Antimicrobial Gelling Fiber Dressing with PHMB

K213473 · Advanced Medical Solutions, Ltd. · FRO · Oct 26, 2023 · SU

Device Facts

• Record ID: K213473
• Device Name: Antimicrobial Gelling Fiber Dressing with PHMB
• Applicant: Advanced Medical Solutions, Ltd.
• Product Code: FRO · SU
• Decision Date: Oct 26, 2023
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Prescription Use: Under the supervision of a healthcare professional, the Antimicrobial Gelling Fiber Dressing with PHMB is indicated for the management of: Post-surgical incisions Pressure ulcers Diabetic ulcers Venous stasis ulcers Donor sites Abrasions Lacerations Superficial and Partial thickness burns Dermatologic disorders Other wounds inflicted by trauma Over-the-Counter Use: The Antimicrobial Gelling Fiber Dressing with PHMB may be used for the management of: Minor abrasions Minor lacerations Minor cuts Minor scalds and bums

Device Story

Sterile, non-woven pad or rope dressing composed of carboxymethylcellulose (CMC) fibers, PHMB (antimicrobial), EDTA, and nylon reinforcement. Used in clinical or home settings for moderate to heavily exuding chronic and acute wounds. Absorbs wound exudate to form a gel, maintaining a moist environment and facilitating autolytic debridement. PHMB reduces microbial colonization within the dressing for up to 7 days. Applied by healthcare professionals or patients (OTC). Output is a physical barrier that manages exudate and reduces bioburden; aids healing by protecting the wound bed and removing non-viable tissue.

Clinical Evidence

Bench testing only. Performance testing included total fluid handling (absorbency, shrinkage), physical testing (wet/dry/bond strength), stability, and package integrity. Antimicrobial efficacy demonstrated in vitro against MRSA, MRSE, VRE, Pseudomonas aeruginosa, Enterobacter Cloacae, Klebsiella pneumonia, Cryptococcus neoformans, and Acremonium strictum. Biocompatibility evaluated per ISO 10993-1.

Technological Characteristics

Non-woven pad/rope of carboxymethylcellulose (CMC) fibers with 0.3-0.9% w/w PHMB, EDTA, and nylon reinforcement. Sterilized via gamma irradiation (SAL 10^-6). Complies with BS EN 13726-1 (absorbency) and ASTM D4169 (distribution).

Indications for Use

Indicated for management of post-surgical incisions, pressure/diabetic/venous stasis ulcers, donor sites, abrasions, lacerations, superficial/partial thickness burns, dermatologic disorders, and trauma wounds. Available for prescription or OTC use for minor abrasions, lacerations, cuts, scalds, and burns.

Predicate Devices

• AMS PHMB Foam Wound Dressing (K181197)
• Aquacel Ag+ Extra (K173675)

Submission Summary (Full Text)

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October 26, 2023

Advanced Medical Solutions Ltd. Kay Mcgrath RA Manager Premier Park, 33 Road One, Winsford Industrial Estate Winsford. Cheshire CW7 3RT United Kingdom

Re: K213473

Trade/Device Name: Antimicrobial Gelling Fiber Dressing with PHMB Regulatory Class: Unclassified Product Code: FRO Dated: June 15, 2023 Received: June 15, 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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# David Krause -S

David Krause, Ph.D. Assistant Director 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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# Indications for Use

#### 510(k) Number (if known) K213473

#### Device Name

Antimicrobial Gelling Fiber Dressing with PHMB

#### Indications for Use (Describe)

Prescription Use:

Under the supervision of a healthcare professional, the Antimicrobial Gelling Fiber Dressing with PHMB is indicated for the management of:

- · Post-surgical incisions
- Pressure ulcers
- · Diabetic ulcers
- · Venous stasis ulcers
- · Donor sites
- · Abrasions
- · Lacerations
- · Superficial and Partial thickness burns
- · Dermatologic disorders
- · Other wounds inflicted by trauma
- Over-the-Counter Use:

The Antimicrobial Gelling Fiber Dressing with PHMB may be used for the management of:

- · Minor abrasions
- · Minor lacerations
- Minor cuts
- Minor scalds and bums

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image contains the logo for Advanced Medical Solutions Ltd. The logo features a stylized blue "A" with a swoosh-like element extending from the top right. Below the logo, the text "Advanced Medical Solutions Ltd" is written in a blue sans-serif font.

