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 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.
The dressing contains an active ingredient, PHMB. Based on in vitro performance data, the Antimicrobial Gelling Fiber Dressing with PHMB effectively reduces microbial colonization within the dressing for up to 7 days.
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 ).

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device called "Antimicrobial Gelling Fiber Dressing with PHMB." It asserts substantial equivalence to predicate devices, but does not contain information related to software, algorithms, AI performance, or specific acceptance criteria for such a system.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details for AI performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document details the device's physical properties, indications for use, and a summary of performance testing, which are primarily related to physical characteristics, sterility, biocompatibility, and antimicrobial efficacy of the dressing itself.

Here's the relevant information that is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions "Performance Testing Summary" but doesn't explicitly list specific acceptance criteria values alongside device performance values in a table format as might be expected for an AI/software device. Instead, it describes general categories of testing and general statements of efficacy.

Acceptance Criteria Category	Reported Device Performance (Summary)
Fluid Handling	Includes absorbency and shrinkage studies conducted.
Physical Strength	Assessed wet, dry, and bond strength.
Stability Testing	Conducted.
Package Integrity	Conducted.
Broad Spectrum Activity	Demonstrated effective against:
	- Methicillin-Resistant S. aureus (MRSA)
	- Methicillin Resistant S. epidermidis (MRSE)
	- Vancomycin-Resistant E. faecalis (VRE)
	- Pseudomonas aeruginosa
	- Enterobacter Cloacae
	- Klebsiella pneumonia
	- Cryptococcus neoformans
	- Acremonium strictum
Biocompatibility	Biocompatible (per ISO 10993-1)

2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a study involving a test set for an AI/algorithm. The performance testing is for the physical medical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a study involving human experts establishing ground truth for an AI/algorithm test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 device is a physical wound dressing and does not involve human readers or AI assistance in an interpretive capacity.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/algorithm. For the physical device, efficacy against microorganisms was demonstrated in vitro.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 LtdPremier Park, 33 Road One, Winsford Industrial Estate Winsford, Cheshire UKCW7 3RTTel: +44 1606 863500Fax: +44 1606 863600
Contact:	Kay McGrathRegulatory Affairs ManagerAdvanced Medical SolutionsTel: +44 7791 188193kay.mcgrath@admedsol.com
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.

Page 1 of 5

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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.The dressing contains an active ingredient, PHMB. Based on in vitro performance data, the Antimicrobial Gelling Fiber Dressing with PHMB effectively reduces microbial colonization within the dressing for up to 7 days.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:	Prescription Use: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.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 burns.

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.The dressing contains an active ingredient, PHMB. Based on in vitro performance data, the Antimicrobial Gelling Fiber Dressing with PHMB effectively reduces microbial colonization within the dressing for up to 7 days.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:

Prescription Use: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.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 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.

Page 2 of 5

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K213473

Comparison of Technological Characteristics:

Page 3 of 5

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 GellingFiber Dressing withPHMB	PHMB Foam WoundDressing	Aquacel Ag+ Extra
Manufacturer	Advanced MedicalSolutions Ltd	Advanced MedicalSolutions Ltd	Convatec
510(k)	K213473	K181197	K173675
Classification	Unclassified(pre-amendment)	Unclassified(pre-amendment)	Unclassified(pre-amendment)
Product code	FRO(Dressing, Wound, Drug)	FRO(Dressing, Wound, Drug)	FRO(Dressing, Wound, Drug)
Indications for use	Prescription Use:Under the supervision ofa healthcare professional,the Antimicrobial GellingFiber Dressing with PHMBis indicated for use in themanagement of post-surgical incisions,pressure ulcers, venousstasis ulcers, diabeticulcers, donor sites,abrasions, lacerations,superficial and partialthickness burns,dermatologic disorders,other wounds inflicted bytrauma.	Prescription Use:PHMB Foam WoundDressings are indicatedfor use in themanagement of post-surgical incisions,pressure sores, venousstasis ulcers, diabeticulcers, donor sites,abrasions, lacerations, 1stand 2nd degree burns,dermatologic disorders,other wounds inflicted bytrauma and, as asecondary dressing orcover dressing for packedwounds.	Prescription Use:Under the supervision of ahealthcare professional:AQUACEL Ag+ EXTRAEnhanced HydrofiberDressing with Silver andStrengthening Fiber maybe used for themanagement of:Wounds as an effectivebarrier to bacterialpenetration of the dressingas this may help reduceinfection, Partial thickness(second degree) burns,Diabetic foot ulcers, legulcers, (venous stasisulcers, arterial ulcers, andleg ulcers of mixedetiology) and pressureulcers/sores (partial & fullthickness), Surgical woundsleft to heal by secondaryintention such as dehiscedsurgical incisions, Surgicalwounds that heal byprimary intent such asdermatological and surgicalincisions (e.g., orthopedicand 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:The Antimicrobial GellingFiber Dressing with PHMBmay be used for themanagement of minorabrasions, minorlacerations, minor cuts,minor scalds and burns		wounds, Wounds that areprone to bleeding, such aswounds that have beenmechanically or surgicallydebrided and donor sites,Oncology wounds withexudate, such asfungoides-cutaneoustumors, fungatingcarcinoma, cutaneousmetastasis, Kaposi'ssarcoma, andangiosarcoma,Management of painfulwounds, Infected wounds.Over-the-Counter Use:The AQUACEL Ag+ EXTRAEnhanced HydrofiberDressing with Silver andStrengthening Fiber maybe used for themanagement of:Abrasions, Lacerations,Minor cuts, Minor scalds
			and burns
Primary Material	Carboxymethylcellulose(CMC) non-woven fiber	Polyurethane (PU) foam	Sodiumcarboxymethylcellulose(CMC) non-woven
Antimicrobialagent	PHMB	PHMB	Silver
Sterility	Gamma irradiationSAL 10-6	Ethylene oxideSAL 10-6	Gamma irradiationSAL 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".

Page 4 of 5

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

PerformanceTestingSummary:	Performance testing included total fluid handling (including absorbency and shrinkage studies),physical testing to assess the wet, dry, and bond strength, stability testing, and package integritytesting. In addition, broad spectrum activity was demonstrated to be effective against the followingthree gram-positive bacteria, three gram-negative bacteria, one yeast, and one mold challengeorganisms within the dressing:Methicillin-Resistant S. aureus (MRSA), Methicillin Resistant S.epidermidis (MRSE), Vancomycin-Resistant E. faecalis (VRE),Pseudomonas aeruginosa, Enterobacter Cloacae, Klebsiellapneumonia, Cryptococcus neoformans, and Acremonium strictum

	BiocompatibilityISO 10993-1; Biological evaluation of medical devices
	Performance testingBS EN 13726-1; Test methods for primary wound dressings - aspects of absorbency.ATCC TM 100; Test Method for Antibacterial Finishes on Textile Materials (modified)
	DistributionASTM D4169; Standard Practice for Performance Testing of Shipping Containers andSystems
Rationale forSubstantialEquivalence:	Antimicrobial Gelling Fiber Dressing with PHMB has substantially equivalent intended use, targetpopulation, active antimicrobial agent, biological characteristics, and performance characteristicsto the predicate device, PHMB Foam Wound Dressing (AMS Ltd, K181197).
Conclusion:	Based on the information provided within this Traditional 510(k) submission, AdvancedMedical Solutions Ltd. concludes that the proposed Antimicrobial Gelling Fiber Dressing withPHMB 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.

Page 5 of 5

Regulation Number and Section

N/A