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Askina Hydrocolloid and Askina Hydrocolloid/Thin react with a wound exudate to form a soft get which permits dressing removal with minimal damage to newly formed tissue. It may be used for superficial wounds e.g. minor abrasions. It may also be used for the following indications under the supervision of a healthcare professional:

•Dermal Ulcers, including

• Partial & Full Thickness Wounds
• · Pressure Ulcers, Stages I-IV
• · Arterial and Venous Leg Ulcers
• •Burns Second Degree
• •Donor Sites
• As an Aid in the Prevention of Skin Breakdown

In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce Askina Hydrocolloid Thin. They are multi layered dressings consisting of an absorbent hydrocolloid layer. This layer reacts with a wound exudate to form a soft gel which permits the dressing to be removed with minimal damage to newly formed tissue. Askina Hydrocolloid provides a moist wound environment while absorbing excess fluid. The moist environment is supportive to healing and promotes autolytic debridement of necrotic fissue.

The provided document is a 510(k) premarket notification for a medical device (Askina Hydrocolloid/Thin dressings) and does not describe acceptance criteria, a study proving device performance against acceptance criteria, or any of the detailed information requested regarding AI/algorithm performance.

Instead, the document focuses on:

• Substantial Equivalence: Establishing that the Askina Hydrocolloid/Thin dressings are substantially equivalent to a legally marketed predicate device (Duoderm CGF). This is the primary regulatory hurdle for 510(k) submissions, not the demonstration of specific performance metrics against pre-defined acceptance criteria through a study as would be detailed for a novel device or AI algorithm.
• Device Description: General information about the dressing's composition and function.
• Materials Testing: Stating that materials conform to ISO Standard 10993, which relates to biocompatibility, not specific performance outcomes.
• Safety and Effectiveness: A general statement about finished product testing for release specifications (physical testing, visual examination) but without providing quantifiable acceptance criteria or study results.
• Indications for Use: The FDA's approved uses for the device and specific limitations on labeling claims.

Therefore, I cannot extract the requested information from the provided text. The document does not contain details about:

1. Acceptance criteria and reported device performance: No specific performance metrics (e.g., healing rates, infection reduction) or quantitative acceptance criteria are presented. The "acceptance criteria" mentioned are internal quality control procedures which ensure the product conforms to design specifications, not clinical performance metrics.
2. Sample size, data provenance, number of experts, adjudication method for a test set: No clinical or algorithmic test set is described.
3. MRMC comparative effectiveness study: Not mentioned.
4. Standalone (algorithm-only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
5. Type of ground truth: Not applicable.
6. Sample size and ground truth establishment for a training set: Not applicable.

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