### K213473

### Traditional 510(k) Summary Statement

| Manufacturer: | Advanced Medical Solutions Ltd<br>Premier Park, 33 Road One, Winsford Industrial Estate Winsford, Cheshire UK<br>CW7 3RT<br>Tel: [phone]<br>Fax: [phone] |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kay McGrath<br>Regulatory Affairs Manager<br>Advanced Medical Solutions<br>Tel: [phone]<br>[e-mail] |
| Date of Summary: | August 22, 2023 |
| Trade Name: | Antimicrobial Gelling Fiber Dressing with PHMB |
| Classification Name: | Dressing, Wound, Drug |
| Classification: | Unclassified |
| Product Code: | FRO |
| Predicate Device(s): | Primary Predicate: AMS PHMB Foam Wound Dressing (K181197) |
| | Secondary Predicate: Aquacel Ag+ Extra (K173675) [Branded as Aquacel Advantage Ag |

Image /page/3/Picture/5 description: The image shows two logos side-by-side. The first logo is for the UK Authorised Economic Operator and features the letters "AE" followed by a symbol of the UK. The second logo is a BSI (British Standards Institution) certification mark, which includes the UKAS MANAGEMENT SYSTEMS logo and the certificate number MD 78010. The BSI logo signifies compliance with certain standards and regulations.

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Image /page/4/Picture/0 description: The image contains the logo for Advanced Medical Solutions Ltd. The logo features a stylized blue "A" with a curved line extending from the top right, resembling a swoosh. Below the logo, the text "Advanced Medical Solutions Ltd" is written in a blue sans-serif font.

# K213473

| Device Description: | Antimicrobial Gelling Fiber Dressing with PHMB, is a sterile, non-woven pad or rope composed of carboxymethylcellulose (CMC) fibers, Polyhexamethylene Biguanide (PHMB), Ethylenediaminetetraacetic acid (EDTA), and a reinforcement layer (nylon) for intact removal. The dressing is soft, conformable, and highly absorbent, making it ideal for use with moderate to heavily exuding chronic and acute wounds. As wound exudate containing microorganisms is absorbed and trapped within the dressing, a gel is formed that conforms to the wound bed and anatomical contours, and aids in maintaining a moist wound environment and removing non-viable tissue and slough (autolytic debridement). This is conducive to the natural healing process.<br>The dressing contains an active ingredient, PHMB. Based on <i>in vitro</i> performance data, the Antimicrobial Gelling Fiber Dressing with PHMB effectively reduces microbial colonization within the dressing for up to 7 days.<br>The device is presented in a range of both flat/pad (160 g/m ² and 200 g/m ² ) and rope (160 g/m ² ) dressings. The dressings are manufactured consistently using the same raw materials, the same manufacturing lines, follow a similar manufacturing process and utilize the same sterilization route. The sterile dressings are supplied in a range of sizes between 4in ² (25cm ² ) to 96in ² (600cm ² ). |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | <b>Prescription Use:</b><br>Under the supervision of a healthcare professional, the Antimicrobial Gelling Fiber Dressing with PHMB is indicated for use in the management of: Post-surgical incisions, Pressure ulcers, Diabetic ulcers, Venous stasis ulcers, Donor sites, Abrasions, Lacerations, Superficial and Partial thickness burns, Dermatological disorders, Other wounds inflicted by trauma.<br><b>Over-the-Counter Use:</b><br>The Antimicrobial Gelling Fiber Dressing with PHMB may be used for the management of: Minor Abrasions, Minor Lacerations, Minor cuts, Minor scalds and burns. |

Image /page/4/Picture/4 description: The image contains two logos. The first logo on the left has the letters "AE" in bold black font, with the text "UK Authorised Economic Operator" underneath. To the right of the letters is a circle containing a map of the UK. The second logo on the right has the letters "bsi" above a heart-shaped design, and a UKAS MANAGEMENT SYSTEMS logo with the number 0003. The text "Certificate No. MD 78010" is below the logos.

