(159 days)
Not Found
No
The device description and performance studies focus on the material properties and antimicrobial efficacy of a wound dressing, with no mention of AI or ML technologies.
No
This device is a wound dressing designed to manage various types of wounds by absorbing exudate and providing an antimicrobial barrier. It is not described as a device that delivers therapy or treatment for the underlying disease.
No
The device is a wound dressing designed for management and protection of wounds, not for diagnosis.
No
The device description clearly describes a physical wound dressing made of polyurethane foam, silicone adhesive, and impregnated with PHMB. It is a tangible, physical medical 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. This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the physical properties of the dressing (foam structure, silicone adhesive) and its antimicrobial function to protect the dressing itself and the wound from bacterial penetration and colonization. This is a treatment mechanism, not a diagnostic test.
- Performance Studies: The performance studies described are related to the dressing's ability to absorb exudate, maintain a moist environment, act as a bacterial barrier, and its antimicrobial efficacy within the dressing. These are all related to the dressing's function as a wound treatment.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (like blood, urine, tissue), detect biomarkers, or provide information for diagnosis.
In summary, the Antimicrobial Silicone PHMB Foam Wound Dressing is a therapeutic device designed to treat wounds, not a diagnostic device used to identify diseases or conditions.
N/A
Intended Use / Indications for Use
Antimicrobial 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,
- · superficial and partial thickness burns,
- · dermatologic disorders,
- · other wounds inflicted by trauma and,
- · as a secondary dressing or cover dressing for packed wounds.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Antimicrobial Silicone PHMB Foam Wound 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 dressing has a microporous hydrophilic foam structure that absorbs wound exudate and maintains a moist wound healing environment.
Based on in vitro performance data, the Antimicrobial Silicone PHMB Foam Wound Dressing provides a barrier to bacterial penetration through the dressing and the PHMB prevents colonization and proliferation of bacteria, yeast and mold within the dressing for up to 7 days. Antimicrobial Silicone PHMB Foam Wound Dressing, when tested in-vitro has demonstrated to be effective against gram positive bacteria, gram negative bacteria, yeast and mold challenge organisms within the dressing.
The perforated wound contact layer contains a gentle silicone adhesive that provides secure, nonirritating adhesion and supports non-traumatic 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 (64cm) to 64 in² (400cm).
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)
Microbial efficacy performance data submitted in support of this 510(k) includes in-vitro testing against a mold challenge organism. Testing was performed on real time aged predicate device in accordance with the well-established modified AATCC TM 100 method previously used for the predicate device.
No other performance tests were conducted for this submission. All performance data leveraged from the predicate device was submitted as part of the original 510(k) submission of the predicate, Silicone PHMB Foam Wound Dressing (K190819) and includes:
Biocompatibility
ISO 10993-1; Biological evaluation of medical devices USP 41-NF36; Pyrogenic Test
Performance testing
BS EN 13726-1; Test methods for primary wound dressings – aspects of absorbency. BS EN 13726-2; Test methods for primary wound dressings – moisture vapour transmission rate of permeable film dressings. BS EN 13726-3; Test methods for primary wound dressings - waterproofness. ASTM D6282-11; Standard Test Method for 90 Degree Peel Resistance of Adhesives. Bacterial barrier.
Distribution
ASTM D4169 – Standard Practice for Performance Testing of Shipping Containers and Systems
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Silicone PHMB Foam Wound Dressing (K190819)
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 contains 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 5, 2023
Advanced Medical Solutions Limited Kay McGrath Regulatory Affairs Specialist Premier Park, 33 Road One Winsford Industrial Estate Winsford, Cheshire CW7 3RT United Kingdom
Re: K223310
Trade/Device Name: Antimicrobial Silicone PHMB Foam Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: March 6, 2023 Received: March 6, 2023
Dear Kay Mcgrath:
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) K223310
Device Name
Antimicrobial Silicone PHMB Foam Wound Dressing
Indications for Use (Describe)
Antimicrobial 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,
- · superficial and partial thickness burns,
- · dermatologic disorders,
- · other wounds inflicted by trauma and,
- · as a secondary dressing or cover dressing for packed wounds.
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for Advanced Medical Solutions Ltd. The logo features a stylized blue "A" with a swoosh above the text. The text "Advanced Medical Solutions Ltd" is written in blue font below the "A" symbol.
