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510(k) Data Aggregation
(238 days)
DRYODINE CADEXOMER-IODINE GEL
Dryodine™ Antibacterial Gel is indicated for use in the management/cleaning of wet ulcers and wounds such as venous stasis ulcers, pressure sores, diabetic foot ulcers, and traumatic and surgical wounds. Dryodine™ Antibacterial Gel assists to keep lesions soft and pliable.
Dryodine™ Antibacterial Gel consists of 0.1mm diameter biodegradable hydrophilic beads of cadexomer dispersed in a hydrophilic gel comprised of polyethylene glycol and poloxamer and contains 0.9% by weight iodine. The device is presented as a prescription product that requiring a physician to diagnosis the disease state and prescribe the product.
The provided text describes a 510(k) premarket notification for a medical device called Dryodine™ Antibacterial Gel. This type of submission is focused on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies with acceptance criteria as one might see for novel devices or drugs.
Therefore, the response will reflect the information available in the provided document, which primarily focuses on demonstrating substantial equivalence rather than detailed performance study with acceptance criteria.
Acceptance Criteria and Device Performance Study for Dryodine™ Antibacterial Gel
The provided 510(k) Premarket Notification for Dryodine™ Antibacterial Gel focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and conducting a primary performance study against those criteria in the typical sense of a novel device. The "performance testing" referenced is in vitro, and its specific acceptance criteria and results are not detailed in the provided summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Material Composition Equivalence | "Both the proposed Dryodine™ Antibacterial Gel and the predicate device Iodosorb Gel consist of 0.1mm diameter biodegradable hydrophilic beads of cadexomer dispersed in a hydrophilic gel comprised of polyethylene glycol and poloxamer and contain 0.9% by weight iodine." | This demonstrates identical material composition to the predicate device. |
| Intended Use Equivalence | "Dryodine™ Antibacterial Gel is indicated for use in the management/cleaning of wet wounds such as venous stasis ulcers, pressure sores, diabetic foot ulcers, and traumatic and surgical wounds. Dryodine™ Antibacterial Gel assists to keep lesions soft and pliable." This matches the intended use of the predicate device. | The indications for use are identical to those implicitly accepted for the predicate devices. |
| Technological Characteristic Equivalence | "Both the proposed and predicate devices are designed to be highly absorbent while providing a moist wound healing environment." | This confirms shared functional characteristics with the predicate device. |
| Safety and Efficacy Equivalence | "Dryodine™ Antibacterial Gel does not raise any new safety and efficacy concerns when compared to the similar legally marketed devices." | This is a conclusion drawn from the demonstrated equivalence in design, materials, construction, intended use, and technological characteristics. Specific clinical safety or efficacy endpoints are not defined or presented in this document for the device itself. |
| In Vitro Effectiveness | "In vitro effectiveness tests were conducted on Dryodine™ Antibacterial Gel." | No specific acceptance criteria or results from these in vitro tests are provided in the summary. The purpose of these tests was likely to support the claim of substantial equivalence. |
2. Sample Size and Data Provenance for the Test Set:
The provided document does not describe a clinical "test set" in the context of a prospective human study for Dryodine™ Antibacterial Gel. The evaluation is based on a comparison to predicate devices already on the market.
- Sample Size: Not applicable in the context of a traditional performance study.
- Data Provenance: Not applicable, as the equivalence is based on the characteristics of the device and its predicate, rather than human data.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. The ground truth for this submission is established through comparison to legally marketed predicate devices and relevant regulations, not through expert consensus on a test set of cases.
4. Adjudication Method for the Test Set:
Not applicable. There was no test set requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not performed. The submission is for a gel wound dressing, not an imaging or diagnostic device where such a study would be relevant.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This is a physical medical device (antibacterial gel), not an algorithm or AI system.
7. Type of Ground Truth Used:
The "ground truth" for the substantial equivalence determination is the regulatory acceptance and established safety and effectiveness of the identified predicate devices (Iodosorb Gel and Triosyn T40 Antimicrobial Dressing). The ground for this submission is substantial equivalence to legally marketed predicate devices.
8. Sample Size for the Training Set:
Not applicable. The device is a physical product, not an algorithm or AI system that requires a "training set."
9. How Ground Truth for the Training Set Was Established:
Not applicable. There was no training set for this device.
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