(268 days)
Not Found
No
The device description and performance studies focus on the physical and antimicrobial properties of a wound dressing, with no mention of AI or ML technology.
Yes
The device is a wound dressing designed to absorb exudate, reduce microbial colonization, and provide a moist healing environment for various types of wounds, indicating its use in treating a condition.
No
Explanation: The ALLEVYN Ag+ dressing is a wound dressing designed for the management of exuding wounds by absorbing exudate and reducing microbial colonization. Its function is therapeutic (healing and protection), not diagnostic (identifying or characterizing a medical condition).
No
The device is a physical wound dressing containing silver sulfate, not a software program.
Based on the provided text, the ALLEVYN Ag+ dressing is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the management of exuding wounds, such as ulcers, traumatic and surgical wounds, and burns. This is a direct application to the body for therapeutic purposes.
- Device Description: The description details a wound dressing designed to absorb exudate, provide a moist wound healing environment, and reduce microbial colonization on the dressing itself. This is a topical application to the wound.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The ALLEVYN Ag+ dressing does not perform any such analysis of bodily specimens.
The device is a medical device, specifically a wound dressing with antimicrobial properties, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ALLEVYN Ag+ dressing is indicated for the management of exuding wounds such as leg and foot ulcers, pressure ulcers, traumatic and surgical wounds, superficial and partial thickness burns.
ALLEVYN Ag+ dressing can also be used under compression bandaging.
Silver sulfate present in the dressing helps reduce microbial colonization on the dressing.
ALLEVYN Ag+ dressing should be used under the supervision of a qualified healthcare professional.
Product codes
FRO
Device Description
The ALLEVYN Ag+ dressing is a: sterile, single-use, composite, absorbent, antimicrobial wound dressing containing silver sulfate within an absorbent pad.
The primary function of the ALLEVYN Ag+ dressing is to absorb exudate and provide a moist woundhealing environment that is optimal for low to highly exuding wounds. As a secondary function the silver in the polyurethane absorbent foam layer of the ALLEVYN Ag+ dressing helps to reduce or inhibit microbial colonization of the device based on in-vitro testing. The antimicrobial agent (silver), is derived from silver sulfate added to the subject device (ALLEVYN Ag+ dressing).
The ALLEVYN Ag+ dressing range includes the following variants which all have the same intended use / indications for use and technological characteristics, and which differ in dimensions, shape and top film colour only):
- ALLEVYN Ag+ Border (including Sacrum) ● Dressings available in square and sacrum sizes with a printed ('Ag+') pink transparent top film.
- ALLEVYN Ag+ Surgical ● Dressings available in rectangles with a printed ('Ag+') clear transparent top film.
The ALLEVYN Ag+ dressing is a composite antimicrobial dressing consisting of:
- . Top Film: Breathable transparent polyurethane top film (clear or with pink depending on dressing size), printed with 'Ag+'
- Superabsorbent Pad: Non-woven superabsorbent particulate pad with cut pattern of slits for ● flexibility and conformability
- Absorbent polyurethane foam layer containing silver sulfate: Absorbent polyurethane foam ● pad impregnated with a powder mix including silver sulfate
- . Wound Contact Layer (WCL): A perforated WCL made of polyurethane film coated with silicone gel adhesive on wound facing side
- . Release Handles: Plain and perforated transparent films
The ALLEVYN Ag+ dressing is provided individually packed in a sealed pouches made from grid-lacquer paper and polyester film laminate; the sealed pouch forms the sterile barrier for each dressing. Multiple pouched dressings are provided in a carton along with a user manual.
The ALLEVYN Ag+ dressing is provided terminally sterilized via Ethylene Oxide Sterilization to a 100 sterility assurance level.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Any (including Sacrum)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D).
Should be used under the supervision of a qualified 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing for the subject device was conducted according to applicable sections of voluntary standards in order to document the following properties and to support substantial equivalence of the subject device:
Performance Bench Testing
Device claims have been based off the below in-vitro testing.
Physical Testing Including:
- Wound Model, Absorbency, Moisture Vapor Transmission Rate, Adhesiveness, Conformability . (Extensibility), Waterproofness and Bacterial Barrier Performance.
Antimicrobial Effectiveness Testing in compliance with: - · Modified AATCC TM100-2019: Test Method for Antibacterial Finishes on Textile Materials
Biocompatibility Assessment and Testing in compliance with: - · ISO 10993: The Biological Evaluation of Medical Devices Standard, with particular reference to Part 1 (2018): Evaluation and testing within a risk management process
- · CDRH Guidance: "Use of International Standard ISO 10993-1, Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process" issued September 4, 2020.
