(314 days)
Not Found
No
The device description focuses on the physical and chemical properties of a wound dressing and does not mention any computational or data-driven components.
Yes
The device is indicated for the management of various wounds, including ulcers and burns, and helps in wound healing by absorbing exudate, maintaining a moist environment, and reducing bacterial colonization, which are therapeutic actions.
No
The device is described as a sterile, single-use dressing for wound management, absorbing exudate and releasing silver ions to reduce bacterial colonization and maintain a moist healing environment. It does not perform any diagnostic function.
No
The device description clearly outlines a physical wound dressing with multiple layers and materials, including foam, silver compounds, polyurethane film, and silicone gel. It is a tangible, sterile, single-use product, not a software application.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this is a wound dressing applied directly to the wound surface to manage exudate and reduce bacterial colonization. It does not involve testing or analyzing samples taken from the body.
- The device's function is therapeutic and protective. It absorbs wound fluid, releases silver ions for antibacterial effect within the dressing, and maintains a moist environment for healing. These are all actions performed on the wound itself, not on a biological sample.
- The description focuses on the physical properties and function of the dressing. It details the layers, materials, and how it interacts with the wound environment. This is typical for a medical device intended for direct application to the body.
Therefore, this device falls under the category of a medical device, specifically a wound dressing, rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The proposed devices are indicated for the management of moderately to highly exuding wounds, such as leg and foot ulcers, pressure ulcers, diabetic foot ulcers, skin abrasions, surgical wounds, donor sites, 1st and 2nd degree burns.
Product codes
FRO
Device Description
It is a sterile, single-use dressing, the foam layer contain about 0.25-0.35mg/cm2 silver. The dressing absorbs wound exudate and releases silver ions within the dressing in the presence of wound fluid to help reduce bacterial colonization of the dressing. It also assists in maintaining a moist environment for optimal wound healing, and allows intact removal.
The proposed devices are available in four configurations:
The basic configuration, Ag Foam Dressing Non-adhesive, consist of a top layer (Vapor permeable and waterproof polyurethane film); a soft, absorbing polyurethane (PU) antimicrobial foam contain silver compounds adhered to the top film with acrylic adhesive. The film backing has the same area as the polyurethane foam layer. The is available in different sizes.
A second adhesive configuration, Ag Foam Dressing Adhesive, consists of a top layer (Vapor permeable and 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 release liner (covered on the foam pad and top film border part). The product line is available in different sizes.
A third adhesive configuration, Silicone Ag Foam Dressing, consists of a top layer (Vapor permeable and waterproof polyurethane film); a center layer (Absorbent polyurethane antibacterial foam pad containing silver compounds adhered to the top film); a wound contact layer (Perforated laminate of acrylic adhesive/polyurethane film/silicone gel, where the acrylic adhesive adheres to the top film, and the silicone gel is for skin adherence); a release liner covers on the silicone gel. The product line is available in different sizes.
A forth adhesive configuration, Silicone Ag Foam dressing with Border, consists of a top layer (Vapor permeable and waterproof polyurethane film); a center layer (A supper absorbent fiber pad, 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 light yellow or light brown appearance and is available in the form of pad and in different sizes packaged in pouches. All dressings 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.
Silicone Ag Foam Dressing and Silicone Ag Foam Dressing with Border are sterilized and sold directly to users after sterilized by EtO using conditions validated following ISO 11135-1: 2014. Ag Foam Dressing Non-adhesive and Ag Foam Dressing Adhesive are sterilized and sold directly to users after sterilized by irradiation using conditions validated following ISO 11137-2: 2013.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wounds
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications was Substantially Equivalent (SE) to the predicate 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 10993-11:2017 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.)
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/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 ADMINISTRATION' in blue text.
May 14, 2020
Winner Medical Co., Ltd. Dan Wang, Regulatory Affairs Specialist Winner Industrial Park, No. 660 Bulong Road, Longhua District Shenzhen City, Guangdong Province, 518109, China
Re: K191819
Trade/Device Name: Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border Regulatory Class: Unclassified Product Code: FRO
Dated: June 27, 2019 Received: July 5, 2019
Dear Dan Wang:
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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
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,
Anjana Jain, Ph.D. Acting 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) K191819
Device Name
Ag Foam Dressing Non-Adhesive; Ag Foam Dressing Adhesive; Silicone Ag Foam Dressing; Silicone Ag Foam Dressing with Border.
