Antimicrobial Silicone PHMB Foam Wound Dressing, is a polyurethane foam trilaminate dressing impregnated with Polyhexamethylene Biguanide (PHMB), an agent that protects the dressing from bacterial penetration and colonization. The foam in the dressing has a microporous hydrophilic foam structure that absorbs wound exudate and maintains a moist wound healing environment.

Based on in vitro performance data, the Antimicrobial Silicone PHMB Foam Wound Dressing provides a barrier to bacterial penetration through the dressing and the PHMB prevents colonization and proliferation of bacteria, yeast and mold within the dressing for up to 7 days. Antimicrobial Silicone PHMB Foam Wound Dressing, when tested in-vitro has demonstrated to be effective against gram positive bacteria, gram negative bacteria, yeast and mold challenge organisms within the dressing.

The perforated wound contact layer contains a gentle silicone adhesive that provides secure, nonirritating adhesion and supports non-traumatic 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 (64cm) to 64 in2 (400cm).

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called "Antimicrobial Silicone PHMB Foam Wound Dressing." The submission aims to demonstrate substantial equivalence to a predicate device, "Silicone PHMB Foam Wound Dressing (K190819)." The key difference is the addition of an antimicrobial claim for the subject device.

Here's an analysis of the acceptance criteria and supporting study information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in the typical numerical performance thresholds (e.g., sensitivity > X%, specificity > Y%). Instead, the "acceptance" is focused on demonstrating substantial equivalence to an existing predicate device, particularly concerning the newly added antimicrobial claim.

Acceptance Criteria (Implicit from the 510(k) submission):

Antimicrobial Efficacy: The modified device must demonstrate efficacy against gram-positive bacteria, gram-negative bacteria, yeast, and mold within the dressing.
Identical Design, Materials, and Manufacturing Process: The subject device must be identical to the predicate device in these aspects, except for modifications related to the antimicrobial claim.
Substantially Equivalent Intended Use and Performance Characteristics: The device's overall intended use and other performance (biocompatibility, absorption, MVTR, waterproofness, peel resistance, bacterial barrier, distribution) must be consistent with the predicate device.
No New Questions of Safety or Effectiveness: The modifications should not introduce new safety or effectiveness concerns.

Reported Device Performance (from "Performance Testing Summary" and "Comparison of Technological Characteristics"):

Acceptance Criteria (Implicit)	Reported Device Performance
Antimicrobial Efficacy (Key criterion for the new claim): Demonstrate efficacy against gram-positive bacteria, gram-negative bacteria, yeast, and mold within the dressing.	"Based on in vitro performance data, the Antimicrobial Silicone PHMB Foam Wound Dressing provides a barrier to bacterial penetration through the dressing and the PHMB prevents colonization and proliferation of bacteria, yeast and mold within the dressing for up to 7 days." "Antimicrobial Silicone PHMB Foam Wound Dressing, when tested in-vitro has demonstrated to be effective against gram positive bacteria, gram negative bacteria, yeast and mold challenge organisms within the dressing." "Microbial efficacy performance data submitted in support of this 510(k) includes in-vitro testing against a mold challenge organism. Testing was performed on real time aged predicate device in accordance with the well-established modified AATCC TM 100 method previously used for the predicate device."
Identical Design, Materials, and Manufacturing Process: The subject device must be identical to the predicate device in these aspects, except for modifications related to the antimicrobial claim. Substantially Equivalent Intended Use and Performance Characteristics: The device's overall intended use and other performance (biocompatibility, absorption, MVTR, waterproofness, peel resistance, bacterial barrier, distribution) must be consistent with the predicate device. No New Questions of Safety or Effectiveness: The modifications should not introduce new safety or effectiveness concerns.	"Antimicrobial Silicone PHMB Foam Wound Dressing has substantially equivalent intended use and performance characteristics, identical design, materials and manufacture process to the predicate device Silicone PHMB Foam Wound Dressing (K190819)." "The subject device, Antimicrobial Silicone PHMB Foam Wound Dressing, is manufactured with the exact same materials and processes as the predicate." All performance data (Biocompatibility, Absorption, MVTR, Waterproofness, Peel Resistance, Bacterial Barrier, Distribution) was leveraged from the predicate device (K190819) and deemed applicable to the subject device. "The modified device... is identical to the predicate... with regard to technology, materials, manufacture process, intended use, and target population. The only difference... is that the subject device has an antimicrobial claim, this minor modification does not raise any new questions of safety or effectiveness."

Acceptance Criteria (Implicit)

Reported Device Performance

Antimicrobial Efficacy (Key criterion for the new claim): Demonstrate efficacy against gram-positive bacteria, gram-negative bacteria, yeast, and mold within the dressing.

