(154 days)
Under the supervision of a healthcare professional, Silver High Performance Dressing can be used in the management of moderate to heavily exuding chronic and acute wounds. The dressing is indicated for use on the following wounds:
- · Pressure ulcers (partial and full thickness)
- · Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)
- · Diabetic foot ulcers
- · Surgical wounds that heal by primary intent such as dermatological and surgical incisions
- · Surgical wounds left to heal by secondary intention such as dehisced surgical incisions and donor sites
- Traumatic wounds
Silver High Performance Dressing is a sterile dressing comprising of an absorbent non-woven fiber pad or ribbon containing ionic silver, with a reinforcement layer to allow intact application and removal of the dressing. The dressing is soft and conformable to anatomical contours. Silver High Performance Dressing manages exudate in moderate to heavily exuding wounds and helps create a favorable environment for moist wound healing. The highly absorbent dressing absorbs exudate from the wound to form a soft gel that intimately conforms to the wound bed and aids in maintaining a moist wound environment, which is conducive to the wound healing environment and aids autolytic debridement (removal of non-viable tissue). The dressing is designed to minimize the risk of maceration and damage to newly formed tissue. Silver High Performance Dressing can be used under compression. Silver High Performance Dressing contains ionic silver, and effectively manages and suppresses colonization and proliferation of bacteria and yeast within the dressing for up to 7 days. Silver High Performance Dressing , when tested in vitro, has been shown to be effective against the following four gram positive bacteria (Vancomycin- resistant enterococcus (VRE), Streptococcus mutans and Staphylococcus aureus and Methicillin - resistant staphylococcus epidermidis (MRSE)), four gram negative bacteria (Enterobacter cloacae, Klebsiella pneumonia, Serratia marcescens and Escherichia coli (E. coli)), and yeast (Candida albicans) challenge organisms within the dressing. The dressings are supplied sterile (gamma irradiation) in a range of sizes, ranging in area from 28cm² (4.34 in-) to 650cm² (100.75 in4).
The provided document {0-6} is a 510(k) premarket notification for the "Silver High Performance Dressing" by Advanced Medical Solutions Ltd. This document primarily focuses on establishing substantial equivalence to a predicate device (AQUACEL® Ag Hydrofiber Dressing - K080383) rather than detailing clinical study results for novel acceptance criteria of an AI/ML medical device.
Therefore, the document does not contain the information requested regarding acceptance criteria and the study that proves an AI/ML device meets them, specifically:
- No table of acceptance criteria and reported device performance for an AI/ML device.
- No sample size for a test set for an AI/ML device, nor its data provenance.
- No information on experts used for ground truth establishment.
- No adjudication method for a test set.
- No multi-reader multiple-case (MRMC) comparative effectiveness study with human readers.
- No standalone (algorithm only) performance for an AI/ML device.
- No type of ground truth used in the context of an AI/ML device (e.g., expert consensus, pathology, outcomes data).
- No sample size for a training set or how its ground truth was established, as this is not an AI/ML device submission.
The studies described in the document are primarily in vitro and animal studies (porcine model) assessing the physical characteristics (absorbency, wet integrity, tensile strength), antimicrobial efficacy of silver, and biocompatibility/wound healing performance of the dressing itself, in comparison to a predicate device. This is typical for a wound dressing submission, not an AI/ML diagnostic or assistive device.
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Image /page/0/Picture/0 description: The image shows 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.
May 29, 2019
Advanced Medical Solutions Ltd. Amy Turner Senior Regulatory Affairs Associate Premier Park, 33, Winsford Industrial Estate Winsford, Cheshire CW7 3RT United Kingdom
Re: K183645
Trade/Device Name: Silver High Performance Dressing Regulatory Class: Unclassified Product Code: FRO Dated: December 20, 2018 Received: December 26, 2018
Dear Amy Turner:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
David Krause Acting Division Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183645
Device Name Silver High Performance Dressing
Indications for Use (Describe)
Under the supervision of a healthcare professional, Silver High Performance Dressing can be used in the management of moderate to heavily exuding chronic and acute wounds. The dressing is indicated for use on the following wounds:
- · Pressure ulcers (partial and full thickness)
- · Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)
- · Diabetic foot ulcers
- · Surgical wounds that heal by primary intent such as dermatological and surgical incisions
- · Surgical wounds left to heal by secondary intention such as dehisced surgical incisions and donor sites
- Traumatic 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/1 description: The image shows the logo for Advanced Medical Solutions Ltd. The logo features a stylized blue "A" with a swoosh above the text. The text "Advanced Medical Solutions Ltd" is written in a blue sans-serif font and is located below the "A" symbol. The logo is simple and professional.
