(286 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 technologies.
Yes.
The device is indicated for the management of wounds and provides a moist healing environment, absorbs exudate, and has antibacterial effects, all of which are therapeutic actions.
No
This device is a wound dressing designed for managing and healing wounds by absorbing exudate and providing antibacterial effects. It does not perform any diagnostic functions like detecting, monitoring, or diagnosing diseases or conditions.
No
The device description clearly states it is a sterile, single-use dressing consisting of calcium alginate fiber impregnated with polyhexamethylene biguanide, which is a physical material, 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 for managing various types of wounds. This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the physical properties of the dressing (alginate fiber, PHMB) and its function in absorbing exudate, forming a gel, and providing antibacterial effects. It does not describe any mechanism for analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies listed evaluate the physical characteristics, biocompatibility, and antibacterial effectiveness of the dressing. These are relevant to a wound care product, not an IVD.
- Key Metrics: The key metric mentioned is "Antibacterial effectiveness," which measures the device's ability to reduce bacteria, a therapeutic function.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic results.
In summary, the LUOFUCON® PHMB Alginate Dressing is a wound care product designed to treat wounds, not to diagnose a condition.
N/A
Intended Use / Indications for Use
Prescription:
LUOFUCON® PHMB 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.
OTC:
LUOFUCON® PHMB Antibacterial Alginate Wound Dressing is indicated for first aid to help in minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
LUOFUCON® PHMB Alginate Dressing /LUOFUCON® PHMB Antibacterial Alginate Wound Dressing is a sterile, single-use dressing consisting of calcium alginate fiber impregnated with polyhexamethylene biguanide, and the maximum polyhexamethylene biquanide content is 0.8% w/w. LUOFUCON® PHMB Alginate Dressing/LUOFUCON® PHMB Antibacterial Alginate Wound Dressing can absorb wound exudate. As wound exudate is absorbed, the alginate forms a gel, which provide a moist wound healing environment, and allows intact removal.
Based on in vitro performance data, LUOFUCON® PHMB Alginate Dressing/LUOFUCON® PHMB Antibacterial Alginate Wound Dressing has broad spectrum antibacterial effects, and the polyhexamethylene biguanide prevents colonization and proliferation of bacteria within the dressing for up to seven days.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance tests were conducted on subject devices in comparison to the predicate devices:
- Appearance
- Size
- Weight per unit area
- Free Swell Absorption Capacity: conducted in accordance with BS EN 13726-1 Test methods for primary wound dressings-Part 1: Aspects of absorbency.
- Loss on Drying: conducted in accordance with USP Lost on Drying
- pH Value: complied with USP Ph.
- PHMB content
- Sterility: conducted in accordance with ISO 11737-2 Sterilization of medical devices- Microbiological Methods-Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.
- Antibacterial effectiveness: conducted in accordance with Modified AATCC TM100.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue. The logo is simple and professional, and it is easily recognizable.
January 28, 2021
Huizhou Foryou Medical Devices Co., Ltd. Guosheng Tan Development Engineer No. 1 Shangxia North Road, Dongjiang Hi-tech Industry Park Huizhou, Guangdong 516005 China
Re: K201016
Trade/Device Name: LUOFUCON® PHMB Alginate Dressing (Prescription use), LUOFUCON® PHMB Antibacterial Alginate Wound Dressing (OTC use) Regulatory Class: Unclassified Product Code: FRO Dated: April 15, 2020 Received: April 17, 2020
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. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 mediation-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,
For Kimberly Ferlin, PhD Assistant Director (Acting) 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
2
Indications for Use
510(k) Number (if known) K201016
Device Name
LUOFUCON® PHMB Alginate Dressing (Prescription use) LUOFUCON® PHMB Antibacterial Alginate Wound Dressing(OTC use)
Indications for Use (Describe) Prescription:
Prescription:
LUOFUCON® PHMB Alginate Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including postoperative wounds, trauma wounds, leg ulcers, diabetic ulcers, graft and donor sites.
OTC:
LUOFUCON® PHMB Antibacterial Alginate Wound Dressing is indicated for first aid to help in minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor 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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510(k) Summary
This 510(k) Summary information is being submitted in accordance with Title 21, CFR Section 807.92.
1. SUBMITTER:
Huizhou Foryou Medical Devices Co., Ltd.