"Based on in vitro performance data, the Antimicrobial Silicone PHMB Foam Wound Dressing provides a barrier to bacterial penetration through the dressing and the PHMB prevents colonization and proliferation of bacteria, yeast and mold within the dressing for up to 7 days." "Antimicrobial Silicone PHMB Foam Wound Dressing, when tested in-vitro has demonstrated to be effective against gram positive bacteria, gram negative bacteria, yeast and mold challenge organisms within the dressing." "Microbial efficacy performance data submitted in support of this 510(k) includes in-vitro testing against a mold challenge organism. Testing was performed on real time aged predicate device in accordance with the well-established modified AATCC TM 100 method previously used for the predicate device."

Identical Design, Materials, and Manufacturing Process: The subject device must be identical to the predicate device in these aspects, except for modifications related to the antimicrobial claim. Substantially Equivalent Intended Use and Performance Characteristics: The device's overall intended use and other performance (biocompatibility, absorption, MVTR, waterproofness, peel resistance, bacterial barrier, distribution) must be consistent with the predicate device. No New Questions of Safety or Effectiveness: The modifications should not introduce new safety or effectiveness concerns.

"Antimicrobial Silicone PHMB Foam Wound Dressing has substantially equivalent intended use and performance characteristics, identical design, materials and manufacture process to the predicate device Silicone PHMB Foam Wound Dressing (K190819)." "The subject device, Antimicrobial Silicone PHMB Foam Wound Dressing, is manufactured with the exact same materials and processes as the predicate." All performance data (Biocompatibility, Absorption, MVTR, Waterproofness, Peel Resistance, Bacterial Barrier, Distribution) was leveraged from the predicate device (K190819) and deemed applicable to the subject device. "The modified device... is identical to the predicate... with regard to technology, materials, manufacture process, intended use, and target population. The only difference... is that the subject device has an antimicrobial claim, this minor modification does not raise any new questions of safety or effectiveness."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions in-vitro testing for antimicrobial efficacy. It does not provide a specific "sample size" in terms of number of patient cases or imaging data. Instead, it refers to testing against "mold challenge organism," "gram positive bacteria, gram negative bacteria, yeast and mold challenge organisms."

Sample Size: Not applicable in the context of patient cases or images for this type of in-vitro study. The "sample" would be the wound dressing material itself and the microbiological cultures. Specific numbers of microbial samples or dressing replicates are not provided.
Data Provenance: In-vitro testing. No country of origin is specified for the testing itself, but the manufacturer is based in the UK. The study is prospective in the sense that the testing was conducted specifically for this submission, although it followed a "well-established modified AATCC TM 100 method previously used for the predicate device."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable to the type of study presented. The ground truth for antimicrobial efficacy is established through standardized objective in-vitro microbiological testing methods (modified AATCC TM 100) using known challenge organisms, not through expert consensus or interpretation of patient data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This is not applicable to the type of study presented. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth from human expert interpretations, typically in diagnostic imaging or clinical trials. Here, the ground truth is determined by the results of the specific in-vitro microbiological assay.

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

This is not applicable. The device is a wound dressing, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical wound dressing, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the antimicrobial efficacy claim, the ground truth is established through objective microbiological culture results using a modified AATCC TM 100 method. This method quantifies the reduction or prevention of microbial growth on the dressing.

For the other performance characteristics (Biocompatibility, Absorption, MVTR, Waterproofness, Peel Resistance, Bacterial Barrier, Distribution), the ground truth was established by various standardized test methods (e.g., ISO 10993-1, USP 41-NF36, BS EN 13726 series, ASTM D6282-11, ASTM D4169).

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not a machine learning or AI device. The testing conducted is for verification of physicochemical and antimicrobial properties.

9. How the ground truth for the training set was established

This is not applicable, as there is no training set mentioned or implied for this device.

Summary

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April 5, 2023

Advanced Medical Solutions Limited Kay McGrath Regulatory Affairs Specialist Premier Park, 33 Road One Winsford Industrial Estate Winsford, Cheshire CW7 3RT United Kingdom

Re: K223310

Trade/Device Name: Antimicrobial Silicone PHMB Foam Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: March 6, 2023 Received: March 6, 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 (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

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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 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 (OS) 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 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,

Julie A. Morabito -S

Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223310

Device Name

Antimicrobial Silicone PHMB Foam Wound Dressing

Indications for Use (Describe)

Antimicrobial 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,
· superficial and partial thickness burns,
· dermatologic disorders,
· other wounds inflicted by trauma and,
· as a secondary dressing or cover dressing for packed wounds.

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for Advanced Medical Solutions Ltd. The logo features a stylized blue "A" with a swoosh above the text. The text "Advanced Medical Solutions Ltd" is written in blue font below the "A" symbol.