Advanced Medical Solutions Limited Premier Park, 33 Road One Winsford Industrial Estate Cheshire. CW7 3RT. UK
510(k) Summary
| Submitted by: | Advanced Medical Solutions LtdPremier Park33 Road OneWinsford Industrial EstateWinsfordCheshireCW7 3RTTel: +44 1606 863500Fax: +44 1606 863600 |
|---|---|
| Contact Person: | Amy Turner |
| Date of Summary: | 29 May 2019 |
| Trade Name: | Silver High Performance Dressing |
| Common Name: | Wound Dressing |
| Classification Name: | Dressing, Wound, Drug |
| Classification: | Unclassified (Pre-amendment) |
| Classification Code: | Product code: FRO |
| Predicate Device(s): | AQUACEL® Ag Hydrofiber Dressing (K080383) |
Image /page/3/Picture/5 description: The image shows two certification logos. The logo on the left has a heart shape inside a circle with the letters "bsi." above the heart. The logo on the right has a crown above a check mark with the words "UKAS MANAGEMENT SYSTEMS" below the check mark. The number "003" is at the bottom of the right logo, and the text "Certificate No. MD78010" is below both logos.
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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 curved line extending from the top right, resembling a swoosh. Below the logo, the text "Advanced Medical Solutions Ltd" is written in blue, indicating the company's name.
Advanced Medical Solutions Limited Premier Park, 33 Road One Winsford Industrial Estate Cheshire. CW7 3RT. UK
Device Description: Silver High Performance Dressing is a sterile dressing comprising of an absorbent non-woven fiber pad or ribbon containing ionic silver, with a reinforcement layer to allow intact application and removal of the dressing. The dressing is soft and conformable to anatomical contours. Silver High Performance Dressing manages exudate in moderate to heavily exuding wounds and helps create a favorable environment for moist wound healing. The highly absorbent dressing absorbs exudate from the wound to form a soft gel that intimately conforms to the wound bed and aids in maintaining a moist wound environment, which is conducive to the wound healing environment and aids autolytic debridement (removal of non-viable tissue). The dressing is designed to minimize the risk of maceration and damage to newly formed tissue. Silver High Performance Dressing can be used under compression. Silver High Performance Dressing contains ionic silver, and effectively manages and suppresses colonization and proliferation of bacteria and yeast within the dressing for up to 7 days. Silver High Performance Dressing , when tested in vitro, has been shown to be effective against the following four gram positive bacteria (Vancomycin- resistant enterococcus (VRE), Streptococcus mutans and Staphylococcus aureus and Methicillin - resistant staphylococcus epidermidis (MRSE)), four gram negative bacteria (Enterobacter cloacae, Klebsiella pneumonia, Serratia marcescens and Escherichia coli (E. coli)), and yeast (Candida albicans) challenge organisms within the dressing. The dressings are supplied sterile (gamma irradiation) in a range of sizes, ranging in area from 28cm² (4.34 in-) to 650cm² (100.75 in4). Indications for Use: Under the supervision of a healthcare professional, Silver High Performance Dressing can be used in the management of moderate to heavily exuding chronic and acute wounds. The dressing is indicated for use on the following wounds: Pressure ulcers (partial and full thickness) Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) Diabetic foot ulcers Surgical wounds that heal by primary intent such as dermatological and surgical incisions Surgical wounds left to heal by secondary intention such as dehisced surgical incisions and donor sites
Image /page/4/Picture/5 description: The image contains two 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 is the UKAS (United Kingdom Accreditation Service) Management Systems logo, which includes a crown above a checkmark and the text "UKAS MANAGEMENT SYSTEMS" above the number "003". Below both logos is the text "Certificate No. MD78010".
