(248 days)
Not Found
No
The description focuses on the material composition and antimicrobial properties of the wound dressing, with no mention of AI or ML.
Yes
The device is indicated for managing various wounds, including burns, ulcers, and post-surgical incisions, which are conditions that require therapeutic intervention for healing.
No
The device description indicates that these are wound dressings, which are used for treatment and management of wounds, not for diagnosis.
No
The device description clearly states that the device is a sterile, single-use dressing made of polyurethane foam containing PHMB, which is a physical material. This indicates it is a hardware medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a wound dressing for managing various types of wounds. This is a topical application for treating the wound itself, not for diagnosing a condition based on in vitro analysis of biological samples.
- Device Description: The description details a sterile, single-use dressing with a foam structure and an antimicrobial agent (PHMB). This aligns with the characteristics of a wound care product, not an in vitro diagnostic device.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.) outside of the body to provide diagnostic information. The "in vitro performance data" mentioned refers to testing the effectiveness of the PHMB against bacteria within the dressing, not for diagnosing an infection in a patient.
- Performance Studies: The performance studies focus on biocompatibility, antimicrobial effectiveness of the dressing, and physical properties relevant to a wound dressing (sterility, seal integrity, etc.). These are not the types of studies typically conducted for IVD devices, which would involve evaluating diagnostic accuracy (sensitivity, specificity, etc.) in relation to a clinical condition.
In summary, the device's function is to treat wounds topically, which falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The proposed devices are indicated for use in the management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, 1st and 2nd degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds.
Product codes
FRO
Device Description
The subject devices are sterile, single-use dressings, the polyurethane foam contain about 0.5% (w/w) Polyhexamethylene Biguanide (PHMB), an agent that is intended to resist bacterial colonization within the dressing. The foam in the dressings has a microporous hydrophilic foam structure that absorbs wound exudate and maintains a moist wound healing environment.
Based on in vitro performance data, the PHMB Foam Wound Dressings have demonstrated to be effective against colonization and proliferation of bacteria within the dressing for up to 7 days.
The proposed device in this submission consists of four variants:
The basic one, PHMB Foam Dressing Non-adhesive, consist of a film backing laminated of acrylic adhesive (Vapor permeable and waterproof polyurethane film); a soft, absorbing polyurethane (PU) antimicrobial foam contain PHMB adhered to the top film with acrylic adhesive. The film backing has the same size with the polyurethane foam layer. The product line is available in different sizes.
A second adhesive variant, PHMB 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 PHMB adhered to the top film, and the top film remained with a border); a release liner (covered on the foam pad and top film border part). The product line is available in different sizes.
A third adhesive variant, Silicone PHMB Foam Dressing, consists of a top layer (Vapor permeable and waterproof polyurethane film); a center layer (Absorbent polyurethane antibacterial foam pad containing PHMB adhered to the top film); a wound contact layer (Perforated silicone gel adhered to the center layer); a release liner covers on the silicone gel. The product line is available in different sizes.
A forth adhesive variant, Silicone PHMB 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 PHMB adhered to the top film, and the top film remained with a border); a wound contact layer (Perforated silicone gel adhered to the center layer); a release liner (covered on the silicone gel).
Silicone PHMB Foam Dressing and Silicone PHMB Foam Dressing with Border are sterilized by EtO using conditions validated following ISO 11135: 2014.
PHMB Foam Dressing Non-adhesive and PHMB Foam Dressing Adhesive are 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
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
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.
- A.STM 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
Biocompatibility tests according to 10993-1 and antimicrobial effectiveness tests according to modified AATCC 100 were conducted.
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/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.
May 14, 2020
Winner Medical Co., Ltd. Dan Wang Regulatory Affairs Specialist Winner Industrial Park, No. 660 Bulong Road, Longhua District Shenzhen, 518109CN
Re: K192463
Trade/Device Name: PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border Regulatory Class: Unclassified Product Code: FRO Dated: April 10, 2020 Received: April 14, 2020
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/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
1
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.
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) K192463
Device Name
PHMB Foam Dressing Non-Adhesive; PHMB Foam Dressing Adhesive; Silicone PHMB Foam Dressing; Silicone PHMB Foam Dressing with Border.
Indications for Use (Describe)
The proposed devices are indicated for use in the management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, 1st and 2nd degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds.
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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K192463 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: K192463
-
- Date of Submission: 09/04/2019
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: PHMB Foam Dressing Non-Adhesive PHMB Foam Dressing Adhesive Silicone PHMB Foam Dressing Silicone PHMB 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
Predicate Device
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510(k) Number: K181197
Product Name: PHMB Foam Wound Dressing
5. Device Description
The subject devices are sterile, single-use dressings, the polyurethane foam contain about 0.5% (w/w) Polyhexamethylene Biguanide (PHMB), an agent that is intended to resist bacterial colonization within the dressing. The foam in the dressings has a microporous hydrophilic foam structure that absorbs wound exudate and maintains a moist wound healing environment.
