PHMB Antimicrobial Foam Wound Dressing

K163062 · Advanced Medical Solutions, Ltd. · FRO · Jul 25, 2017 · SU

Device Facts

• Record ID: K163062
• Device Name: PHMB Antimicrobial Foam Wound Dressing
• Applicant: Advanced Medical Solutions, Ltd.
• Product Code: FRO · SU
• Decision Date: Jul 25, 2017
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

PHMB Foam Wound Dressings are indicated for use in the temporary management (<24 hours) 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.

Device Story

PHMB Foam Wound Dressing is a microporous hydrophilic polyurethane foam impregnated with Polyhexamethylene Biguanide (PHMB). Device absorbs wound exudate; maintains moist healing environment; provides barrier to bacterial penetration; prevents bacterial colonization/proliferation within dressing. Available in non-adhesive and adhesive versions; supplied sterile. Used in clinical settings for temporary management (<24 hours) of various acute and chronic wounds. Healthcare providers apply dressing to wound site; PHMB agent acts as antimicrobial barrier. Benefits include exudate management and reduction of bacterial colonization risk within dressing.

Clinical Evidence

No clinical data. Evidence consists of in-vitro and animal testing. In-vitro testing demonstrated broad-spectrum antimicrobial activity against MRSA, MRSE, VRE, E. coli, K. pneumoniae, P. aeruginosa, C. albicans, and R. mucilaginosa. Bench testing included fluid handling and peel adhesion. Biological evaluation performed per BS EN ISO 10993-1 for limited contact (<24 hours).

Technological Characteristics

Microporous hydrophilic polyurethane foam impregnated with PHMB. Supplied sterile for single use. Dimensions range from 4 in² to 64 in². Non-border and border (adhesive) configurations. Biocompatibility evaluated per BS EN ISO 10993-1 (Category A, limited contact).

Indications for Use

Indicated for temporary management (<24 hours) of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, lacerations, 1st and 2nd degree burns, dermatologic disorders, trauma wounds, and as secondary/cover dressing for packed wounds.

Predicate Devices

• Kendall™ AMD Antimicrobial Wound Dressing (K082296)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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 text "Advanced Medical Solutions Ltd" is written in blue, with the words arranged on a single line.

Advanced Medical Solutions Limited Premier Park, 33 Road One Winsford Industrial Estate Cheshire. CW7 3RT. UK Tel : [phone] Fax : [phone] Web : www.admedsol.com Registered in England 2666957 VAT No. GB636 5551 27

## 510(k) Summary Statement

| Submitted by: | Advanced Medical Solutions Ltd<br>Premier Park<br>33 Road One<br>Winsford Industrial Estate<br>Winsford<br>Cheshire<br>CW7 3RT<br>Tel: [phone]<br>Fax: [phone] |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kay M&Grath |
| Date of Summary: | 25 July 2017 |
| Trade Name: | PHMB Foam Wound Dressing |
| Common Name: | PHMB Wound Dressing |
| Classification Name: | Dressing, Wound, Drug |
| Classification: | Unclassified (Pre-amendment) |
| Classification Code: | Product code: FRO |
| Predicate Device(s): | Kendall™ AMD Antimicrobial Wound Dressing (K082296) |

Image /page/0/Picture/4 description: The image shows two certification logos. The first logo on the left is the BSI (British Standards Institution) logo, which features a heart shape inside a circle. The second logo on the right includes a crown above the text "UKAS MANAGEMENT SYSTEMS" and a check mark. Below the logos, the text "Certificate No. MD78010" is visible.

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Image /page/1/Picture/0 description: The image features the logo for Advanced Medical Solutions Ltd. The logo consists of a stylized blue letter "A" with a swoosh-like design element, positioned above the company name. The text "Advanced Medical Solutions Ltd" is written in a clear, sans-serif font, with the company name in blue.