Human Factors and Usability Testing in compliance with:
- · CDRH Guidance: Applying Human Factors and Usability Engineering to Medical devices and ISO 62366 -1:2015 and IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 18, 2023
Smith & Nephew Medical Limited Hannah Sharp Senior Regulatory Affairs Specialist 101 Hessle Road Hull, Yorkshire HU3 2BN United Kingdom
Re: K223526
Trade/Device Name: ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing Regulatory Class: Unclassified
Product Code: FRO Dated: November 22, 2022 Received: July 21, 2023
Dear Hannah Sharp:
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.
1
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 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.
Yu=chieh Chiu -S
Yu-Chieh Chiu, 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) K223526
Device Name ALLEVYN Ag+ dressing
Indications for Use (Describe)
ALLEVYN Ag+ dressing is indicated for the management of exuding wounds such as leg and foot ulcers, traumatic and surgical wounds, superficial and partial thickness burns.
ALLEVYN Ag+ dressing can also be used under compression bandaging.
Silver sulfate present in the dressing helps reduce microbial colonization on the dressing.
ALLEVYN Ag+ dressing should be used under the supervision of a qualified healthcare professional.
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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3
ALLEVYN® Ag+ dressing Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing Traditional 510(k) Premarket Notification 510(k) Summary: K223526
21 CFR 807.92 (a)(1): Submitter's Information 510(k) Owner Name Smith & Nephew Medical Ltd Address 101 Hessle Road, Hull, HU3 2BN, United Kingdom Establishment 8043484 Registration Number Contact Name Hannah Sharp, Senior Regulatory Affairs Specialist (+44)7740 531714 Telephone Number Date Prepared August 17, 2023 21 CFR 807.92 (a)(2): Device Information Device Name ALLEVYNTM Ag+ dressing (Trade/Proprietary Name) Variants: ALLEVYNTM Ag+ Border (including Sacrum) ● ALLEVYN™ Ag+ Surgical . Common Name Antimicrobial silicone gel adhesive composite hydrocellular foam dressing Review Panel General and Plastic Surgery Regulation Number N/A (Unclassified) Regulatory Class Unclassified (Pre-amendment) Product Code FRO 21 CFR 807.92 (a)(3): 510(k) Number: K100029 Legally marketed device to Device Name: MEPILEX™ Border Ag Dressing which equivalence is claimed
21 CFR 807.92 (a)(4): Device Description
The ALLEVYN Ag+ dressing is a: sterile, single-use, composite, absorbent, antimicrobial wound dressing containing silver sulfate within an absorbent pad.
The primary function of the ALLEVYN Ag+ dressing is to absorb exudate and provide a moist woundhealing environment that is optimal for low to highly exuding wounds. As a secondary function the silver in the polyurethane absorbent foam layer of the ALLEVYN Ag+ dressing helps to reduce or inhibit microbial colonization of the device based on in-vitro testing. The antimicrobial agent (silver), is derived from silver sulfate added to the subject device (ALLEVYN Ag+ dressing).
The ALLEVYN Ag+ dressing range includes the following variants which all have the same intended use / indications for use and technological characteristics, and which differ in dimensions, shape and top film colour only):
- ALLEVYN Ag+ Border (including Sacrum) ● Dressings available in square and sacrum sizes with a printed ('Ag+') pink transparent top film.
- ALLEVYN Ag+ Surgical ● Dressings available in rectangles with a printed ('Ag+') clear transparent top film.
The ALLEVYN Ag+ dressing is a composite antimicrobial dressing consisting of:
- . Top Film: Breathable transparent polyurethane top film (clear or with pink depending on dressing size), printed with 'Ag+'
- Superabsorbent Pad: Non-woven superabsorbent particulate pad with cut pattern of slits for ● flexibility and conformability
4
nith Nephew
ALLEVYN® Ag+ dressing Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing Traditional 510(k) Premarket Notification
- Absorbent polyurethane foam layer containing silver sulfate: Absorbent polyurethane foam ● pad impregnated with a powder mix including silver sulfate
- . Wound Contact Layer (WCL): A perforated WCL made of polyurethane film coated with silicone gel adhesive on wound facing side
- . Release Handles: Plain and perforated transparent films
The ALLEVYN Ag+ dressing is provided individually packed in a sealed pouches made from grid-lacquer paper and polyester film laminate; the sealed pouch forms the sterile barrier for each dressing. Multiple pouched dressings are provided in a carton along with a user manual.