Advanced Medical Solutions Limited Premier Park, 33 Road One, Winsford Industrial Estate, Winsford, Cheshire, CW7 3RT, UK Tel: +44 (0) 1606 863500 Fax: +44 (0) 1606 863600 Web: www.admedsol.com Registered in England 2666957 VAT No. GB 636 5551 27
K223310
510(k) Summary
| Submitted by: | Advanced Medical Solutions Ltd
Premier Park
33 Road One
Winsford Industrial Estate
Winsford
Cheshire
CW7 3RT
Tel: +44 1606 863500 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kay McGrath |
| Date of Summary: | April 04, 2023 |
| Trade Name: | Antimicrobial Silicone PHMB Foam Wound Dressing |
| Common Name: | Wound Dressing |
| Classification Name: | Dressing, Wound, Drug |
| Classification: | Unclassified (Pre-amendment) |
| Classification Code: | Product code: FRO |
| Predicate Device(s): | Silicone PHMB Foam Wound Dressing (K190819) |
Image /page/3/Picture/5 description: The image contains two logos. The first logo is for the UK Authorised Economic Operator, and it features the letters AEO in bold black font, with a map of the UK inside of a circle. The second logo is for BSI, and it features the letters BSI in a circle above the words UKAS MANAGEMENT SYSTEMS 0003.
Certificate No. MD 78010
Page 1 of 5
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Image /page/4/Picture/0 description: The image shows the logo for Advanced Medical Solutions Ltd. The logo features a blue stylized letter "A" with a curved line extending from the top right. Below the logo, the text "Advanced Medical Solutions Ltd" is written in blue.
K223310
Device Antimicrobial Silicone PHMB Foam Wound Dressing, is a polyurethane foam trilaminate dressing Description: impregnated with Polyhexamethylene Biguanide (PHMB), an agent that protects the dressing from bacterial penetration and colonization. The foam in the dressing has a microporous hydrophilic foam structure that absorbs wound exudate and maintains a moist wound healing environment.
Based on in vitro performance data, the Antimicrobial Silicone PHMB Foam Wound Dressing provides a barrier to bacterial penetration through the dressing and the PHMB prevents colonization and proliferation of bacteria, yeast and mold within the dressing for up to 7 days. Antimicrobial Silicone PHMB Foam Wound Dressing, when tested in-vitro has demonstrated to be effective against gram positive bacteria, gram negative bacteria, yeast and mold challenge organisms within the dressing.
The perforated wound contact layer contains a gentle silicone adhesive that provides secure, nonirritating adhesion and supports non-traumatic 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 (64cm) to 64 in2 (400cm).
Indications for Antimicrobial Silicone PHMB Foam Wound Dressing is indicated for use in the management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, Use: lacerations, superficial and partial thickness burns, dermatologic disorders, other wounds inflicted by trauma and as a secondary dressing or cover dressing for packed wounds.
Image /page/4/Picture/8 description: The image contains two logos. The first logo is for the UK Authorized Economic Operator, and it features the letters "AEO" in bold, black font, followed by the words "UK Authorized Economic Operator" in a smaller font. To the right of the letters is a black circle containing a white outline of the United Kingdom. The second logo is for BSI (British Standards Institution) and UKAS (United Kingdom Accreditation Service). The BSI logo features the letters "bsi" above a heart-shaped symbol, while the UKAS logo features a crown above a checkmark, with the words "UKAS MANAGEMENT SYSTEMS" below. The number "0003" is at the bottom of the UKAS logo.
Page 2 of 5
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Image /page/5/Picture/0 description: The image contains the logo for Advanced Medical Solutions Ltd. The logo features a stylized letter A in blue, with a curved line extending from the top right of the A. The text "Advanced Medical Solutions Ltd" is written in blue below the logo.
K223310
Comparison of Technological Characteristics:
Antimicrobial Silicone PHMB Foam Wound Dressing is a modification of the predicate device to include updated product labelling in support of an antimicrobial product offering.
Antimicrobial Silicone PHMB Foam Wound Dressing has substantially equivalent intended use and performance characteristics, identical design, materials and manufacture process to the predicate device Silicone PHMB Foam Wound Dressing (K190819). Antimicrobial 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. Based on in vitro testing, the PHMB within the dressing is efficacious against gram positive bacteria, gram negative bacteria, yeast and mold. The dressing is semi-occlusive allowing the exchange of gases within the dressing 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. The following table shows the comparison of technological characteristics between the subject and predicate devices.
| | Subject
(modified device) | Predicate | Similarities and
Differences |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Product Name | Antimicrobial Silicone
PHMB Foam Wound
Dressing | Silicone PHMB Foam
Wound Dressing | |
| Manufacturer | Advanced Medical
Solutions Ltd | Advanced Medical
Solutions Ltd | Identical |
| 510(k) | K223310 | K190819 | - |
| Classification | Unclassified
(pre-amendment) | Unclassified
(pre-amendment) | Identical |
| Product code | FRO (Dressing,
Wound, Drug) | FRO (Dressing,
Wound, Drug) | Identical |
| Indications for use | Antimicrobial 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, superficial
and partial thickness
burns, dermatologic
disorders, other
wounds inflicted by
trauma and,
as a secondary
dressing or cover | 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 | Different - Subject
device includes an
antimicrobial claim |
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Image /page/5/Picture/8 description: The image shows three logos. The first logo is for the UK Authorised Economic Operator, and it features the letters AEO in bold black font, with a graphic of the UK in a circle. The second logo is for BSI, and it features the letters BSI in a circle with a heart-shaped design. The third logo is for UK Management Systems, and it features a checkmark inside of a circle with a crown on top.
