(41 days)
No
The device description and performance studies focus on the material properties and antimicrobial efficacy of a wound dressing, with no mention of AI or ML.
Yes
This device is a dressing used to manage wounds (e.g., pressure ulcers, diabetic foot ulcers), which directly contributes to healing and provides therapy for the patient's condition.
No
This device is an antimicrobial wound dressing used for the management of wounds. Its purpose is to treat or manage existing conditions, not to diagnose them.
No
The device description clearly describes a physical wound dressing made of gelling fiber with silver, not a software application.
Based on the provided text, 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 wounds, applied directly to the wound bed. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a dressing that absorbs exudate, forms a gel, and provides antimicrobial properties within the dressing. It does not describe any process of analyzing biological samples in vitro to diagnose a condition.
- Lack of Diagnostic Language: The text does not mention any diagnostic purpose, analysis of samples, or providing information about a patient's health status based on testing biological materials.
IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is a wound dressing applied externally for treatment.
N/A
Intended Use / Indications for Use
Under the supervision of a healthcare professional, High Performance Antimicrobial Gelling Fiber with Silver can be used in the management of moderate to heavily exuding chronic and acute wounds. The antimicrobial 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
Product codes
FRO
Device Description
High Performance Antimicrobial Gelling Fiber with Silver is an antimicrobial, absorbent gelling fiber dressing comprising of a non-woven pad or ribbon containing ionic silver, with a reinforcement layer to allow intact application and removal of the dressing. The dressing is sterile, soft and conformable to anatomical contours.
High Performance Antimicrobial Gelling Fiber with Silver 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. High Performance Antimicrobial Gelling Fiber with Silver can be used under compression.
High Performance Antimicrobial Gelling Fiber with Silver contains ionic silver, and effectively manages and suppresses colonization and proliferation of micro-organisms within the dressing for up to 7 days.
High Performance Antimicrobial Gelling Fiber with Silver, when tested in vitro, has been shown to be effective against gram positive bacteria, gram negative bacteria, yeast and mold challenge organisms within the dressing.
The dressings are supplied sterile (gamma irradiation) in a range of sizes, ranging in area from 28cm2 (4.34 in2) to 650cm2 (100.75 in2).
High Performance Antimicrobial Gelling Fiber with Silver is a modification of the predicate device to include updated product labelling in support of an antimicrobial product offering.
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
Under the supervision of a healthcare professional
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
Performance data submitted in support of this 510(k) includes in-vitro testing against a mold challenge organism.
No other performance testing or biocompatibility evaluation were conducted for this submission. All performance data was submitted as part of the original 510(k) submission for the predicate, Silver High Performance Dressing (K183645). The subject device, High Performance Antimicrobial Gelling Fiber with Silver, is manufactured with the exact same materials and processes as the predicate.
Key Metrics
Not Found
Predicate Device(s)
Silver High Performance Dressing (K183645)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
May 12, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
Advanced Medical Solutions Ltd. Kay McGrath Regulatory Affairs Manager Premier Park, 33, Winsford Industrial Estate Winsford. Cheshire CW7 3RT United Kingdom
Re: K210974
Trade/Device Name: High Performance Antimicrobial Gelling Fiber with Silver Regulatory Class: Unclassified Product Code: FRO Dated: March 30, 2021 Received: April 1, 2021
Dear Kay McGrath:
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
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.
Lixin Liu. Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210974
Device Name
High Performance Antimicrobial Gelling Fiber with Silver
Indications for Use (Describe)
Under the supervision of a healthcare professional, High Performance Antimicrobial Gelling Fiber with Silver can be used in the management of moderate to heavily exuding chronic and acute wounds. The antimicrobial 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 letter "A" in blue, with a swoosh extending from the top right of the "A". 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
510(k) Summary
| Submitted by: | Advanced Medical Solutions Ltd
Premier Park
33 Road One
Winsford Industrial Estate
Winsford
Cheshire
CW7 3RT
Tel: +44 1606 863500 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kay M'Grath |
| Date of Summary: | May 04, 2021 |
| Trade Name: | High Performance Antimicrobial Gelling Fiber with Silver |
| Common Name: | Wound Dressing |
| Classification Name: | Dressing, Wound, Drug |
| Classification: | Unclassified (Pre-amendment) |
| Classification Code: | Product code: FRO |
| Predicate Device(s): | Silver High Performance Dressing (K183645) |
Image /page/3/Picture/5 description: The image shows two certification logos. The first logo on the left is the BSI (British Standards Institution) logo, which features a heart-shaped symbol 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 number 003 below. The text "Certificate No. MD78010" is printed below the logos.
