(378 days)
Not Found
No
The device description and performance studies focus on the material properties and antibacterial effectiveness of a wound dressing, with no mention of AI or ML.
Yes
The device is described as a 'Gelling Fiber Dressing' intended for the management of various wounds, including burns, diabetic foot ulcers, and surgical wounds, acting as an effective barrier to bacterial penetration. This directly indicates its use in medical treatment and healing, classifying it as a therapeutic device.
No
Explanation: This device is a wound dressing designed to absorb fluid and provide an antibacterial barrier for wound management. It does not perform any diagnostic functions like identifying or characterizing a medical condition.
No
The device description clearly indicates it is a physical dressing composed of fibers and ionic silver, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a wound dressing used for the management of various types of wounds. This is a topical application for treating the wound itself, not for diagnosing a condition based on in vitro testing of samples from the body.
- Device Description: The description details the composition and function of the dressing in absorbing wound fluid and creating a healing environment. It mentions in vitro testing for antibacterial properties of the dressing, not for diagnosing a patient's condition.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information. The device's function is directly on the wound surface.
Therefore, this device falls under the category of a wound care product, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Prescription:
LUOFUCON® Extra Silver Gelling Fiber Dressing may be used for the management of moderate to heavily exuding chronic and acute wounds as an effective barrier to bacterial penetration of the dressing, including:
Partial thickness burns (second degree);
Diabetic foot ulcers;
Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology);
Pressure ulcers (partial and full thickness);
Donor sites;
Surgical wounds;
Traumatic wounds.
OTC:
LUOFUCON® Silver Antibacterial Gelling Fiber Dressing may be used for: Minor abrasions; Minor lacerations; Minor cuts; Minor scalds and burns.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
LUOFUCON® Extra Silver Gelling Fiber Dressing is a soft, conformable, non-woven pad or ribbon dressing composed of carboxymethyl cellulose fibers, high-density polyethylene and Polyethylene terephthalate fibers and 1.1% (w/w) ionic silver. Based on in vitro testing, the silver in the dressing inhibits bacterial growth in the dressing and provides a barrier against bacterial penetration through the dressing for up to seven days. This conformable and highly absorbent dressing absorbs wound fluid and creates a soft gel, provides an ideal moist wound healing environment.
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
Prescription: Under the supervision of a healthcare professional.
OTC: Not specified, implies general public.
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)
The following performance tests were conducted on subject device in comparison to the predicate device:
- Free Swell Absorption Capacity (EN 13726-1)
- Fluid Retention Rate
- Shrinkage
- Wet Tensile Strength
- Loss on Drying (USP )
- pH Value (USP )
- Silver Content
- Antibacterial Effectiveness (AATCC TM100)
- Bacterial Barrier Effectiveness
Summary of Biocompatibility Testing: The subject device raised no new safety concerns for biocompatibility. Based on "Use of International Standard ISO 10993-1, Biological evaluation of medical devices-Part 1_Evaluation and testing within a risk management process", the subject is categorized as surface devices for breached or compromised surface with prolonged duration. The subject device was evaluated for:
- Cytotoxicity (ISO 10993-5)
- Sensitization (ISO 10993-10)
- Irritation (ISO 10993-10)
- Systemic toxicity (ISO 10993-11)
- Implantation (ISO 10993-6)
- Material-mediated pyrogenicity (USP )
Summary of Animal Testing: A porcine full thickness dermal wound healing study was carried out to evaluate cytotoxicity of the subject device. The study demonstrated that there were no biologically relevant differences between subject device and predicate device (K121275) in terms of wound healing performance characteristics and histopathology after wound creation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Free Swell Absorption Capacity: ≥15g/100cm²
- pH Value: 5.0-8.0
- Silver Content: 1.1% (w/w)
- Antibacterial Effectiveness: 4 Log Reduction for six organisms up to 7 days (MRSA/VRE/Streptococcus pyogenes/Escherichia coli/ Pseudomonas aeruginosa/Klebsiella pneumonia)
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 21, 2022
Huizhou Foryou Medical Devices Co., Ltd. Junfeng Zhang Development Engineer North Shangxia Rd, Dongjiang Hi-tech Industrial Park Huizhou, Guangdong 516005 China
Re: K210718
Trade/Device Name: LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing Regulatory Class: Unclassified Product Code: FRO
Dear Junfeng Zhang:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter sent on March 23, 2022. Specifically, FDA is updating this SE Letter for an updated IFU form and no date on the SE Letter.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-472-6328, Julie.Morabito@fda.hhs.gov
Sincerely,
Julie A. Morabito - S
Julie Morabito Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder font, and the word "ADMINISTRATION" in a smaller font below.
