(249 days)
Not Found
No
The device description and performance studies focus on the physical properties and antibacterial effectiveness of a wound dressing, with no mention of AI or ML.
Yes
The device, PHMB Wound Dressing, is intended for use in the management and healing of various wounds, including post-surgical incisions, pressure sores, ulcers, burns, and abrasions. Its function to absorb wound exudates and resist bacterial colonization directly contributes to the healing process, which is a therapeutic effect.
No
The device is a wound dressing designed for the management and absorption of wound exudates, intended for therapeutic rather than diagnostic purposes.
No
The device description clearly states it is a sterile wound dressing made of physical materials (polyester viscose non-woven backing, absorbent pad, PET film, acrylic adhesive). It is a physical product, 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 external injuries.
- Device Description: The description details a sterile wound dressing designed to absorb exudates and resist bacterial colonization within the dressing. This aligns with the function of a wound care product.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease or condition, or to collect, prepare, or examine a specimen taken from the human body for diagnostic purposes. The antibacterial activity is within the dressing itself, not for analyzing a patient sample.
- Performance Studies: The performance studies focus on the physical properties of the dressing, sterilization, biocompatibility, and the antibacterial effectiveness within the dressing. These are relevant to a wound care product, not an IVD.
IVD devices are used to perform tests on samples (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such tests.
N/A
Intended Use / Indications for Use
Prescription Use: PHMB Wound Dressings are indicated for use in the management of post-surgical incisions, pressure sores, venous stass ulcers, diabetic ulcers, donor sites, abrasions, first and superficial second degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds.
OTC Use: For Over-the-Counter Use, PHMB Wound Dressing is used for minor lacerations, minor lacerations, minor cuts, minor scalds, and minor burns.
Product codes
FRO
Device Description
The proposed device PHMB Wound Dressing is a sterile wound dressing. It is used as a primary or secondary dressing to absorb wound exudates. Based on in vitro testing, the antibacterial agent PHMB in dressing helps to resist bacterial colonization within the dressing for up to 7 days.
The proposed device is available in two configurations,
The first one, PHMB Island Wound Dressing with acrylic adhesive, consists of a polyester viscose non-woven backing layer coated with acrylic adhesive as the top layer, a center soft absorbent pad which is made of non-woven fabric containing 0.2 % PHMB and it is laminated with the PET film, and a release liner covers on the top adhesive layer border part.
The second one, PHMB Pad Wound Dressing, only consists of a soft absorbent pad containing 0.2 % PHMB and the non-woven absorbent pad is laminated with the PET film.
The PHMB Island Wound Dressings with acrylic adhesive are supplied in a range of sizes within the range from 25 cm² to 400 cm², while for PHMB Pad Wound Dressings are supplied in a range of sizes within the range from 25 cm². For each configuration, it has exactly the same materials, chemicals, and physical properties and are different only in size.
All variants of proposed device, PHMB Wound Dressing, are sterilized by Ethylene Oxide using conditions validated following ISO 11135:2014.
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)
Non-clinical tests were conducted to verify that the proposed device met all design specifications and 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 10993-6:2016 Biological Evaluation of Medical Devices- Part 6: Tests for Local Effects after implantation.
- 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-NF:2021 Bacterial Endotoxins Test
PHMB Wound Dressing in vitro testing has demonstrated ≥ 4 log-reduction of four gram positive bacteria (Vancomycin-resistant enterococcus (VRE), Bacillus subtilis, Staphylococcus aureus and Methicillin-resistant Staphylococcus aureus (MRSA)), four gram negative bacteria (Serratia marcescens, Pseudomonas aeruginosa, Escherichia coli, and Klebsiella pneumonia) challenge organisms within the dressing for up to 7 days. This testing was performed using a modified AATCC 100 method.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Antibacterial Effectiveness: ≥4 Log reduction
Antibacterial Duration: 7 days
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). 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 is in blue and includes the agency's name, "U.S. Food & Drug Administration."
January 30, 2023
Winner Medical Co., Ltd. Yi Fu Regulatory Affairs Specialist 660 Bulong Road, Longhua District Shenzhen, China
Re: K221532
Trade/Device Name: PHMB Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: January 14, 2023 Received: January 17, 2023
Dear Yi Fu:
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
1
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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
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) K221532
Device Name PHMB Wound Dressing
Indications for Use (Describe)
Prescription Use:
PHMB Wound Dressings are indicated for use in the management of post-surgical incisions, pressure sores, venous stass ulcers, diabetic ulcers, donor sites, abrasions, first and superficial second degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds.
