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K Number
K242406
Device Name
SiOxC Cream
Manufacturer
SiOxMed, LLC
Date Cleared
2025-03-13

(211 days)

Product Code
FRO
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K241660,K052643
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

SiOxC Cream is a skin emulsion indicated for management of dry intact skin by maintaining a moist skin environment. Not to be used on Breached or Compromised skin or open sores.

Device Description

SiOxC Cream is a fragrance free, preservative protected, non-sterile, topical cream intended for management of dry skin. SiOxC Cream supports a moist environment. SiOxC Cream is provided prescription only in various sizes for single patient use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "SiOxC Cream". However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML medical device.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device for a topical cream, primarily through:

  • Comparison of technological characteristics: This involves comparing the composition, principle of operation, preservative, available offerings, reapplication frequency, sterility, and biocompatibility of the SiOxC Cream with a predicate device (EPICERAM® Skin Barrier Emulsion).
  • Non-clinical performance testing: This includes characterization of pH, viscosity, macroscopic and microscopic appearance, and preservative effectiveness testing (USP ) to support shelf-life.
  • Biocompatibility testing: Conducted according to ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-23.
  • Human Repeat Insult Patch Test (HRIPT): This study assessed the potential for dermal irritation and sensitization.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as it pertains to an AI/ML medical device, because the provided text is for a topical cream and lacks any mention of AI/ML or corresponding performance metrics.

The text states that SiOxC Cream is a "skin emulsion indicated for management of dry intact skin by maintaining a moist skin environment." and that it is "unclassified". This is a non-AI/ML product review.

N/A