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Image /page/5/Picture/0 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.

### K213473

#### Comparison of Technological Characteristics:

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Antimicrobial Gelling Fiber Dressing with PHMB is a multi-layer one piece dressing design incorporating an absorbent non-woven pad or rope composed of carboxymethylcellulose (CMC) fibers, containing 0.3 - 0.9%w/w PHMB. Based on in vitro testing, the PHMB within the dressing has been shown to be effective against gram-positive and gram-negative bacteria, mold, and yeast microorganisms. The dressing is designed to minimize the risk of maceration and damage to newly formed tissue. The dressing, when gelled with exudate is non-adherent to the wound bed and can be easily removed. The Antimicrobial Gelling Fiber Dressing with PHMB can be used under compression. The following table shows a comparison of technological characteristics between the subject device and the predicate and reference devices.

| | Subject | Primary Predicate | Secondary Predicate |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Antimicrobial Gelling<br>Fiber Dressing with<br>PHMB | PHMB Foam Wound<br>Dressing | Aquacel Ag+ Extra |
| Manufacturer | Advanced Medical<br>Solutions Ltd | Advanced Medical<br>Solutions Ltd | Convatec |
| 510(k) | K213473 | K181197 | K173675 |
| Classification | Unclassified<br>(pre-amendment) | Unclassified<br>(pre-amendment) | Unclassified<br>(pre-amendment) |
| Product code | FRO<br>(Dressing, Wound, Drug) | FRO<br>(Dressing, Wound, Drug) | FRO<br>(Dressing, Wound, Drug) |
| Indications for use | Prescription Use:<br>Under the supervision of<br>a healthcare professional,<br>the Antimicrobial Gelling<br>Fiber Dressing with PHMB<br>is indicated for use in the<br>management of post-<br>surgical incisions,<br>pressure ulcers, venous<br>stasis ulcers, diabetic<br>ulcers, donor sites,<br>abrasions, lacerations,<br>superficial and partial<br>thickness burns,<br>dermatologic disorders,<br>other wounds inflicted by<br>trauma. | Prescription Use:<br>PHMB Foam Wound<br>Dressings are indicated<br>for use in the<br>management of post-<br>surgical incisions,<br>pressure sores, venous<br>stasis ulcers, diabetic<br>ulcers, donor sites,<br>abrasions, lacerations, 1st<br>and 2nd degree burns,<br>dermatologic disorders,<br>other wounds inflicted by<br>trauma and, as a<br>secondary dressing or<br>cover dressing for packed<br>wounds. | Prescription Use:<br>Under the supervision of a<br>healthcare professional:<br>AQUACEL Ag+ EXTRA<br>Enhanced Hydrofiber<br>Dressing with Silver and<br>Strengthening Fiber may<br>be used for the<br>management of:<br>Wounds as an effective<br>barrier to bacterial<br>penetration of the dressing<br>as this may help reduce<br>infection, Partial thickness<br>(second degree) burns,<br>Diabetic foot ulcers, leg<br>ulcers, (venous stasis<br>ulcers, arterial ulcers, and<br>leg ulcers of mixed<br>etiology) and pressure<br>ulcers/sores (partial & full<br>thickness), Surgical wounds<br>left to heal by secondary<br>intention such as dehisced<br>surgical incisions, Surgical<br>wounds that heal by<br>primary intent such as<br>dermatological and surgical<br>incisions (e.g., orthopedic<br>and vascular). Traumatic |

Image /page/5/Picture/6 description: The image contains two logos. The first logo is for the UK Authorised Economic Operator, and it features the letters AEO with an image of the UK inside of the letter O. The second logo is for the UKAS Management Systems, and it features a heart-shaped symbol with the letters BSI inside of it. The UKAS Management Systems logo also features a crown and the number 0003.

Certificate No. MD 78010

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Image /page/6/Picture/0 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 text "Advanced Medical Solutions Ltd" is written in blue, with each word on the same line.

