(140 days)
lamin®-2 Hydrating Gel is intended to be used for the dressing and management of pressure ulcers (stage I-IV), diabetic ulcers, stasis ulcers, 1st and 2nd degree burns, arterial ulcers, pressure sores, cuts, abrasions, irritations of the skin, and skin conditions associated with peristomal care. The dressing is intended to cover a wound or burn on a patient's skin, provide a moist wound environment and protect against abrasion, friction, desiccation, and external contamination.
lamin®-2 Hydrating Gel acts to provide a moist wound environment and protect the wound. lamin®-2 Hydrating Gel was designed to provide a soothing, moist environment for each application to various types of wounds. lamin®-2 Hydrating Gel Wound Dressing is a low bioburden, preserved preparation of water, glycerin, carbopol (carbomer), prezatide copper acetate and parabens to form a hydrogel dressing.
The provided document is a 510(k) summary for the Iamin-2 Hydrating Gel, a medical device intended to serve as a hydrogel dressing for various wound types. The device is being submitted for substantial equivalence to existing predicate devices.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Strict acceptance criteria and specific performance metrics in the way one might expect for a diagnostic or AI-powered device are not explicitly stated in this 510(k) summary. For a Class II (or unclassified) device like a wound dressing seeking substantial equivalence, the "acceptance criteria" are primarily met by demonstrating that the device has the same technological characteristics and intended use as legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness.
Therefore, the table would look something like this, focusing on the comparison to predicate devices:
| Acceptance Criteria (Implicit for 510(k) Substantial Equivalence for Wound Dressings) | Reported Device Performance (Iamin®-2 Hydrating Gel) |
|---|---|
| Intended Use: Device provides a moist wound environment and protects the wound. | "Iamin®-2 Hydrating Gel acts to provide a moist wound environment and protect the wound." (Directly stated, identical to predicates). |
| Technological Characteristics (e.g., form, absorptive ability, occlusion, conformability, sterility, moist wound healing, appearance): Comparable to predicate devices. | "The technological characteristics of the device such as form, absorptive ability, occlusion, conformability, sterility, moist wound healing and appearance are not different from the predicate devices cited." (Directly stated). |
| Material Composition: Similar to predicate devices, providing a soothing, moist environment. | "Iamin®-2 Hydrating Gel Wound Dressing is a low bioburden, preserved preparation of water, glycerin, carbopol (carbomer), prezatide copper acetate and parabens to form a hydrogel dressing." (Implied to be functionally similar to predicates as it's designed to provide a "soothing, moist environment"). |
| Safety: No new safety concerns raised compared to predicate devices. | Implied by the FDA's substantial equivalence determination for general controls. Restrictions on labeling (e.g., no third-degree burns, no claims of accelerating healing) further define safe use. |
| Effectiveness: Provides a moist environment and protection, not claiming accelerated healing. | "The dressing is intended to cover a wound or burn on a patient's skin, provide a moist wound environment and protect against abrasion, friction, desiccation, and contamination." (Consistent with predicate claims). |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not mention a specific "test set" or clinical study with patient samples in the traditional sense for evaluating the performance of the Iamin®-2 Hydrating Gel itself. This typically means that for devices like simple wound dressings established through precedent, the demonstration of substantial equivalence relies heavily on:
- Comparison of device characteristics: Chemical composition, physical properties, intended use, and technological characteristics are compared against legally marketed predicate devices.
- Existing knowledge and scientific principles: The understanding that hydrogels create a moist wound environment is well-established.
Therefore, there is no information provided on sample size, data provenance (e.g., country of origin), or whether data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable or provided in the context of this 510(k) submission. "Ground truth" as it's typically understood for diagnostic or AI systems (e.g., pathology reports for image analysis) is not relevant for demonstrating substantial equivalence for a wound dressing based on its physical and chemical properties matching predicates.
The "experts" involved are primarily the FDA reviewers who assess the submission based on regulatory guidelines and existing scientific understanding of wound care products.
4. Adjudication Method
This information is not applicable or provided. Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical trials or performance studies where expert reviewers evaluate patient cases against a reference standard. Since no such study is described for the Iamin®-2 Hydrating Gel, there's no adjudication method mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned or relevant for this type of device submission. MRMC studies are used to compare the diagnostic accuracy or effectiveness of different diagnostic methods or technologies, often involving human readers with and without AI assistance. The Iamin®-2 Hydrating Gel is a physical wound dressing, not a diagnostic tool or an AI-assisted system.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
This is not applicable. The device is a physical hydrogel dressing, not an algorithm or an AI system. Therefore, no standalone algorithm performance study was conducted or reported.
7. Type of Ground Truth Used
The concept of "ground truth" (expert consensus, pathology, outcomes data) as it pertains to diagnostic accuracy is not applicable to this 510(k) submission.
For this device, the "truth" is established by:
- Scientific principles: The known benefits of a moist wound environment for healing.
- Regulatory precedent: The characteristics of legally marketed predicate devices that have already been deemed safe and effective for similar indications.
- Material science: The properties of the ingredients to form a hydrogel.
8. Sample Size for the Training Set
This is not applicable. The device is not an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set mentioned for an AI algorithm.
In summary, the provided 510(k) summary for the Iamin®-2 Hydrating Gel focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics, rather than on detailed clinical study data or performance metrics for a novel technology. This is a common approach for unclassified or Class II medical devices that fit well within existing product categories with established safety and effectiveness profiles. The "study" here is primarily the comparison of the device's characteristics and intended use to those of the predicate devices.
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