Indications for Use (Describe)
The proposed devices are indicated for the management of moderately to highly exuding wounds, such as leg and foot ulcers, pressure ulcers, diabetic foot ulcers, skin abrasions, surgical wounds, donor sites, 1st and 2nd degree burns.
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) |
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3
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: K191819 -
- Date Prepared: 05/14/2020
2. Submitter Identification
Winner Medical Co., Ltd.
Winner Industrial Park, No. 660 Bulong Road, Longhua District, Shenzhen City, Guangdong Province, 518109, China
Contact Person: Dan Wang
Position: Regulatory Affairs Specialist Tel: +86-755 28138888 Fax: +86-755 28134588 Email:wangdan@winnermedical.com
3. Identification of Proposed Device
Trade/Proprietary Name: Ag Foam Dressing Non-Adhesive Ag Foam Dressing Adhesive Silicone Ag Foam Dressing Silicone Ag Foam Dressing with Border Common name: Antimicrobial dressing
Regulatory Information
Classification Name: Dressing, Wound, Drug; Classification: Unclassified; Product Code: FRO; Review Panel: General & Plastic Surgery;
4. Identification of Predicate Device
Primary Predicate Device: 510(k) Number: K120828
4
Product Name: Biatain Silicone Ag Foam Dressings
Secondary Predicate Device: 510(k) Number: K100218 Product Name: Biatain Ag Foam Dressing
5. Device Description
It is a sterile, single-use dressing, the foam layer contain about 0.25-0.35mg/cm2 silver. The dressing absorbs wound exudate and releases silver ions within the dressing in the presence of wound fluid to help reduce bacterial colonization of the dressing. It also assists in maintaining a moist environment for optimal wound healing, and allows intact removal.
The proposed devices are available in four configurations:
The basic configuration, Ag Foam Dressing Non-adhesive, consist of a top layer (Vapor permeable and waterproof polyurethane film); a soft, absorbing polyurethane (PU) antimicrobial foam contain silver compounds adhered to the top film with acrylic adhesive. The film backing has the same area as the polyurethane foam layer. The is available in different sizes.
A second adhesive configuration, Ag Foam Dressing Adhesive, consists of a top layer (Vapor permeable and 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 release liner (covered on the foam pad and top film border part). The product line is available in different sizes.
A third adhesive configuration, Silicone Ag Foam Dressing, consists of a top layer (Vapor permeable and waterproof polyurethane film); a center layer (Absorbent polyurethane antibacterial foam pad containing silver compounds adhered to the top film); a wound contact layer (Perforated laminate of acrylic adhesive/polyurethane film/silicone gel, where the acrylic adhesive adheres to the top film, and the silicone gel is for skin adherence); a release liner covers on the silicone gel. The product line is available in different sizes.
5
A forth adhesive configuration, Silicone Ag Foam dressing with Border, consists of a top layer (Vapor permeable and waterproof polyurethane film); a center layer (A supper absorbent fiber pad, 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 light yellow or light brown appearance and is available in the form of pad and in different sizes packaged in pouches. All dressings 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.
Silicone Ag Foam Dressing and Silicone Ag Foam Dressing with Border are sterilized and sold directly to users after sterilized by EtO using conditions validated following ISO 11135-1: 2014. Ag Foam Dressing Non-adhesive and Ag Foam Dressing Adhesive are sterilized and sold directly to users after sterilized by irradiation using conditions validated following ISO 11137-2: 2013.
6. Intended Use Statement
The proposed devices are indicated for the management of moderately to highly exuding wounds, such as leg and foot ulcers, pressure ulcers, diabetic foot ulcers, skin abrasions, surgical wounds, donor sites, 1st and 2nd degree burns.
7. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications was Substantially Equivalent (SE) to the predicate 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.
6
- 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 10993-11:2017 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
8. Clinical Test Conclusion
No clinical study is included in this submission.
9. Substantially Equivalent (SE) Comparison
Silver Foam Dressing is compared with the following Predicate Device in terms of intended use, mechanism, material, and performance.
