K Number

Device Name

PHMB Antimicrobial Foam Wound Dressing

Manufacturer

Advanced Medical Solutions Ltd.

Date Cleared

2017-07-25

(265 days)

Product Code

FRO

Regulation Number

N/A

Intended Use

PHMB Foam Wound Dressings are indicated for use in the temporary management (<24 hours) of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions , lacerations, 1st and 2nd degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds.

Device 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 .

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K082296

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material properties and antimicrobial efficacy of the wound dressing, with no mention of AI or ML technology.

Therapeutic

Yes
The device is a wound dressing used for the management of various wounds, including post-surgical incisions, pressure sores, and burns, which are conditions requiring therapeutic intervention.

Diagnostic

Explanation: The device, PHMB Foam Wound Dressing, is described as a wound dressing designed for temporary management of various wounds by absorbing exudate and providing a barrier against bacterial penetration. Its function is to protect and manage wounds, not to diagnose medical conditions or diseases.

SaMD (Software as a Medical Device)

The device description clearly states it is a physical wound dressing made of polyurethane foam impregnated with PHMB, which is a hardware component.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes the device as a wound dressing for the temporary management of various types of wounds. This is a topical application for treating the body directly.
Device Description: The description details a physical dressing designed to absorb exudate and provide a barrier to bacteria on the wound surface.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The "in vitro performance data" mentioned refers to testing the dressing's properties (like bacterial effectiveness within the dressing), not diagnosing a condition in a patient.

IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is applied to the body for wound management.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

PHMB Foam Wound Dressings are indicated for use in the temporary management (

Regulation Number and Section

N/A

Summary

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 Ltd
Premier Park
33 Road One
Winsford Industrial Estate
Winsford
Cheshire
CW7 3RT
Tel: +44 1606 863500
Fax: +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.

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 (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 (