(262 days)
Under the supervision of a health care professional, this dressing may be used as a primary wound dressing over:
- abrasions
- ulcers
- trauma wounds
- · surgical wounds
- · first and second degree burns
- donor sites
This product is not designed, sold or intended for use except as indicated.
Agem® Ag Mesh Dressing with Silver is a nonwoven dressing that contains (8mg/gm of dressing) of silver sulfate. The soft, absorbent dressing is supplied sterile and may be custom cut to fit the wound. The porous, non-occlusive dressing conforms to the wound base. The dressing creates an effective barrier and silver ions from the silver sulfate have been demonstrated in vitro to reduce the number of bacteria and yeast in the dressing.
This document describes the premarket notification for the Agem® Ag Mesh Dressing with Silver. It seeks to prove substantial equivalence to a predicate device (3M™ Tegaderm™ Silver Nonwoven Dressing, K053256) rather than establishing independent acceptance criteria and proving the device meets them through a study.
Therefore, many of the requested elements are not directly applicable in the format of a standalone performance study. However, I can extract and infer information relevant to the substantial equivalence claim.
Acceptance Criteria and Reported Device Performance
The core of this submission is to demonstrate that the Agem® Ag Mesh Dressing with Silver is substantially equivalent (SE) to the predicate device in terms of safety and effectiveness. This implies that the proposed device must meet the same performance characteristics as the predicate.
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Agem® Ag Mesh Dressing with Silver) |
|---|---|
| Biocompatibility (Cytotoxicity, irritation, sensitization) | No deleterious effects observed; same biocompatibility performance as predicate. |
| In vitro reduction against microorganisms (Gram-negative, Gram-positive bacteria, yeast, mold) | Evaluated and demonstrated antibacterial effective barrier. |
| Antibacterial duration | 7 days |
| Silver Sulfate concentration | 8 mg/g |
| pH value | Evaluated |
| Rate of moisture | Evaluated |
| Fracture strength | Evaluated |
| Absorbency | Evaluated |
| Minimum Effective Concentration (MEC) | Evaluated |
| Silver release | Evaluated |
| Material (Patient contacting) | Cotton nonwoven |
| Sterilization method | 60Co Irradiation Sterilization |
| Indications for Use | Abrasions, Ulcers, Trauma wounds, Surgical wounds, First and second degree burns, Donor sites |
| Contraindications | Hypersensitivity to silver or cotton; not for surgical sponge or third-degree burns. |
Study Details Based on Substantial Equivalence Claim:
Given this is a 510(k) submission based on substantial equivalence, the "study" proving the device meets acceptance criteria is an analysis demonstrating similarity to a legally marketed predicate device, backed by non-clinical testing.
1. Sample size used for the test set and the data provenance:
* Test Set: The document does not describe a "test set" in the context of a clinical trial or a large-scale performance study. Instead, non-clinical tests were performed on the Agem® Ag Mesh Dressing with Silver. The sample size for each specific non-clinical test (biocompatibility, performance testing) is not explicitly stated.
* Data Provenance: The data is generated internally/by contractors for the submitting company, Shenzhen Yuanxing Nano-Pharma Co., Ltd., based in Shenzhen, China. It is retrospective in the sense that the testing was performed to support a pre-market submission, not as part of an ongoing clinical trial.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* This is not applicable as there is no "ground truth" derived from expert consensus on a clinical test set in this document. The "ground truth" for the non-clinical tests would be established by standard laboratory methods and validated protocols.
3. Adjudication method for the test set:
* Not applicable, as there is no clinical test set requiring expert adjudication.
4. 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:
* Not applicable. This is a medical device (wound dressing) submission, not an AI/software as a medical device (SaMD) submission. No human reader or AI component is involved in its function or evaluation as described here.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This is a medical device (wound dressing) submission, not an AI/SaMD submission.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* The "ground truth" for the non-clinical tests would be based on laboratory standards and validated test procedures (e.g., standard microbiological methods for antibacterial efficacy, ISO standards for biocompatibility).
7. The sample size for the training set:
* Not applicable. This is a medical device (wound dressing) submission, not an AI/SaMD submission, so there is no "training set."
8. How the ground truth for the training set was established:
* Not applicable.
N/A