4
Image /page/4/Picture/1 description: The image shows the logo for Advanced Medical Solutions Ltd. The logo features a stylized blue letter 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 logo.
Advanced Medical Solutions Limited Premier Park, 33 Road One Winsford Industrial Estate Cheshire. CW7 3RT. UK
| Device Description: | High Performance Antimicrobial Gelling Fiber with Silver is an antimicrobial, absorbent gelling fiber dressing comprising of a non- woven pad or ribbon containing ionic silver, with a reinforcement layer to allow intact application and removal of the dressing. The dressing is sterile, soft and conformable to anatomical contours. |
|---|---|
| High Performance Antimicrobial Gelling Fiber with Silver 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. High Performance Antimicrobial Gelling Fiber with Silver can be used under compression. | |
| High Performance Antimicrobial Gelling Fiber with Silver contains ionic silver, and effectively manages and suppresses colonization and proliferation of micro-organisms within the dressing for up to 7 days. | |
| High Performance Antimicrobial Gelling Fiber with Silver, when tested in vitro , has been shown to be effective against gram positive bacteria, gram negative bacteria, yeast and mold challenge organisms within the dressing. | |
| The dressings are supplied sterile (gamma irradiation) in a range of sizes, ranging in area from 28cm² (4.34 in²) to 650cm² (100.75 in²). | |
| High Performance Antimicrobial Gelling Fiber with Silver is a modification of the predicate device to include updated product labelling in support of an antimicrobial product offering. | |
| Indications for Use: | Under the supervision of a healthcare professional, High Performance Antimicrobial Gelling Fiber with Silver can be used in the management of moderate to heavily exuding chronic and acute wounds. The antimicrobial 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 |
Image /page/4/Picture/5 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 check mark and the number "003" below. The text "Certificate No. MD78010" is printed below the logos.
5
Image /page/5/Picture/1 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.
| Surgical wounds that heal by primary intent such as dermatological anc
surgical incisions
Surgical wounds left to heal by secondary intention such as dehisced
surgical incisions and donor sites
| Traumatic wounds | |
|---|---|
| Substantial | |
| Equivalence: | High Performance Antimicrobial Gelling Fiber with Silver has |
| substantially equivalent intended use and performance characteristics, | |
| identical design, materials and manufacture process to the predicate | |
| device Silver High Performance Dressing (K183645). | |
| Technological | |
| characteristics: | High Performance Antimicrobial Gelling Fiber with Silver is a one |
| piece non-woven dressing 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 gram positive bacteria, gram negative bacteria, | |
| yeast and mold. The dressing is absorbent, soft and conformable to | |
| the wound bed and anatomical contours. | |
| Performance Testing | |
| Summary: | Performance data submitted in support of this 510(k) includes in-vitro |
| testing against a mold challenge organism. | |
| No other performance testing or biocompatibility evaluation were | |
| conducted for this submission. All performance data was submitted as | |
| part of the original 510(k) submission for the predicate, Silver High | |
| Performance Dressing (K183645). The subject device, High | |
| Performance Antimicrobial Gelling Fiber with Silver, is manufactured | |
| with the exact same materials and processes as the predicate. | |
| Conclusion: | Based on the information provided within this 510(k) submission, |
| Advanced Medical Solutions Ltd. concludes that the proposed High | |
| Performance Antimicrobial Gelling Fiber with Silver is substantially | |
| equivalent to the predicate device listed, Silver High Performance | |
| Dressing (K183645). |
Image /page/5/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." inside of 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 features a crown above a check mark. Below the logos, the text "Certificate No. MD78010" is visible.