PHMB Antimicrobial Foam Wound Dressing by Advanced Medical Solutions Ltd.

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 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 in vitro 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 in-vitro 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, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Candida albicans and Rhodotorula mucilaginosa . 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 squared to 64 in squared .

AI/ML Overview

The provided documentation is a 510(k) Summary Statement for a medical device called "PHMB Foam Wound Dressing." It describes the device, its intended use, claims substantial equivalence to a predicate device, and summarizes performance testing. However, it does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML device.

This document describes a conventional wound dressing, not an AI/ML powered device. Therefore, the questions related to AI/ML device performance (like sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance with AI, etc.) are not applicable to this document.

Here's a breakdown of what the document does provide and why it doesn't fit the AI/ML framework:

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

Acceptance Criteria (Implied/General): The document implies acceptance criteria are met by demonstrating substantial equivalence to a predicate device and by providing in-vitro and animal testing results that show the dressing's functional and biological safety properties. These are not explicitly numerical or threshold-based acceptance criteria for an AI model's performance metrics.
Reported Device Performance:
- Barrier to bacterial penetration and prevention of colonization and proliferation within the dressing (<24 hours).
- Effectiveness (in-vitro) against:
  - Three gram-positive bacteria: MRSA, MRSE, VRE
  - Three gram-negative bacteria: Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa
  - Two yeast challenge organisms: Candida albicans, Rhodotorula mucilaginosa
- Total fluid handling.
- Peel adhesion (for adhesive versions only).
- Biological evaluation: Cleared as a (Category A) limited contact device (<24 hours) in accordance with BS EN ISO 10993-1.

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

Not applicable for an AI/ML device. The document refers to in-vitro and animal testing, not a "test set" of data for an algorithm. Details of the sample sizes for these specific lab tests are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable for an AI/ML device. "Ground truth" in this context would refer to the results of the in-vitro and animal studies, which are laboratory measurements, not expert consensus on an AI's output.

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

Not applicable for an AI/ML device.

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 for an AI/ML device.

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

Not applicable for an AI/ML device.

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

Not applicable in the AI/ML sense. The "ground truth" for this device's performance would be the direct results of the microbiological and physical in-vitro tests and animal studies detailed in the summary.

8. The sample size for the training set:

Not applicable for an AI/ML device.

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

Not applicable for an AI/ML device.

In summary: The provided document describes a conventional medical device (wound dressing) and its regulatory submission. It does not provide any information relevant to the performance or validation of an AI/ML powered medical device.

Summary

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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 : +44 (0)1606 863500 Fax : +44 (0)1606 863600 Web : www.admedsol.com Registered in England 2666957 VAT No. GB636 5551 27

510(k) Summary Statement

Submitted by:	Advanced Medical Solutions LtdPremier Park33 Road OneWinsford Industrial EstateWinsfordCheshireCW7 3RTTel: +44 1606 863500Fax: +44 1606 863600
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.

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 in vitro 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 in-vitro 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, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Candida albicans and Rhodotorula mucilaginosa .
	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.

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

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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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Regulation Number and Section

N/A