(17 days)
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No
The device description focuses on the material properties and function of a wound dressing, with no mention of AI or ML.
Yes
The device is a wound dressing designed to manage exuding wounds and provide a moist healing environment, which falls under the definition of a therapeutic device as it treats or alleviates a condition.
No
The device is a wound dressing designed for managing exuding wounds, not for diagnosis. It reacts with wound exudate to form a gel, providing a moist healing environment.
No
The device description clearly indicates it is a physical wound dressing made of Alginate/CarboxymethyIcellulose fibre, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a wound dressing for managing exuding wounds. This is a topical application for wound care, not a diagnostic test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details the physical properties and function of the dressing in contact with wound exudate. It does not describe any process of analyzing biological samples to diagnose a condition.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, genes, etc.)
- Providing diagnostic information about a disease or condition
Therefore, the Sorbcel™ Alginate/CMC Wound Dressings are classified as a wound care device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Innovative Technologies' Sorbcel™ Alginate/CMC Wound Dressings, are highly conformable, sterile, primary wound dressings intended to provide an environment ideally suited for the management of moderate to heavily exuding partial to full thickness wounds.
Product codes
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Device Description
The non-woven Alginate/CarboxymethyIcellulose fibre preparation, which includes various sizes of flat dressings and wound packing, reacts with wound exudate to form an integral, gelatinous, mass providing for a moist healing environment. The gel may easily be lifted away from the wound, reducing the potential for delicate peri-wound tissue damage during dressing changes. Dressings are supplied sterile in single use pouches or blister packs. Product is gamma irradiated in accordance with the Sterilisation Of Health Care Products - Requirements For Validation and Routine Control - Radiation Sterilisation, 3rd Edition (ANSI/AAMI/ ISO11137-1994) and Microbiological Methods for Gamma Sterilisation (AAMI TIR8-1991) for qualification of Method 1 for dosimetric release with a sterility assurance level of 10-6 Biocompatibility testing including cytotoxicity, haemolysis, acute systemic toxicity, skin irritation and sensitisation has been successfully completed per ISO/Tripartite quidelines.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
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