(211 days)
Not Found
No
The device is a simple antimicrobial wound dressing. The summary does not mention any computational or analytical capabilities, let alone AI/ML. The performance studies focus on biological and physical properties, not algorithmic performance.
Yes.
The device is indicated to cover, protect, absorb exudate, and maintain moisture balance of wounds, and it incorporates an antimicrobial agent to inhibit bacterial growth, which are all therapeutic functions.
No
The device is an antimicrobial wound dressing designed to cover, protect, absorb exudate, and maintain moisture balance, rather than diagnose conditions.
No
The device is described as a physical dressing (gauze, super sponge, non-woven sponge) with an antimicrobial agent, indicating it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for covering and protecting wounds, absorbing exudate, and maintaining moisture balance. This is a topical application for wound care.
- Device Description: The description details a dressing with an antimicrobial agent. This is consistent with a wound dressing, not a diagnostic test performed in vitro (outside the body).
- Performance Studies: The performance studies focus on biocompatibility, sterilization residuals, seal strength, and antimicrobial effectiveness within the dressing. These are all relevant to a wound dressing's function and safety, not to diagnosing a condition or analyzing a sample from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
Antimicrobial gauze sponge dressing, antimicrobial super sponge dressing, and antimicrobial non-woven sponge dressing are indicated to cover and protect, absorb wound exudate, and maintain moisture balance of minor cuts, minor abrasions, minor lacerations, and minor burns.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
The devices are available in three configurations, which are Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing and Antimicrobial non-woven sponge dressing. All of them consist of (1) a dressing (base material) and (2) anti-microbial agent. For each configuration, it is available in several models, which are different in size and quantity of anti-microbial agent.
Based on in vitro testing, the product can achieve board spectrum antimicrobial effect within the dressing for Gram+ and Gram- Bacteria and Fungi. It has been shown to have 4 log bacterial reduction in vitro against the following test organisms: Staphylococcus aureus (ATCC 6538), Escherlchia coli (ATCC 25922), Candida albicans (ATCC 10231), Pseudomona aeruginosa (ATCC 9027) and Bacillus subtilis (ATCC 6633), Streptococcus pyogenes (ATCC 19615), Serratia marcescens (ATCC 31026), Aspergillus niger (ATCC 16404). The effective inhibition of bacteria is 7 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
Over-The-Counter Use (21 CFR 801 Subpart C)
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. Since the proposed device has the same device design as the primary predicate device, the tests performed for the primary predicate device can be leveraged for the proposed device. These tests including: cytotoxicity, skin sensitization, irritation, acute systemic toxicity, pyrogen, implantation and subacute systemic toxicity, bacterial endotoxin, antimicrobial effectiveness test, EO ECH residue test.
The performance test, including antimicrobial effectiveness test and liquid absorbency test were conducted on the proposed device.
The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests for In Vitro Cytotoxicity.
- ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals.
- ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization.
- ISO 10993-6:2016 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
- ISO 10993-11:2006 Biological Evaluation of Medical Devices- Part 11: Tests For Systemic Toxicity.
- ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials.
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- USP Bacterial Endotoxins Test
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Based on in vitro testing, the product can achieve board spectrum antimicrobial effect within the dressing for Gram+ and Gram- Bacteria and Fungi. It has been shown to have 4 log bacterial reduction in vitro against the following test organisms: Staphylococcus aureus (ATCC 6538), Escherlchia coli (ATCC 25922), Candida albicans (ATCC 10231), Pseudomona aeruginosa (ATCC 9027) and Bacillus subtilis (ATCC 6633), Streptococcus pyogenes (ATCC 19615), Serratia marcescens (ATCC 31026), Aspergillus niger (ATCC 16404).
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). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 13, 2023
Winner Medical Co., Ltd. Mingni Liu Regulatory Affairs Specialist Winner Industrial Park, No. 660 Bulong Road, Longhua District Shenzhen, Guangdong 518109 China
Re: K221755
Trade/Device Name: Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing
Regulatory Class: Unclassified Product Code: FRO Dated: December 15, 2022 Received: December 15, 2022
Dear Mingni Liu:
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
1
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 and Part 809 ); medical device reporting (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 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
2
Indications for Use
510(k) Number (if known) K221755
Device Name
Antimicrobial gauze sponge dressing: Antimicrobial super sponge dressing: Antimicrobial non-woven sponge dressing
Indications for Use (Describe)
Antimicrobial gauze sponge dressing, antimicrobial super sponge dressing, and antimicrobial non-woven sponge dressing are indicated to cover and protect, absorb wound exudate, and maintain moisture balance of minor abrasions, minor lacerations, and minor burns.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Tab#7 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K221755
- Date of Preparation: June 08, 2022 1.
-
- Sponsor Identification
Winner Medical Co., Ltd
Winner Industrial Park, No. 660 Bulong Road, Longhua District, Shenzhen City, Guangdong Province, 518109, China
Establishment Registration Number: 9616433
Contact Person: Mingni Liu Position: RA Engineer Tel: +86-755 28138888-8822 Fax:+86-755 28134588 Email:2346@winnermedical.com
3. Identification of Proposed Device
Trade Name: Antimicrobial gauze sponge dressing (OTC) Antimicrobial super sponge dressing (OTC) Antimicrobial non-woven sponge dressing (OTC)
Regulatory Information
Classification Name: Dressing, Wound, Drug; Classification: Unclassified; Product Code: FRO; Review Panel: General & Plastic Surgery;
Indications for use:
4
Antimicrobial gauze sponge dressing, antimicrobial super sponge dressing, and antimicrobial non-woven sponge dressing are indicated to cover and protect, absorb wound exudate, and maintain moisture balance of minor cuts, minor abrasions, minor lacerations, and minor burns.
