(17 days)
Biatain Silicone Ag Foam Dressings are indicated for use in the management of moderately to highly exuding leg ulcers and pressure sores. The dressing can also be used for 2nd degree burns, donor sites, post operative wounds and skin abrasions.
Biatain Silicone Ag Foam Dressings are wound dressings for exuding wounds with delayed healing due to bacteria or where there is a risk of infection. Biatain Ag Foam Dressings consist of a Top film (Printed high moisture-permeable barrier polyurethane (PU) film); a Center part (Soft, absorbing polyurethane (PU) antimicrobial foam (same Biatain Ag foam from Coloplast cleared via K100218) pads adhered to the top film with hot melt acrylic adhesive to avoid delamination when wet); a Border part (Perforated laminate of acrylic adhesive/melt blown polyurethane film/silicone adhesive, where the acrylic adhesive adheres to the top film, and the silicone adhesive is for skin adherence); and a Release liner: 3-part release liner that covers both center and border part. The foam contains silver, which is released upon contact with wound exudate. The dressings are available in different sizes. The dressing is square-shaped with rounded corners. Foam thickness is 3 mm. Biatain Silicone Ag foam dressing is protected with semi-permeable film backings that are waterproof and provide bacterial barriers. The dressings are individually-packed in a pouch: All dressings are sterile and are for single use only.
This 510(k) summary describes a medical device, the Biatain Silicone Ag Foam Dressing, which is a topical wound dressing. The submission aims to demonstrate substantial equivalence to a predicate device rather than providing a study on novel performance claims. As such, the information you've requested regarding acceptance criteria and a study proving those criteria (which are typically associated with AI/ML device performance or new functional claims) is not directly applicable to this type of submission.
Specifically:
- No new performance claims: The document states that "Substantial equivalency is supported by bench testing compared to the predicate device and biocompatibility testing performed on the subject device." There are no explicit acceptance criteria for diagnostic accuracy, sensitivity, specificity, or other performance metrics typically associated with AI/ML systems or novel diagnostic/therapeutic functions.
- Focus on substantial equivalence: The core of this 510(k) is to demonstrate that the new device (Biatain Silicone Ag Foam Dressings) is "substantially equivalent in performance, indications, design and materials" to a legally marketed predicate device (Coloplast's Biatain Ag Adhesive Dressings, cleared under K100218). This means the focus is on showing the new device is as safe and effective as the existing one, not on proving new levels of performance against specific clinical benchmarks.
Therefore, many of the requested categories are not relevant to this specific premarket notification:
- Table of acceptance criteria and reported device performance: Not applicable. The document does not define specific performance acceptance criteria or report performance metrics in the way an AI/ML device or a device with new functional claims would. The "performance" being assessed here is largely about equivalence in material properties and physical characteristics demonstrated through bench testing.
- Sample size for test set and data provenance: No "test set" in the context of clinical performance evaluation (e.g., patient data for diagnostic accuracy) is mentioned. Bench testing data is used.
- Number of experts used to establish ground truth & qualifications: Not applicable. There is no ground truth establishment in the diagnostic sense.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable. This is a wound dressing, not an AI-assisted diagnostic tool.
- Standalone performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for training set: Not applicable. This is not an AI/ML device requiring a training set.
- How ground truth for training set was established: Not applicable.
Summary of relevant information from the provided text:
- Device: Biatain Silicone Ag Foam Dressings
- Claim: Substantial Equivalence to predicate device (Biatain Ag Adhesive Dressings, K100218).
- Support for claim: Bench testing (comparing material properties, design, and performance characteristics to the predicate) and biocompatibility testing.
- Indications for Use: Management of moderately to highly exuding leg ulcers and pressure sores. Also for 2nd degree burns, donor sites, post-operative wounds, and skin abrasions.
To answer your request based on the provided text, the response must reflect that these specific questions are not addressed in this type of 510(k) submission which focuses on substantial equivalence rather than novel performance claims against specific clinical outcomes or diagnostic accuracy.
N/A