(77 days)
Normlyel is indicated for protecting granulating wounds and maintaining a moist wound environment in open wounds such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, and open surgical wounds.
Normlgel® 0.9% Isotonic Saline Gel is a sterile sodium chloride solution in amorphus gel form. Normlgel is composed of water, sodium chloride, sodium hydroxide, xanthan gum, and potassium phosphate. Normigel is indicated for protecting granulating wounds and maintaining a moist wound environment in open wounds such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, and open surgical wounds. Normlgel® 0.9% Isotonic Saline Gel represents a new formulation of our own currently marketed Normlgel Protective Wound Gel product. This new formulation provides a higher viscosity. Normlgel® 0.9% Isotonic Saline Gel is provided in 5 gm and 15 gm volumes in aluminum tubes. The tube nozzle is sealed with an aluminum foil which can be opened by employing a puncturing device integral to the inner surface of the cap. The nozzles are fitted with a poly retaining ring/collar which prevents the aluminum foil from being inadvertently punctured during manufacturing and handling.
The provided text describes a 510(k) submission for a medical device called Normlgel® 0.9% Isotonic Saline Gel. This submission focuses on establishing substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not available in the provided documents. The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often without requiring new clinical trials if the technological characteristics and intended use are similar.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
- Not applicable / Not provided. The submission does not detail specific quantitative "acceptance criteria" for device performance in a clinical setting, nor does it report such performance metrics. The focus is on demonstrating "substantial equivalence" based on materials, formulation, and intended use compared to an existing device.
- The biocompatibility testing mentioned ("in accordance with the ISO 10993 Part I") would have acceptance criteria for biological responses, but these are not explicitly detailed in terms of their thresholds or outcomes.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided for clinical performance. There is no indication of a "test set" in the context of clinical performance data. The device is a gel for wound care, and its substantial equivalence is based on its composition and intended use being similar to a predicate device.
- Biocompatibility testing would involve in-vitro or in-vivo testing with a "sample size" of cells or animals, but these details are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Since there's no clinical "test set" described for performance evaluation, there's no mention of experts establishing a ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical "test set" and thus no adjudication method are described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a medical gel, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to this type of product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. As noted above, this is a medical gel, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for clinical performance. The "ground truth" in a 510(k) for a device like this is primarily the established safety and efficacy of the predicate device (Normlgel® Protective Wound Gel in this case) and the scientific understanding of the ingredients and their function in wound care.
- For biocompatibility, the ground truth would be defined by the ISO 10993 standards and accepted biological responses.
8. The sample size for the training set
- Not applicable. This submission doesn't describe a "training set" in the context of machine learning or clinical trials.
9. How the ground truth for the training set was established
- Not applicable. No training set is described.
Summary of Acceptance/Equivalence Rationale from the Document:
The acceptance of Normlgel® 0.9% Isotonic Saline Gel by the FDA is based on its substantial equivalence to a previously marketed predicate device, Normlgel® Protective Wound Gel. Key points supporting this were:
- Similar intended use: Both are indicated for protecting granulating wounds and maintaining a moist wound environment for various types of open wounds.
- Similar composition: The new formulation is presented as an isotonic saline gel with similar base ingredients (water, sodium chloride, etc.) to the predicate. The primary difference noted is a "higher viscosity."
- Biocompatibility: The device was tested in accordance with ISO 10993 Part I, demonstrating acceptable biocompatibility.
- Safety and Effectiveness: The FDA's 510(k) clearance implies that, based on the provided information, the new device is as safe and effective as the predicate device for its stated indications, subject to certain labeling limitations imposed by the FDA (e.g., no claims for third-degree burns, accelerated healing, long-term dressing, or treatment/cure).
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