(115 days)
Not Found
No
The device description and performance studies focus on the material properties and antimicrobial efficacy of the wound dressing, with no mention of AI or ML technologies.
Yes
The device is indicated for use in the management of various wounds, including post-surgical incisions, pressure sores, and ulcers, which are conditions addressed by therapeutic devices. Additionally, its description as a wound dressing that absorbs exudate, maintains a moist wound healing environment, and protects against bacterial penetration and colonization supports its therapeutic function in promoting wound healing.
No
The device is a wound dressing designed for management of wounds, not for diagnosis. It absorbs exudate and provides a barrier against bacteria, which are therapeutic functions.
No
The device description clearly outlines a physical wound dressing made of polyurethane foam with silicone adhesive, impregnated with PHMB. It describes material properties, absorption capabilities, and physical dimensions, indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the management of various types of wounds on the human body (post-surgical incisions, pressure sores, ulcers, burns, etc.). This is a direct application to the patient's body for therapeutic purposes.
- Device Description: The description details a wound dressing designed to absorb exudate, maintain a moist environment, and provide a barrier to bacterial penetration. These are all functions related to wound care on a living organism.
- Performance Studies: The performance studies mentioned are in-vitro (testing in a lab setting, but not on human samples for diagnostic purposes) and animal testing, focusing on the dressing's properties and effectiveness in a wound environment.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
In Vitro Diagnostics (IVDs) are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for the diagnosis, monitoring, or screening of diseases or conditions. This device does not fit that definition.
N/A
Intended Use / Indications for Use
Silicone 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, 1st and 2nd degree burns, dermatologic disorders, other wounds inflicted by trauma, and as a secondary dressing for packed wounds.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
The subject device, Silicone PHMB Foam Dressing, is a polyurethane foam trilaminate dressing impregnated with Polyhexamethylene Biguanide (PHMB), an agent that protects the dressing from bacterial penetration and colonization. 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 Silicone PHMB Foam Wound Dressing provides a barrier to bacterial penetration through the dressing and the PHMB prevents colonization and proliferation of bacteria within the dressing for up to 7 days. Silicone PHMB Foam Wound Dressing, when tested in-vitro has demonstrated to be effective against the following bacteria (MRSA, Streptococcus pyogenes, VRE, Escherichia coli, Klebsiella pneumoniae, Serratia marcescens) and yeast (Candida albicans) challenge organisms within the dressing.
The perforated wound contact layer contains a gentle silicone adhesive that provides secure, non-irritating adhesion and supports nontraumatic removal during dressing changes.
The device is presented in a border (adhesive) version. The dressing is supplied sterile in a range of sizes between 10.24 in2 to 64 in2.
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)
Performance data submitted in support of this 510k included in-vitro and animal testing.
Performance testing included total fluid handling, and peel adhesion. In addition broad spectrum activity was demonstrated to be effective against the following bacteria and yeast challenge organisms within the dressing:
Methicillin-Resistant S. aureus (MRSA)
Streptococcus pyogenes
Vancomycin-Resistant E. faecalis (VRE)
Escherichia coli
Klebsiella pneumonia
Serratia marcescens
Candida albicans
Biological evaluation for prolonged contact (
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.
July 25, 2019
Advanced Medical Solutions Ltd. Adam Gregory Senior RA Associate Premier Park, 33 Road One, Winsford Industrial Estate Winsford. CW7 3RT GB
Re: K190819
Trade/Device Name: Silicone PHMB Foam Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: June 28, 2019 Received: July 1, 2019
Dear Adam Gregory:
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 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,
Cynthia Chang, 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K190819
Device Name Silicone PHMB Foam Wound Dressing
Indications for Use (Describe)
Silicone 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, 1st and 2nd degree burns, dermatologic disorders, other wounds inflicted by trauma, and as a secondary 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the logo for Advanced Medical Solutions Ltd. The logo features a blue stylized letter A with a swoosh extending from the top right. Below the logo, the company name "Advanced Medical Solutions Ltd" is written in blue font.