K213473

| | Over-the-Counter Use:<br>The Antimicrobial Gelling<br>Fiber Dressing with PHMB<br>may be used for the<br>management of minor<br>abrasions, minor<br>lacerations, minor cuts,<br>minor scalds and burns | | wounds, Wounds that are<br>prone to bleeding, such as<br>wounds that have been<br>mechanically or surgically<br>debrided and donor sites,<br>Oncology wounds with<br>exudate, such as<br>fungoides-cutaneous<br>tumors, fungating<br>carcinoma, cutaneous<br>metastasis, Kaposi's<br>sarcoma, and<br>angiosarcoma,<br>Management of painful<br>wounds, Infected wounds.<br>Over-the-Counter Use:<br>The AQUACEL Ag+ EXTRA<br>Enhanced Hydrofiber<br>Dressing with Silver and<br>Strengthening Fiber may<br>be used for the<br>management of:<br>Abrasions, Lacerations,<br>Minor cuts, Minor scalds |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | and burns |
| Primary Material | Carboxymethylcellulose<br>(CMC) non-woven fiber | Polyurethane (PU) foam | Sodium<br>carboxymethylcellulose<br>(CMC) non-woven |
| Antimicrobial<br>agent | PHMB | PHMB | Silver |
| Sterility | Gamma irradiation<br>SAL 10-6 | Ethylene oxide<br>SAL 10-6 | Gamma irradiation<br>SAL 10-6 |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible |
| Storage | Store below 25°C (77°F) | Store below 25°C (77°F) | 10-25°C/50-77°F |

Image /page/6/Picture/4 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 the "O". The second logo is for BSI, a business standards company, and it features the letters "bsi" above a heart-shaped symbol with a checkmark inside a circle, and the words "UKAS MANAGEMENT SYSTEMS" below, along with the number "0003".

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Certificate No. MD 78010

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Image /page/7/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 text "Advanced Medical Solutions Ltd" is written in blue, with the first two words on one line and "Ltd" on the next.

## K213473

| Performance<br>Testing<br>Summary: | Performance testing included total fluid handling (including absorbency and shrinkage studies),<br>physical testing to assess the wet, dry, and bond strength, stability testing, and package integrity<br>testing. In addition, broad spectrum activity was demonstrated to be effective against the following<br>three gram-positive bacteria, three gram-negative bacteria, one yeast, and one mold challenge<br>organisms within the dressing:<br>Methicillin-Resistant S. aureus (MRSA), Methicillin Resistant S.<br>epidermidis (MRSE), Vancomycin-Resistant E. faecalis (VRE),<br>Pseudomonas aeruginosa, Enterobacter Cloacae, Klebsiella<br>pneumonia, Cryptococcus neoformans, and Acremonium strictum |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |
| | Biocompatibility<br>ISO 10993-1; Biological evaluation of medical devices |
| | Performance testing<br>BS EN 13726-1; Test methods for primary wound dressings - aspects of absorbency.<br>ATCC TM 100; Test Method for Antibacterial Finishes on Textile Materials (modified) |
| | Distribution<br>ASTM D4169; Standard Practice for Performance Testing of Shipping Containers and<br>Systems |
| Rationale for<br>Substantial<br>Equivalence: | Antimicrobial Gelling Fiber Dressing with PHMB has substantially equivalent intended use, target<br>population, active antimicrobial agent, biological characteristics, and performance characteristics<br>to the predicate device, PHMB Foam Wound Dressing (AMS Ltd, K181197). |
| Conclusion: | Based on the information provided within this Traditional 510(k) submission, Advanced<br>Medical Solutions Ltd. concludes that the proposed Antimicrobial Gelling Fiber Dressing with<br>PHMB is substantially equivalent to the predicate device listed. |

Image /page/7/Picture/4 description: The image shows two logos side by side. The first logo on the left has the letters 'AE' in bold black font, followed by an image of the UK with a triangle pointing towards it. Below the letters, the text 'UK Authorised Economic Operator' is written. The second logo on the right has the 'bsi' logo on top of a circle with a heart-shaped design inside. To the right of this circle, there is a crown above a check mark, with the text 'UKAS MANAGEMENT SYSTEMS' below it, and the number '0003' below that. The text 'Certificate No. MD 78010' is written below the second logo.

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