Advanced Medical Solutions Limited Premier Park, 33 Road One Winsford Industrial Estate Cheshire. CW7 3RT. UK Tel : [phone] Fax : [phone] Web : www.admedsol.com Registered in England 2666957 VAT No. GB636 5551 27

| Device Description: | The subject device, PHMB Foam Wound Dressing, is a polyurethane foam 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 <i>in vitro</i> performance data, the 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 while in use (<24 hours). |
| | PHMB Foam dressings, when tested <i>in-vitro</i> have been demonstrated to be effective against the following three gram positive bacteria, three gram negative bacteria and two yeast challenge organisms within the dressing: MRSA, MRSE, VRE, <i>Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Candida albicans</i> and <i>Rhodotorula mucilaginosa</i> . |
| | The device is presented in Non-border (non-adhesive) and border (adhesive) versions. |
| | The dressing is supplied sterile in a range of sizes between 4 in ² to 64 in ² . |
| Indication for Use: | PHMB Foam Wound Dressings are indicated for use in the temporary management (<24 hours) 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. |

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Image /page/2/Picture/0 description: The image shows the logo for Advanced Medical Solutions Ltd. The logo consists of a blue stylized letter A with a swoosh above the text. The text "Advanced Medical Solutions Ltd" is written in blue, with each word on a separate line.

Advanced Medical Solutions Limited Premier Park, 33 Road One Winsford Industrial Estate Cheshire. CW7 3RT. UK Tel : [phone] Fax : [phone] Web : www.admedsol.com Registered in England 2666957 VAT No. GB636 5551 27

| Substantial Equivalence: | PHMB Foam Wound Dressing has substantially equivalent intended use, design, materials, labeling, and performance characteristics to the predicate device Kendall ™ AMD Antimicrobial Wound Dressing (K082296). |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological characteristics: | 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 are supplied sterile for single use |

The PHMB concentration differs between the predicate and PHMB Foam Wound Dressing, however they provide equivalent efficacious performance.

Image /page/2/Picture/4 description: The image shows two logos side-by-side, along with a certificate number. The logo on the left is the BSI (British Standards Institution) logo, which features the letters 'bsi' above a heart shape inside of a circle. The logo on the right is the UKAS (United Kingdom Accreditation Service) logo, which features a crown above a check mark, with the words 'UKAS MANAGEMENT SYSTEMS' below. The certificate number is MD78010.

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Image /page/3/Picture/0 description: The image shows the logo for Advanced Medical Solutions Ltd. The logo consists of a blue stylized letter A inside of a circle. The text "Advanced Medical Solutions Ltd" is written in blue below the logo.

Performance Testing

Advanced Medical Solutions Limited Premier Park, 33 Road One Winsford Industrial Estate Cheshire. CW7 3RT. UK Tel : [phone] Fax : [phone] Web : www.admedsol.com Registered in England 2666957 VAT No. GB636 5551 27

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 (adhesive version only). In addition broad spectrum activity was demonstrated to be effective against the following three gram positive bacteria, three gram negative bacteria and two yeast challenge organisms within the dressing: |
| Methicillin-Resistant S. aureus (MRSA) |
| Methicillin Resistant S. epidermidis (MRSE) |
| Vancomycin-Resistant E. faecalis (VRE) |
| Pseudomonas aeruginosa |
| Escherichia coli |
| Klebsiella pneumoniae |
| Candida albicans |
| Rhodotorula mucilaginosa |

Biological evaluation demonstrates that PHMB Foam Wound Dressings are cleared as a (Category A) limited contact device (<24 hours) in accordance with the requirements of BS EN ISO 10993-1 (Biological Evaluation of Medical Devices).

Conclusion:

Based on the information provided within this 510(k) submission, Advanced Medical Solutions Ltd. concludes that the proposed PHMB Foam Wound Dressing is substantially equivalent to the predicate device listed.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 25, 2017

Advanced Medical Solutions Ltd. Kay McGrath RA Manager Premier Park, 33 Road One, Winsford Industrial Estate Winsford, CW7 3RT GB

Re: K163062

Trade/Device Name: PHMB Foam Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: June 21, 2016 Received: June 23, 2017

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. 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 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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