Huizhou Foryou Medical Devices Co., Ltd. Junfeng Zhang Development Engineer North Shangxia Rd, Dongjiang Hi-tech Industrial Park Huizhou, Guangdong 516005 China
Re: K210718
Trade/Device Name: LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing Regulatory Class: Unclassified Product Code: FRO Dated: December 13, 2021 Received: December 17, 2021
Dear Junfeng Zhang:
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. 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 located 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.
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 803) for
2
devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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,
Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic 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) K210718
Device Name
LUOFUCON® Extra Silver Gelling Fiber Dressing (Prescription use) LUOFUCON® Silver Antibacterial Gelling Fiber Dressing (OTC use)
Indications for Use (Describe)
Prescription:
LUOFUCON® Extra Silver Gelling Fiber Dressing may be used for the management of moderate to heavily exuding chronic and acute wounds as an effective barrier to bacterial penetration of the dressing, including:
Partial thickness burns (second degree);
Diabetic foot ulcers;
Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology);
Pressure ulcers (partial and full thickness);
Donor sites;
Surgical wounds;
Traumatic wounds.
OTC:
LUOFUCON® Silver Antibacterial Gelling Fiber Dressing may be used for: Minor abrasions; Minor lacerations; Minor cuts; Minor scalds and 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)
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4
510(k) Summary
1. Submitter
Huizhou Foryou Medical Devices Co., Ltd.
Address: North Shangxia Rd, Dongjiang Hi-tech Industrial Park, 516005, Huizhou, PEOPLE'S REPUBLIC OF CHINA.
Phone: +86-0752-5302185
Contact Person: Junfeng Zhang
Date Prepared: March 22, 2022
2. Subject Device
Trade Name: LUOFUCON® Extra Silver Gelling Fiber Dressing (Prescription use) LUOFUCON® Silver Antibacterial Gelling Fiber Dressing (OTC use) Common Name: Silver Gelling Fiber Dressing Classification Name: Dressing, Wound, Drug Regulatory Class: Unclassified Product Code: FRO Review Panel: General & Plastic Surgery
3. Predicate Device
510(k) Number: K121275
Product Name: Aquacel™ Ag Extra™ with Hydrofiber™ Dressing with Silver and Strengthening Fiber
Manufacturer: Convatec Inc.
510(k) Number: K183645
5
Product Name: Silver High Performance Dressing Manufacturer: Advanced Medical Solutions Ltd.
4. Device Description
LUOFUCON® Extra Silver Gelling Fiber Dressing is a soft, conformable, non-woven pad or ribbon dressing composed of carboxymethyl cellulose fibers, high-density polyethylene and Polyethylene terephthalate fibers and 1.1% (w/w) ionic silver. Based on in vitro testing, the silver in the dressing inhibits bacterial growth in the dressing and provides a barrier against bacterial penetration through the dressing for up to seven days. This conformable and highly absorbent dressing absorbs wound fluid and creates a soft gel, provides an ideal moist wound healing environment.
These antibacterial claims are based on in vitro testing, no clinical studies have been conducted to support these claims.
5. Indications for Use
Prescription:
Under the supervision of a healthcare professional:
LUOFUCON® Extra Silver Gelling Fiber Dressing may be used for the management of moderate to heavily exuding chronic and acute wounds as an effective barrier to bacterial penetration of the dressing, including:
Partial thickness burns (second degree);
Diabetic foot ulcers;
Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology); Pressure ulcers (partial and full thickness);
Donor sites;
Surgical wounds;
6
Traumatic wounds.
