(357 days)
BIONECT® Hydrogel Spray is indicated for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), wounds including cuts, abrasions, donor sites, and post-operative incisions, irritations of the skin, and first and second degree burns.
BIONECT® Hydrogel is a clear, colorless, aqueous solution that is prepared from sodium hyaluronate and purified water to form a hydrogel dressing. Sodium hyaluronate is a polysaccharide biopolymer that can increase the viscosity of the gel. BIONECT® Hydrogel Spray, since it is a hydrogel dressing, provides a soothing, moist environment that is supportive to wound healing.
This document, K973724, is a 510(k) Premarket Notification for BIONECT® Hydrogel Spray. It describes the device, its intended use, and claims substantial equivalence to a predicate device, BIONECT® Hydrogel.
Here's an analysis of the provided information concerning acceptance criteria, clinical studies, and data provenance:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in the typical sense of a medical device's performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the acceptance for BIONECT® Hydrogel Spray appears to be based on:
- Substantial Equivalence: To the predicate device, BIONECT® Hydrogel. This implies that if the predicate device is considered safe and effective, and the new device is substantially equivalent in function, intended use, and technological characteristics, it will also be considered safe and effective.
- Biocompatibility: Showing that the device is not harmful when in contact with the body.
- Safety in Clinical Use: Demonstrating safety in human subjects for its intended use.
| Acceptance Criteria Category | Stated Performance / Evidence |
|---|---|
| Substantial Equivalence (to BIONECT® Hydrogel) | Claimed for function, intended use, and technological characteristics (occlusion, bioburden level, moist wound healing). |
| Biocompatibility | Performed in vitro and in vivo studies (cytotoxicity, dermal irritation, dermal sensitization) on the bulk solution, in accordance with FDA recommendations (ISO-10993). All tests "support the safe use." |
| Clinical Safety | Clinical experience in approximately 45 patients with various ulcers and surgical wounds in 2 clinical trials (1 controlled), conducted in Europe, "indicates that BIONECT® Hydrogel Spray is safe for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "approximately 45 patients" were included in the clinical trials.
- Data Provenance:
- Country of Origin: "all conducted in Europe."
- Retrospective or Prospective: Not explicitly stated as retrospective or prospective, but clinical trials are generally prospective studies. Given the context of seeking premarket notification, these would typically be designed as prospective studies to gather safety and efficacy data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally relevant for AI/CAD device submissions where expert consensus or adjudication is needed to define "ground truth" for image interpretation or diagnosis.
For a hydrogel wound dressing like BIONECT® Hydrogel Spray, the "ground truth" for safety and effectiveness is established through standard medical assessments of wound healing progress, adverse events, etc., conducted by treating physicians and medical staff. The document does not specify a number of experts or their qualifications for establishing ground truth in the clinical trials, as this is typically inherent in the conduct of clinical investigations by medical professionals.
4. Adjudication Method for the Test Set
Again, adjudication methods like 2+1 or 3+1 are primarily used in AI/CAD studies where there's a need to resolve discrepancies in expert interpretation of data (e.g., medical images).
For a wound dressing study, clinical outcomes are assessed by the treating physicians and investigators. There is no mention of an explicit adjudication method for the clinical trial results in this document. Any disputes or differing opinions on patient outcomes would typically be resolved through standard clinical practice and protocol adherence, rather than a formal expert adjudication panel as seen in AI studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for evaluating human reader performance, especially with or without an AI assist, in interpreting medical images or data. BIONECT® Hydrogel Spray is a wound dressing, not an imaging or diagnostic device. Therefore, no MRMC comparative effectiveness study was done or would be applicable for this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This concept is applicable to AI/CAD algorithms that provide automated analysis. BIONECT® Hydrogel Spray is a physical medical device (a hydrogel dressing), not an algorithm. Therefore, no standalone performance assessment (in the context of an algorithm) was done.
7. The Type of Ground Truth Used
For the clinical trials, the "ground truth" for the device's safety and effectiveness would be based on:
- Clinical Outcomes Data: This includes observations of wound healing progression (e.g., reduction in wound size, epithelization), resolution of skin irritations, absence of infection, and reporting of adverse events. These are assessed by clinicians following established clinical protocols.
- Patient Feedback: (Implicitly) regarding comfort, pain, and other subjective experiences.
8. The Sample Size for the Training Set
There is no mention of a "training set" as this term is specific to machine learning and AI model development. This device is a hydrogel dressing, not an AI product.
9. How the Ground Truth for the Training Set Was Established
Since there is no AI component or "training set," this question is not applicable. The ground truth for the clinical studies (for safety and function) was established through direct clinical observation and assessment by medical professionals in the context of the clinical trials.
N/A