(88 days)
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.
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 in squared to 64 in squared.
This is a 510(k) premarket notification for a medical device, specifically a PHMB Foam Wound Dressing. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study with acceptance criteria for an AI/algorithm-based diagnostic device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth for an AI device is not applicable to this document.
The document describes the device's in vitro performance against various bacteria and yeast, and biological evaluation, but these are not the type of studies relevant to the detailed AI/algorithm questions.
Here's why each specific point you asked for is not available in the provided text:
- A table of acceptance criteria and the reported device performance: This document describes the performance of the wound dressing in terms of its ability to absorb exudate, maintain a moist environment, and prevent bacterial colonization in vitro. It does not present acceptance criteria for an AI's diagnostic performance (e.g., sensitivity, specificity, AUC).
- Sample sized used for the test set and the data provenance: The document mentions in vitro performance data and animal testing, but not clinical test sets or data provenance in the context of an AI device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant for a wound dressing's in vitro or animal testing.
- Adjudication method for the test set: Not applicable for this type of device submission.
- 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 relates to AI-assisted human reading, which is not applicable here.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
- The type of ground truth used: For this device, the "ground truth" would be established through laboratory testing (e.g., bacterial inhibition, fluid absorption measurements) and biological evaluation for safety, not expert consensus or pathology on images.
- The sample size for the training set: Not applicable as there is no AI training.
- How the ground truth for the training set was established: Not applicable as there is no AI training.
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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
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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
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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 LtdPremier Park33 Road OneWinsford Industrial EstateWinsfordCheshireCW7 3RTTel: +44 1606 863500Fax: +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 (<30 days), conducted in accordance with "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management process" demonstrates that PHMB Foam Wound Dressings meet the requirements of BS EN ISO 10993-1 (Biological Evaluation of Medical Devices) and are safe. | |
| 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 and does not raise different questions of safety or effectiveness. |
Image /page/5/Picture/4 description: The image shows two certification logos. The 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 logo on the right is the UKAS (United Kingdom Accreditation Service) Management Systems logo, which includes a crown above a check mark and the words "UKAS MANAGEMENT SYSTEMS" above the number "003". Below the logos, the text "Certificate No. MD78010" is printed.
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