Who is the manufacturer of Silicone PHMB Foam Wound Dressing?

Advanced Medical Solutions, Ltd. filed the 510(k) submission for Silicone PHMB Foam Wound Dressing (K190819).

What is the FDA product code for Silicone PHMB Foam Wound Dressing?

FRO. as a Class U device in the SU panel.

What is the regulatory pathway for Silicone PHMB Foam Wound Dressing?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Silicone PHMB Foam Wound Dressing?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Silicone PHMB Foam Wound Dressing

K190819 · Advanced Medical Solutions, Ltd. · FRO · Jul 25, 2019 · SU

Device Facts

Record ID	K190819
Device Name	Silicone PHMB Foam Wound Dressing
Applicant	Advanced Medical Solutions, Ltd.
Product Code	FRO · SU
Decision Date	Jul 25, 2019
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended 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.

Device Story

Silicone PHMB Foam Wound Dressing is a sterile, single-use, trilaminate polyurethane foam dressing impregnated with 0.8-1.1% w/w Polyhexamethylene Biguanide (PHMB). The microporous hydrophilic foam absorbs wound exudate, maintains a moist healing environment, and provides a barrier to bacterial penetration. The wound contact layer features a gentle silicone adhesive for secure, non-traumatic removal. The device is used in clinical settings for wound management. PHMB acts as an antimicrobial agent within the dressing to prevent bacterial colonization and proliferation for up to 7 days. The dressing is semi-occlusive, allowing gas and moisture exchange. Healthcare providers apply the dressing to the wound site to manage exudate and protect the wound from external contamination, potentially facilitating healing.

Clinical Evidence

No clinical data. Evidence consists of in-vitro performance testing and animal testing. In-vitro testing demonstrated antimicrobial efficacy against MRSA, Streptococcus pyogenes, VRE, E. coli, Klebsiella pneumoniae, Serratia marcescens, and Candida albicans. Bench testing confirmed high fluid handling capacity and peel adhesion. Biological evaluation for prolonged contact (<30 days) conducted per BS EN ISO 10993-1 confirmed the device is safe.

Technological Characteristics

Trilaminate polyurethane foam dressing; 0.8-1.1% w/w PHMB; silicone adhesive wound contact layer; semi-occlusive; sterile (Ethylene Oxide); sizes 10.24-64 in2. Complies with BS EN ISO 10993-1 for biological evaluation.

Indications for Use

Indicated for management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, lacerations, 1st/2nd degree burns, dermatologic disorders, trauma wounds, and as secondary/cover dressing for packed wounds.

Predicate Devices

PHMB Foam Wound Dressing (K181197)

Related Devices

K223310 — Antimicrobial Silicone PHMB Foam Wound Dressing · Advanced Medical Solutions Limited · Apr 5, 2023
K192463 — PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border · Winner Medical Co., Ltd. · May 14, 2020
K163062 — PHMB Antimicrobial Foam Wound Dressing · Advanced Medical Solutions, Ltd. · Jul 25, 2017
K181197 — PHMB Foam Wound Dressing · Advanced Medical Solutions, Ltd. · Aug 3, 2018
K191536 — Biatain Silicone Ag · Coloplast A/S · Feb 21, 2020

Submission Summary (Full Text)

{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) | <table><tr><td> <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</td></tr><tr><td><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table> | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------| | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | | | | | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* {3}------------------------------------------------ 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. {4}------------------------------------------------ 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'. {5}------------------------------------------------ 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'. {6}------------------------------------------------ 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 (<30 days), conducted in accordance with "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management process" demonstrates that Silicone PHMB Foam Wound 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 Silicone PHMB Foam Wound Dressing is substantially equivalent to the predicate 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.