The ALLEVYN Ag+ dressing is provided terminally sterilized via Ethylene Oxide Sterilization to a 100 sterility assurance level.
21 CFR 807.92 (a)(5): Intended Use / Indications for Use
ALLEVYN Ag+ dressing is indicated for the management of exuding wounds such as leg and foot ulcers, pressure ulcers, traumatic and surgical wounds, superficial and partial thickness burns.
ALLEVYN Ag+ dressing can also be used under compression bandaging.
Silver sulfate present in the dressing helps reduce microbial colonization on the dressing.
ALLEVYN Ag+ dressing should be used under the supervision of a qualified healthcare professional.
5
Smith Nephew
ALLEVYN® Ag+ dressing
Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing
Traditional 510(k) Premarket Notification
21 CFR 807.92 (a)(6): Comparison of Technological Characteristics between the Subject and Predicate Devices
The ALLEVYN Ag+ dressing is substantially equivalent to predicate MEPILEX™ BORDER AG DRESSING (K100029) based on:
- The same intended use / indications for use, same principles of operation and similar technological characteristics .
- . Any minor differences in technological characteristics, do not rated with and effectiveness when compared to the predicated ovice, as demonstrated via performance verification testing.
In-vitro bench testing and animal studies are the subject device is as safe and effective as the predicate device.
The following table shows a comparison of the technological characteristics between the subject device.
| Product Characteristic | Subject Device
(ALLEVYN Ag+ Dressing) | Predicate Device
(MEPILEX™ Border Ag Dressing) |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | FRO (Dressing, Wound, Drug) | FRO (Dressing, Wound, Drug) |
| Product Classification | Unclassified (Pre-amendment) | Unclassified (Pre-amendment) |
| | Combination Product (device-drug) | Combination Product (device-drug) |
| Intended Use /
Indications for Use | The management of exuding wounds such as leg and foot ulcers, pressure
ulcers, traumatic and surgical wounds, superficial and partial thickness burns | The management of exuding wounds such as leg and foot ulcers, pressure
ulcers, traumatic and surgical wounds, superficial and partial thickness burns |
| | Can also be used under compression bandaging | Can also be used under compression bandaging |
| | Silver sulfate present in the dressing helps reduce microbial colonization on
the dressing | Silver sulfate present in the dressing helps reduce microbial colonization on
the dressing |
| | ALLEVYN Ag+ dressing should be used under the supervision of a
qualified healthcare professional | |
| User Group | Rx Only. Should be used under the supervision of a qualified healthcare
professional | Rx Only. Should be used under the supervision of a qualified healthcare
professional |
| Dressing Wear Time | Up to 7 days, except in the sacral area where dressings can be left in place
for up to 5 days | Up to 7 days |
| Anatomical sites | Any (including Sacrum) | Any (including Sacrum) |
K223526, Page 3 of 6
6
Smith Nephew
Antimicrobial Agent -
Antimicrobial Agent -
Antimicrobial Agent -
Mechanism of Release
Method of Sterilization
Concentration
Identity
Silver, derived from silver sulfate
Silver, derived from silver sulfate.
Dissolution by contact with aqueous solution (e.g., wound exudate)
1.9 - 3.0 mg/cm²
Ethylene Oxide
| ALLEVYN® Ag+ dressing | K223526, Page 4 of 6 | |
|---|---|---|
| Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing | ||
| Traditional 510(k) Premarket Notification | Materials | |
| • Top Film: Breathable transparent polyurethane top film (clear or with pink | ||
| pigment), printed with 'Ag+' | • Top Film: Breathable transparent polyurethane top film clear or with beige | |
| pigment) | ||
| • Superabsorbent Pad: Non-woven Superabsorbent Particulate (SAP) | ||
| fibrous layer | • Non-woven wicking layer | |
| • Superabsorbent Pad: Non-woven superabsorbent fibrous layer | ||
| (polyacrylate fibres) | ||
| • Non-woven wicking layer | ||
| • Wicking PE/PP non-woven | ||
| • Absorbent polyurethane foam layer containing silver sulfate, and other | ||
| excipients including activated charcoal | • Absorbent polyurethane foam layer containing silver sulfate and | |
| activated charcoal throughout | ||
| • Wound Contact Layer (WCL): Perforated film wound contact layer, | ||
| coated with a silicone gel adhesive on the wound facing side | • Wound Contact Layer (WCL): Safetac™ soft silicone wound contact layer | |
| • Release Handles: Removable protective material | • Release Handles: Removable protective material | |
| Function | Fluid absorbency | Fluid absorbency |
| Function | Fluid retention in the dressing | Fluid retention in the dressing |
| Function | Breathability/evaporation of fluid | Breathability/evaporation of fluid |
| Function | Extensibility and conformability | Extensibility and conformability |
| Function | Bacterial barrier | Bacterial barrier |
| Function | Antimicrobial effect in the dressing | Antimicrobial effect in the dressing |
Silver, derived from silver sulfate
Silver, derived from silver sulfate.