Based on in vitro performance data, the PHMB Foam Wound Dressings have demonstrated to be effective against colonization and proliferation of bacteria within the dressing for up to 7 days.
The proposed device in this submission consists of four variants:
The basic one, PHMB Foam Dressing Non-adhesive, consist of a film backing laminated of acrylic adhesive (Vapor permeable and waterproof polyurethane film); a soft, absorbing polyurethane (PU) antimicrobial foam contain PHMB adhered to the top film with acrylic adhesive. The film backing has the same size with the polyurethane foam layer. The product line is available in different sizes.
A second adhesive variant, PHMB 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 PHMB adhered to the top film, and the top film remained with a border); a release liner (covered on the foam pad and top film border part). The product line is available in different sizes.
A third adhesive variant, Silicone PHMB Foam Dressing, consists of a top layer (Vapor permeable and waterproof polyurethane film); a center layer (Absorbent polyurethane antibacterial foam pad containing PHMB adhered to the top film); a wound contact layer (Perforated silicone gel adhered to the center layer); a release liner covers on the silicone gel. The product line is available in different sizes.
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A forth adhesive variant, Silicone PHMB 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 PHMB adhered to the top film, and the top film remained with a border); a wound contact layer (Perforated silicone gel adhered to the center layer); a release liner (covered on the silicone gel).
Silicone PHMB Foam Dressing and Silicone PHMB Foam Dressing with Border are sterilized by EtO using conditions validated following ISO 11135: 2014.
PHMB Foam Dressing Non-adhesive and PHMB Foam Dressing Adhesive are sterilized by irradiation using conditions validated following ISO 11137-2: 2013.
6. Intended Use Statement
The proposed devices are indicated for use in the management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions , lacerations , 1st and 2nd degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds.
7. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specification s 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.
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- ISO 10993-11:2017 Biological Evaluation Of Medical Devices- Part 11: Tests For Systemic Toxicity.
- A.STM 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
The proposed devices are compared with the following Predicate Device in terms of intended use, mechanism, material, specifications, and performance.
K181197, PHMB Foam Wound Dressing, Manufactured by Advanced Medical Solutions Ltd.
The following table shows similarities and differences of use, design, material, and processing between the subject device and the predicate device.
These data came from commercially product labeling and 510(k) summary.
| Item | Proposed Devices | Predicate Device
(K181197) | Substantial
Equivalence |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Product Code | FRO | FRO | SE |
| Class | Unclassified | Unclassified | SE |
| Intended Use | The proposed devices are
indicated for use in the
management of post-surgical
incisions, pressure sores,
venous stasis ulcers, diabetic
ulcers, donor sites, abrasions ,
lacerations, 1st and 2nd degree
burns, dermatologic disorders,
other wounds inflicted by
trauma and, as a secondary | PHMB Foam Wound
Dressings are indicated for use
in the management of post-
surgical incisions, pressure
sores, venous stasis ulcers,
diabetic ulcers, donor sites,
abrasions, lacerations, 1st and
2nd degree burns,
dermatologic disorders, other
wounds inflicted by trauma | SE |
| | cover dressing for | and, as a secondary dressing or | |
| | packed wounds. | cover dressing for packed wounds. | |
| Mechanism | Polyurethane foam and super absorbent fiber pad for absorbing liquid;
PHMB present in the foam for reducing bacteria
colonization in the dressing;
Silicone soft contact layer for self-adhesive;
Backing film for vapor permeable and waterproof. | Polyurethane foamfor absorbing liquid;
PHMB present in the foam for reducing bacteria colonization in the dressing;
Clear polyurethane wound contact layer with acrylic adhesive for self-adhesive;
Backing film for vaporpermeable and waterproof. | SE |
| Material | Polyurethane film, polyurethane foam contain PHMB, release liner, some with super absorbent fiber, non - woven fabrics or | Polyurethane film, Polyurethane foam containing PHMB,
Clear polyurethane with acrylic adhesive | No new questions of safety or effectiveness raised. |
| Antimicrobial
Effectiveness | Reduction of Staphylococcus aureus, Escherlchia coli, Candida albicans, Pseudomona aeruginosa, MRSA, VRE, Klebsiella | Reduction of MRSA, MRSE, VRE, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumonia, Candida albicans, Rhodotorula mucilaginosa > 4 log | SE |
| Antibacterial
Duration | 7days | 7days | SE |
| Single Use | Yes | Yes | SE |
| Sterilization | PHMB Foam Dressing Non- Adhesive,
PHMB Foam Dressing Adhesive sterilized by irradiation;
Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border | Irradiation | |
| Biocompatibility | Biocompatibility in accordance to 10993-1(breached or compromised surfaces with prolonged | 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
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8
The proposed device has the 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 and antimicrobial effectiveness s tests according to modified AATCC 100 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.