(268 days)
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.
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.
This document is a 510(k) Premarket Notification for the ALLEVYN Ag+ dressing, seeking substantial equivalence to a predicate device. It primarily relies on non-clinical performance testing rather than clinical studies. Therefore, many of the requested points regarding acceptance criteria and clinical study details will not be applicable.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with numerical targets and direct "reported device performance" against those targets in the format typically seen with quantitative clinical endpoints. Instead, it lists types of performance bench tests conducted to demonstrate equivalence to the predicate device. The conclusion states that the subject device is "as safe and effective as the predicate device" based on these tests, implying the performance met the standard set by the predicate.
| Performance Characteristic Tested | Reported Device Performance (Implied) | Equivalence to Predicate |
|---|---|---|
| Wound Model | Performance similar to predicate (not explicitly detailed) | Demonstrated |
| Absorbency | Performance similar to predicate (not explicitly detailed) | Demonstrated |
| Moisture Vapor Transmission Rate | Performance similar to predicate (not explicitly detailed) | Demonstrated |
| Adhesiveness | Performance similar to predicate (not explicitly detailed) | Demonstrated |
| Conformability (Extensibility) | Performance similar to predicate (not explicitly detailed) | Demonstrated |
| Waterproofness | Performance similar to predicate (not explicitly detailed) | Demonstrated |
| Bacterial Barrier Performance | Performance similar to predicate (not explicitly detailed) | Demonstrated |
| Antimicrobial Effectiveness | Complied with Modified AATCC TM100-2019 | Demonstrated (as safe and effective as predicate) |
| Biocompatibility | Complied with ISO 10993 and CDRH Guidance | Demonstrated (as safe and effective as predicate) |
| Human Factors and Usability | Complied with CDRH Guidance and ISO 62366-1:2015 and IEC 62366-1 Edition | Demonstrated (no new or different questions of safety/effectiveness) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily refers to "in-vitro testing" and "bench testing." It does not specify sample sizes for these tests, nor does it provide information on data provenance in terms of country of origin or whether it was retrospective or prospective, as these are typically considerations for human clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to the non-clinical bench testing described in this document. Experts are typically involved in establishing ground truth for clinical studies or evaluating images/data from human subjects.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to the non-clinical bench testing described in this document. Adjudication methods are typically used in clinical studies when multiple readers/experts are interpreting results from human subjects.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. The submission explicitly states: "No clinical data is relied upon in this submission to determine substantial equivalence." The device is a wound dressing, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a wound dressing, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical bench testing, the "ground truth" would be established by the validated methodologies and reference standards of the respective in-vitro and laboratory tests (e.g., AATCC TM100-2019 for antimicrobial effectiveness, ISO 10993 for biocompatibility). These standards define what constitutes an acceptable performance or outcome for that specific test.
8. The sample size for the training set
This is not applicable. There is no mention of a "training set" as this device is a physical wound dressing and not an AI/machine learning model.
9. How the ground truth for the training set was established
This is not applicable as no training set was used.
N/A