OTC Use:
For Over-the-Counter Use, PHMB Wound Dressing is used for minor lacerations, minor lacerations, minor cuts, 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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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: __K221532
-
- Date of Submission: January 26th, 2023
2. Submitter Identification
Winner Medical Co., Ltd.
Winner Industrial Park, No. 660 Bulong Road, Longhua District, Shenzhen City, Guangdong Province, 518109, China
Contact Person: Yi Fu
Position: Regulatory Affairs Specialist Tel: +86-755 28138888 Fax: +86-755 28134588 Email: 3911 @winnermedical.com
3. Identification of Proposed Device
Trade/Proprietary Name: PHMB Wound Dressing Common name: Antibacterial Wound 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: K192463
Product Name: PHMB Foam Dressing Non-Adhesive,
PHMB Foam Dressing Adhesive
Silicone PHMB Foam Dressing
Silicone PHMB Foam Dressing with Border
Manufacturer: Winner Medical Co., Ltd.
4
Secondary Predicate Device: K121522
Product Name: Poly FIT™+ Absorbing Antimicrobial Dressings (OTC)
Poly FITTM+ High Absorbing Antimicrobial Dressings (OTC) Manufacturer: PolyRemedy, Inc.
5. Device Description
The proposed device PHMB Wound Dressing is a sterile wound dressing. It is used as a primary or secondary dressing to absorb wound exudates. Based on in vitro testing, the antibacterial agent PHMB in dressing helps to resist bacterial colonization within the dressing for up to 7 days.
The proposed device is available in two configurations,
The first one, PHMB Island Wound Dressing with acrylic adhesive, consists of a polyester viscose non-woven backing layer coated with acrylic adhesive as the top layer, a center soft absorbent pad which is made of non-woven fabric containing 0.2 % PHMB and it is laminated with the PET film, and a release liner covers on the top adhesive layer border part.
The second one, PHMB Pad Wound Dressing, only consists of a soft absorbent pad containing 0.2 % PHMB and the non-woven absorbent pad is laminated with the PET film.
The PHMB Island Wound Dressings with acrylic adhesive are supplied in a range of sizes within the range from 25 cm² to 400 cm², while for PHMB Pad Wound Dressings are supplied in a range of sizes within the range from 25 cm². For each configuration, it has exactly the same materials, chemicals, and physical properties and are different only in size.
All variants of proposed device, PHMB Wound Dressing, are sterilized by Ethylene Oxide using conditions validated following ISO 11135:2014.
6. Intended Use Statement
Prescription Use:
PHMB Wound Dressings are indicated for use in the management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, first and superficial second degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds.
5
OTC Use:
For Over-the-Counter Use, PHMB Wound Dressing is used for minor abrasions, minor lacerations, minor cuts, minor scalds, and minor burns.
7. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications and 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 10993-6:2016 Biological Evaluation of Medical Devices- Part 6: Tests for Local Effects after implantation.
- 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-NF:2021 Bacterial Endotoxins Test
PHMB Wound Dressing in vitro testing has demonstrated ≥ 4 log-reduction of four gram positive bacteria (Vancomycin-resistant enterococcus (VRE), Bacillus subtilis, Staphylococcus aureus and Methicillin-resistant Staphylococcus aureus (MRSA)), four gram negative bacteria (Serratia marcescens, Pseudomonas aeruginosa, Escherichia coli, and Klebsiella pneumonia) challenge organisms within the dressing for up to 7 days. This testing was performed using a modified AATCC 100 method.
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8. Clinical Test Conclusion
No clinical study is included in this submission.
9. Substantially Equivalent (SE) Comparison
The subject devices are compared with the following Predicate Devices in terms of intended use, mechanism, material, specifications, and performance. These data came from commercially product labeling and 510(k) summary.
Note: There are four available configurations in PHMB Foam Dressing (K192463). For SE comparison, the configuration-PHMB Foam Dressing Adhesive is mainly used in SE comparison, particularly in material components, technology, principle of operation, sizes and performance characteristics. This configuration, PHMB Foam Dressing Adhesive, of the primary predicate device is chosen because the dressing structure of proposed device (PHMB Island Wound Dressing) is most similar to PHMB Foam Dressing Adhesive configuration. PHMB Pad Wound Dressing is exactly the same as the absorbent pad contained in the PHMB Island Wound Dressing with acrylic adhesive.
