(231 days)
ProThelial™ & Orafate Sucralfate Malate Paste forms a protective layer over the oral mucosa by adhering to the mucosal surface which allows it to protect against further irritation and relieve pain. The paste may be used in the management of mouth lesions of all types including aphthous ulcer, stomatitis, mucositis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lesions associated with oral surgery.
ProThelial™ & Orafate Sucralfate Paste is an amorphous hydrogel paste formed by the controlled reaction of sucralfate with a limited quantity of malic acid and calcium carbonate solution. The amorphous hydrogel paste formed by this reaction binds reversibly to wounds and is intended to form a protective film that covers wounds, protects against further irritation and relieves pain. ProThelial™ & Orafate Sucralfate Paste may be administered directly to an accessible oral wound to provide an adherent physical covering of the wound bed. Although prepared by reaction of sucraffate with an acid, the polymerized sucralfate self-buffers to a pH 5.0 - 7.0.
The provided 510(k) summary does not describe acceptance criteria or a study proving the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on shared active ingredients, polymerization mechanism, intended use, and similar technological characteristics.
Therefore, many of the requested sections regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert involvement, and ground truth establishment are not present in this document.
Here's a breakdown of what can be extracted and what is explicitly not mentioned:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The submission focuses on substantial equivalence rather than meeting specific performance criteria demonstrated through a direct performance study with acceptance criteria. The "performance" is implicitly tied to being "as safe, as effective, and performs as well as the predicate devices."
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. No specific test set or clinical study demonstrating performance metrics with a sample size is described. The submission relies on the established safety and efficacy of the active ingredient (sucralfate) in the predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided. There is no mention of a test set with ground truth established by experts.
4. Adjudication Method for the Test Set
This information is not provided. As no test set with ground truth is described, there's no adjudication method mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done (or at least not described in this summary). The submission is not a comparative effectiveness study but a substantial equivalence claim.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a medical paste, not an AI algorithm.
7. The Type of Ground Truth Used
This information is not provided as no specific study requiring a defined ground truth for performance evaluation is described. The "ground truth" for the substantial equivalence claim is the established safety and efficacy profile of sucralfate as an active ingredient in similar products.
8. The Sample Size for the Training Set
Not applicable. This device is a medical paste, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is a medical paste, not a machine learning model, so there is no "training set" or ground truth for it.
Key Information from the Document Regarding "Proof"
The "proof" of the device's suitability for market, according to this 510(k) summary, rests entirely on the concept of substantial equivalence to already approved predicate devices.
- Basis for Substantial Equivalence:
- Identical Active Ingredient: Sucralfate is identified as the "sole active ingredient" and "clinically effective component" in ProThelial™ & Orafate Sucralfate Malate Paste, and it is also the active ingredient in the predicate devices (K043587 Sucralfate HCl Topical Paste and K082856 Carapaste® Oral Wound Dressing).
- Similar Mechanism of Action: All devices require and facilitate the polymerization of sucralfate to form a protective film, and proper operation requires mucoadherence.
- Identical Intended Use: The indications for use are identical for the subject device and the predicate devices, covering a range of oral lesions and aiming to form a protective layer to relieve pain and irritation.
- Similar Technological Characteristics: The table comparing the devices highlights very similar patient groups, areas of use, product type (paste), and presentation (non-sterile).
- Non-Clinical Performance Data: The submission states that "The non-clinical performance data relied on in this submission for a determination of substantial equivalence is the identical nature of clinically effective component of this and the predicate devices." It also mentions "non-clinical tests involve those required by USP national standards to verify the presence sucralfate."
- Conclusion: The manufacturer concludes that "ProThelial™ & Orafate are substantially equivalent to predicate devices K0435897 and K082856" based on these comparisons, asserting that the subject device is "as safe, as effective, and performs as well as the predicate devices."
In summary, this 510(k) summary does not present clinical study data with acceptance criteria for the new device. Instead, it argues that because the new device is fundamentally the same (in active ingredient, mechanism, and intended use) as already approved devices, it can be considered equally safe and effective without new, extensive performance studies.
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