LogoFDA 510(k) Search
K Number
K181074
Device Name
Simple Science Antimicrobial Facial and Eyelid Cleanser
Manufacturer
Simple Science LLC
Date Cleared
2018-08-17

(115 days)

Product Code
FRO
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K160095
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For Over-the-Counter Use: For management of minor skin abrasions, minor lacerations, minor irritations, and intact skin of the face, eyelid and eyelashes.

Device Description

Simple Science Antimicrobial Facial & Eyelid Cleanser is a clear hypotonic solution topically applied to skin, eyelid and wound areas. The subject device is a wound management and cleansing solution that is intended for cleansing, irrigating, and debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings (e.g. gauze). The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. Simple Science Antimicrobial Facial & Eyelid Cleanser contains the following ingredients: Ionized water (99.927%), Sodium chloride (0.06%), Hypochlorous acid (0.011%) and hypochlorite Ion (0.002%). Simple Science Antimicrobial Facial & Eyelid Cleanser will be supplied in 2 oz Glass bottle with spray inserts / caps.

AI/ML Overview

The provided text does not contain information about acceptance criteria for device performance in the context of image analysis, AI models, or diagnostic accuracy. Instead, it is a 510(k) summary for a medical device called "Simple Science Antimicrobial Facial & Eyelid Cleanser."

The acceptance criteria and study information requested in the prompt (e.g., sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details) are relevant to the evaluation of AI/ML-based medical devices or diagnostic tools. The document describes a physical product and its regulatory submission, focusing on:

  • Device Description: A clear hypotonic solution for topical application.
  • Intended Use: For management of minor skin abrasions, minor lacerations, minor irritations, and intact skin of the face, eyelid, and eyelashes.
  • Technological Characteristics: Contains ionized water, sodium chloride, hypochlorous acid, and hypochlorite ion. It's a wound management and cleansing solution.
  • Performance Testing (for this physical product):
    • Biocompatibility studies (ISO 10993): Cytotoxicity, sensitization, ocular studies.
    • Preservative effectiveness: Supported by USP testing against specific bacteria (Proteus mirabilis, Serratia marcescens, MRSA, VRE, Acinetobacter baumannii).
    • Stability study: Demonstrates stability and effectiveness for a 12-month shelf life.

Since the document is about a topical cleanser and not an AI/ML diagnostic device, it does not include the specific details requested in your prompt regarding acceptance criteria, study design, and ground truth for such technologies. Therefore, I cannot construct the table or answer the specific questions about AI/ML performance from this document.

N/A