(112 days)
Silver PU Antibacterial Foam Dressings are indicated for the management of light to moderate exuding partial and full thickness wounds, such as: '. - Decubitus (pressure) ulcers - Diabetic ulcers 0 - Leg ulcers . - Graft and donor sites - Lacerations and abrasions 9 - 1st and 2nd degree burns - Trauma wounds (dermal lesions, trauma injuries or incisions) e - Post-operative surgical wounds The Silver PU Antibacterial Foam Dressings are indicated for external use only
The Silver PU Antibacterial Foam Dressings is available in two variants: Silver PU Antimicrobial Foam Dressing - Non-Adherent variant consists of a low friction waterproof polyurethane film, which also provides a bacterial barrier, laminated to hydrophilic absorbent polyurethane foam with a silver coated nylon mesh wound contact layer. Silver PU Antimicrobial Foam Dressing - Island variant consists of a polyurethane waterproof membrane coated with pressure sensitive acrylic adhesive, which also provides a bacterial barrier, with a centrally located hydrophilic absorbent polyurethane foam with a silver coated nylon mesh wound contact layer. Each Silver PU Antibacterial Foam Dressing contains a minimum of 0.26mg/cm² of elemental silver, the antibacterial action of the silver protects the dressing from bacterial contamination and provides an effective barrier to bacterial penetration. The antibacterial properties of the dressing are effective for up to 7 days, as demonstrated in vitro, against a broad spectrum of microorganisms associated with wound infection, such as Staphylococcus aureus, including MRSA, Staphylococcus epidermidis, including MRSE, Strentococcus pvogenes, Enterococcus faecalis (VRE) and Escherichia coli. Silver Antibacterial Foam Dressings may reduce odour caused by micro-organisms in the wound. Odour reduction results from the antibacterial effect in the dressing. Silver PU Antibacterial Foam Dressings are soft, highly absorbent, conformable and create the ideal environment for moist wound healing. Silver PU Antibacterial Foam Dressings are suitable for use under compression bandaging. Silver PU Antibacterial Foam Dressings are available in various sizes and shapes. The dressings are packaged in individual pouches, then into shelf cartons.
The document describes a 510(k) submission for Silver PU Antibacterial Foam Dressings. The acceptance criteria and supporting studies are presented in the form of performance data demonstrating substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance |
|---|---|---|
| Antimicrobial Properties | Effectiveness against broad-spectrum microorganisms associated with wound infection (e.g., Staphylococcus aureus (including MRSA), Staphylococcus epidermidis (including MRSE), Streptococcus pyogenes, Enterococcus faecalis (VRE), Escherichia coli). | Effective for up to 7 days, as demonstrated in vitro, against a broad spectrum of microorganisms associated with wound infection, including those listed. |
| Material Composition | Minimum elemental silver content | Each dressing contains a minimum of 0.26mg/cm² of elemental silver. |
| Biological Evaluation | Biocompatibility according to BS EN ISO 10993-1 | Demonstrated to be in compliance with the requirements of BS EN ISO 10993-1. |
| Sterilization | Sterilization validation | Performed in compliance with harmonized standards. |
| Physical Performance | Soft, highly absorbent, conformable, creates ideal environment for moist wound healing. Suitable for use under compression bandaging. | Reported as soft, highly absorbent, conformable, and creates the ideal environment for moist wound healing. Suitable for use under compression bandaging. |
| Manufacturing Quality | Manufacturing according to product specification and GMP. Risk analysis per BS EN ISO 14971. | Manufactured according to product specification and under good manufacturing practices (GMP). Risk analysis performed in accordance with BS EN ISO 14971, with manufacturing controls developed and implemented. |
| Safety and Effectiveness | Device meets established specifications prior to release to ensure safety, effectiveness, and correct labeling. | Advanced Medical Solutions Ltd, Silver PU Antibacterial Foam Dressings meets all the established specifications prior to release to ensure the device is safe, effective and correctly labelled for its intended use. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "antimicrobial, animal and bench testing" but does not specify sample sizes for these tests. Data provenance for these tests is not explicitly stated as retrospective or prospective, nor does it mention a country of origin for the data itself, beyond the manufacturing location of the applicant (United Kingdom) and the predicate device manufacturers (unspecified locations, but common for global medical device companies).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This submission focuses on the performance of a wound dressing, not a diagnostic or AI-driven device requiring expert-established ground truth for a test set. The "ground truth" for this type of device lies in objective measurements from laboratory, animal, and bench testing.
