(188 days)
MedTrade Products AQUANOVA Super-Absorbent OTC is indicated for minor burns, superficial cuts, lacerations and abrasions, and minor irritations of the skin.
Under the supervision of a healthcare professional AQUANOVA may be used for wounds such as leg ulcers (Stages I-IV), diabetic ulcers, surgical wounds (postoperative, donor sites, dermatological), burns (first and second degree), and the management of surgical or traumatic wounds which have been left to heal by secondary intention.
AQUANOVA may also be used for the local management of wounds that are prone to bleeding such as wounds that have been surgically or mechanically debrided, donor sites, and traumatic wounds. AQUANOVA can be used in the control of minor bleeding.
Aditionally, AQUANOVA may be used for exudate absorption in oncology wounds (e.g. fungating cutaneous tumours, cutaneous metastases and Kaposi's sarcomas).
MedTrade Products AQUANOVA Super-Absorbent is a mixture of chitosan, chitosan derivatives and structural materials to produce a soft pad woven dressing.
Chitosan is a material consisting of cellulostic polymer, poly-N-acetylglucosamine. A similar chitosan material has been self-affirmed as a GRAS (Generally Recognised As Safe) food ingredient in accordance with 21 CFR s 170.30. The GRAS report refers to safety studies in human beings and several apecies of animals. The studies sited represent research on the safety and use of chitosan, which have been published over a period of decades by scientists from around the world. This large body of scientific literature satisfies the requirement in 21 CFR s 170.30 (a), that a general recognition of safety requires common knowledge about the substance throughout the scientific community. Several bornedical applications of chitosan have already been reported.
Chitosan has many advantages due to its non-toxicity and biodegradability without damaging the environment. It is a biocompatible material that breaks down slowly in to a harmless product, glucosamine that can be absorbed completely by the body. However, no product will be available to break down as with integrity studies have demonstrated that the dressing remains intact for removal from the wound.
Med Trade Products AQUANOVA Super-Absorbent Dressings are provided in sterile single use pouches. Pouches will be provided in a carton with an information leaflet.
The provided document is a 510(k) premarket notification letter for MedTrade Products AQUANOVA Super-Absorbent Dressing. This type of regulatory document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with acceptance criteria and performance data for a new device.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth for a study is not available within this document. The document primarily identifies predicate devices and compares general features.
Here's a breakdown of why the requested information cannot be found in this document:
- Acceptance Criteria and Reported Device Performance: This document does not present specific acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) for the AQUANOVA device itself. Instead, it argues that AQUANOVA is substantially equivalent to existing predicate devices based on its chemistry, physical composition, and intended uses.
- Sample Size and Data Provenance (Test Set): No test set or related performance study is described.
- Number of Experts and Qualifications (Ground Truth for Test Set): Not applicable as there's no test set described.
- Adjudication Method (Test Set): Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
- Standalone Performance (Algorithm Only): Not applicable as this is a physical medical device, not an AI algorithm.
- Type of Ground Truth Used: Not applicable.
- Sample Size for the Training Set: Not applicable as this is not an AI/ML device requiring a training set.
- How Ground Truth for the Training Set was Established: Not applicable.
The document highlights the following in lieu of a detailed study:
- Substantial Equivalence: The primary "study" is the demonstration of substantial equivalence to three predicate devices:
- Comparative Features: A table is provided comparing the AQUANOVA dressing to these predicate devices based on:
- Chemistry: All use chitosan as an absorbent, except Aquacel which uses sodium carboxymethylcellulose.
- Physical Composition: AQUANOVA and the first two predicates are soft absorbent pads; Celox is absorbent granules.
- Indications For Use: Similar indications are highlighted between AQUANOVA and Convatec's Aquacel for both professional and OTC use, and between AQUANOVA OTC and Celox OTC for minor wounds/bleeding.
- Packaging: Paper Pouch for AQUANOVA, Paper/Poly Pouch for Aquacel, Foil Pouch for Celox, Unknown for Clo-sur P.A.D.
- Sterilisation Method: Gamma Irradiation for AQUANOVA, Aquacel, and Celox, Unknown for Clo-sur P.A.D.
- Chitosan Safety: The document references that a similar chitosan material has been self-affirmed as GRAS (Generally Recognized As Safe) food ingredient, citing scientific literature for safety studies in humans and animals. This addresses the biocompatibility and safety aspect rather than performance in a clinical study.
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