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K183645
Image /page/5/Picture/1 description: The image shows the logo for Advanced Medical Solutions Ltd. The logo features a stylized blue "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
Traumatic wounds Substantial Silver High Performance Dressing has substantially equivalent intended Equivalence: use, design, materials, labeling, and performance characteristics to the predicate device AQUACEL® Ag Hydrofiber Dressing (K080383). Technological Silver High Performance Dressing is a one piece non-woven dressing characteristics: composed of fibers containing ionic silver, with a reinforcement layer to allow intact application and removal of the dressing. Based on in vitro testing, the silver within the dressing is efficacious against four gram positive bacteria, four gram negative bacteria, and a yeast. The dressing is absorbent, soft and conformable to the wound bed and anatomical contours. Performance Testing Performance data submitted in support of this 510(k) includes in-vitro and animal testing. Summary: Performance testing includes absorbency, wet integrity, lateral wicking, conformability, wet tensile strength and dry tensile strength. Silver High Performance Dressing , when tested in vitro, has been shown to be effective against the following four gram positive bacteria, four gram negative bacteria and one yeast organisms: Vancomycin- resistant enterococcus (VRE) Streptococcus mutans Staphylococcus aureus Methicillin - resistant staphylococcus epidermidis (MRSE) Enterobacter cloacae Klebsiella pneumoniae Serratia marcescens Escherichia coli (E. coli) Candida albicans The results of performance testing demonstrate that Silver High Performance Dressings are substantially equivalent to the predicate, AQUACEL® Ag Hydrofiber Dressing (K080383).
Biocompatibility evaluation, 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 Silver High Performance Dressings meet the requirements of BS EN ISO 10993-1 (Biological Evaluation of Medical Devices) with satisfactory results except for the in vitro cytotoxicity study.
Image /page/5/Picture/5 description: The image contains two logos. The first logo is the BSI (British Standards Institution) logo, which features the letters "bsi." inside of a heart shape, all enclosed in a circle. The second logo is the UKAS (United Kingdom Accreditation Service) Management Systems logo, which includes a crown above a check mark, with the text "UKAS MANAGEMENT SYSTEMS" below it, and the number "003" at the bottom. Below both logos is the text "Certificate No. MD78010".
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Image /page/6/Picture/1 description: The image shows the logo for Advanced Medical Solutions Ltd. The logo consists of a blue stylized letter A inside of a circle with a swoosh extending from the right side of the A. Below the logo is the company name, "Advanced Medical Solutions Ltd," in blue font.
Advanced Medical Solutions Limited Premier Park, 33 Road One Winsford Industrial Estate Cheshire. CW7 3RT. UK
Advanced Medical Solutions Ltd
A pre-clinical GLP study was performed to evaluate the local tissue effects of Silver High Performance Dressing and whether its in vitro cytotoxic effect may delay wound healing following repeated application to excisional full thickness dermal wounds in a porcine model. Tissues were evaluated by macroscopic and histopathological observations until robust tissue response diminished and complete reepithelisation occurred; this study demonstrated that there were no biologically relevant differences between the test subjects (Silver High Performance Dressing, AQUACEL® Ag Hydrofiber Dressing and a Negative Control) in terms of wound healing performance characteristics and local tolerance after wound creation.
- Based on the information provided within this 510(k) submission, Conclusion: Advanced Medical Solutions Ltd. concludes that the proposed Silver High Performance Dressing is substantially equivalent to the predicate device listed, Aquacel Ag Hydrofiber Dressing.
Image /page/6/Picture/6 description: The image shows two certification logos. The first logo is the BSI (British Standards Institution) logo, which features a heart shape with the letters "bsi." inside of it. The second logo is the UKAS (United Kingdom Accreditation Service) Management Systems logo, which features a crown above a check mark. Below the logos is the text "Certificate No. MD78010".
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