4. Adjudication Method for the Test Set:
Not applicable. As above, this type of submission does not involve an adjudication method by human readers for a test set in the same way an AI diagnostic device would.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this submission. This type of study is typically performed for diagnostic devices where human reader performance is a key metric, often with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical wound dressing and does not involve an algorithm or AI. Therefore, a standalone algorithm performance study is irrelevant.
7. The Type of Ground Truth Used:
The ground truth used for this device's evaluation is based on:
- In vitro microbiological testing: To demonstrate antibacterial efficacy against specific pathogens.
- Animal testing: Implies studies on living organisms, likely for biocompatibility, wound healing, or safety aspects. The specifics are not detailed.
- Bench testing: Involves laboratory tests to assess physical properties like absorption, integrity, silver release, and barrier functions.
- Biocompatibility testing: Performed according to BS EN ISO 10993-1 standards, which involves a series of tests to determine the biological response of the device material in contact with the body.
- Sterilization validation: To confirm the effectiveness of the sterilization process.
These types of ground truth are objective, measurable outcomes in a laboratory or controlled environment, rather than expert consensus on diagnostic images or pathology.
8. The Sample Size for the Training Set:
Not applicable. This submission is for a physical medical device (wound dressing), not an AI/machine learning model. Therefore, there is no "training set" in the context of AI.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As stated above, there is no training set for this type of device.
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K091013
page 1 of 2
JUL 30 2009
Section 5 - Traditional 510(k) Notification :- Summary
This Traditional 510(k) notification is to provide substantial equivalence for Advanced Medical Solutions Limited's Silver PU Antibacterial Foam Dressings, which are substantially equivalent to currently marketed devices intended for wound care.
| Submitted by:- | Advanced Medical Solutions LimitedRoad ThreeWinsford Industrial EstateWinsford, CheshireCW7 3PDUnited Kingdom |
|---|---|
| Contact:- | Mrs Claire RyanRegulatory Affairs ManagerTelephone: + 44(0)1606 545569Fax: + 44(0)1606 863600Email: claire.ryan@admedsol.com |
| Date prepared:- | 3rd April 2009 |
| Common Name:- | Silver PU Antibacterial Foam Dressings |
| Trade Names:- | Not yet defined |
| Classification Name:- | Dressing, Wound, Drug |
| Classification:- | Unclassified |
| Product Code:- | FRO |
Legally marketed device(s) for substantial equivalence comparison :-
Allevyn Ag Dressings, 510(k) # K063835, manufactured by Smith & Nephew. Mepilex Ag Dressing, 510(k) # K071354 / K061554, manufactured by Mölnlycke Health Care.
Device Description :-
The Silver PU Antibacterial Foam Dressings is available in two variants:
Silver PU Antimicrobial Foam Dressing - Non-Adherent variant consists of a low friction waterproof polyurethane film, which also provides a bacterial barrier, laminated to hydrophilic absorbent polyurethane foam with a silver coated nylon mesh wound contact layer.
Silver PU Antimicrobial Foam Dressing - Island variant consists of a polyurethane waterproof membrane coated with pressure sensitive acrylic adhesive, which also provides a bacterial barrier, with a centrally located hydrophilic absorbent polyurethane foam with a silver coated nylon mesh wound contact layer.
Each Silver PU Antibacterial Foam Dressing contains a minimum of 0.26mg/cm² of elemental silver, the antibacterial action of the silver protects the dressing from bacterial contamination and provides an effective barrier to bacterial penetration.
