(147 days)
BioAquaCare™ is an hydrogel wound dressing intended for the management of wounds and provides a moist environment that supports the autolytic debridement of areas of the wound that are necrotic. BioAquaCare™ wound dressing provides an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. It is intended for use with dry, light and moderately exuding partial and full-thickness wounds such as minor burns, superficial injuries, lacerations, cuts, abrasions, incisions and surgical wounds, and skin tears. The dressing also protects against abrasion, desiccation, and external contamination. The moist environment has a cooling effect that may reduce pain.
Under the direction of a health care professional, BioAquaCare™ is indicated for the local management of: (1) chronic wounds such as pressure ulcers, lower extremity ulcers, venous ulcers, arterial ulcers, and diabetic ulcers; and (2) 2nd degree burns and donor sites.
BioAquaCare™ is intended for single use only.
BioAquaCare™ is not intended for treatment of third degree burns.
BioAquaCare™ wound dressing is composed of the following ingredients: 1) PEG-Soy protein; 2) EDTA; 3) sodium phosphate; 4) sodium chloride; 5) water; and 6) Liquid Germall Plus® as a preservative. The preservative contained in BioAquaCare™ aids in providing an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. BioAquaCare™ contains up to 95% water which enables the dressing to provide a moist environment even if the wound bed is dry. BioAquaCare™ will not breakdown during use, so all the BioAquaCare™ components are removed from the wound when the dressings are lifted away. BioAquaCare™ does not include any medicinal substance, animal/human tissue or biologics. BioAquaCare™ is supplied either with or without medical grade gauze for mechanical support, and with a backing which serves to control the rate of water evaporation from the wound dressing upon application to the wounds.
BioAquaCare™ is packaged in either a single use blister packages or in plastic bag. BioAquaCare™ is supplied in a variety of sizes (i.e., 5 cm x 5 cm, 10 cm x 10 cm, 8 cm x 20 cm, 10 cm x 20 cm, or 10 cm x 27 cm). BioAquaCare™ is manufactured under aseptic conditions in a controlled class 100 clean room environment.
The medical device described in the provided text is BioAquaCare™, a hydrogel wound dressing.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for the BioAquaCare™ device. Instead, it describes general performance observations from "various in vitro and animal studies." The primary claim is substantial equivalence to predicate devices, implying that its performance is at least comparable.
| Acceptance Criterion | Reported Device Performance (as stated in document) |
|---|---|
| Biocompatibility | "functioned as intended and the performance observed was as expected" |
| Preservative system effectiveness | "functioned as intended and the performance observed was as expected" |
| Effectiveness in managing different wound types (partial thickness, full thickness, incision, thermal burns, chemical burns, scarification) | "functioned as intended and the performance observed was as expected" |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Various in vitro and animal studies were conducted." However, it does not provide specific sample sizes for these studies. The data provenance (e.g., country of origin, retrospective/prospective) is also not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention using experts to establish ground truth for a test set. This type of device (hydrogel wound dressing) would typically involve laboratory testing and animal models, rather than clinical studies requiring expert adjudication of images or patient data to establish ground truth.
4. Adjudication Method for the Test Set
Since there is no mention of expert involvement in establishing ground truth for a test set, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not mentioned or indicated to have been performed. This type of study is more common for diagnostic imaging devices where human readers interpret results.
6. Standalone Performance Study
The document describes "various in vitro and animal studies" to characterize the device's performance, implying a standalone algorithm/device performance evaluation rather than a human-in-the-loop study. The phrase "BioAquaCare™ functioned as intended and the performance observed was as expected" refers to the device's intrinsic characteristics.
7. Type of Ground Truth Used
The ground truth for the performance studies was likely established through laboratory measurements and direct observation of biological responses in animal models. For example, biocompatibility would be assessed using established assays, and wound healing effectiveness would be measured by physiological parameters and visual assessment in animal subjects. The document does not explicitly state "expert consensus," "pathology," or "outcomes data" in the context of ground truth for these studies, but rather focuses on characterizing the device's function.
8. Sample Size for the Training Set
The document does not mention a training set sample size. This is because the device is not an AI/ML algorithm that requires training data. It is a physical medical device (a wound dressing).
9. How the Ground Truth for the Training Set Was Established
As the device is not an AI/ML algorithm, there is no training set and therefore no ground truth established for a training set.
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