(Information on range of concentration of silver sulfate not publicly
Dissolution by contact with aqueous solution (e.g., wound exudate)
1.2 mg/cm²
available)
Ethylene Oxide
7
Smith Nephew
ALLEVYN® Ag+ dressing Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing Traditional 510(k) Premarket Notification
K223526, Page 5 of 6
| Traditional 510(k) Premarket Notification | |
|---|---|
| Dressing Sizes | |
| ALLEVYN Ag+ Border dressing | |
| (with pink outer film): | |
| 7.5cm x 7.5cm (3" x 3") ---17.5cm x 17.5cm (7" x 7") | MEPILEX Border Ag dressings |
| (with beige outer film): | |
| 7.5cm x 7.5cm (3" x 3") ---10cm x 30cm (4" x 12") | |
| ALLEVYN Ag+ Border Sacrum dressing | |
| (with pink outer film): | |
| 17.2cm x 17.5cm (6.8" x 6.9") &21.6cm x 23cm (8.5" x 9") | MEPILEX Border Sacrum Ag dressings |
| (with beige outer film): | |
| 18cm x 18cm (7.2" x 7.2") &23cm x 23cm (9.2" x 9.2") | |
| ALLEVYN Ag+ Surgical dressing | |
| (with clear outer film): | |
| 10cm x 20cm (4" x 8") ---10cm x 30cm (4" x 11.8") | MEPILEX Border Post-Op Ag dressings |
| (with clear outer film): | |
| 10cm x 15cm (4" x 6") ---10cm x 35cm (4" x 14") |
8
Smith Nepher
ALLEVYN® Ag+ dressing Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing
Traditional 510(k) Premarket Notification
21 CFR 807.92 (b)(1): Brief discussion of nonclinical tests submitted/referenced/ relied on in this submission to determine substantial equivalence
Non-clinical performance testing for the subject device was conducted according to applicable sections of voluntary standards in order to document the following properties and to support substantial equivalence of the subject device:
Performance Bench Testing
Device claims have been based off the below in-vitro testing.
Physical Testing Including:
- Wound Model, Absorbency, Moisture Vapor Transmission Rate, Adhesiveness, Conformability . (Extensibility), Waterproofness and Bacterial Barrier Performance.
Antimicrobial Effectiveness Testing in compliance with:
- · Modified AATCC TM100-2019: Test Method for Antibacterial Finishes on Textile Materials
Biocompatibility Assessment and Testing in compliance with:
- · ISO 10993: The Biological Evaluation of Medical Devices Standard, with particular reference to Part 1 (2018): Evaluation and testing within a risk management process
- · CDRH Guidance: "Use of International Standard ISO 10993-1, Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process" issued September 4, 2020.
Human Factors and Usability Testing in compliance with:
- · CDRH Guidance: Applying Human Factors and Usability Engineering to Medical devices and ISO 62366 -1:2015 and IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION.
Conclusion
Based on the results of the performance testing undertaken, it can be concluded that the subject device (ALLEVYN Ag+ dressing) is as safe and effective as the predicate device is substantially equivalent to MEPILEX™ BORDER AG DRESSING (K100029).
21 CFR 807.92 (b)(2): Brief discussion of clinical tests submitted/referenced/ relied on in this submission to determine substantial equivalence
No clinical data is relied upon in this submission to determine substantial equivalence.
21 CFR 807.92 (b)(3): Conclusions drawn
Based on the comparison and analysis provided within this subject device can be deemed substantially equivalent to the legally marketed predicate device (MEPILEX™ Border Ag Dressing). To the extent that there are differences between the subject device and the predicate, these differences do not raise new or different questions of safety or effectiveness when compared to the predicate device.