510(k) Summary Statement
Submitted by:
Contact Person:
Date of Summary:
Trade Name:
Common Name:
Classification:
Classification Name:
Classification Code:
Advanced Medical Solutions Ltd Premier Park 33 Road One Winsford Industrial Estate Winsford Cheshire CW7 3RT Tel: +44 1606 863500 Fax: +44 1606 863600 Adam Gregory 25 July 2019 Silicone PHMB Foam Wound Dressing PHMB Wound Dressing Dressing, Wound, Drug Unclassified (Pre-amendment) Product code: FRO
Predicate Device(s): PHMB Foam Wound Dressing (K181197)
Image /page/3/Picture/7 description: The image shows two logos side-by-side. The logo on the left has a heart shape inside a circle with the letters "bsi." above the heart. The logo on the right has a crown above a check mark with the words "UKAS MANAGEMENT SYSTEMS" below the check mark. The number "003" is below the words. The text "Certificate No. MD78010" is below both logos.
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Image /page/4/Picture/1 description: The image shows the logo for Advanced Medical Solutions Ltd. The logo features a stylized blue "A" inside of a circle. The text "Advanced Medical Solutions Ltd" is written in blue below the logo.
The subject device, Silicone PHMB Foam Dressing, is a polyurethane Device Description: foam trilaminate dressing impregnated with Polyhexamethylene Biguanide (PHMB), an agent that protects the dressing from bacterial penetration and colonization. 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 Silicone PHMB Foam Wound Dressing provides a barrier to bacterial penetration through the dressing and the PHMB prevents colonization and proliferation of bacteria within the dressing for up to 7 days. Silicone PHMB Foam Wound Dressing, when tested in-vitro has demonstrated to be effective against the following bacteria (MRSA, Streptococcus pyogenes, VRE, Escherichia coli, Klebsiella pneumoniae, Serratia marcescens) and yeast (Candida albicans) challenge organisms within the dressing.
The perforated wound contact layer contains a gentle silicone adhesive that provides secure, non-irritating adhesion and supports nontraumatic removal during dressing changes.
The device is presented in a border (adhesive) version. The dressing is supplied sterile in a range of sizes between 10.24 in2 to 64 in2.
- Indication for Use: Silicone 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 and, as a secondary dressing or cover dressing for packed wounds.
- Substantial Equivalence: Silicone PHMB Foam Wound Dressing has substantially equivalent intended use, design, materials, labeling, and performance characteristics to the predicate device PHMB Foam Wound Dressing (K181197).
Image /page/4/Picture/9 description: The image contains two logos. The first logo on the left is the BSI (British Standards Institution) logo, which features the letters 'bsi' above a heart shape, all enclosed within a circle. The second logo on the right is the UKAS (United Kingdom Accreditation Service) Management Systems logo, which includes a crown above a checkmark and the text 'UKAS MANAGEMENT SYSTEMS' above the number '003'. Below both logos is the text 'Certificate No. MD78010'.
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Image /page/5/Picture/1 description: The image features the logo for Advanced Medical Solutions Ltd. The logo consists of a stylized letter "A" in blue, with a curved line extending from the top right of the "A". Below the logo, the text "Advanced Medical Solutions Ltd" is written in blue, with the words stacked on top of each other.
