K Number

Device Name

LUOFUCON Silicone Ag foam dressing

Manufacturer

HUIZHOU FORYOU MEDICAL DEVICES Co., Ltd.

Date Cleared

2016-08-17

(225 days)

Product Code

FRO

Regulation Number

N/A

Intended Use

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

Device Description

LUOFUCON® Silicone Ag foam dressing has a multilayer structure, it consists of a soft silicone wound contact layer, an absorbent polyurethane foam pad containing about 0.25~0.35mq/cm² silver ions, a vapor permeable waterproof film. LUOFUCON® Silicone Ag foam dressing can absorb exudates, maintains a moist wound healing environment and has good antibacterial preservative properties within the dressing. It has been shown that antibacterial preservative effectiveness within the dressing for up to 7days, as demonstrated in vitro. All dressings are sterilized and sold after sterilization by EO using conditions validated following ISO 11135: 2014. LUOFUCON® Silicone Ag foam dressing in this submission consists of two variants: The first variant, Non-Border Silicone Ag Foam dressing consists of a top layer (Vapor permeable waterproof polyurethane film); a center layer (Absorbent polyurethane antibacterial foam pad containing silver compounds adhered to the top film); a wound contact layer (Perforated silicone gel adhered to the center layer); a release liner covers on the silicone gel. The second variant, Silicone Ag Foam dressing With Border consists of a top layer (Vapor permeable waterproof polyurethane film); a center layer (A thin non woven and absorbent polyurethane antibacterial foam pad containing silver compounds adhered to the top film, and the top film remained border part); a wound contact layer (Perforated silicone gel adhered to the center layer and top film); a release liner (covered on the silicone gel). The dressing has white or light brown appearance and is available in the form of pad and in different sizes of pouch package. All dressings use the same material of backing film, foam pad, silicone gel and release film. With Border version additionally adds a thin non woven as foam auxiliary layer, but it wouldn't impact the product properties.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K100029, K140954

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical structure and material properties of a wound dressing with antibacterial properties, with no mention of AI or ML.

Therapeutic

Yes
The device is a wound dressing that aids in wound healing and infection control, which are therapeutic actions.

Diagnostic

Explanation: The device is a wound dressing designed for managing exuding wounds and reducing bacterial colonization. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

The device description clearly outlines a physical, multi-layer wound dressing with material components (silicone, foam, film) and a sterilization process, indicating it is a hardware medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is for the "management of exuding wounds." This is a therapeutic application, not a diagnostic one.
Device Description: The description details a wound dressing with absorbent and antibacterial properties. It does not describe any components or functions related to analyzing samples from the human body to provide diagnostic information.
Performance Studies: The performance study described evaluates the "antibacterial preservative activity" of the dressing, which is a measure of its effectiveness in inhibiting bacterial growth within the dressing itself, not in diagnosing a condition in a patient.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for the diagnosis of a disease or condition.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a wound dressing used for treatment and management of wounds.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

FRO

Device Description

LUOFUCON® Silicone Ag foam dressing can absorb exudates, maintains a moist wound healing environment and has good antibacterial preservative properties within the dressing. It has been shown that antibacterial preservative effectiveness within the dressing for up to 7days, as demonstrated in vitro.

All dressings are sterilized and sold after sterilization by EO using conditions validated following ISO 11135: 2014.

LUOFUCON® Silicone Ag foam dressing in this submission consists of two variants:

The first variant, Non-Border Silicone Ag Foam dressing consists of a top layer (Vapor permeable waterproof polyurethane film); a center layer (Absorbent polyurethane antibacterial foam pad containing silver compounds adhered to the top film); a wound contact layer (Perforated silicone gel adhered to the center layer); a release liner covers on the silicone gel.

The second variant, Silicone Ag Foam dressing With Border consists of a top layer (Vapor permeable waterproof polyurethane film); a center layer (A thin non woven and absorbent polyurethane antibacterial foam pad containing silver compounds adhered to the top film, and the top film remained border part); a wound contact layer (Perforated silicone gel adhered to the center layer and top film); a release liner (covered on the silicone gel).

The dressing has white or light brown appearance and is available in the form of pad and in different sizes of pouch package. All dressings use the same material of backing film, foam pad, silicone gel and release film. With Border version additionally adds a thin non woven as foam auxiliary layer, but it wouldn't impact the product properties.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Wounds (leg and foot ulcers, pressure ulcers, traumatic and surgical wounds, superficial and partial thickness 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

LUOFUCON® Silicone Ag Foam Dressing meets biocompatibility requirements per ISO 10993-5, ISO10993-10, and ISO 10993-11. It's physical and 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.

Modified AATCC 100-2004 was used to evaluate the antibacterial preservative activity of the subject device. Predicate Device 1 chooses the ASTM E2149-01 as the test method. Both the subject device and predicate devices can get antibacterial preservative 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.

Key Metrics

Antibacterial preservative activity: >4 log reduction for seven days for all six bacteria.
Biocompatibility: No Toxic Effect (ISO10993-5), No Effect (ISO 10993-10) for Skin Irritation and Sensitization, No Effect (ISO 10993-11) for Systematic Toxicity.

