(88 days)
No
The description focuses on the material properties and antimicrobial action of the wound dressing, with no mention of AI or ML.
Yes
The device is a wound dressing indicated for the management of various wounds, including post-surgical incisions, pressure sores, and burns, by absorbing exudate and protecting against bacterial penetration, fulfilling a therapeutic role in the wound healing process.
No
This device is a wound dressing designed to protect and manage wounds, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a physical wound dressing made of polyurethane foam impregnated with PHMB, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the management of various types of wounds. This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the physical properties of the dressing (foam structure, absorption) and the antimicrobial properties of PHMB within the dressing to protect it from bacterial colonization. It does not describe any function related to analyzing samples from the human body to provide diagnostic information.
- Performance Studies: The performance studies described are related to the dressing's ability to handle fluid, adhere to skin, and prevent bacterial growth within the dressing. These are performance characteristics of a wound dressing, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing patient samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information about a patient's health status or disease.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to manage and protect wounds on the body, which is a therapeutic intervention.
N/A
Intended Use / Indications for Use
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, 1st and 2nd degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing for packed wounds.
Product codes (comma separated list FDA assigned to the subject device)
FRO
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 for up to 7 days. PHMB Foam dressing, when tested in-vitro has demonstrated to be effective against the following three gram positive bacteria (MRSA, MRSE, VRE), three gram negative bacteria (Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa) and two yeast (Candida albicans, Rhodotorula mucilaginosa) challenge organisms within the dressing. The device is available in Non-border (non-adhesive) and Border (adhesive) versions. The dressing is supplied sterile in a range of sizes between 4 in2 to 64 in2.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 for prolonged contact (
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 3, 2018
Advanced Medical Solutions Ltd. Rose Guang QA/RA Director Premier Park, 33 Road One, Winsford Industrial Estate Winsford, CW7 3RT Gb
Re: K181197
Trade/Device Name: PHMB Foam Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: May 2, 2018 Received: May 7, 2018
Dear Rose Guang:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
for 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
2
Indications for Use
510(k) Number (if known) K181197
Device Name PHMB Foam Wound Dressing
Indications for Use (Describe)
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, 1st and 2nd degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing for packed wounds.
Type of Use (Select one or both, as applicable):
| ☑ 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 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 a blue sans-serif font.
Advanced Medical Solutions Limited Premier Park, 33 Road One Winsford Industrial Estate Cheshire. CW7 3RT. UK
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: | Rose Guang |
| Date of Summary: | 03 August 2018 |
| 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): | PHMB Foam Wound Dressing (K163062) |
| Reference Device(s): | Kendall™ AMD Antimicrobial Wound Dressing (K082296) |
Image /page/3/Picture/4 description: The image shows two certification logos. The first logo on the left is the BSI (British Standards Institution) logo, which features the letters 'bsi' above a heart shape, all enclosed in a circle. The second logo on the right is the UKAS (United Kingdom Accreditation Service) Management Systems logo, which includes a crown above a checkmark, with the text 'UKAS MANAGEMENT SYSTEMS' below it, and the number '003' at the bottom. Below the logos, the text 'Certificate No. MD78010' is printed.
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Image /page/4/Picture/1 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. The text "Advanced Medical Solutions Ltd" is written in blue below the logo.
Advanced Medical Solutions Limited Premier Park, 33 Road One Winsford Industrial Estate Cheshire. CW7 3RT. UK
| 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 for up to 7 days. PHMB Foam dressing, when tested in-vitro has demonstrated to be effective against the following three gram positive bacteria (MRSA, MRSE, VRE), three gram negative bacteria (Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa) and two yeast (Candida albicans, Rhodotorula mucilaginosa) challenge organisms within the dressing. The device is available in Non-border (non-adhesive) and Border (adhesive) versions. The dressing is supplied sterile in a range of sizes between 4 in2 to 64 in2. |
|---|---|
| Indication for Use: | 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, 1st and 2nd degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds. |
| Substantial Equivalence: | PHMB Foam Wound Dressing has substantially equivalent intended use and labeling, identical design, materials, and performance characteristics to the predicate device PHMB Foam Wound Dressing (K163062). |
Image /page/4/Picture/4 description: The image shows two logos side-by-side. The logo on the left is a circle containing a heart shape with the letters "bsi." above it. The logo on the right has a crown above a check mark with the words "UKAS MANAGEMENT SYSTEMS" below it, and the number "003" at the bottom. The text "Certificate No. MD78010" is located below the two logos.
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Image /page/5/Picture/1 description: The image shows the logo for Advanced Medical Solutions Ltd. The logo features a stylized blue letter "A" with a swoosh extending from the top right. The text "Advanced Medical Solutions Ltd" is written in blue below the logo.
Advanced Medical Solutions Limited Premier Park, 33 Road One Winsford Industrial Estate Cheshire. CW7 3RT. UK
| Technological characteristics: | 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 which is efficacious against three gram negative bacteria, three gram positive bacteria, and two yeast microorganisms within the dressing. The dressing is semi-occlusive allowing the exchange of gases such as oxygen and moisture, and has a film that provides a barrier to bacterial penetration through the dressing. The wound contact side of the dressing protects the wound bed from adhering to the dressing. PHMB Foam Wound Dressing is identical 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. |
|---|---|
| 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 for prolonged contact ( |