FRO Regulation Number: Unclassified Review Panel: General & Plastic Surgery #### Predicate Device Information: (1) K041316, "Silver Alginate II Dressing", manufactured by "Advanced Medical Solutions, Inc" located in Cheshire, England CW7 3PD (2) K023612, "Antibacterial Barrier Wound Contact Dressing", manufactured by "Argentum Medical LLC" located in Lakemont, Georgia 30552 #### Device description: Luofucon Antibacterial Alginate Dressing is a sterile, non-woven pad composed of a high G Section 5: 510(K) Summary: OTC I p {5}------------------------------------------------ Section 5: 510(K) Summary: OTC K120181 p 6/8 (guluronic acid) calcium alginate and metallic silver particles, which absorbs wound exudate. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal. The alginate material consists of metallic silver that provides effective protection against microbial contamination of the dressing material. Odour reduction results from the bacteria reduction effect in the dressing. The dressing has an off-white appearance and is available in the form of pad and in three different sizes (50 mm x 50 mm, 100 mm x 10 mm, 200 mm x .100 mm), packaged in pouches. Additional sizes may also be manufactured per customer request. All dressings have the exactly the same material, chemical, and physical properties and are different only in size. All dressings are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006. Product Information: | Active Agent: | Silver Particles | |------------------------------|-------------------------------------------------------------------------------| | Active Against Pathogens: | Gram positive and Gram negative bacteria | | Spectrum of Activity: | Board spectrum protection against Gram positive and Gram negative bacteria | | Concentration on the device: | Each dressing contains 50ug/100cm2 silver particles | #### Intended Use: OTC: First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns. #### Comparison to Predicate Devices Luofucon Antibacterial Alginate Dressing is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance. (1) K041316, "Silver Alginate II Dressing", manufactured by "Advanced Medical Solutions, Inc" located in Cheshire, England CW7 3PD (2) K023612, "Antibacterial Barrier Wound Contact Dressing", manufactured by "Argentum Medical LLC" located in Lakemont, Georgia 30552 The following table shows similarities and differences of use, design, material, and processing methods between our device and the predicate devices. 2 p {6}------------------------------------------------ | Description | Our Device | Predicate Device 1 (K041316) | Predicate Device 2 (K023612) | |-----------------------|---------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------------------------| | Indication for Use | OTC: First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns. | OTC: N/A This predicate is a prescription product. | OTC: Same as ours | | Prescription/ OTC | OTC | Prescription | Prescription and OTC | | Mechanism | Silver provides protection against bacteria; calcium alginate for exudate absorption and wound care | Same | Silver provides protection against bacteria; nylon fabric for wound care | | Design/ Material | Calcium alginate and silver | Calcium alginate, carboxymethylcellulose (CMC) and silver | Nylon fabric and silver | | Single Use | Yes | Yes | Yes | | Sterile | Sterile | Sterile | Sterile | | | | Fable 5.1: Comparison of Intended Use, Design, and Material | |--|--|-------------------------------------------------------------| | | | | Luofucon Antibacterial Alginate Dressing and its predicate device (K041316) utilize calcium alginate for the exudate absorption and wound management. K041316 also has small quantity of carboxymethylcellulose (CMC) while our device does not have. This slight difference is insignificant and does not affect the intended use and performance of the device. K023612 utilizes nylon fabric for the wound care purpose, which is different from our device and K041316. However, nylon fabric permits fluid passage from wound, and similar to calcium alginate, it also helps maintaining moist environment for optimal wound heal. The difference between our device and K023612 does not change the intended use and performance of the device. Luofucon Antibacterial Alginate Dressing and its predicate devices are made from similar materials, utilize same antibacterial mechanism, and have similar intended use. Biocompatibility tests were conducted following procedures outlined in the respective consensus standards, and results for Luofucon Antibacterial Alginate Dressing met all relevant requirements in the test standards, and are comparable to the predicate devices. Protection against bacteria was measured following AATCC 100-2004 for total of six (three Gram positive and three Gram negative) bacteria to evaluate the broad spectrum effectiveness. Luofucon Antibacterial Alginate Dressing is effective (>99.99% reduction) for all 6 bacteria and effect lasts for one day. {7}------------------------------------------------ Section 5: 510(K) Summary: OTC The results are comparable to the predicate devices when the dressings are changed daily during use. This is clarified in our product labeling. K041316 has longer protection duration than our product. However, we have specified in the User Instruction that daily changed is required when using our products. In summary, Luofucon Antibacterial Alginate Dressing meets biocompatibility requirements per ISO 10993-5, ISO 10993-10, and ISO 10993-11. It's physical and performance meets the requirements of its pre-defined acceptance criteria and intended uses. All dressings are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006. The product is safe and effective for its intended use. AATCC 100-2004 was used to evaluate the protection against bacteria of the product. This method only specifies the use of one gram positive bacteria (Staphylococcus aureus) and one gram negative bacteria (Klebsiella pneumoniae). However, we evaluated total of six (three Gram positive and three Gram negative) bacteria to evaluate broad spectrum effectiveness of this alginate dressing. #### Substantial Equivalent Statement Based on the comparison of intended use, design, materials, and performance, our Luofucon Antibacterial Alginate Dressing is substantial equivalent to its predicate devices. > 4 p {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three branches instead of one. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Huizhou Foryou Medical Devices Company, Limited % Manton Business and Technology Services Chengyu Shen 5 Carey Street Pennington, New Jersey 08534 Re: K120181 Trade/Device Name: Luofucon Antibacterial Alginate Dressing Regulatory Class: Unclassified Product Code: FRO Dated: December 14, 2012 Received: January 03, 2013 Dear Chengyu Shen: 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. Ilsting 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. February 14, 2013 {9}------------------------------------------------ Page 2 - Chengyu Shen If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Sincerely yours, ## Peter 🇿Rumm -S Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {10}------------------------------------------------ Section 4: Indication for Use: OTC ## Section 4: Indication for Use Statement Luofucon Antibacterial Alginate Dressing (OTC) 510(k) Number (if known): K120181 Device Name: Luofucon Antibacterial Alginate Dressing Indications for Use: OTC: First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use X (Part 21 CFR 801 Subpart C) ### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) #### Concurrence of CDRH, Office of Device Evaluation (ODE) # Jiyounggyang (Division Sign-Off) Division of Surgical Devices 510(k) Number K120181 p 【 {11}------------------------------------------------ Section 4: Indication for Use: Prescription K120181 p2/2 ## Section 4: Indication for Use Statement Luofucon Silver Alginate Dressing (Prescription) 510(k) Number (if known): K120181 Device Name: Luofucon Silver Alginate Dressing Indications for Use: Prescription: Luofucon Silver Alginate Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including postoperative wounds, trauma wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites. Prescription Use X-(Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ## Jiyo ying Dang (Division Sign-Off) Division of Surgical Devices 510(k) Number K120181 Section 4: Indications for Use: Prescription p 1