| Device Type | Subject | Predicate | Substantial
Equivalence |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Silicone PHMB Foam Wound
Dressing | PHMB Foam Wound Dressing | |
| Indications for Use | | | |
| Intended Use | Wound dressing containing
PHMB designed for the
management of wounds. | Wound dressing containing
PHMB designed for the
management of wounds. | Equivalent |
| Indications for
Use | 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
• as a secondary dressing or
cover dressing for packed
wounds. | 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
• as a secondary dressing or
cover dressing for packed
wounds. | Equivalent |
| Single Use | Yes | Yes | Equivalent |
| Materials | | | |
| | Polyurethane backing layer | Polyurethane backing layer | Comparison to
predicate device |
| | Polyurethane foam layer
containing Polyhexamethylene
Biguanide (PHMB) | Polyurethane foam layer
containing Polyhexamethylene
Biguanide (PHMB) | shows no new
questions of
safety or |
| Construction | Clear polyurethane wound
contact layer with silicone
adhesive | Clear polyurethane wound
contact layer with acrylic
adhesive | effectiveness,
and no change
to intended use
compared to
predicate or
reference device |
| Performance | | | |
| Exudate | A high absorbency capacity for | A high absorbency capacity for | Equivalent |
| Management | | | |
| | wound exudates and high total fluid handling | wound exudates and high total fluid handling | |
| Moist
Environment | Maintains a moist wound healing environment | Maintains a moist wound healing environment | Equivalent |
| Wound
Protection | Provides a barrier to bacterial penetration through the dressing | Provides a barrier to bacterial penetration through the dressing | Equivalent |
| Sterility | Yes, Ethylene Oxide | Yes, Gamma irradiation | Comparison to
predicate device
shows no new
questions of
safety or
effectiveness,
and no change
to intended use
compared to
predicate or
reference device |
Image /page/5/Picture/4 description: The image shows two logos side-by-side. The logo on the left is the BSI logo, which features the letters 'bsi' inside of a heart shape. The logo on the right is the UKAS Management Systems logo, which features a crown above the letters 'UKAS' and the words 'MANAGEMENT SYSTEMS'. Below the logos is the text 'Certificate No. MD78010'.
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Image /page/6/Picture/1 description: The image shows the logo for Advanced Medical Solutions Ltd. The logo features a stylized blue "A" with a swoosh extending from the top right. The text "Advanced Medical Solutions Ltd" is written in blue below the logo.
Advanced Medical Solutions Limited Premier Park, 33 Road One Winsford Industrial Estate Cheshire. CW7 3RT. UK Tel : +44 (0)1606 863500 Fax : +44 (0)1606 863600 Web : www.admedsol.com
Registered in England 2666957 VAT No. GB636 5551 27
Technological characteristics Silicone PHMB Foam Wound Dressing is a multi-layer one piece dressing design incorporating an absorbent polyurethane foam pad containing 0.8-1.1 %w/w PHMB which is efficacious against bacteria and yeast microorganisms within the dressing. The dressing is semi-occlusive allowing the exchange of gases such as oxygen and moisture, and has a film that provides a barrier to bacterial penetration through the dressing. The silicone wound contact layer contains a gentle silicone adhesive that provides secure, non-irritating adhesion and supports non-traumatic removal during dressing changes. Silicone PHMB Foam Wound Dressing is equivalent to the predicate device listed when compared to the technological characteristics such as design, materials, chemical composition, and manufacture and are supplied sterile for single use.
Image /page/6/Picture/7 description: The image contains two logos. The first logo on the left is the BSI (British Standards Institution) logo, which features the letters 'bsi' above a heart shape, all enclosed within a circle. The second logo on the right includes a crown above the letters 'UKAS' and the words 'MANAGEMENT SYSTEMS' with the number '003' below. The text 'Certificate No. MD78010' is located below the logos.
7
Image /page/7/Picture/1 description: The image shows the logo for Advanced Medical Solutions Ltd. The logo consists of a blue circular shape with a stylized "A" inside. The text "Advanced Medical Solutions Ltd" is written in blue below the logo. The logo is simple and professional, and the blue color gives it a sense of trust and reliability.
| Performance Testing
Summary: | Performance data submitted in support of this 510k included in-vitro
and animal testing. |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Performance testing included total fluid handling, and peel adhesion. In
addition broad spectrum activity was demonstrated to be effective
against the following bacteria and yeast challenge organisms within the
dressing:
Methicillin-Resistant S. aureus (MRSA)
Streptococcus pyogenes
Vancomycin-Resistant E. faecalis (VRE)
Escherichia coli
Klebsiella pneumonia
Serratia marcescens
Candida albicans |
| | Biological evaluation for prolonged contact (