Address: No.1 Shangxia North Road, Dongjiang Hi-tech Industry Park, Huizhou,
Guangdong, China Phone: +86-0752-5302185 Fax: +86-0752-5302020 Contact Person: Guosheng Tan Date Prepared: April 15, 2020
2. SUBJECT DEVICE
Name of Device: LUOFUCON® PHMB Alginate Dressing (Prescription use),
LUOFUCON® PHMB Antibacterial Alginate Wound Dressing (OTC use)
Common or Usual Name: PHMB Alginate Dressing Classification Name: Dressing, Wound, Drug Regulatory Class: Unclassified Product Code: FRO
3. PREDICATE DEVICES:
510(k) Number: K082296 Product Name: COPA AMD antimicrobial wound dressing Manufacturer: Kendall, a Division of Tyko Healthcare Group LP
4
510(k) Number: K172554
Product Name: LUOFUCON® Extra Silver Alginate Dressing (Prescription use)/ LUOFUCON® Antibacterial Alginate Wound Dressing (OTC Use) Manufacturer: Huizhou Foryou Medical Devices Co., Ltd.
4. DEVICE DESCRIPTION:
LUOFUCON® PHMB Alginate Dressing /LUOFUCON® PHMB Antibacterial Alginate Wound Dressing is a sterile, single-use dressing consisting of calcium alginate fiber impregnated with polyhexamethylene biguanide, and the maximum polyhexamethylene biquanide content is 0.8% w/w. LUOFUCON® PHMB Alginate Dressing/LUOFUCON® PHMB Antibacterial Alginate Wound Dressing can absorb wound exudate. As wound exudate is absorbed, the alginate forms a gel, which provide a moist wound healing environment, and allows intact removal.
Based on in vitro performance data, LUOFUCON® PHMB Alginate Dressing/LUOFUCON® PHMB Antibacterial Alginate Wound Dressing has broad spectrum antibacterial effects, and the polyhexamethylene biguanide prevents colonization and proliferation of bacteria within the dressing for up to seven days.
5. INDICATIONS FOR USE:
Prescription:
LUOFUCON® PHMB 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.
5
ОТС:
LUOFUCON® PHMB Antibacterial Alginate Wound Dressing is indicated for first aid to help in minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.
6. COMPARISON WITH THE PREDICATE DEVICE:
LUOFUCON® PHMB Alginate Dressing/ LUOFUCON® PHMB Antibacterial Alginate Wound Dressing is Compared with the Predicate Devices in terms of intended use, design, material, specifications, and performance. The following table shows their similarities and differences.
| Item | Subject Device
(K201016) | Primary Predicate Device
(K082296) | Secondary Predicate Device
(K172554) |
|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | FRO | FRO | FRO |
| Class | Unclassified | Unclassified | Unclassified |
| Indications for use | Prescription:
LUOFUCON® PHMB
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.
OTC:
LUOFUCON® PHMB
Antibacterial Alginate
Wound Dressing is
indicated for first aid to help
in minor abrasions, minor
cuts, minor lacerations,
minor scrapes, minor scalds
and minor burns. | Prescription:
COPA AMD Dressing are
indicated for use in the
management of
post-surgical incisions,
pressure sores, venous
stasis ulcers, diabetic
ulcers, donor sites,
abrasions, lacerations, first
and second-degree burns,
dermatologic disorders,
other wounds inflicted by
trauma, and as a secondary
dressing or cover dressing
for packed wounds. | Prescription:
LUOFUCON® Extra 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.