Device Description-
The devices are available in three configurations, which are Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing and Antimicrobial non-woven sponge dressing. All of them consist of (1) a dressing (base material) and (2) anti-microbial agent. For each configuration, it is available in several models, which are different in size and quantity of anti-microbial agent.
Based on in vitro testing, the product can achieve board spectrum antimicrobial effect within the dressing for Gram+ and Gram- Bacteria and Fungi. It has been shown to have 4 log bacterial reduction in vitro against the following test organisms: Staphylococcus aureus (ATCC 6538), Escherlchia coli (ATCC 25922), Candida albicans (ATCC 10231), Pseudomona aeruginosa (ATCC 9027) and Bacillus subtilis (ATCC 6633), Streptococcus pyogenes (ATCC 19615), Serratia marcescens (ATCC 31026), Aspergillus niger (ATCC 16404). The effective inhibition of bacteria is 7 days.
5. Identification of Predicate Device
Primary Predicate Device 510(k) Number: K181315 Product Name: Antimicrobial gauze sponge dressing Antimicrobial super sponge dressing Antimicrobial non-woven sponge dressing
Secondary Predicate Device 510(k) Number: K070653 Product Name: Kendall Kerlix AMD Antimicrobial Gauze Dressing (OTC)
The Antimicrobial gauze sponge dressing (OTC)/ Antimicrobial super sponge dressing(OTC)/ Antimicrobial non-woven sponge dressing(OTC) for OTC use is substantially equivalent in intended use, function, and composition to Antimicrobial gauze sponge dressing/ Antimicrobial super sponge dressing/ Antimicrobial non-woven sponge dressing (Rx) cleared by FDA under 510(k) No. K181315. The primary purpose of this 510(k) is to allow OTC retail marketing of this dressing. Labeling of the OTC product has been revised to include added directions for use for a non-professional retail population.
-
- Non-Clinical Test Conclusion
5
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. Since the proposed device has the same device design as the primary predicate device, the tests performed for the primary predicate device can be leveraged for the proposed device. These tests including: cytotoxicity, skin sensitization, irritation, acute systemic toxicity, pyrogen, implantation and subacute systemic toxicity, bacterial endotoxin, antimicrobial effectiveness test, EO ECH residue test.
The performance test, including antimicrobial effectiveness test and liquid absorbency test were conducted on the proposed device.
The test results demonstrated that the proposed device complies with the following standards:
-
ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests for In Vitro Cytotoxicity.
-
ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals.
-
ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization.
-
ISO 10993-6:2016 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
-
ISO 10993-11:2006 Biological Evaluation of Medical Devices- Part 11: Tests For Systemic Toxicity.
-
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials.
- A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
-
USP Bacterial Endotoxins Test
-
- Clinical Test Conclusion
No clinical study is included in this submission.
-
- Substantially Equivalent (SE) Comparison
| Item | Proposed Device | Primary Predicate Device | Secondary Predicate Device |
|---|---|---|---|
| K181315 | K070653 | ||
| Product Code | FRO | FRO | FRO |
| Regulation | |||
| Number | NA | NA | NA |
Table 1 Comparison of Technology Characteristics
6
| Intended Use | Antimicrobial gauze sponge
dressing (OTC),
antimicrobial super sponge
dressing (OTC), and
antimicrobial non-woven
sponge dressing (OTC) are
indicated to cover and
protect, absorb wound
exudate, and maintain
moisture balance of minor
cuts, minor abrasions, minor
lacerations, and minor burns. | The Antimicrobial gauze
sponge dressing /
Antimicrobial super sponge
dressing / Antimicrobial non-
woven sponge dressing are
intended to use as primary or
secondary dressings for
exuding wounds, surgical
incisions, lacerations,
abrasions, first and second
degree burns, wound packing,
donor sites, catheter sites, I.V.
sites and central lines. Also
may be used for securement of
primary dressing. The
antimicrobial activity of the
PHMB and benzalkonium
chloride in dressing helps
resist bacterial colonization
within the dressing. | The Kendall Kerlix AMD
Antimicrobial Gauze
Dressing is intended for
OTC use. It is used as a
primary dressing for
exuding wounds, burns, as a
cover for surgical wounds,
and to secure and prevent
movement of primary
dressings. |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Single Use | Yes | Yes | Yes |
| Antimicrobial | Polyhexamethylene
Biguanide HCl
(PHMB)
Benzalkonium chloride
(BKC) | Polyhexamethylene Biguanide
HCl
(PHMB)
Benzalkonium chloride (BKC) | Polyhexamethylene
Biguanide HCl
(PHMB) |
| Antimicrobial
Time | 7 days | 7 days | Unknown |
| Sterilization | EO Sterilization | EO Sterilization | EO Sterilization |
| SAL | 10-6 | 10-6 | 10-6 |
| Material | Gauze rolls / Fluff gauze
rolls /
Non-woven,
Polyhexamethylene
Biguanide HCl
(PHMB)
Benzalkonium chloride
(BKC) | Gauze rolls / Fluff gauze rolls /
Non-woven,
Polyhexamethylene Biguanide
HCl
(PHMB)
Benzalkonium chloride (BKC) | Gauze rolls / Fluff gauze
rolls /
Polyhexamethylene
Biguanide HCl
(PHMB) |
| Biocompatibility | Comply with ISO 10993-5,
ISO 10993-10, ISO 10993-6
and ISO 10993-11 | Comply with ISO 10993-5,
ISO 10993-10, ISO 10993-6
and ISO 10993-11 | Comply with ISO 10993-1 |
9. Substantially Equivalent (SE) Conclusion
7
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.