(347 days)
Advanced Medical Solutions Ltd's Silver Foam Wound Dressings are indicated for moderately to heavily exuding, partial to full thickness wounds, including: pressure ulcers; leg ulcers; diabetic foot ulcers; graft wounds and donor sites; skin tears; first and second-degree burns; surgical wounds; lacerations and abrasions.
(Brand name*) Silver Foam Adhesive and Non-Adhesive Wound Dressings are sterile, extremely absorbent, conformable, and semi-permeable to moisture vapour, and assist in maintaining a moist environment for optimal wound healing. (Brand name*) Silver Foam Adhesive and Non-Adhesive Wound Dressings contain nominally 1% ionic silver (silver sodium hydrogen zirconium phosphate); the action of which protects the dressing from bacterial colonisation, and provides an effective barrier to bacterial penetration. The antimicrobial properties of the dressing are effective for up to 7 days, as demonstrated in vitro, against bacterial and fungal strains known to be detrimental to wound healing, such as; Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans, Streptococcus pyogenes, Staphylococcus epidermidis, MRSA (Methicillin resistant Staphylococcus aureus) MRSE (Methicillin resistant Staphylococcus epidermidis), and VRE (Vancomycin resistant Enterococcus faecium). The antibacterial effect in the (Brand name*) Silver Foam Adhesive and Non-Adhesive Wound Dressings supports the reduction of odour caused by microorganisms absorbed in wound exudate. (Brand name*) Silver Foam Adhesive and Non-Adhesive Wound Dressings may be used with a compression bandage.
This is a 510(k) premarket notification for a medical device (wound dressing), not a study describing AI software. Therefore, the requested information about acceptance criteria, study design, and AI performance metrics is not applicable and cannot be extracted from the provided text.
Specifically:
- No AI component: The device described is a physical wound dressing containing silver, not an AI software or system.
- No clinical study to prove acceptance criteria for AI: The document is a regulatory submission demonstrating substantial equivalence to a predicate device, primarily through comparison of physical characteristics, intended use, and existing in-vitro antimicrobial testing, not a clinical trial evaluating advanced performance metrics for AI.
- No "acceptance criteria" in the context of AI performance: The "acceptance criteria" here refer to regulatory requirements for demonstrating safety and effectiveness of a physical medical device, not performance benchmarks for an AI algorithm.
Therefore, I cannot provide the requested table and information as it pertains to AI performance.
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SECTION 11 510(k) SUMMARY
General Information
This 510(k) is to provide notification of substantial equivalence for Advanced Medical Solutions Ltd's Silver Foam Wound Dressing, which is substantially equivalent to currently marketed devices intended for wound care.
| Submitted by: | Advanced Medical Solutions Ltd.,Road Three,Winsford Industrial Estate,Winsford,Cheshire,CW7 3PD,England |
|---|---|
| Contact: | Mr. John GreenhamRegulatory Affairs Manager |
| Telephone: | 44 (0)1606 545569 |
| Fax: | 44 (0)1606 863600 |
| e-mail: | john.greenham@admedsol.com |
| Date prepared: | 04 August 2004 |
| Classification: | Dressing, wound and burn occlusive (21 CFR 878.4020) |
| Trade name: | Silver Foam Adhesive and Non-Adhesive Wound Dressings |
| Common name: | Topical Wound Dressings |
| Predicate devices: | K022416 Contreet® Foam Dressing, Adhesive and Non-Adhesive |
| Indications for use: | Advanced Medical Solutions Ltd's (Brand name*) SilverFoam Adhesive and Non-Adhesive Wound Dressings areindicated for moderately to heavily exuding, partial to fullthickness wounds, including: pressure ulcersleg ulcers; diabetic foot ulcers; graft wounds and donor sitesskin tears; first and second-degree burns; surgical wounds;lacerations and abrasions. |
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Product
Description:
(Brand name*) Silver Foam Adhesive and Non-Adhesive Wound Dressings are sterile, extremely absorbent, conformable, and semi-permeable to moisture vapour, and assist in maintaining a moist environment for optimal wound healing.