OTC:
LUOFUCON® Antibacterial
Alginate Wound Dressing is
first aid to help in minor
abrasions, minor cuts,
lacerations, scrapes, minor
scalds and burns. |
| Mechanism | | | |
| Alginate for absorbing liquid, PHMB in the alginate for reducing bacteria colonization in the dressing. | Polyurethane foam for absorbing liquid, PHMB present in the Polyurethane foam for reducing bacteria colonization in the dressing. | Alginate for absorbing liquid, silver present in the alginate for reducing bacteria colonization in the dressing. | |
| Material | | | |
| Alginate 99.2% w/w, PHMB 0.80% w/w | Polyurethane foam 99.5% w/w, PHMB 0.50% w/w | Alginate 99.2%, Silver 0.80% w/w | |
| Antibacterial agent | | | |
| PHMB | PHMB | Silver | |
| Dressing Use-life | | | |
| Up to Seven days | Up to Seven days | Up to Seven days | |
| Shelf-life | | | |
| Two years | / | Two years | |
| Package information | | | |
| Aluminum foil or paper aluminum plastic pouch, box and Carton | Paper-plastic bag, box and Carton | Aluminum foil pouch, box and Carton | |
| Single Use | | | |
| Yes | Yes | Yes | |
| Sterilization | | | |
| Gamma Irradiation | Gamma Irradiation | Gamma Irradiation | |
| Size | | | |
| Prescription:
Max. 200mm×200mm
OTC:
Max. 200mm×200mm | Prescription:
Max.20.3cm×20.3cm | Prescription:
Max. 200mm×200mm
OTC:
Max. 200mm×100mm | |
| Weight per unit area | | | |
| 120 g/m² - 240 g/m² | N/A | 120 g/m² - 240 g/m² | |
| Free swell absorption capacity | | | |
| ≥12g/100cm² | N/A | ≥12g/100cm² | |
| pH value | | | |
| 4.0-5.0 | N/A | 4.0-7.0 | |
| PHMB content | | | |
| 0.40-0.80% w/w | 0.50% w/w | N/A | |
| Antibacterial effectiveness | | | |
| 4 Log Reduction for six organisms up to 7 days (MRSA/VRE/ Streptococcus 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 six organisms up to 7 days (MRSA/VRE/ Streptococcus pyogenes/Escherichia coli/ Pseudomonas aeruginosa/ Klebsiella pneumonia) | |
6
7. SUBSTANTIAL EQUIVALENCE DISCUSSION:
LUOFUCON® PHMB Alginate Dressing/LUOFUCON® PHMB Antibacterial Alginate Wound Dressing and its predicate devices (K082296, K172554) have the similar
7
function design and are made of the similar materials. The alginate or polyurethane foam is designed for exudate absorption and wound care, and the PHMB presented in the dressing as an antimicrobial agent is used for antibacterial effectiveness. The biocompatibility of subject device is evaluated according to ISO 10993-1, and the antibacterial effectiveness of both subject device and predicate devices can achieve 4 Log Reduction. Therefore, device materials in the subject device and predicated device do not raise any different question of safety and effectiveness. The predicate device (K172554) is also used for supporting the subject device's performance and indications for use (Prescription use and OTC use), because both subject device and predicate device (K172554) use alginate as the substrate for the antibacterial dressing, both of which have similar performance, such as size, weight per unit area, free swell absorption capacity, pH value.
Performance Testing
The following performance tests were conducted on subject devices in comparison to the predicate devices:
- Appearance
- Size
- Weight per unit area ●
- Free Swell Absorption Capacity: conducted in accordance with BS EN ● 13726-1 Test methods for primary wound dressings-Part 1: Aspects of absorbency.
- Loss on Drying: conducted in accordance with USP Lost on Drying
- pH Value: complied with USP Ph.
- PHMB content
- Sterility: conducted in accordance with ISO 11737-2 Sterilization of medical ● devices- Microbiological Methods-Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.
- Antibacterial effectiveness: conducted in accordance with Modified AATCC TM100.
Biocompatibility Testing
Based on Table A.1 of ISO 10993-1 and Table A.1 of "Use of International
8
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 device for breached or compromised surface with prolonged duration. The device has been demonstrated to safe for its intended use. The subject device was evaluated for:
- Cytotoxicity .
- Sensitization
- Irritation
- Systemic toxicity
- Implantation
- Material-mediated pyrogenicity
Pre-Clinical Studies
A porcine wound healing study was carried out to evaluate the safety for the subject device, and the study results showed that the local tissue response to subject device is addressed for implantation biocompatibility endpoint.
8. SUBSTANTIAL EQUIVALENCE CONCLUSION:
Based on the comparison of intended use, design, materials, performance and biocompatibility testing, the subject device, LUOFUCON® PHMB Alginate Dressing/LUOFUCON® PHMB Antibacterial Alginate Wound Dressing, is determined to be Substantially Equivalent (SE) to the predicate devices, COPA AMD antimicrobial wound dressing (K082296) and LUOFUCON® Extra Silver Alginate Dressing (Prescription use)/ LUOFUCON® Antibacterial Alginate Wound Dressing (OTC Use)(K172554), in respect of safety and effectiveness.