Advanced Medical Solutions Limited Premier Park, 33 Road One, Winsford Industrial Estate, Winsford, Cheshire, CW7 3RT, UK Tel: +44 (0) 1606 863500 Fax: +44 (0) 1606 863600 Web: www.admedsol.com Registered in England 2666957 VAT No. GB 636 5551 27

K223310

510(k) Summary

Submitted by:	Advanced Medical Solutions LtdPremier Park33 Road OneWinsford Industrial EstateWinsfordCheshireCW7 3RTTel: +44 1606 863500
Contact Person:	Kay McGrath
Date of Summary:	April 04, 2023
Trade Name:	Antimicrobial Silicone PHMB Foam Wound Dressing
Common Name:	Wound Dressing
Classification Name:	Dressing, Wound, Drug
Classification:	Unclassified (Pre-amendment)
Classification Code:	Product code: FRO
Predicate Device(s):	Silicone PHMB Foam Wound Dressing (K190819)

Image /page/3/Picture/5 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 of a circle. The second logo is for BSI, and it features the letters BSI in a circle above the words UKAS MANAGEMENT SYSTEMS 0003.

Certificate No. MD 78010

Page 1 of 5

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K223310

Device Antimicrobial Silicone PHMB Foam Wound Dressing, is a polyurethane foam trilaminate dressing Description: impregnated with Polyhexamethylene Biguanide (PHMB), an agent that protects the dressing from bacterial penetration and colonization. The foam in the dressing has a microporous hydrophilic foam structure that absorbs wound exudate and maintains a moist wound healing environment.

The perforated wound contact layer contains a gentle silicone adhesive that provides secure, nonirritating adhesion and supports non-traumatic 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 (64cm) to 64 in2 (400cm).

Indications for Antimicrobial Silicone PHMB Foam Wound Dressing is indicated for use in the management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, Use: lacerations, superficial and partial thickness burns, dermatologic disorders, other wounds inflicted by trauma and as a secondary dressing or cover dressing for packed wounds.

Image /page/4/Picture/8 description: The image contains two logos. The first logo is for the UK Authorized Economic Operator, and it features the letters "AEO" in bold, black font, followed by the words "UK Authorized Economic Operator" in a smaller font. To the right of the letters is a black circle containing a white outline of the United Kingdom. The second logo is for BSI (British Standards Institution) and UKAS (United Kingdom Accreditation Service). The BSI logo features the letters "bsi" above a heart-shaped symbol, while the UKAS logo features a crown above a checkmark, with the words "UKAS MANAGEMENT SYSTEMS" below. The number "0003" is at the bottom of the UKAS logo.

Page 2 of 5

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Image /page/5/Picture/0 description: The image contains the logo for Advanced Medical Solutions Ltd. The logo features a stylized letter A in blue, with a curved line extending from the top right of the A. The text "Advanced Medical Solutions Ltd" is written in blue below the logo.

K223310

Comparison of Technological Characteristics:

Antimicrobial Silicone PHMB Foam Wound Dressing is a modification of the predicate device to include updated product labelling in support of an antimicrobial product offering.

Antimicrobial Silicone PHMB Foam Wound Dressing has substantially equivalent intended use and performance characteristics, identical design, materials and manufacture process to the predicate device Silicone PHMB Foam Wound Dressing (K190819). Antimicrobial 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. Based on in vitro testing, the PHMB within the dressing is efficacious against gram positive bacteria, gram negative bacteria, yeast and mold. The dressing is semi-occlusive allowing the exchange of gases within the dressing 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. The following table shows the comparison of technological characteristics between the subject and predicate devices.

	Subject(modified device)	Predicate	Similarities andDifferences
Product Name	Antimicrobial SiliconePHMB Foam WoundDressing	Silicone PHMB FoamWound Dressing
Manufacturer	Advanced MedicalSolutions Ltd	Advanced MedicalSolutions Ltd	Identical
510(k)	K223310	K190819	-
Classification	Unclassified(pre-amendment)	Unclassified(pre-amendment)	Identical
Product code	FRO (Dressing,Wound, Drug)	FRO (Dressing,Wound, Drug)	Identical
Indications for use	Antimicrobial SiliconePHMB Foam WoundDressings areindicated for use inthe management ofpost-surgical incisions,pressure sores,venous stasis ulcers,diabetic ulcers, donorsites, abrasions,lacerations, superficialand partial thicknessburns, dermatologicdisorders, otherwounds inflicted bytrauma and,as a secondarydressing or cover	Silicone PHMB FoamWound Dressings areindicated for use inthe management ofpost-surgicalincisions, pressuresores, venous stasisulcers, diabeticulcers, donor sites,abrasions,lacerations, 1st and2nd degree burns,dermatologicdisorders, otherwounds inflicted bytrauma and,as a secondarydressing or cover	Different - Subjectdevice includes anantimicrobial claim

Image /page/5/Picture/7 description: The image shows the text "Page 3 of 5". This indicates that the image is a page from a document, specifically page 3 of a total of 5 pages. The text is written in a clear, bold font, making it easily readable. The purpose of this text is to provide context and indicate the position of the page within the larger document.