K120828, Biatain Silicone Ag Foam Dressings, Manufactured by Coloplast A/S.
K100218, Biatain Ag Foam Dressings, Manufactured by Coloplast A/S.
The following table shows similarities and differences of use, design, material, and processing
methods between propoesd device and two predicate devices.
These data came from commercially product labeling and 510(k) summary.
| Item | Proposed Device | Primary Predicate Device (K120828) | Secondary Predicate Device (K100218) |
|---|---|---|---|
| Product Code | FRO | FRO | FRO |
| Class | Unclassified | Unclassified | Unclassified |
| Intended Use | The proposed devices | ||
| are indicated for the | |||
| management of | |||
| moderately to highly | |||
| exuding wounds, such | |||
| as leg and foot ulcers, | |||
| pressure ulcers, diabetic | |||
| foot ulcers, traumatic | |||
| and surgical wounds, | |||
| donor sites, 1st and 2nd | |||
| degree burns. | Biatain Silicone Ag Foam | ||
| Dressings are indicated for | |||
| use in the management of | |||
| moderately to highly | |||
| exuding leg ulcers and | |||
| pressure sores. The | |||
| dressing can also be used | |||
| for 2nd degree bumns, | |||
| donor sites, post operative | |||
| wounds and skin abrasions. | Biatain Ag Foam Adhesive | ||
| & Non-Adhesive Dressings | |||
| are indicated for use in the | |||
| management of moderately | |||
| to highly exuding leg ulcers | |||
| and pressure sores. The | |||
| dressing | |||
| can also be used for 2nd | |||
| degree burns, donor sites, | |||
| post operative wounds and | |||
| skin abrasions. Biatain Ag | |||
| Foam Non-Adhesive | |||
| Dressings are additionally | |||
| indicated for diabetic foot | |||
| ulcers. | |||
| Mechanism | Polyurethane foam and | ||
| super absorbent fiber | |||
| pad for absorbing | |||
| liquid; | |||
| Silver compounds | |||
| present in the foam for | |||
| reducing bacteria | |||
| colonization in the | |||
| dressing; | |||
| Silicone soft contact | |||
| layer for self-adhesive; | |||
| Backing film for | |||
| waterproof. | Same | Same | |
| Material | Polyurethane film , | ||
| polyurethane | |||
| foam containing silver, | |||
| super absorbent fiber, | |||
| non- woven fabrics, | |||
| Silicone, | |||
| Release liner | Polyurethane film , | ||
| Polyurethane | |||
| foam containing silver, | |||
| Silicone contact layer, | |||
| Release liner | Polyurethane | ||
| foam containing silver, | |||
| Polyurethane film | |||
| Release liner | |||
| Antibacterial | |||
| Duration | 7 days | 7 days | 7 days |
| Single Use | Yes | Yes | Yes |
| Sterilization | Ag Foam Dressing | ||
| Non-Adhesive & | |||
| Ag Foam Dressing | |||
| Adhesive sterilization | Sterilization by: EtO | ||
| SAL: 10-6 | Sterilization by: Irradiation | ||
| SAL: 10-6 | |||
| Silicone Ag Foam | |||
| Dressing & | |||
| Silicone Ag Foam | |||
| Dressing with Border | |||
| sterilization byEtO. | |||
| SAL: 10-6 | |||
| Biocompatibility | Biocompatibility in | ||
| accordance to 10993- | |||
| 1(breached or | |||
| compromised surfaces | |||
| with prolonged | |||
| contact(>24h to 30d)) | Biocompatibility in | ||
| accordance to 10993- | |||
| 1(breached or | |||
| compromised surfaces with | |||
| prolonged contact(>24h to | |||
| 30d)) | Biocompatibility in | ||
| accordance to 10993- | |||
| 1(breached or compromised | |||
| surfaces with prolonged | |||
| contact(>24h to 30d)) |
Table 1 Comparison of intended use and Technological Characteristics
7
8
The proposed device has same intended use, and similar technological characteristics to the predicate device. In order to address the questions raised from differences in technological characteristics, biocompatibility tests according to 10993-1 were conducted. These are no new questions of the safety and efficacy raised.
10. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.