ОТС:
LUOFUCON® Silver Antibacterial Gelling Fiber Dressing may be used for:
Minor abrasions;
Minor lacerations;
Minor cuts;
Minor scalds and burns.
| Items | Subject Device | Primary Predicate Device
(K121275) | Secondary Predicate Device
(K183645) |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Prescription:
Under the supervision of
a healthcare
professional:
LUOFUCON® Extra Silver
Gelling Fiber Dressing
may be used for the
management of
moderate to heavily
exuding chronic and
acute wounds as an
effective barrier to
bacterial penetration of
the dressing, including:
Partial thickness burns
(second degree);
Diabetic foot ulcers;
Leg ulcers (venous stasis
ulcers, arterial ulcers and
leg ulcers of mixed
etiology);
Pressure ulcers (partial
and full thickness);
Donor sites;
Surgical wounds;
Traumatic wounds.
OTC:
LUOFUCON® Silver
Antibacterial Gelling
Fiber Dressing may be
used for:
Minor abrasions; | Prescription:
Under the supervision of a
healthcare professional:
Aquacel™ Ag Extra™ with
Hydrofiber™ Dressing with
Silver and Strengthening
Fiber may be used for the
management of wounds as
an effective barrier to
bacterial penetration of the
dressing as this may help
reduce infection; partial
thickness (second degree)
burns; diabetic foot ulcers,
leg ulcers, (venous stasis
ulcers, arterial ulcers and
leg ulcers of mixed etiology)
and pressure ulcers/sores
(partial & full thickness);
surgical wounds left to heal
by secondary intention such
as dehisced surgical
incisions; surgical wounds
that heal by primary intent
such as dermatological and
surgical incisions (e.g.
orthopedic and vascular);
traumatic wounds; wounds
that are prone to bleeding,
such as wounds that have
been mechanically or
surgically debrided and | Under the supervision of a
healthcare professional,
Silver High Performance
Dressing can be used in the
management of moderate
to heavily exuding chronic
and acute wounds. The
dressing is indicated for use
on the following wounds:
Pressure ulcers (partial and
full thickness);
Leg ulcers (venous stasis
ulcers, arterial ulcers and
leg ulcers of mixed
etiology);
Diabetic foot ulcers;
Surgical wounds that heal
by primary intent such as
dermatological and surgical
incisions;
Surgical wounds left to heal
by secondary intention such
as dehisced surgical
incisions and donor sites;
Traumatic wounds. |
| | Minor lacerations;
Minor cuts;
Minor scalds and burns. | donor sites; oncology
wounds with exudate, suchas fungoides-cutaneous
tumors, fungating
carcinoma, cutaneous
metastasis, Kaposi's
sarcoma, and
angiosarcoma; painful
wounds and infected | |
| | | wounds.
OTC:
Aquacel™ Ag Extra™ with
Hydrofiber™ Dressing with
Silver and Strengthening
Fiber may be used for
abrasions, lacerations,
minor cuts, minor scalds
and burns. | |
| Prescription/
OTC | Prescription and OTC | Prescription and OTC | Prescription |
| Mechanism | The dressing absorbs
wound fluid and creates
a soft gel, which
provides an ideal moist
wound healing
environment. Based on
in vitro testing, the silver
in the dressing inhibits
bacterial growth in the
dressing and provides a
barrier against bacterial
penetration through the
dressing for up to seven
days. | The dressing absorbs
wound fluid and creates a
soft gel, which provides an
ideal moist wound healing
environment. The silver in
the dressing kills wound
bacteria held in the dressing
and provides a barrier
against bacterial
penetration of the dressing. | The highly absorbent
dressing absorbs exudate
from the wound to form a
soft gel that intimately
conforms to the wound bed
and aids in maintaining a
moist wound environment.