Image /page/5/Picture/8 description: The image shows three logos. The first logo is for the UK Authorised Economic Operator, and it features the letters AEO in bold black font, with a graphic of the UK in a circle. The second logo is for BSI, and it features the letters BSI in a circle with a heart-shaped design. The third logo is for UK Management Systems, and it features a checkmark inside of a circle with a crown on top.

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Image /page/6/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 company name "Advanced Medical Solutions Ltd" is written in blue font.

K223310

	dressing for packedwounds.	dressing for packedwounds.
Primary Material	Polyurethane (PU)foam	Polyurethane (PU)foam	Identical
Antimicrobial agent	PHMB(0.8-1.1%w/w)	PHMB(0.8-1.1%w/w)	Identical
Sterilization method(terminal)	Ethylene oxideSAL 10⁻⁶	Ethylene oxideSAL 10⁻⁶	Identical
Biocompatibility	Biocompatible	Biocompatible	Identical
Storage	Store below 25°C(77°F)	Store below 25°C(77°F)	Identical
Range of availablesizes	10.24 in² (64 cm) to 64in² (400 cm)	10.24 in² (64 cm) to64 in² (400 cm)	Identical

Image /page/6/Picture/4 description: The image shows the text "Page 4 of 5". This indicates that the image is a page from a document. The document has at least 5 pages. This is page number 4.

Image /page/6/Picture/5 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 graphic of the United Kingdom inside of a circle. The second logo is for BSI (British Standards Institution), and it features the BSI logo with the UKAS Management Systems logo. The certificate number MD 78010 is printed below the BSI logo.

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Image /page/7/Picture/0 description: The image shows the logo for Advanced Medical Solutions Ltd. The logo features a stylized blue "A" with a curved line extending from the top right. The text "Advanced Medical Solutions Ltd" is written in blue below the logo.

K223310

Performance Testing Summary:

Page 5 of 5

Microbial efficacy performance data submitted in support of this 510(k) includes in-vitro testing against a mold challenge organism. Testing was performed on real time aged predicate device in accordance with the well-established modified AATCC TM 100 method previously used for the predicate device.

No other performance tests were conducted for this submission. All performance data leveraged from the predicate device was submitted as part of the original 510(k) submission of the predicate, Silicone PHMB Foam Wound Dressing (K190819) and includes:

Biocompatibility

ISO 10993-1; Biological evaluation of medical devices USP 41-NF36; <151> Pyrogenic Test

Performance testing

BS EN 13726-1; Test methods for primary wound dressings – aspects of absorbency. BS EN 13726-2; Test methods for primary wound dressings – moisture vapour transmission rate of permeable film dressings. BS EN 13726-3; Test methods for primary wound dressings - waterproofness. ASTM D6282-11; Standard Test Method for 90 Degree Peel Resistance of Adhesives. Bacterial barrier.

Distribution

ASTM D4169 – Standard Practice for Performance Testing of Shipping Containers and Systems

The subject device, Antimicrobial Silicone PHMB Foam Wound Dressing, is manufactured with the exact same materials and processes as the predicate.

Rationale for The modified device, Antimicrobial Silicone PHMB Foam Wound Dressing, is identical to the predicate, Silicone PHMB Foam Wound Dressing (K190819), with regard to technology, materials, Substantial Equivalence: manufacture process, intended use, and target population. The only difference between the predicate and subject device is that the subject device has an antimicrobial claim, this minor modification does not raise any new questions of safety or effectiveness. Therefore, the Antimicrobial Silicone PHMB Foam Wound Dressing, is substantially equivalent to the predicate, Silicone PHMB Foam Wound Dressing (K190819).
Conclusion: Antimicrobial Silicone 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 manufacture and are supplied sterile for single use. Based on the information provided within this 510(k), Advanced Medical Solutions Ltd. concludes that the proposed Antimicrobial Silicone PHMB Foam Wound Dressing is substantially equivalent to the predicate device listed, Silicone PHMB Foam Wound Dressing (K190819).

Image /page/7/Picture/15 description: The image shows two logos side by side. The first logo has the letters "AEO" in bold, followed by a graphic of the UK map inside a circle, and the words "UK Authorised Economic Operator" underneath. The second logo is a square containing two circular logos, one with the letters "bsi" and a heart-shaped design, and the other with a crown, a checkmark, and the words "UKAS MANAGEMENT SYSTEMS" and the number "0003".

Certificate No. MD 78010

Regulation Number and Section

N/A