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091013
Page 272
The antibacterial properties of the dressing are effective for up to 7 days, as demonstrated in vitro, against a broad spectrum of microorganisms associated with wound infection, such as Staphylococcus aureus, including MRSA, Staphylococcus epidermidis, including MRSE, Strentococcus pvogenes, Enterococcus faecalis (VRE) and Escherichia coli. Silver Antibacterial Foam Dressings may reduce odour caused by micro-organisms in the wound. Odour reduction results from the antibacterial effect in the dressing.
Silver PU Antibacterial Foam Dressings are soft, highly absorbent, conformable and create the ideal environment for moist wound healing.
Silver PU Antibacterial Foam Dressings are suitable for use under compression bandaging.
Silver PU Antibacterial Foam Dressings are available in various sizes and shapes. The dressings are packaged in individual pouches, then into shelf cartons.
Indications for use:
Silver PU Antibacterial Foam Dressings are indicated for the management of light to moderate exuding partial and full thickness wounds, such as decubitus (pressure) ulcers, diabetic ulcers, leg ulcers, graft and donor sites, lacerations and abrasions, 18 and 210 degree burns, trauma (dermal lesions, trauma injuries or incisions) and post-operative surgical wounds. Silver PU Antibacterial Foam Dressings are indicated for external use only.
Manufacturing :-
Silver PU Antibacterial Foam Dressings will be manufactured according to the product specification and under good manufacturing practices (GMP). A risk analysis has been performed in accordance with BS EN ISO 14971 to identify possible failure mode during manufacturing. Manufacturing controls have been developed and implemented to address the identified risk factors based on the criticality of the failure mode.
Advanced Medical Solutions Ltd, Silver PU Antibacterial Foam Dressings meets all the established specifications prior to release to ensure the device is safe, effective and correctly labelled for its intended use.
Testing :-
Performance data for the Silver PU Antibacterial Foam Dressings have been established using antimicrobial, animal and bench testing. The biocompatibility of Advanced Medical Solutions Limited Silver PU Antibacterial Foam Dressings have been demonstrated to be in compliance with the requirements of BS EN ISO 10993-1(Biological Evaluation of Medical Devices). Sterilisation validation has been performed in compliance with harmonised standards.
Statement of Substantial Equivalence:-
The indication for use, performance testing and antimicrobial activity for the Silver PU Antibacterial Foam Dressings are substantially equivalent to the predicate devices; Allevyn Ag Dressings, 510(k) # K063835, manufactured by Smith & Nephew and Mepilex Ag Dressing, 510(k) # K071354 / K061554. manufactured by Moinlycke Health Care. The biocompatibility and performance testing for the Silver PU Antibacterial Foam Dressings have demonstrated that the device is safe and effective for the indications of use.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three legs and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Advanced Medical Solutions Limited % Ms. Claire Ryan Road Three Winsford Industrial Estate Winsford, Cheshire CW7 3PD United Kingdom
JUL 3 0 2009
Re: K091013
Trade/Device Name: Silver PU Antibacterial Foam Dressings Regulatory Class: Unclassified Product Code: FRO Dated: July 17, 2009 Received: July 22, 2009
Dear Ms. Ryan:
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.
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 (reporting of medical device-related 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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Page 2 - Ms. Claire Ryan
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
. Sincerely yours,
incerely yours,
ark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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000020
Indications for Use
510(k) Number (if known): KO91013
Device Name: Silver PU Antibacterial Foam Dressings
Indications for Use:
Silver PU Antibacterial Foam Dressings are indicated for the management of light to moderate exuding partial and full thickness wounds, such as: '.
- Decubitus (pressure) ulcers �
- Diabetic ulcers 0
- Leg ulcers .
- Graft and donor sites �
- Lacerations and abrasions 9
- 1st and 2nd degree burns �
- Trauma wounds (dermal lesions, trauma injuries or incisions) e
- Post-operative surgical wounds
The Silver PU Antibacterial Foam Dressings are indicated for external use only
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Kione for MKM
Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091013
N/A