Silver High Performance
Dressing contains ionic
silver, and effectively
manages and suppresses
colonization and
proliferation of bacteria and
yeast within the dressing for
up to 7 days. |
| Design/
Material | Non-woven dressing,
consist of carboxymethyl
cellulose fiber, ionic
silver and enhance
fiber(High-density
polyethylene and
Polyethylene
terephthalate) | Non-woven dressing,
consist of carboxymethyl
cellulose fiber, ionic silver
and enhance
fiber(regenerated cellulose) | Non-woven dressing,
consist of carboxymethyl
cellulose fiber, alginate
fiber, ionic silver and
reinforcement layer (nylon
fiber) |
| Antimicrobial
Duration | Seven days | Seven days | Seven days |
| Antimicrobial
Activity | Broad spectrum | Broad spectrum | Broad spectrum |
| Single Use | Yes | Yes | Yes |
| Sterilization | Radiation | Radiation | Radiation |
| Size | Max. 300mm×200mm
Min. 50mm×50mm | Max. 300mm×200mm
Min. 50mm×50mm | Ranging in area from 28cm2
to 650cm2 |
6. Summary of Substantial Equivalence
7
K210718
8
| Free Swell
Absorption
| Capacity | ≥15g/100cm² | NA | NA |
|---|---|---|---|
| pH Value | 5.0-8.0 | NA | NA |
| Silver Content | 1.1% (w/w) | 1.2% (w/w) | NA |
| Antibacterial | |||
| Effectiveness | 4 Log Reduction for six | ||
| organisms up to 7 days | |||
| (MRSA/VRE/Streptococc | |||
| us pyogenes/Escherichia | |||
| coli/ Pseudomonas | |||
| aeruginosa/Klebsiella | |||
| pneumonia) | 4 Log Reduction for six | ||
| organisms up to 7 days | |||
| (MRSA/VRE/Streptococcus | |||
| pyogenes/Escherichia coli/ | |||
| Pseudomonas aeruginosa | |||
| /Klebsiella pneumonia) | 4 Log Reduction for nine | ||
| organisms up to 7 days | |||
| (MRSE/VRE/Streptococcus | |||
| mutans/ Staphylococcus | |||
| aureus/Enterobacter | |||
| cloacae/ Klebsiella | |||
| pneumonia/ Serratia | |||
| marcescens/ Escherichia | |||
| coli/Candida albicans) |
The subject device and its predicate device (K121275) both utilize ionic silver as the antibacterial ingredient and utilize carboxymethyl cellulose fiber for the exudate absorption and wound management. The subject device has the similar intended use with the predicate device.
The secondary predicate device (K183645) is used for supporting the subject device's indications for use (Prescription use), and both subject device and secondary predicate device (K183645) use carboxymethyl cellulose fiber, ionic silver and enhance fiber for the antibacterial dressing.
Both subject device and predicate devices are sterilized by radiation.
The intended use, material, performance are similar to those of the predicate devices and do not raise any new issues concerning safety or effectiveness.
1) Summary of Performance Testing
The following performance tests were conducted on subject device in comparison to the predicate device:
- Free Swell Absorption Capacity (EN 13726-1)
9
- Fluid Retention Rate O
- Shrinkage
- Wet Tensile Strength
- Loss on Drying (USP ) 0
- O pH Value (USP )
- O Silver Content
- Antibacterial Effectiveness (AATCC TM100) ●
- Bacterial Barrier Effectiveness
Summary of Biocompatibility Testing 2)
The subject device raised no new safety concerns for biocompatibility. Based on "Use of International Standard ISO 10993-1, Biological evaluation of medical devices-Part 1_Evaluation and testing within a risk management process", the subject is categorized as surface devices for breached or compromised surface with prolonged duration. The subject device was evaluated for:
- 0 Cytotoxicity (ISO 10993-5)
- O Sensitization (ISO 10993-10)
- Irritation (ISO 10993-10)
- Systemic toxicity (ISO 10993-11) O
- Implantation (ISO 10993-6)
- 0 Material-mediated pyrogenicity (USP )
Summary of Animal Testing 3)
A porcine full thickness dermal wound healing study was carried out to evaluate cytotoxicity of the subject device. The study demonstrated that there were no biologically relevant differences between subject device and predicate device (K121275) in terms of wound healing performance characteristics and
10
histopathology after wound creation.
7. Conclusions
Based on the comparison of intended use, design, materials, and performance, the subject device, LUOFUCON® Extra Silver Gelling Fiber Dressing/ LUOFUCON® Silver Antibacterial Gelling Fiber Dressing, is determined to be Substantially Equivalent (SE) to the predicate devices, Aquacel™ Ag Extra™ with Hydrofiber™ Dressing with Silver and Strengthening Fiber (K121275) and Silver High Performance Dressing (K183645) in respect of safety and effectiveness.