(80 days)
Not Found
No
The description focuses on the physical structure and material properties of the wound dressing, with no mention of AI or ML.
Yes
The device is a wound dressing designed to aid in the healing of various wounds by absorbing exudates, maintaining a moist wound environment, and reducing bacterial colonization. These actions are directly aimed at treating and managing wounds, qualifying it as a therapeutic device.
No
Explanation: The device is a wound dressing designed for managing exuding wounds and reducing bacterial colonization. It absorbs exudates and maintains a moist wound healing environment. It does not perform any diagnostic function.
No
The device description clearly outlines a physical, multi-layer wound dressing with silver ions, indicating it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states 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. This aligns with a therapeutic device, not a diagnostic one that analyzes samples from the body.
- Performance Studies: The performance studies focus on "antibacterial preservative activity" and "biocompatibility," which are relevant to a wound dressing's function and safety, not diagnostic accuracy.
- Key Metrics: The key metrics are related to "Antibacterial Activity," measuring the reduction of bacteria, which is a therapeutic outcome.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis.
N/A
Intended Use / Indications for 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.
Product codes
FRO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
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.
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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
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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;
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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
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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
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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.
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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.