(115 days)
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.
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.
The provided text describes a 510(k) submission for a medical device, the "Silicone PHMB Foam Wound Dressing." This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical outcome studies with specific acceptance criteria as might be seen for novel devices or high-risk applications.
Therefore, the information typically requested in your prompt (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, effect sizes, adjudication methods, type of ground truth for training) is not applicable in the context of this 510(k) submission for a wound dressing.
Instead, the submission focuses on performance testing (in-vitro and animal testing) and biological evaluation to demonstrate safety and functional equivalence to the predicate device.
Here's what can be extracted from the document regarding the device's performance and the supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) for a wound dressing, "acceptance criteria" are generally framed as demonstrating equivalence to a predicate device in terms of design, materials, indications for use, and performance characteristics. The specific metrics for "device performance" are primarily related to its physical and antimicrobial properties rather than diagnostic accuracy metrics.
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance (Silicone PHMB Foam Wound Dressing) |
|---|---|
| Intended Use (Wound dressing containing PHMB for wound management) | Equivalent to Predicate Device: Wound dressing containing PHMB designed for the management of wounds. |
| Indications for Use (Specific wound types) | Equivalent to Predicate Device: 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. |
| Single Use | Yes, Equivalent to Predicate Device. |
| Materials (Polyurethane backing layer, PHMB foam layer) | Equivalent to Predicate Device: Polyurethane backing layer, Polyurethane foam layer containing Polyhexamethylene Biguanide (PHMB). (Note: Comparison also notes a change in wound contact layer adhesive from acrylic to silicone, but concludes no new questions of safety/effectiveness). |
| Construction (Wound contact layer with adhesive) | Comparable to Predicate Device: Clear polyurethane wound contact layer with silicone adhesive. (Predicate had acrylic adhesive, but deemed not to raise new questions of safety or effectiveness). |
| Exudate Management (High absorbency, high total fluid handling) | Equivalent to Predicate Device: A high absorbency capacity for wound exudates and high total fluid handling. |
| Moist Environment Maintenance | Equivalent to Predicate Device: Maintains a moist wound healing environment. |
| Wound Protection (Barrier to bacterial penetration) | Equivalent to Predicate Device: Provides a barrier to bacterial penetration through the dressing. In-vitro performance shows it 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. |
| Sterility (Provided as sterile) | Yes, Ethylene Oxide (Predicate was Gamma irradiation). Comparison deemed not to raise new questions of safety or effectiveness. |
| Effectiveness against bacteria/yeast within dressing (in-vitro) | Demonstrated effectiveness against: Methicillin-Resistant S. aureus (MRSA), Streptococcus pyogenes, Vancomycin-Resistant E. faecalis (VRE), Escherichia coli, Klebsiella pneumonia, Serratia marcescens, and Candida albicans. |
| Biocompatibility (ISO 10993-1 compliance for prolonged contact) | Meets the requirements of BS EN ISO 10993-1 (Biological Evaluation of Medical Devices) and is safe. |
| Physical Performance (e.g., peel adhesion) | Performance testing included total fluid handling and peel adhesion. (Specific numerical results not provided in this summary, but indicated as having been submitted and reviewed). |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in terms of "test set" for human performance, as this is a device for physical wound management. The performance data relied on in-vitro and animal testing. Specific numbers of samples or animals are not provided in this summary document.
- Data Provenance: Not explicitly stated but the applicant is based in the UK (Advanced Medical Solutions Ltd, Winsford, Cheshire, CW7 3RT GB). The studies conducted would typically comply with international standards (e.g., ISO for biological evaluation). The document does not specify if the studies were retrospective or prospective, but in-vitro and animal studies are typically prospective experimental designs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is not a diagnostic device requiring expert interpretation for ground truth. Ground truth for in-vitro antimicrobial effectiveness would be based on laboratory microbiological assays, and for physical properties, on engineering and material science standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No human interpretation or adjudication process is described for this device's performance evaluation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is not an AI/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithmic device. The "standalone" performance refers to the intrinsic properties of the wound dressing (e.g., absorbency, antimicrobial activity).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For Antimicrobial Efficacy: Ground truth established via
- In-vitro microbiological assays: (e.g., confirming inhibition of bacterial/yeast growth on/in the dressing).
- For Biocompatibility: Ground truth established via
- Compliance with International Standard ISO 10993-1: Biological evaluation based on established protocols and endpoints (e.g., cytotoxicity, sensitization, irritation) in animal models or in-vitro tests.
- For Physical Performance: Ground truth established via
- Standardized physical testing methods: (e.g., for absorbency, fluid handling, peel adhesion), often against industry benchmarks or the predicate device's measured properties.
8. The sample size for the training set:
- Not Applicable. This is not a machine learning/AI device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI/ML algorithm.
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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
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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
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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 | SubstantialEquivalence |
|---|---|---|---|
| Product Name | Silicone PHMB Foam WoundDressing | PHMB Foam Wound Dressing | |
| Indications for Use | |||
| Intended Use | Wound dressing containingPHMB designed for themanagement of wounds. | Wound dressing containingPHMB designed for themanagement of wounds. | Equivalent |
| Indications forUse | Indicated for use in themanagement 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 bytrauma• as a secondary dressing orcover dressing for packedwounds. | Indicated for use in themanagement 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 bytrauma• as a secondary dressing orcover dressing for packedwounds. | Equivalent |
| Single Use | Yes | Yes | Equivalent |
| Materials | |||
| Polyurethane backing layer | Polyurethane backing layer | Comparison topredicate device | |
| Polyurethane foam layercontaining PolyhexamethyleneBiguanide (PHMB) | Polyurethane foam layercontaining PolyhexamethyleneBiguanide (PHMB) | shows no newquestions ofsafety or | |
| Construction | Clear polyurethane woundcontact layer with siliconeadhesive | Clear polyurethane woundcontact layer with acrylicadhesive | effectiveness,and no changeto intended usecompared topredicate orreference 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 | ||
| MoistEnvironment | Maintains a moist wound healing environment | Maintains a moist wound healing environment | Equivalent |
| WoundProtection | 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 topredicate deviceshows no newquestions ofsafety oreffectiveness,and no changeto intended usecompared topredicate orreference 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.
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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 TestingSummary: | Performance data submitted in support of this 510k included in-vitroand animal testing. |
|---|---|
| Performance testing included total fluid handling, and peel adhesion. Inaddition broad spectrum activity was demonstrated to be effectiveagainst the following bacteria and yeast challenge organisms within thedressing:Methicillin-Resistant S. aureus (MRSA)Streptococcus pyogenesVancomycin-Resistant E. faecalis (VRE)Escherichia coliKlebsiella pneumoniaSerratia marcescensCandida albicans | |
| Biological evaluation for prolonged contact (<30 days), conducted inaccordance with "Use of International Standard ISO 10993-1, BiologicalEvaluation of Medical Devices Part 1: Evaluation and Testing within aRisk Management process" demonstrates that Silicone PHMB FoamWound Dressings meet the requirements of BS EN ISO 10993-1(Biological Evaluation of Medical Devices) and are safe. | |
| Conclusion: | Based on the information provided within this 510(k) submission,Advanced Medical Solutions Ltd. concludes that the proposed SiliconePHMB Foam Wound Dressing is substantially equivalent to thepredicate device listed. |
Image /page/7/Picture/4 description: The image shows two certification 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 in a circle. The second logo on the right is the UKAS (United Kingdom Accreditation Service) Management Systems logo, which includes a crown above a check mark and the number 003 below the text. The certificate number MD78010 is printed below the logos.
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