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Image /page/6/Picture/0 description: The image contains the logo for Advanced Medical Solutions Ltd. The logo features a stylized blue "A" with a swoosh extending from the top right. Below the logo, the company name "Advanced Medical Solutions Ltd" is written in blue font.
Advanced Medical Solutions Limited Premier Park, 33 Road One, Winsford Industrial Estate, Winsford, Cheshire, CW7 3RT, UK Tel: +44 (0) 1606 863500 Fax: +44 (0) 1606 863600 Web: www.admedsol.com Registered in England 2666957 VAT No. GB 636 5551 27
K223310
| | dressing for packed
wounds. | dressing for packed
wounds. | |
|------------------------------------|-----------------------------------------|-----------------------------------------|-----------|
| Primary Material | Polyurethane (PU)
foam | Polyurethane (PU)
foam | Identical |
| Antimicrobial agent | PHMB
(0.8-1.1%w/w) | PHMB
(0.8-1.1%w/w) | Identical |
| Sterilization method
(terminal) | Ethylene oxide
SAL 10⁻⁶ | Ethylene oxide
SAL 10⁻⁶ | Identical |
| Biocompatibility | Biocompatible | Biocompatible | Identical |
| Storage | Store below 25°C
(77°F) | Store below 25°C
(77°F) | Identical |
| Range of available
sizes | 10.24 in² (64 cm) to 64
in² (400 cm) | 10.24 in² (64 cm) to
64 in² (400 cm) | Identical |
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Image /page/7/Picture/0 description: The image shows the logo for Advanced Medical Solutions Ltd. The logo features a stylized blue "A" with a curved line extending from the top right. The text "Advanced Medical Solutions Ltd" is written in blue below the logo.
K223310
Performance Testing Summary:
Page 5 of 5
Microbial efficacy performance data submitted in support of this 510(k) includes in-vitro testing against a mold challenge organism. Testing was performed on real time aged predicate device in accordance with the well-established modified AATCC TM 100 method previously used for the predicate device.
No other performance tests were conducted for this submission. All performance data leveraged from the predicate device was submitted as part of the original 510(k) submission of the predicate, Silicone PHMB Foam Wound Dressing (K190819) and includes:
Biocompatibility
ISO 10993-1; Biological evaluation of medical devices USP 41-NF36; Pyrogenic Test
Performance testing
BS EN 13726-1; Test methods for primary wound dressings – aspects of absorbency. BS EN 13726-2; Test methods for primary wound dressings – moisture vapour transmission rate of permeable film dressings. BS EN 13726-3; Test methods for primary wound dressings - waterproofness. ASTM D6282-11; Standard Test Method for 90 Degree Peel Resistance of Adhesives. Bacterial barrier.
Distribution
ASTM D4169 – Standard Practice for Performance Testing of Shipping Containers and Systems
The subject device, Antimicrobial Silicone PHMB Foam Wound Dressing, is manufactured with the exact same materials and processes as the predicate.
- Rationale for The modified device, Antimicrobial Silicone PHMB Foam Wound Dressing, is identical to the predicate, Silicone PHMB Foam Wound Dressing (K190819), with regard to technology, materials, Substantial Equivalence: manufacture process, intended use, and target population. The only difference between the predicate and subject device is that the subject device has an antimicrobial claim, this minor modification does not raise any new questions of safety or effectiveness. Therefore, the Antimicrobial Silicone PHMB Foam Wound Dressing, is substantially equivalent to the predicate, Silicone PHMB Foam Wound Dressing (K190819).
- Conclusion: Antimicrobial Silicone PHMB Foam Wound Dressing is substantially 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. Based on the information provided within this 510(k), Advanced Medical Solutions Ltd. concludes that the proposed Antimicrobial Silicone PHMB Foam Wound Dressing is substantially equivalent to the predicate device listed, Silicone PHMB Foam Wound Dressing (K190819).
Image /page/7/Picture/15 description: The image shows two logos side by side. The first logo has the letters "AEO" in bold, followed by a graphic of the UK map inside a circle, and the words "UK Authorised Economic Operator" underneath. The second logo is a square containing two circular logos, one with the letters "bsi" and a heart-shaped design, and the other with a crown, a checkmark, and the words "UKAS MANAGEMENT SYSTEMS" and the number "0003".
Certificate No. MD 78010