Predicate Device(s)

K100029, K140954

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three overlapping profiles suggesting a sense of community and support. The profiles are rendered in a dark color, creating a strong contrast against the white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 17, 2016

Huizhou Foryou Medical Devices Co., Ltd. Guosheng Tan Development Engineer North Shangxia Road Dongjiang Hi-Tech Industry Park Huizhou, 516005 P.R. China

Re: K160022

Trade/Device Name: Luofucon Silicone Ag Foam Dressing Regulatory Class: Unclassified Product Code: FRO Dated: July 13, 2016 Received: July 18, 2016

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 devicerelated 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.

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/ResourcesforYou/Industry/default.htm. 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

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

K160022

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-001

510(k) Number (if known)

Device Name

LUOFUCON® Silicone Ag foam dressing

Indications for Use (Describe)

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."

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:_ K160022

1. Date of Submission: 12/20/2015

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: qstan@foryougroup.com

3. Subject Device Identification:

Device Name: LUOFUCON® Silicone Ag Foam Dressing Common Name: Silver Foam Dressing Classification Name: Silicone, Dressing, Wound, Drug; Product Code: FRO; Regulation Number: Unclassified; Review Panel: General & Plastic Surgery;

4. Predicate Device Identification:

First: 510(k) Number: K100029

Product Name: Mepilex Border Ag Dressing

Manufacturer: Mölnlycke Health Care

Second: 510(k) Number: K140954

Product Name: LUOFUCON® Silver PU Antibacterial Foam Dressing Manufacturer: Huizhou Foryou Medical Devices Co., Ltd.

5. Device Description:

All dressings are sterilized and sold after sterilization by EO using conditions validated following ISO 11135: 2014.

LUOFUCON® Silicone Ag foam dressing in this submission consists of two variants:

film); a release liner (covered on the silicone gel).

6. Intended Use Statement:

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

7. Comparison to the Predicate Device

LUOFUCON® Silicone Ag Foam Dressing 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.
K140954, LUOFUCON® Silver PU Antibacterial 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	Predicate Device2
	(K160022)	(K100029)	(K140954)
Intended Use	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.
Silver compounds present
in the dressing helps
reduce bacterial
colonization in the
dressing.	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.
Mepilex Border Ag can
also be used under
compression bandaging.
Silver sulfate present in
the dressing helps reduce
microbial colonization on
the dressing.	LUOFUCON® Silver PU
Antibacterial Foam
Dressing is indicated for
exudates absorption and
the management of
partial to full thickness
wounds, including leg
ulcers, pressure ulcers,
diabetic foot ulcers,
second-degree burns,
donor sites,
postoperative wounds
and skin abrasions.
Mechanism	Polyurethane foam for
absorb liquid, Silver
compounds present in
the foam for reducing
bacteria within the
dressing. Silicone soft
contact layer for self-
adhesive, baking film for
waterproof.	Polyurethane foam and
non-woven for absorb
liquid, Silver compounds
present in the foam for
reducing bacteria in the
dressing, Silicone soft
contact layer for self-
adhesive, baking film for
waterproof.	Polyurethane foam for
absorb liquid, Silver
compounds present in
the foam for reducing
bacteria within the
dressing.
Material	Polyurethane foam
containing silver,
Silicone and
polyurethane film; with
border version additional
has non-woven fabrics	Silicone , polyurethane
foam containing silver
and activated carbon,
polyacrylate fibre, non-
woven fabrics,
polyurethane film	Polyurethane foam
containing silver
Antibacterial
preservative
Duration	Seven days	Seven days	Seven days
Single Use	Yes	Yes	Yes
Sterilization	Ethylene Oxide	Ethylene Oxide	Irradiation
Item	Subject Device
(K160022)	Predicate Device 1
(K100029)	Predicate Device2
(K140954)
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
Preservative
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
Preservative
Duration	Seven days	Seven days	Seven days

Table 5-1 Comparison of Intended Use, Design and Material

LUOFUCON® Silicone Ag Foam Dressing and its predicate devices (K100029、 K140945) utilize silver compound as the antibacterial preservative agent, and utilize polyurethane foam for the exudates absorption and wound management. One difference between subject device and predicate device 1(K100029) is that the predicate device has added a super polyacrylate absorbent fibers used to enhance the product fluid absorption performance. LUOFUCON® Silicone Ag Foam Dressing is modified from LUOFUCON® Silver PU Antibacterial Foam Dressing (K140945) which had no silicone wound contact layer and sterilized with Irradiation. These differences do not impact the safety and efficacy of our subject devices, because their functions have no change.

Therefore, LUOFUCON® Silicone Ag Foam Dressing and its predicate devices are made from similar materials, utilize same antibacterial preservative mechanism, and have similar intended use.

Table 5-2 Comparison of Biocompatibility and Performance Testing

Substantial Equivalent Statement

Based on the comparison of intended use, design, materials, and performance, the subject device, LUOFUCON® Silicone Ag foam dressing, is determined to be Substantially Equivalent (SE) to the predicate devices, Mepilex Border Ag Foam Dressing (K100029) and LUOFUCON® Silver PU Antibacterial Foam Dressing (K140954), in respect of safety and effectiveness.