| Item | Subject Device
K221532 | Primary Predicate
Device
K192463 | Secondary Predicate
Device
K121522 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | FRO | FRO | FRO |
| Class | Unclassified | Unclassified | Unclassified |
| Intended Use | Prescription Use:
PHMB Wound
Dressings are indicated
for use in the
management of post-
surgical incisions,
pressure sores, venous
stasis ulcers, diabetic
ulcers, donor sites,
abrasions, lacerations,
first and superficial
second degree burns, | Prescription Use:
PHMB Foam Dressing
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 | Prescription Use:
Under the supervision of
a healthcare professional,
PolyFITTM + Absorbing
Antimicrobial Dressings
and PolyFITTM + High
Absorbing Antimicrobial
Dressings may be used
for the management
of:PolyFITTM +
Absorbing Antimicrobial
Dressings are intended as |
| | dermatologic disorders,
other wounds inflicted
by trauma and, as a
secondary dressing or
cover dressing for
packed wounds.
Over-the-Counter Use:
For Over-the-Counter
Use, PHMB Wound
Dressing is used for
minor abrasions, minor
lacerations, minor cuts,
minor scalds, and minor
burns. | inflicted by trauma and,
as a secondary dressing
or cover dressing for
packed wounds. | effective barriers to
inhibit microbial
proliferation within the
dressing and reduce
microbial penetration
through the dressing.
PolyFITTM + Absorbing
Antimicrobial Dressings
are for use as adjunctive
treatment in the
management of
exudating wounds,
partial and full-thickness
wounds, such as pressure
ulcers lower extremity
ulcers (venous or
arterial), diabetic foot
ulcers, surgical or
traumatic wounds
(including those left
open to heal by
secondary intention).
They are not intended for
wounds with exposed
tendon or bone, for 3rd
degree burns or for dry
wounds.
Over-the-Counter Use:
For Over-the-Counter
Use, PolyFITTM+
Absorbing Antimicrobial
Dressings and
PolyFITTM+ High
Absorbing Antimicrobial
Dressings may be used
for minor abrasions,
minor lacerations, minor
cuts, minor scalds, and
minor burns. |
| Material
components | Polyester viscose non-
woven fabrics layer with
acrylic adhesive; | For PHMB Foam
Dressing Adhesive, the
dressing contains:
Polyurethane top layer | Fibers containing
polyethylene oxide
(PEO), polyethylene-co-
vinly-alcohol (EVOH), |
| | | | |
| | 100% cotton absorbent
pad;
PHMB;
PET film;
Release liner. | with acrylic adhesive;
Thin non-woven fabrics
layer;
Polyurethane foam
absorbent pad;
PHMB;
Release liner. | polycaprolactone (PCL)
and PHMB. |
| Technology | Absorbent pad is made
of cotton which is
impregnated with 0.2%
(w/w) PHMB | Absorbent pad is made
of a thin non-woven and
polyurethane foam
impregnated with 0.5%
(w/w) PHMB | Dressing is made of
gelling fibers which is
embedded with 0.3%
PHMB |
| Characteristics | • Absorbent pad
laminated with PET
film absorbs exudates
• PHMB resists bacterial
colonization within the
dressing
• Island model has
adhesive border for
self-adhesive | • Absorbent foam pad
absorbs exudates
• PHMB resists bacterial
colonization within the
dressing
• Island model has
adhesive border for
self-adhesive | • Fibers absorbs
exudates
• PHMB inhibits
microbial proliferation
within the dressing and
reduce microbial
penetration through the
dressing. |
| Principle of
operation | Absorbent pad for
absorbing liquid;
PHMB presents in the
center absorbent pad to
resist bacterial
colonization within the
dressing; | Polyurethane foam pad
for absorbing liquid;
PHMB presents in the
center absorbent foam
pad to resist bacterial
colonization within the
dressing; | Fiber for absorbing
liquid;
PHMB embedded in the
fibers ensures that when
bacteria come in contact
with PHMB molecule
the outer cell wall of the
bacteria is disrupted. |
| Model | Island Model and
Pad Model | Island Model and
Pad Model | NA |
| Antibacterial
Effectiveness | ≥4 Log reduction | ≥4 Log reduction | Not publicly available |
| Antibacterial
Duration | 7 days | 7 days | Not publicly available |
| Single use | Yes | Yes | Yes |
| Sterilization | EtO Sterilization | PHMB Foam Dressing
Adhesive sterilized by
Gamma irradiation | Not publicly available |
| Bio-
compatibility | Biocompatibility in
accordance to 10993-1 | Biocompatibility in
accordance to 10993-1 | Biocompatibility in
accordance to 10993-1 |
Table 1. Comparison of Intended use, Design and Technological Characteristics
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8
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10. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the subject devices are determined to be
Substantially Equivalent (SE) to the predicate devices.