(Brand name*) Silver Foam Adhesive and Non-Adhesive Wound Dressings contain nominally 1% ionic silver (silver sodium hydrogen zirconium phosphate); the action of which protects the dressing from bacterial colonisation, and provides an effective barrier to bacterial penetration. The antimicrobial properties of the dressing are effective for up to 7 days, as demonstrated in vitro, against bacterial and fungal strains known to be detrimental to wound healing, such as; Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans, Streptococcus pyogenes, Staphylococcus epidermidis, MRSA (Methicillin resistant Staphylococcus aureus) MRSE (Methicillin resistant Staphylococcus epidermidis), and VRE (Vancomycin resistant Enterococcus faecium).
The antibacterial effect in the (Brand name*) Silver Foam Adhesive and Non-Adhesive Wound Dressings supports the reduction of odour caused by microorganisms absorbed in wound exudate.
(Brand name*) Silver Foam Adhesive and Non-Adhesive Wound Dressings may be used with a compression bandage.
Statement of technological characteristics of the subject Device compared to the predicate device:
The (Brand name*) Silver Foam Adhesive and Non-Adhesive Wound Dressings are substantially equivalent to Contreet® Foam Adhesive and Non-Adhesive Dressings.
(Brand name*) Silver Foam Adhesive and Non-Adhesive Wound Dressings and the predicate device have the same intended use and have almost identical indications for use (e.q. partial and full thickness wounds, pressure ulcers, donor sites, leg ulcers, diabetic foot ulcers, second degree burns, post-operative wounds and abrasions).
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(Brand name*) Silver Foam Adhesive and Non-Adhesive Wound Dressings and the predicate device consist of an outer moisture vapour permeable hydrophobic membrane and a hydrophilic foam that contains the same percentage of silver. The adhesive variants incorporate an adhesive border. Both devices are provided sterile to the user, for single use, and both devices incorporate silver, to provide an effective barrier to bacterial penetration.
Both devices are biocompatible, exhibit absorbent properties, assist in maintaining a moist environment for optimal wound healing, permit intact removal, have a similar method of affixation, and have the same recommended frequency of dressing changes.
Both devices shave a similar range of product sizes, are sterilised by gamma irradiation, and have similar contraindications.
Although there are some differences between the devices, these differences are minor and raise no new questions of safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a logo with a circular border containing text. Inside the circle are three curved lines that resemble waves or stylized bird wings. The logo is black and white and appears to be of low resolution.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 6 2004
Mr. John E. Greenham Regulatory Affairs Manager Advanced Medical Solutions Ltd. Road Three, Winsford Industrial Estate, Winsford, Cheshire, CW7 3PD U.K.
Re: K032742
Trade/Device Name: Silver Foam Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: June 23, 2004 Received: July 6, 2004
Dear Mr. Greenham:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed four became of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 tist stated in the encrosals) to tegans and the Medical Device Amendments, or to conninered pror to May 20, 1978, the ecordance with the provisions of the Federal Food, Drug, de necs that have been reclasion in avire approval of a premarket approval application (PMA). and Cosmetic Fee (110) market the device, subject to the general controls provisions of the Act. The r ou may, mercrore, mains 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 such additional controls. Existing major regulations affecting your device can Inay oc subject to sublications, 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 I Tease oc advised that I Drivisation that your device complies with other requirements of the Act that I Dr I has intatutes and regulations administered by other Federal agencies. You must or any I cacial butther and eaginements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality Bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. John E. Greenham
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to begin maneting your antial equivalence of your device to a legally prematication: "The PDF miding of casification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your at (301) 594-4659. Also, please note the regulation entitled, Colliact the Office of County of County (21CFR Part 807.97). You may obtain Missuanumg Uy reference to prements on prements on the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
for Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K032742
Advanced Medical Solutions Ltd's Device Name: Silver Foam Wound Dressing
Indications For Use:
Advanced Medical Solutions Ltd's Silver Foam Wound Dressings are indicated for Advanced Medical Solutions Eta 8 Girls + Samel + Samel + Samel
- pressure ulcers .
- leg ulcers .
- diabetic foot ulcers .
- graft wounds and donor sites ●
- skin tears .
- first and second degree burns ●
- surgical wounds .
- lacerations and abrasions. .
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use ----------------------------------------------------------------------------------(21 CFR 807 Subpart C)
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
uriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number_________________________________________________________________________________________________________________________________________________________________
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